Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM

K992874 · Wr Medical Electronics Co. · KTB · Nov 18, 1999 · Physical Medicine

Device Facts

• Record ID: K992874
• Device Name: Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
• Applicant: Wr Medical Electronics Co.
• Product Code: KTB · Physical Medicine
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2

Indications for Use

The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output. This device is to be used in scientific studies of the anatomy, physiology, and biochemistry of the skin & associated structures.

Device Story

Q-Sweat is a measurement-only device designed to quantify sweat rate and volume. It utilizes a small measuring chamber affixed to the skin to capture sweat (water) samples. The device calculates moisture output from the skin surface. It is intended for use in scientific research settings to study skin anatomy, physiology, and biochemistry. It does not provide diagnostic information or indicate the presence of disease. The device is operated by researchers or clinicians to document sweat output for study purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Measurement-only device; utilizes a small chamber affixed to the skin to capture moisture. Principle of operation is the calculation of evaporative water loss/sweat output. No specific materials, energy sources, or software architecture details provided.

Indications for Use

Indicated for measuring sweat output from human skin for use in scientific studies of skin anatomy, physiology, and biochemistry. Not for diagnostic use.

Regulatory Classification

Identification

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined. Additionally, an iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted: (A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended; (B) Testing of the ability of the device to maintain a safe pH level; and (C) If used in the ear, testing of the device to demonstrate mechanical safety. (ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following: (A) A description and/or graphical representation of the electrical output; (B) A description of the electrode materials and pH buffer; (C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and (D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning: *Warning:* Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile. (vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.

Predicate Devices

• Abrams Model WVD-101 Evaporative Water Loss Instrument
• Servo-Med Evaporimeters EP1C and EP1D
• DermaLab TEWL Device
• Tewarneter TM 210

Submission Summary (Full Text)

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# 510K SUMMARY OF SAFETY & EFFECTIVENESS

This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

The assigned 510K number is: _________________________________________________________________________________________________________________________________________________

NOV 1 8 1999

## APPLICANT INFORMATION:

WR Medical Electronics Co. 123 North Second Street Stillwater, MN 55082 USA Tel: [phone] Fax: [phone] Attn: Patrick J. Anderson, President

# DEVICE INFORMATION:

Trade Name: Q-Sweat Quantitative Sweat Measurement System

Common Name: Evaporimeter, Evaporative Water Loss Device, Hydrograph, Trans Epidermal Water Loss (TEWL) Device, or Sweat Measuring Device

# EQUIVALENT DEVICE:

Predicate Device No. 1: Abrams Model WVD-101 Evaporative Water Loss Instrument, 1322 Rensen Street, Lansing, MI 48910-3688

Predicate Device No. 2: (Pre-Amendment) Servo-Med Evaporimeters EP1C and EP1D, Box 110, S-162 12 Stockholm, Sweden, or Box 129, Ikinna, Sweden

Predicate Device No. 3: DermaLab TEWL Device, Cortex Technologies, Smedevaenget 10 9560 Hadsund, Denmark

Predicate Device No. 4: Tewarneter TM 210, ACA Derm, 120 Independence, Menlo Park, CA 94025

### DEVICE DESCRIPTION:

The O-Sweat device is measurement-only device which is designed to measure the rate & volume of sweating by capturing a sample of sweat (water) inside a small measuring chamber which is affixed to the skin. It does not measure any other parameters of the sweat sample. The measurement made is simply a calculation of moisture given off by the skin.

### INTENDED USE:

The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output. This device is to be used in scientific studies of the anatomy, physiology, and biochemistry of the skin & associated structures.

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### COMPARISON TO PREDICATE DEVICE:

WR Medical Electronics Co. claims substantial equivalence to several devices that are used for measuring the rate of sweating form the skin of humans. The use of the Q-Sweat device on a human does not effect the body any differently than the use of the predicate devices on humans; nor does the use of the Q-Sweat raise any new questions of safety or effectiveness. The Q-Sweat device operates in the nearly exact same fashion as the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Mr. Patrick J. Anderson President WR Medical Electronics Company 123 North Second Street 55082 Stillwater, Minnesota

K992874 Re: Q-Sweat Quantitative Sweat Trade Name: Measurement System Requlatory Class: II Product Code: KTB Dated: August 23, 1999 Received: August 26, 1999

Dear Mr. Anderson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Patrick J. Anderson

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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page 1 of 1

510(k) NUMBER (IF KNOWN): K992874

DEVICE NAME: Q-SWEAT™ QUANTITATIVE SWEAT MEASUREMENT SYSTEM

INDICATIONS FOR USE:

The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output.

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over - The - Counter - Use (Optional Format 1-2-96

Signature

(Division Sidn-Off) Division of General Restorative De 510(k) Number