(30 days)
The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
The US-100 Ultrasound Therapy Unit consists of a main unit and two applicators. The device may be operated in continuous or pulsed modes. The US-100 has an output power of 8 W and operates at 0.8 MHz. It is supplied with one applicator, and another smaller applicator is available as an option. The device has an LCD screen that serves as the interface with the user to specify options, provide messages, and display parameters.
The provided document is a 510(k) summary for the US-100 Ultrasound Therapy Unit. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety testing. It does not contain information regarding clinical studies, acceptance criteria related to clinical performance, or studies proving the device meets specific clinical performance acceptance criteria.
Therefore, I am unable to provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions related to sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
The document only states the following regarding "performance data":
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of clinical performance. The document refers to "performance data ... which demonstrate equivalence" for "a few characteristics" and "performance testing carried out by Ito Co, Ltd. on the US-100 addressed the following issues: Electrical Safety, Electromagnetic Emissions, Various Safety and Integrity Issues, and Performance Standard of 21 CFR 1050."
- Reported Device Performance: No specific numerical performance metrics are reported in this summary. The summary states that the device "has the same technological characteristics as the predicate device" and that "performance data were provided, which demonstrate equivalence" for a few characteristics (listed as Electrical Safety, Electromagnetic Emissions, Various Safety and Integrity Issues, and Performance Standard of 21 CFR 1050). The results of these tests, however, are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The testing mentioned (Electrical Safety, EMC, etc.) is likely laboratory-based engineering performance testing of the device itself, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This information would be relevant for clinical performance studies, which are not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-enabled device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-enabled device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. For the engineering performance tests mentioned, the "ground truth" would be established by relevant engineering standards and specifications (e.g., electrical safety standards).
8. The sample size for the training set
- Not applicable. No training set is mentioned for this type of device and submission.
9. How the ground truth for the training set was established
- Not applicable.
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OCT - 9 2003
510(k) Summary
US-100 Ultrasound Therapy Unit
Common/Classification Name: Ultrasonic Diathermy Device, 21 CFR 890.5300
Ito Company, Ltd. 3-3-3 Toyotama-Minami Nerima-Ku Tokyo 176-8605, Japan
Contact: K. Sunayama, Prepared: September 5, 2003
LEGALLY MARKETED PREDICATE DEVICES A.
The US-100 Ultrasound Therapy Unit is substantially equivalent to the ultrasound section of the Sonicator Plus 992 (K984142) by Mettler.
DEVICE DESCRIPTION B.
The US-100 Ultrasound Therapy Unit consists of a main unit and two applicators. The device may be operated in continuous or pulsed modes. The US-100 has an output power of 8 W and operates at 0.8 MHz. It is supplied with one applicator, and another smaller applicator is available as an option.
The device has an LCD screen that serves as the interface with the user to specify options, provide messages, and display parameters.
். INTENDED USE
The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The US-100 Ultrasound Therapy Unit is a medical device, and it has very similar indications for use as the legally marketed predicate device. The differences do not change the intended therapeutic effect. The US-100 Ultrasound Therapy Unit has the same technological characteristics as the predicate device. For a few characteristics, performance data were provided, which demonstrate equivalence. This premarket notification
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to assure substantial equivalence except for a few of the characteristics where performance testing was carried out (e.g., electrical safety, EMC).
E. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are the same as those of the predicate device and other ultrasound diathermy devices.
F. TESTING
Performance testing carried out by Ito Co, Ltd. on the US-100 addressed the following issues:
- Electrical Safety; (1)
- (2) Electromagnetic Emissions;
- Various Safety and Integrity Issues, and (3)
- Performance Standard of 21 CFR 1050. (4)
CONCLUSIONS G.
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Ito Company, Ltd. C/o T. Whit Athey, Ph.D. Senior Consultant The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 Brookeville, MD 20833-2233
Re: K032793
Trade/Device Name: US-100 Portable Ultrasound Therapy Unit Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: September 8, 2003 Received: September 9, 2003
Dear Dr. Athey,
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 - Suite 200
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), please contact the Office of Compliance at (301) 594-1308. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark M. Milken
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: US-100 Ultrasound Therapy Unit
Indications For Use:
The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
(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 -------
Merle N. Millenson
(Division Sign-Off)
Division of General. Restorative and Neurological Devices
510(k) Number K032793
000024
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz 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)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.