AMNISCREEN HOME DETECTION LINER KIT

K071100 · Common Sense , Ltd. · CEN · Oct 15, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071100
• Device Name: AMNISCREEN HOME DETECTION LINER KIT
• Applicant: Common Sense , Ltd.
• Product Code: CEN · Clinical Chemistry
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1550
• Device Class: Class 1

Intended Use

The Amniscreen™ Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.

Device Story

Device consists of a Testing Panty-Liner (TPL) with a detachable indicator strip and a Drying Tray (DT); used by pregnant women at home. Patient wears TPL until wetness is sensed (up to 12 hours); removes indicator strip; observes for color change (blue-green indicates pH ≥ 5.2); uses DT to dry strip for 30 minutes if needed. Healthcare provider interprets results to confirm amniotic fluid leakage; aids in clinical decision-making regarding pregnancy management. Benefits include early detection of amniotic fluid leakage.

Clinical Evidence

Prospective clinical study of 339 pregnant participants at three hospital sites. Primary endpoints: sensitivity and specificity compared to clinician-performed Nitrazine paper test. Results: sensitivity 95.65%, specificity 84.46%. Correlation between patient and trained staff result reading exceeded 97.4%. No significant safety issues reported.

Technological Characteristics

Panty-liner with integrated indicator strip; proprietary polymer coating containing Nitrazine Yellow. pH-sensitive colorimetric indicator (yellow to blue-green for pH ≥ 5.2). Passive, non-invasive sampling. Shelf-stable. Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per standards.

Indications for Use

Indicated for pregnant women experiencing vaginal wetness to detect potential amniotic fluid leakage. Contraindicated if sexual intercourse, vaginal douching, or use of vaginal products occurred within 12 hours; if recent vaginal bleeding/spotting exists; or during sweating (e.g., exercise). Users must alert providers if diagnosed with vaginal infection within 3 days, using antibiotics, or on a diet altering vaginal pH.

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

• Amniotest™ (k914419)

Submission Summary (Full Text)

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## Section 5. 510(k) Summary

### 007 1 5 2007 5.1. 510(k) summary information: 5.1.1. Submitter's name: Common Sense Ltd 5.1.1.1. Address: 7 Haeshel St, Caesarea 38900, POB 3567, Israel 5.1.1.2. Telephone: [phone], Fax: [phone]. Contact person: Menashe Terem, CEO 5.1.1.4. Date: April 25, 2007, Rev. October 11, 2007 5.1.1.5.

5.1.2.

- Name of the device: AmniScreen™ Home Detection Liner Kit 5.1.2.1.
- Classification name: Urinary pH (nonquantitative) test system 5.1.2.2.
- Identification of the legally marketed predicate device: 5.1.3. AMNIOTEST(TM), 510(k) no: K914419

5.1.4. A description of the device: The AmniScreen™ Home Detection Liner Kit contains a Testing Panty-Liner (TPL) and a Drying Tray (DT). The TPL comprises a regular panty-liner and an indicator strip assembled into the panty-liner, covered with two layers of one-way perforated film. The indicator strip is removed after use and placed in the DT for 30 minutes before reading the test results. When the indicator strip has been in contact with amniotic fluid, the user will observe a blue-green stain on the yellow background of the strip. An elevated pH level of the fluid causes the stain. The stains on the strip are caused by the sensitivity of a proprietary polymer, which coats the strip and contains the traditional indicator - Nitrazine Yellow, to pH levels above 5.2 units. The proprietary polymer is also sensitive to certain concentrations of ammonium in the tested fluid, and when the color changes are created by fluids with a certain concentration level of ammonium, and pH levels up to 7.0 units, these color changes are reversible and during a drying period of 30 minutes the blue-green stains fade back to yellow.

5.1.5. The intended use of the device: The AmniScreen™ Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.

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Technological characteristics comparison of AmniScreen™ Home 5.1.6. Detection Liner Kit vs. Predicate Device:

| Characteristic | AmniScreenTM Home<br>Detection Liner Kit | AMNIOTESTTM |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Sample collecting<br>device | Panty-liner | Swab |
| Sample collecting<br>Method | Passive, non-invasive | Active, invasive |
| Duration of test | Up to 12 hours | 15 seconds |
| Chemical<br>parameters | pH | pH |
| Result reading | Blue-green stain on yellow<br>background | Comparing to a color scale |
| Urine Interference | Urine with pH level more<br>than 7.0 units | None |
| Sensitivity | Detects intermittent leaks<br>that may be undetectable<br>by Standard Clinical<br>Diagnosis<br>95.65% based on pivotal<br>study results | |
| Specificity | 84.46% based on pivotal<br>study results | |
| Interference | Interference from urine<br>with pH levels of 7.0 and<br>above, and from BV with<br>pH levels of 5.0 and above | Interference from sampling, and<br>from BV with pH level of 6.5 or<br>above |

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## 510(k) Summary Performance data:

5.1.7. Non-clinical tests: Lab tests to prove efficacy and pH cutoff were performed in the developer's labs and are performed on every batch as part of the manufacturing QC. Reference safety tests were performed by laboratories holding certificates to test for cvto-toxicity, irritation and sensitization (see section 15). Biological bio-burden tests were performed in the developer's labs and are performed as part of the manufacturing OC. Shelf life, storage, temperature limits and transportation tests were performed in the developer's labs.

5.1.8. Clinical tests: 339 pregnant participants, arriving at hospitals at three different test sites sensing unexplained wetness, were enrolled in a clinical study to test AmniScreen™. Two of the participants reported of being very uncomfortable when performing the test. The users or the trained staff encountered no safety issues. Two of the participants reported they had a problem using the AmniScreen™ Home Detection Liner Kit or reading the results. The correlation between the result readings by the participants and trained staff exceeded 97.4%, and there was no significant effect of the result-reading source on the performance of the AmniScreen™ (i.e., sensitivity and specificity achieved by both are almost identical). The sensitivity and specificity of the AmniScreen™ Home Detection Liner Kit in the study were substantially equivalent to predicate device performance, which was demonstrated by a Nitrazine Paper test performed by clinicians.

5.1.9. The conclusions drawn from the non-clinical and clinical tests: From the biocompatibility tests it can be concluded that the AmniScreen™ Home Detection Liner Kit complies with the required safety standards regarding cyto-toxicity, irritation and sensitization. The AmniScreen™ Home Detection Liner Kit may be mechanically safer to the user than AMNIOTEST™ as it is not inserted into the vagina. From the pivotal clinical study it can be concluded that the sensitivity and specificity of the AmniScreen™ Home Detection Liner Kit are substantially equivalent to the predicate device. From the comparison of staff result reading to patient readings, it can be concluded that the AmniScreen™ Home Detection Liner Kit is acceptable to be used as a home test.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Common Sense Ltd. c/o Heller Ehrman, LLP 1717 Rhode Island Avenue, N.W. Washington, DC 20036 Attn: Ms. Natasha Leskovsek

OCT 1 5 2007

Re: k071100 Trade/Device Name: AmniScreen™ Home Detection Liner Kit Regulation Number: 21 CFR§862.1550 Regulation Name: Urinary pH (nonquantitative) test system. Regulatory Class: Class I Product Code: CEN Dated: September 12, 2007 Received: September 13, 2007

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 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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# Indication for Use

510(k) Number (if known): K071100

Device Name:

AmniScreen™ Home Detection Liner Kit

Indication For Use:

The AmniScreen Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

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

510(k) K071100