(89 days)
Not Found
No
The description focuses on "electronic nose" technology and gas sensor arrays, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic device used to detect volatile compounds for the indirect measurement of bacterial presence, serving as an adjunct for the diagnosis of Bacterial Vaginosis (BV). It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an automated in vitro diagnostic device" and is "intended for use as an adjunct for the diagnosis of Bacterial vaginosis (BV)."
No
The device description explicitly states it uses "electronic nose" technology with an array of gas sensors based on conducting polymer technology to detect volatile compounds. This indicates the device includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence..."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LIB, LRH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina (High Vaginal Swab)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%: 92.1%), and the percent agreement between clinical diagnosis and OMA™-BV was 75.2% (95%CI: 71.7% to 78.6%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent agreement between Amsel and OMA™-BV was 82.0% (95%CI: 78.9% to 85.0%).
Percent agreement between Nugent-positive and OMA™-BV was 82.0% with 95% CI: (76.0%: 87.1%).
Percent agreement between Nugent-negative and OMA™-BV was 88.9% with 95% CI: (85.0%: 92.1%).
Percent agreement between clinical diagnosis and OMA™-BV was 75.2% (95%CI: 71.7% to 78.6%).
Inter-site reproducibility: kappa statistic of 0.7688.
Inter-run reproducibility (repeatability): kappa statistic of 0.7464.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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510(k) Premarket Notification The Osmetech Microbial Analyser™ - Bacterial Vaginosis
510(K) SUMMARY
1023677
| SUBMITTED BY: | Osmetech plc
Electra House
Electra Way
Crewe, CW1 6WZ
United Kingdom |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | JAN 2 9 2003 |
| CONTACT NAME: | Andrew Tummon, Healthcare Project Manager |
| DATE PREPARED: | January 23, 2003 |
| DEVICE TRADE NAME: | Osmetech Microbial Analyser™- Bacterial
Vaginosis (OMATM-BV) |
| COMMON NAME: | Microorganism Differentiation and Identification
Device |
| CLASSIFICATION NAME
AND PRODUCT CODE: | 21 CFR 866.2660, Microscopic Differentiation and
Identification, LIB or LRH |
| DEVICE CLASSIFICATION: | Class I |
| DEVICE PANEL: | Microbiology Branch |
| PREDICATE DEVICE: | Osmetech Microbial Analyser™ - Urinary Tract
Infection (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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Page 2 -
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