(88 days)
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Not Found
No
The summary describes a device that delivers pulsed radio-frequency energy for pain relief and does not mention any AI or ML components or functionalities.
Yes
The device description explicitly states, "The Energex is a therapeutic medical device." Additionally, its intended use is for "temporary relief of chronic temporomandibular joint (TMJ) pain," which is a therapeutic purpose.
No
The device description states it is a "therapeutic medical device" used for "relief of chronic TMJ pain," not for diagnosing conditions.
No
The device description explicitly states it "delivers pulsed radio-frequency energy to tissue," indicating a hardware component is involved in the therapeutic action.
Based on the provided information, the Energex device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary relief of chronic temporomandibular joint (TMJ) pain." This describes a therapeutic application directly on the patient's body.
- Device Description: The device "delivers pulsed radio-frequency energy to tissue." This is a physical therapy modality applied externally or internally to the body, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Energex device's function and intended use clearly fall outside of this definition.
N/A
Intended Use / Indications for Use
The Energex is indicated for use for the temporary relief of chronic temporomandibular joint (TMJ) pain.
Product codes
NHH
Device Description
The Energex is a therapeutic medical device that delivers pulsed radio-frequency energy to tissue as indicated for the relief of chronic TMJ pain.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Temporomandibular joint (TMJ)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This equivalence was shown through bench, animal and clinical data submitted in the 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing connection and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2005
Orthosonix, Incorporated C/O Mr. Russell Pagano 615 7th St NE, 1st Floor Washington, DC 20002
Re: K013094
Trade/Device Name: Orthosonix Energex ® Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: NHH Dated: September 14, 2001 Received: September 17, 2001
Dear Mr. Pagano:
This letter corrects our substantially equivalent letter of December 14, 2001.
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 (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 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.
1
Page 2 - Mr. Russell Pagano
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.
This letter will allow you to continue 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 de-ice 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html
Sincerely yours,
Qve
Shih-Shin Liang, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Premarket Notification
Orthosonix Energex
013094
Indication for Use Statement
510(k) Number (if known):
Device Name:
Orthosonix Energex®
Indication for Use:
The Energex is indicated for use for the temporary relief of chronic temporomandibular joint (TMJ) pain.
Susan Runny
'Division Sign-Off) - Chision of Dign-Off)
Division of Dental, Infection Control, ind General Hospital (k) Number _ KC ત્વા
ii.CONFIDENTIAL
Appendices
3
510(k) Summary
DEC 1 4 2001 Orthosonix, Inc. Energex®
Sponsor 1.
Orthosonix 180 Old Tappan Road Old Tappan, New Jersey 07675
Contact Person: Thomas Fagan President
2. Device Name
| Classification Name: | Shortwave diathermy device |
|---|---|
| Proprietary Name: | Orthosonix Energex® |
3. Indications for Use
The Energex is indicated for use for the temporary relief of chronic temporomandibular joint (TMJ) pain.
4. Device Description
The Energex is a therapeutic medical device that delivers pulsed radio-frequency energy to tissue as indicated for the relief of chronic TMJ pain.
Basis for Substantial Equivalence રું.
The Energex is substantially equivalent to shortwave diathermy devices that are also indicated for the relief of joint pain. This equivalence was shown through bench, animal and clinical data submitted in the 510(k).