(89 days)
Not Found
No
The device description and intended use are purely mechanical and chemical, with no mention of computational analysis or learning algorithms.
No.
The device is intended for checking pH levels, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is intended for checking the pH level of a woman's vagina, which is a measurement taken to identify or monitor a physiological state, thus serving a diagnostic purpose.
No
The device description explicitly states it is comprised of a "flat probe" and "a strip of phenaphthazine pH paper," which are physical hardware components.
Based on the provided information, the pHEM-CHEK is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "checking the pH level of a woman's vagina." This involves testing a sample (vaginal fluid) in vitro (outside the body) to obtain diagnostic information (pH level).
- Device Description: The device uses pH paper, which is a reagent used to measure a chemical property (pH) of a sample. This is a common component of IVD tests.
- Anatomical Site: While the sample is collected from the vagina, the test itself is performed in vitro on the collected sample.
- Predicate Devices: The listed predicate devices (K850858 and K850305) are likely also IVD devices related to vaginal pH testing, further supporting this classification.
The definition of an IVD device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Measuring vaginal pH falls under obtaining diagnostic information about the state of health.
N/A
Intended Use / Indications for Use
The pHEM-CHEK is intended for checking the pH level of a woman's vagina.
Product codes
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Device Description
The pHEM-CHEK is comprised of a flat probe on which a strip of phenaphthazine pH paper is mounted. One end of the probe will be textured for better gripping and a strip of phenaphthazine pH paper will be mounted on the flat surface of the opposing end. A color chart, provided by the manufacturer of the pH paper, will be enclosed in each box of probes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
biocompatibility testing was conducted and the findings presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510 (k) SUMMARY pHEM-CHEK™ February 12, 1996
MAY 1 5 1996
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR
807.87 and the SMDA 807.87 and the SMDA.
1. Submitter of 510 (k)
Joel S. Faden, Ph.D. (Consultart) 11605 Hitching Post Lane Rockville, MD 20852
Telephone: (301)881-9139 Facsimile: (301)881-9249
2. Name of Device:
-
A. Trade/Proprietary Name:
pHEM-CHEK™ -
B. Common/Usual Name:
pH paper -
c. Classification Name:
In accordance with FDA's manual, "Classification Names for Medical Devices and In Vitro Diagnostic Products" and FDA's listing of victor Diagnostic
clearances - prodicts of prior - 510 prior - 510(k) clearances, predicate devices were assigned to classification fredatable devices were assigned to
classification 21 CFR 884.1550 "Amniotic fluid sampler".
3. Sponsor/Manufacturer:
| Name/Address: | FEMTEK Inc.
50 Bellefontaine Street
Pasadena, CA 91105-3181 |
|--------------------------|-------------------------------------------------------------------|
| Attention: | James C. Caillouette, M.D., President |
| Telephone:
Facsimile: | 818-796-7145
818-568-9559 |
1
4 . Reason for Submitting the 510(k)
This document is being submitted on behalf of Femtek, Inc. (Femtek). Femtek wishes to commercially distribute its new pHEM-CHEK™ device for the general application of testing the pH level of the vagina.
5. Device Description
The pHEM-CHEK is comprised of a flat probe on which a strip of phenaphthazine pH paper is mounted. One end of the probe will be textured for better gripping and a strip of phenaphthazine pH paper will be mounted on the flat surface of the opposing end. A color chart, provided by the manufacturer of the pH paper, will be enclosed in each box of probes.
6. Intended Use
The pHEM-CHEK is intended for checking the pH level of a woman's vagina.
7. Substantial Equivalence
PH paper, phenaphthazine, has been prescribed in medical textbooks published as early as 1950 to test the pH level of the vagina. In fact, Nitrazine®, a phenaphthazine pH paper distributed by Apothecon®, A Bristol-Myers Squibb Company, was cited and recommended in such publications. PH paper for measuring vaginal pH has also been the subject of prior 510(k) clearances, K850858 and K850305. It is currently the practice of physicians to press a strip pH paper against the vaginal wall while holding it with either the fingers or a hemostat. Femtek has merely made it more convenient for the physician by mounting phenaphthazine paper on the end of a probe, thus allowing for a less cumbersche procedure. The placement of the pH paper on a probe, for purposes of convenience, does not alter the intended use, safety or the effectiveness of the application of the pH paper and its measure of pH. New issues of safety and effectiveness are not raised by nounting the predicate pH paper on a probe.
2
Copies of the pHEM-CHEK package insert and outer package labels and an engineering drawing of the device were provided. Further, biocompatibility testing was conducted and the findings presented.
Since, the pHEM-CHEK has the same intended use, safety and effectiveness as the legally marketed predicate devices, the pHEM-CHEK is substantially equivalent.