(89 days)
The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence by semi-quantitative analysis of volatile compounds released into the headspace above a high vaginal swab. The OMA™-BV is indicated for use as an adjunct for the diagnosis of Bacterial vaginosis (BV). The device may be used together with other clinical and patient information when diagnosing BV including pH, vaginal discharge characteristics, amine odor and clue cells or gram stain procedures that are currently commonly used to diagnose infection.
The OMA™-BV uses "electronic nose" technology for the detection of volatile compounds released from microorganisms in human specimens. The principle is based on the release of volatile compounds from bacteria into the headspace [the volume above the High Vaginal Swab (HVS) samples] of clinical samples. The volatile compounds are detected by an array of gas sensors based on patented conducting polymer technology.
Acceptance Criteria and Study for Osmetech Microbial Analyser™ - Bacterial Vaginosis (OMA™-BV)
The Osmetech Microbial Analyser™ - Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use as an adjunct for the diagnosis of Bacterial Vaginosis (BV).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% agreement"). Instead, it reports the observed performance in comparison to established clinical methods. The implicit acceptance is based on demonstrating comparable or better agreement than existing comparisons between those clinical methods themselves.
| Acceptance Criteria (Implicit) | Reported Device Performance (OMA™-BV) |
|---|---|
| Percent agreement between Amsel criteria and OMA™-BV should be comparable to existing diagnostics. | 82.0% (95%CI: 78.9% to 85.0%) agreement with Amsel criteria. |
| Percent agreement between Nugent-positive and OMA™-BV should be comparable to existing diagnostics. | 82.0% (95%CI: 76.0% to 87.1%) agreement with Nugent-positive. |
| Percent agreement between Nugent-negative and OMA™-BV should be comparable to existing diagnostics. | 88.9% (95%CI: 85.0% to 92.1%) agreement with Nugent-negative. |
| Percent agreement between clinical diagnosis and OMA™-BV should be comparable to existing diagnostics. | 75.2% (95%CI: 71.7% to 78.6%) agreement with clinical diagnosis. |
| Inter-site reproducibility (kappa statistic) should demonstrate good agreement. | 0.7688 (good inter-site reproducibility). |
| Inter-run reproducibility (repeatability) (kappa statistic) should demonstrate good agreement. | 0.7464 (good inter-run reproducibility). |
| Interference from common vaginal substances should be minimal or well-understood. | One vaginal douche product interfered (label updated to advise against use 48 hours prior). Blood was a confounding factor (warning included in label). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number for the entire test set. The percentages reported are based on a "multi-center clinical trial of subjects with suspected BV."
- Data Provenance: Prospective, multi-center clinical trial conducted in the U.S. and the U.K.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience). However, it references established clinical procedures for BV diagnosis:
- Amsel criteria
- Nugent scoring system (Gram stain procedures)
- Clinical diagnosis (presumably by clinicians/physicians)
This implies that the "ground truth" was established by multiple clinical professionals utilizing these standard diagnostic methods. Their specific qualifications are not detailed beyond "clinicians" for "clinical diagnosis" and presumably laboratory personnel and clinicians for Nugent scoring and Amsel criteria.
4. Adjudication Method for the Test Set
The document does not specify a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the ground truth. It states that the OMA™-BV was compared to "the combination of three clinical procedures commonly used to diagnose BV (the Nugent scoring system, Amsel criteria, and clinical diagnosis)." This suggests that each of these methods independently contributed to the comparative dataset, but the process for combining or adjudicating their results to form a single "ground truth" for each patient is not detailed. It relies on the existing clinical consensus of these combined methods lacking a single "gold standard."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study compared the OMA™-BV device performance to established clinical procedures rather than directly comparing human readers with and without AI assistance.
- Effect Size: Not applicable, as an MRMC study was not described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described clinical trial evaluated the standalone performance of the OMA™-BV device. The device generated its results independently, which were then compared against the results from the established clinical diagnostic methods. The device is intended as an adjunct, meaning it works with human clinicians, but the performance data presented is the device's direct agreement with the clinical standards.
7. The Type of Ground Truth Used
The type of ground truth used was a composite clinical diagnosis/expert consensus, based on established clinical procedures for BV diagnosis. Specifically, it was determined by the "combination of three clinical procedures commonly used to diagnose BV (the Nugent scoring system, Amsel criteria, and clinical diagnosis)." The document explicitly states, "Since there is no "gold standard" for diagnosis of BV, agreement between current clinical procedures and the OMA™-BV device results was used to compare BV diagnostic methods."
8. The Sample Size for the Training Set
The document does not specify a separate sample size for a training set. The clinical trial data reported appears to be the primary performance evaluation. While "the detection threshold of the BV device has been set to detect levels of volatile metabolites found in specimens associated with BV, as demonstrated in a multi-center clinical trial," this might imply some forms of internal calibration or development against a dataset, but a distinct "training set" in the context of machine learning model development (as might be expected for an AI device today) is not provided.
9. How the Ground Truth for the Training Set Was Established
As a separate training set is not explicitly mentioned, the method for establishing its ground truth is also not detailed. Any internal development or calibration would have presumably relied on similar clinical diagnostic methods (Nugent, Amsel, clinical diagnosis) to determine the "levels of volatile metabolites found in specimens associated with BV."
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510(k) Premarket Notification The Osmetech Microbial Analyser™ - Bacterial Vaginosis
510(K) SUMMARY
1023677
| SUBMITTED BY: | Osmetech plcElectra HouseElectra WayCrewe, CW1 6WZUnited Kingdom |
|---|---|
| JAN 2 9 2003 | |
| CONTACT NAME: | Andrew Tummon, Healthcare Project Manager |
| DATE PREPARED: | January 23, 2003 |
| DEVICE TRADE NAME: | Osmetech Microbial Analyser™- BacterialVaginosis (OMATM-BV) |
| COMMON NAME: | Microorganism Differentiation and IdentificationDevice |
| CLASSIFICATION NAMEAND PRODUCT CODE: | 21 CFR 866.2660, Microscopic Differentiation andIdentification, LIB or LRH |
| DEVICE CLASSIFICATION: | Class I |
| DEVICE PANEL: | Microbiology Branch |
| PREDICATE DEVICE: | Osmetech Microbial Analyser™ - Urinary TractInfection (OMATM-UTI, Osmetech plc, K011043,21 CFR 866.2660) |
DEVICE DESCRIPTION:
The OMA™-BV uses "electronic nose" technology for the detection of volatile compounds released from microorganisms in human specimens. The principle is based on the release of volatile compounds from bacteria into the headspace [the volume above the High Vaginal Swab (HVS) samples] of clinical samples. The volatile compounds are detected by an array of gas sensors based on patented conducting polymer technology.
STATEMENT OF INTENDED USE:
The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence by semiquantitative analysis of volatile compounds released into the headspace above a high vaginal swab. The OMA™-BV is indicated for use as an adjunct for the diagnosis of Bacterial vaginosis (BV). The device may be used together with other clinical and patient information when diagnosing BV including pH, vaginal discharge characteristics, amine odor and clue cells or gram stain procedures that are currently commonly used to diagnose infection.
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SUBSTANTIAL EQUIVALENCE COMPARISON:
The technology used for the OMA™-BV in the detection of BV relies on the same principles and device design as that of the OMA™-UTI (K011043):
- (1) The OMA™-BV and the OMA™-UTI both provide a negative or positive result for the condition under study (BV or UTI);
- (2) The OMA™-BV and OMA™-UTI devices utilize the same technology to measure the same analytes, albeit in different types of sample media: and
- (3) No new issues of safety or effectiveness are raised by the difference in intended use between the OMA™-BV and the predicate. The detection threshold of the BV device has been set to detect levels of volatile metabolites found in specimens associated with BV, as demonstrated in a multi-center clinical trial of subjects with suspected BV.
INTENDED USE OF THE OMA™-BV AND PREDICATE DEVICES:
The intended use of the OMA™-BV and the predicate device (OMA™-UTI) are essentially the same in that they are both automated in vitro diagnostic devices that indirectly measure bacterial presence by qualitative analysis of volatile compounds released into the headspace above the clinical sample.
The main difference in intended use between the OMA™-BV and the predicate is in the nature of the clinical samples being analyzed. To ensure that this change to detection of BV does not impact on device safety or effectiveness, a multi-center clinical trial was conducted in the U.S. and the U.K. Since there is no "gold standard" for diagnosis of BV , agreement between current clinical procedures and the OMA™-BV device results was used to compare BV diagnostic methods.
TECHNOLOGICAL CHARACTERISTICS OF THE OMA™-BV AND PREDICATE DEVICES:
The OMATM-BV and the OMA™-UTI utilize identical technology.
CLINICAL PERFORMANCE DATA
A multi-center clinical trial was conducted to compare the performance and results of the OMA™-BV to the combination of three clinical procedures commonly used to diagnose BV (the Nugent scoring system, Amsel criteria, and clinical diagnosis) in a statistically designed study.
Results of this clinical trial showed that the percent agreement between Amsel and OMA™-BV was 82.0% (95%CI: 78.9% to 85.0%), the percent agreement between Nugent-positive and OMA™-BV was 82.0% with 95% CI: (76.0%: 87.1%), the percent agreement between Nugent-negative and OMA™-BV was 88.9% with 95% CI: (85.0%:
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92.1%), and the percent agreement between clinical diagnosis and OMA™-BV was 75.2% (95%CI: 71.7% to 78.6%).
Reproducibility
As part of the clinical laboratory study in support of this 510(k) premarket notification, two reproducibility studies were included to test for the Inter-site and Inter-run reproducibility (repeatability). The inter-site reproducibility study demonstrated good inter-site reproducibility, with a kappa statistic of 0.7688. The inter-run reproducibility (repeatability) study also demonstrated good inter-run reproducibility, with a kappa statistic of 0.7464.
Interference Studies
Data on interfering substances was obtained from two studies: bench testing and the pivotal clinical study. Bench testing revealed that only one vaginal douche product tested (in quantities equal to that of the average total patient sample) was found to interfere with the OMATM-BV result. No other substances were found to interfere with the OMATM-BV result. Therefore, vaginal douches should not be used 48 hours prior to sample collection for OMA™-BV analysis to ensure a representative microbial flora, as per the vaginal douche label and the OMA™-BV label.
In the pivotal clinical trial there was some evidence that blood was a confounding factor. Hence, specimens containing blood should not be analyzed using the OMA™-BV. This is included as a warning in the OMA™-BV label.
Other Clinical Data
The clinical procedures Amsel criteria and the Gram stain Nugent scoring system for the diagnosis of BV were evaluated against each other to determine the performance of the two systems. Results of this comparison demonstrated that, for each way of reporting the Nugent intermediate results (i.e., reported as positive, negative or excluded), the Amsel / Nugent agreements were comparable to or worse than the OMA™-BV / Amsel and the OMA™-BV / Nugent agreement.
CONCLUSIONS
It is concluded that the clinical performance and the technology of the OMA™-BV is substantially equivalent to the OMA™-UTI. The results of the multi-center pivotal clinical trial provide additional evidence that any differences between the devices do not impact on the safety or effectiveness of the OMA™-BV.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three horizontal lines representing its wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 9 2003
Mr. James White Chief Executive Officer Osmetech plc Electra House, Electra Way Crew, CW1 6WZ United Kingdom
Re: K023677
Trade/Device Name: Osmetech Microbial Analyser™ - Bacterial Vaginosis (OMA™ - BV) Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: LIB, LRH Dated: November 1, 2002 Received: November 1, 2002
Dear Mr. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Osmetech plc
510(k) Premarket Notification The Osmetech Microbial Analyser™ - Bacterial Vaginosis
INDICATIONS FOR USE/INTENDED USE STATEMENT 3.0
510(k) Number (if known): __________________________________________________________________________________________________________________________________________________
Device Name: Osmetech Microbial Analyser™ - Bacterial Vaginosis (OMA™-BV)
Indications for Use/Intended Use:
The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence by semi-quantitative analysis of volatile compounds released into the headspace above a high vaginal swab. The OMA™-BV is indicated for use as an adjunct for the diagnosis of Bacterial vaginosis (BV). The device may be used together with other clinical and patient information when diagnosing BV including pH, vaginal discharge characteristics, amine odor and clue cells or gram stain procedures that are currently commonly used to diagnose infection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PRESCRIPTION USE
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Freddie - Poole
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.