(55 days)
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.
SeliTherm Model C100
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.
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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 (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" (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 (800) 638-2041 or (301) 443-6597 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
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.