VS-SENSE TEST

K091287 · Common Sense , Ltd. · CEN · Aug 31, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091287
• Device Name: VS-SENSE TEST
• Applicant: Common Sense , Ltd.
• Product Code: CEN · Clinical Chemistry
• Decision Date: Aug 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1550
• Device Class: Class 1

Intended 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.

Device Story

VS-Sense is a qualitative, colorimetric vaginal pH indicator swab. Device utilizes nitrazine yellow indicator to detect vaginal discharge pH levels. When vaginal discharge pH is ≥ 4.7, swab changes color from yellow to blue or green. Used in clinical settings by healthcare providers to evaluate symptomatic women. Device serves as an adjunct to standard clinical examinations (e.g., Amsel criteria, Nugent Gram stain) to aid in identifying conditions like bacterial vaginosis. Clinician visually interprets color change on swab; result informs clinical decision-making alongside other diagnostic tests. Benefits include rapid, point-of-care assessment of vaginal pH to assist in differential diagnosis of vaginal symptoms.

Clinical Evidence

Prospective clinical study of 254 pre-menopausal symptomatic women. Compared VS-Sense results against clinical diagnosis (defined by Trichomonas culture, Gram stain Nugent score > 7, or 3 Amsel criteria). VS-Sense demonstrated 86% sensitivity (95% CI: 78%-91%) and 94% specificity (95% CI: 88%-97%). Overall agreement with clinical diagnosis was 90%.

Technological Characteristics

Vaginal swab with tip coated in proprietary polymer matrix containing Nitrazine Yellow indicator. Qualitative colorimetric pH detection (yellow to blue/green) for pH >4.7. Standalone device, no energy source, no software.

Indications for Use

Indicated for pre-menopausal symptomatic women aged 18 or older presenting with acute vulvovaginal symptoms. Contraindicated in women who are menopausal, have blood in vaginal secretions, have had sexual relations or vaginal douching within 12 hours, have applied vaginal medication within 3 days, or have symptoms/signs of pelvic inflammatory disease.

Regulatory Classification

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.

Predicate Devices

• Phem Check™ (k960648)

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone], Fax: [phone].
- 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.

{1}------------------------------------------------

| Characteristic | VS-SENSETM | PHEM-CHEKTM |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Sample collecting<br>device | Swab | Swab |
| Sample collecting<br>Method | Insert into vagina and come<br>in contact with vaginal<br>secretion | Insert into vagina and come in<br>contact with vaginal secretion |
| Duration of test | 10 seconds | 10 seconds + comparing to<br>color scale |
| Chemical<br>parameters | pH | pH |
| Other parameters<br>that affect the assay | Buffer capacity | NA |
| Result reading | Blue or green stain on<br>yellow background | Comparing to a color scale |
| Sensitivity | Stand-alone 86.3%<br>As 2nd test of the Amsel<br>Criteria procedure 97%<br>Based on pivotal study<br>results | Stand-alone 91%<br>As 2nd test of the Amsel<br>Criteria procedure 99%<br>Based on pivotal study results |
| Specificity | Stand-alone 93.9%<br>As 2nd test of the Amsel<br>Criteria procedure 43.5%<br>Based on pivotal study<br>results | Stand-alone 84.2%<br>As 2nd test of the Amsel<br>Criteria procedure 43.42%<br>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.

{2}------------------------------------------------

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).

{3}------------------------------------------------

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. [phone]. 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 [phone]. 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 [phone] 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

{4}------------------------------------------------

# 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