The pHEM-ALERT® test mcasures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms: Itching, Burning, Unpleasant odor, Unusual discharge. This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have follow-up by your neartheate provider. This device is not validated for use in pregnant women.

Device Description

The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package inscrt. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated package miser. "The present of differentiating normal and abnormal conditions in for modeling vagina price is inserted into the vagina and the measurement taken.

AI/ML Overview

The provided text describes the pHEM-ALERT device, its intended use, and two clinical studies conducted to support its substantial equivalence to a previously marketed device. However, it does not explicitly state specific acceptance criteria (e.g., minimum accuracy percentages or precision values) that the device needed to meet. Instead, it concludes that the device demonstrated "reasonable test performance" and "acceptable" characteristics.

Based on the provided information, here's an attempt to answer the questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
User could read and understand labeling.*	Found to be "well designed, readable and understandable."
User could record accurate results.*	Found to be "well designed, readable and understandable" and "demonstrated reasonable test performance."
Not affected by anticipated variation in user technique.*	"Was not affected by anticipated variation in user technique."
Overall test performance is reasonable and acceptable.*	"Demonstrated reasonable test performance" and "test performance characteristics of this version of the pHEM-ALERT are reasonable and acceptable."

Note: The document does not provide specific quantitative acceptance criteria (e.g., "X% of users understood the labeling"). The stated performance is a qualitative summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "Two clinical studies" were designed and carried out.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies were conducted "in support of the Substantial Equivalency" by FemTek, LLC (Pasadena, CA) and Joel S. Faden, Ph.D., Inc. (Rockville, MD), suggesting they were likely conducted in the US. The studies were designed to address the needs of the "lay user," implying they were prospective studies involving actual users.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

Not explicitly stated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC or AI-assisted study was mentioned. The device is a simple pH paper for lay users, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a "pH paper" used by a "lay user" with a "color chart." It's a physical, user-interpreted test, not an algorithm.

7. The Type of Ground Truth Used

The document implies that the ground truth for "accurate results" and "reasonable test performance" would have been established against a reference method for vaginal pH measurement, likely a laboratory pH meter or a clinical expert's assessment, but this is not explicitly stated. The focus of the studies was on the lay user's ability to read and understand the device and its labeling, and to get "accurate results" which infers comparison to a true pH value.

8. The Sample Size for the Training Set

This device is not an AI/machine learning product, so there is no "training set" in that sense. The "clinical studies" described would serve as the validation/test set for demonstrating user comprehension and reasonable performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set mentioned for an algorithm.

Summary

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K012230

OCT - 92001

510(k) SUMMARY pHEM-ALERT September 30, 2001

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA), The information provided in this 510(k) premarket notification was in accordance with 21 CFR 807.87.

1. Sponsor/Submitter

Sponsor

FemTek, LLC 50 Bellefontaine Street Pasadena, CA 91105-3181 Attention: James C. Caillouette, M.D., President Telephone: 626-796-7148 Facsimile: 626-793-1651

Submitted by:

Consultant

Joel S. Faden, Ph.D., Inc. 11605 Hitching Post Lane Rockville, MD 20852 Contact person: Joel Faden 301-881-9139 Telephone: 301-881-9249 Facsimile:

2. Name of Device

Trade Name: pHEM-ALERT Common/Usual Name: pH paper Classification Name: "Obstetric pH Paper", 85LNW, unclassified

3. Legally Marketed Predicate Devices

pHEM-ALERT 510(k) K960648

4. Indications for Use / Intended Use

The indications and intended uses for the pHEM-ALERT device are:

"The pHEM-ALERT® test mcasures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms:

Itching ●
Burning ●
Unpleasant odor .

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Unusual discharge . ●
This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have follow-up by your neartheate provider. This device is not validated for use in pregnant women."

5. Device Description

6. Substantial Equivalence

This version of the pHEM-ALERT is identical to the currently available version, except for the package insert, which has been modified to specifically address the needs of the lay user.

Two clinical studies were designed and carried in support of the Substantial Equivalency. The studies were designed to address the requirements, of appropriate guidelines. In particular, the clinical studies were performed to demonstrate that the lay user could read and understand the labeling and record accurate results The pHEM-ALERT and its labeling were found to be well designed, readable and understandable. The pHEM-ALERT was not affected by anticipated wariation in user technique. The pHEM-ALERT demonstrated reasonable test performance.

In conclusion, these data demonstrated that the test performance characteristics of this version of the pHEMALERT are reasonable and acceptable and that this version of the pHEM-ALERT is substantially equivalent to the original version.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 92001

FemTek, LLC c/o Joel S. Faden, Ph.D. President/CEO 11605 Hitching Post Lane Rockville, MD 20852

K012230 Re:

Trade/Device Name: pHEM-ALERT Regulation Number: 21 CFR 862.1550 Regulation Name: Urinary pH (nonquantitative) test system Regulatory Class: Class I, reserved Product Code: LNW Dated: July 15, 2001 Received: July 16, 2001

Dear Dr. Faden:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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pHEM-ALERT 510(k)

CONFIDENTIAL

INDICATIONS FOR USE

Device Name: pHEM-ALERT

Indications For Use:

The indications and intended uses for the OTC version of the pHEM-ALERT device are:

"The pHEM-ALERT® test measures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms:

Itching .
Burning .
속 Unpleasant odor
Unusual discharge .

This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding). This device is not validated for use in pregnant women."

Coper

(Division Sigiff)
Division of Conical Laboratory Devices
510(k) Numb
012230

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over-The-Counter: V

(Optional Format 1-2-96)

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.