Recipient: OptoviIe, Inc..
Product: RTVue Optical Coherence Tomography (OCT) with the Normative Database (NDB)
Our inspection revealed your device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C.360(k)
The FDA acknowledges your voluntary action to correct software versions 3.5 and higher that have been distributed to customer by issuing a “Roll Back” software update. This software update is designed to remove the NDB feature and bring your device into compliance. In addition, we acknowledge the receipt of your responses to the list of FDA-483 observations and that you have promised to correct those observations. At this time, your corrective actions are on going and the adequacies of them cannot be fully reviewed and evaluated.
In addition, FDA noted nonconformance with regards to section 501(h) of the Act, 21 U.S.C. 351(h), due to deficiencies of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 C.F.R. Part at 21 C.F.R. Part 820. These deviations include, but are not limited to, the following:
1. Failure to validate the device software for the RTVue OCT with NDB, software versions 3.5 and 4.0 as required by 21 CFR 820.30(g). Specifically:
a. Software 3.5 Version C, was tested between (b)(4). The test result shows a failure with sequence (b)(4). The failure was identified as (b)(4), unreasonable video baseline, known “bug”.
b. Verification and Validation for Version D was approved on (b)(4) to address the test result identified from the testing of software Version C. Verification and Validation testing was performed on software 3.5 Version D, on (b)(4). The report identifies a “Remaining Defect List” and Number (b)(4) is identified as “Critical”, “Spectrometer Motor Error!” This software version was released on (b)(4) without addressing defect number (b)(4) and without supporting documentation software defect number (b)(4) was corrected.
c. Verification and Validation test results/raw data for software 4.0, Version B, were performed on (b)(4) and (b)(4). Sections of the test data were not performed, unsigned, and/or missing as follows:
I. Section 16 – Cornea Module, not performed.
II. Section 11 – Gridline Examine and Analyze, not performed.
III. Section 10.2 – Verify (b)(4) new function, unsigned and undated.
IV. Section 15 – Combined Progression of (b)(4) and (b)(4) scans, a test sequence was not performed.
V. Unidentified Section, raw test data missing. This test section is signed-off by an employee, with a completion date of (b)(4).
d. Electronic sign-off copy of the Verification and Validation Report for software 4.0, Version B. found the following:
I. Section 16 – all sequence is entered as pass without supporting data to demonstrate the test was performed.
II. Section 11 – all sequence entered as pass without supporting data to demonstrate the test was performed.
III. Section 10.2 – contains an electronic signature of an employee, dated (b)(4)
IV. Section 15 – all sequence entered as pass without supporting data to demonstrate the test was performed.
V. Section 3.1 – Verify Calibration Data is entered as being completed on (b)(4) There is no supporting data to demonstrate sequence testing was performed. However, the last sequence test page of this test section is identical to a test performed by an employee on (b)(4), not (b)(4) as entered into the firm’s electronic sign-off copy.
e. Verification and Validation report for software version 2.0 is not available for review. According to your employee, once the results are entered into your electronic report, the raw tests data are discarded. Therefore, you have no evidence the sequence testing was performed.
3. Failure to implement compliant handling procedures in reviewing and evaluating customer reports of device failures as required by 21 CFR 820.198(a). Specially, in-house servicing records contain events of reported device failures that were not entered and/or handled as product complaints.
a. An electronic file titled, (b)(4) revealed service dates ranging from (b)(4). This spreadsheet identify the date of service, unit model, serial number, consumer contact information, subject matter, the fix, the service date, and close date. In the review of the electronic record, the types of problems entered are as follows:
I. Cannot tum on SLD, RTVue 100 with software version 18.104.22.168. The correction was not identified and the source of the problem is identified as the scanner.
II. Segmentation failed on NHH4, RTVue 100 with software version 3.5.25. The correction is identified as “application” and the source of the problem was identified as “algorithm error”.
III. Error, spectrometer signal auto, RTVue 100 with software 3.6.12. The correct is identified as “other” and the source of the problem is “other”.
IV. Spectrometer failed, RTVue 100 with software version 22.214.171.124. The correction is identified a “part replacement” and the source of the problem is the spectrometer.
V. Spectrometer failed, RTVue 100 with software version 126.96.36.199. The correction is identified as “part replacement” and the source of the problem is the spectrometer.
5. Failure to establish Servicing procedures as required by 21 CFR 820.00(a). Specially, your service manual does not address issues related to software failures.
FDA office: San Francisco District Office