SELITHERM, MODEL C100

• K Number: K030382
• Device Name: SELITHERM, MODEL C100
• Manufacturer: SELICOR, INC.
• Date Cleared: 2003-04-01 ( 55 days)
• Product Code: IMJ
• Regulation Number: 890.5290
• Type: Traditional
• Panel: Physical Medicine
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: K083433

Intended Use

Diathermy Component. Indications for Use: To generate deep heating within body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.

Muscle Stimulator Component To increase local blood flow, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, and immediate post surgical stimulation of calves to prevent deep vein thrombosis.

Device Description

SeliTherm Model C100

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for the SeliTherm Model C100 device. This document does not contain the kind of detailed information requested about acceptance criteria and study designs that would typically be found in a clinical study report or a more comprehensive premarket submission.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Information about experts used for ground truth.
• Adjudication methods.
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training data was established.

The letter merely states that the device is "substantially equivalent" to legally marketed predicate devices for the indications for use listed. This phrase implies that the FDA has determined the new device performs as intended and is as safe and effective as a similar device already on the market, but it does not provide the specifics of the data used to reach that conclusion.

Therefore,Based on the provided text, I cannot answer the questions about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance studies, acceptance criteria, or methodology of such studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 1 2003

Selicor. Inc. James B. Bingham Manger, Regulatory Affairs 7000 North Mopac, Second Floor Austin, Texas 78731

Re: K030382

Trade/Device Name: SeliTherm Model C100 Regulation Number: 21 CFR 890.5290 and 21 CFR 890.5850 Regulation Name: Shortwave Diathermy Device Regulatory Class: Class II Product Code: IMJ and IPF Dated: January 29, 2003 Received: February 5, 2003

Dear Mr. Bingham:

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 - Mr. James B. Bingham

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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Ver/ 3 - 4/24/96

Selicor, Inc. Applicant:____

510(k) Number (if known):_ Unknown

Device Name:_SeliTherm C100

Diathermy Component. Indications for Use: To generate deep heating within body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.

Muscle Stimulator Component To increase local blood flow, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, and immediate post surgical stimulation of calves to prevent deep vein thrombosis.

Concurrence of CDRH, Office of Device Evaluation (OD)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

R. Mark A. Millican

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number -

Number K030382

Regulation Number and Section

N/A