The VS-SENSE™ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.

Device Description

The VS-SENSE™ comprises a regular vaginal swab with its tip coated by an indicating polymer. When the indicating tip has been in contact with vaginal secretion, with elevated pH level, the user will observe a blue or green stain on the yellow background of the tip. The stains on the tip are caused by the sensitivity of a proprietary polymer, which coats the tip and contains the traditional indicator - Nitrazine Yellow. The VS-SENSE™ polymer matrix has a specific composition of ingredients that changes color when the pH of the vaginal discharge is greater than 4.7 +0.3/-0.2.

AI/ML Overview

Acceptance Criteria and Study for VS-SENSE™

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VS-SENSE™ device are implicitly based on demonstrating substantial equivalence to the predicate device, PHEM-CHEK™. The key performance metrics compared are sensitivity and specificity, both as a standalone test and as a second test within the Amsel Criteria procedure.

Characteristic	Acceptance Criteria (from Predicate PHEM-CHEK™)	Reported VS-SENSETM Performance
Sensitivity (Stand-alone)	91%	86.3%
Sensitivity (As 2nd test of the Amsel Criteria procedure)	99%	97%
Specificity (Stand-alone)	84.2%	93.9%
Specificity (As 2nd test of the Amsel Criteria procedure)	43.42%	43.5%

Note: The document states that the VS-SENSETM's performance is "Based on pivotal study results," implying that these reported values represent the device's actual performance in the study and were considered acceptable for substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only refers to "pivotal study results" when reporting the sensitivity and specificity values.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. However, it mentions that the device is intended to be used in conjunction with "other clinical examinations, such as the Amsel criteria or the Nugent Gram stain," which are often interpreted by trained medical professionals.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The comparison presented is between the standalone performance of the VS-SENSE™ and the predicate device, and their performance as a second test within the Amsel Criteria procedure. There is no information about how much human readers improve with AI vs. without AI assistance, as this device uses a visual indicator and not AI.

6. Standalone Performance Study

Yes, a standalone study was done. The document reports "Stand-alone" sensitivity and specificity for the VS-SENSE™ as 86.3% and 93.9% respectively, and for the predicate PHEM-CHEK™ as 91% and 84.2% respectively. This indicates that the algorithm's performance without human-in-the-loop assistance was evaluated. The device itself is a visually-read swab, so "algorithm" here refers to the chemical reaction and visual indication, interpreted by a user.

7. Type of Ground Truth Used

The type of ground truth used is implied to be based on an assessment of conditions characterized by elevated vaginal pH, such as bacterial vaginosis, likely diagnosed using established clinical methods like the Amsel criteria or Nugent Gram stain. These methods typically rely on expert interpretation of clinical signs and microscopic findings.

8. Sample Size for the Training Set

The document does not provide information about the sample size for the training set.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established.

Summary

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K091287

Section 5. 510(k) Summary

AUG 3 1 2009

5.1. 510(k) summary information:

5.1.1.
5.1.1.1. Submitter's name: Common Sense Ltd
5.1.1.2. Address: 7 Haeshel St, Caesarea 38900, POB 3567, Israel
Telephone: 972-4-6277101, Fax: 972-4-6277103 5.1.1.3.
Contact person: Ms. Natasha Leskovsek, US Regulation Consultant 5.1.1.4.
Date: August 21, 2009 5.1.1.5.

5.1.2.

Name of the device: VS-SENSETM 5.1.2.1.
5.1.2.2. Classification name: Paper, Obstetric pH
Identification of the legally marketed predicate device: 5.1.3. PHEM-CHEKTM, 510(k) no: K960648

A description of the device: The VS-SENSE™ comprises a regular vaginal swab with its tip coated by an indicating polymer. When the indicating tip has been in contact with vaginal secretion, with elevated pH level, the user will observe a blue or green stain on the yellow background of the tip. The stains on the tip are caused by the sensitivity of a proprietary polymer, which coats the tip and contains the traditional indicator - Nitrazine Yellow. The VS-SENSE™ polymer matrix has a specific composition of ingredients that changes color when the pH of the vaginal discharge is greater than 4.7 +0.3/-0.2.

The intended use of the device: The VS-SENSE™ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.

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Characteristic	VS-SENSETM	PHEM-CHEKTM
Sample collectingdevice	Swab	Swab
Sample collectingMethod	Insert into vagina and comein contact with vaginalsecretion	Insert into vagina and come incontact with vaginal secretion
Duration of test	10 seconds	10 seconds + comparing tocolor scale
Chemicalparameters	pH	pH
Other parametersthat affect the assay	Buffer capacity	NA
Result reading	Blue or green stain onyellow background	Comparing to a color scale
Sensitivity	Stand-alone 86.3%As 2nd test of the AmselCriteria procedure 97%Based on pivotal studyresults	Stand-alone 91%As 2nd test of the AmselCriteria procedure 99%Based on pivotal study results
Specificity	Stand-alone 93.9%As 2nd test of the AmselCriteria procedure 43.5%Based on pivotal studyresults	Stand-alone 84.2%As 2nd test of the AmselCriteria procedure 43.42%Based on pivotal study results

Technological characteristics comparison of VS-SENSE™ vs. Predicate Device: 5.1.4.

(*) PHEM-CHEK™ reads pH levels in the same manner as pH paper does, thus pH readings in our study were used to simulate the results of using PHEM-CHEK.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using a black and white color scheme.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Common Sense Ltd. c/o Natasha Leskovsek Cooley Godward Kronish LLP 777 610 Street NW Suite 1100 Washington, District of Columbia 20001

AUG 8 1 2009

Re: K091287

Trade Name: VS-SENSE™ Regulation Number: 21 CFR §862.1550 Regulation Name: Urinary pH (non-quantitative) test system Regulatory Class: Class I, meets limitation of exemption 862.9(b)(6) Product Codes: CEN Dated: July 17, 2009 Received: July 21, 2009

Dear Ms. Leskovsek:

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, listing 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 miust 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at. (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): KO 9128

Device Name: VS-SENSE™

Indications For Use: The VS-SENSE™ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.

Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Beniam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091287

Page 1 of

Regulation Number and Section

§ 862.1550 Urinary pH (nonquantitative) test system.

(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(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 § 862.9.