HYDROTONE-THERMAL CAPSULE SYSTEM by NATS CORP.

The provided document is a 510(k) clearance letter from the FDA for the Hydrotone-Thermal Capsule System. It confirms that the device is substantially equivalent to a legally marketed predicate device for the indicated uses. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter focuses on regulatory clearance, indicating the device can be marketed. It lists the "Indications for Use" as "Hydrotherapy; Relieve pain and itching." and provides contraindications. It does not include any performance metrics, study design, or results that would typically be found in a study demonstrating the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test sets.
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Mr. Richard C. Lanzillotto Agent for HydroCo North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734

Re: K991184 Hydrotone-Thermal Capsule System Trade Name: Regulatory Class: II Product Code: ILJ Dated: May 5, 1999 Received: May 7, 1999

Dear Mr. Lanzillotto:

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, Drug, and Cosmetic Act (Act). 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 (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 In addition, FDA may publish further announcements action. 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. Richard C. Lanzillotto

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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 5

INDICATIONS FOR USE

510(k) Number (if known):

Hydrotone-Thermal Capsule System Device Name: Indications for Use: Hydrotherapy;

Relieve pain and itching.

Contraindications:

Not for children, elderly or handicapped unless supervised.
Prolonged immersion in hot water may induce hyperthermia. -
-Do not use following strenuous exercise.
Pregnant women should consult a medical doctor before using this system.
-Consult with a medical doctor if using medication prior to using this system.
Do not use with alcohol or drugs. The combination could result in fatal hyperthermia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Teedle

(Division Sign-Off)
Division of General Restorative Devices K991184
510(k) Number.

Regulation Number and Section

§ 890.5100 Immersion hydrobath.

(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.