Ultrasound therapy 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 (21 CFR 890.5300)

IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR ION THEFULL LONSE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS.

Device Description

The SW Ultrasound Line 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.

AI/ML Overview

The provided document outlines the 510(k) premarket notification for the "SW ULTRASOUND" device. This is a notification for substantial equivalence to a legally marketed predicate device, rather than a de novo approval requiring extensive clinical efficacy studies against specific performance criteria.

Therefore, the information you've requested regarding acceptance criteria and performance studies, particularly in the context of diagnostic accuracy, human reader effectiveness with AI, and standalone algorithm performance, is not present in these documents. The focus here is on demonstrating that the new device is as safe and effective as an existing device, primarily through technological comparison and basic safety testing.

Here's an breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, accuracy) because it is for an ultrasonic diathermy device (therapeutic, not diagnostic). The substantial equivalence is based on:

Acceptance Criteria Category	Reported Device Performance
Intended Use	Identical to predicate device (therapeutic deep heat for selected medical conditions like pain, muscle spasms, joint contractures, excluding malignancies).
Technological Characteristics	"The technological characteristics of the SW Ultrasound device are the same as those of the predicate device."
Electrical Safety	Testing carried out and presumably met relevant standards (though specific results are not detailed).
Electromagnetic Compatibility (EMC)	Testing carried out and presumably met relevant standards.
Temperature Rise in Phantom	Testing carried out to compare temperature rise during SW Ultrasound procedures with that of the predicate device, implying similar thermal effects.
Compliance with 21 CFR 1050.1	Testing carried out to demonstrate compliance.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of this 510(k). The "testing" referred to are physical and electrical performance tests on the device itself, not a clinical test set of patient data.
Data Provenance: Not applicable. The testing was conducted by Starbene on its own device and a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the sense of expert adjudicated patient data is not relevant for this type of device submission. The "ground truth" for the engineering tests would be the established scientific principles and regulatory standards for electrical safety, EMC, and thermal effects.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" of patient data requiring adjudication.

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 device is a therapeutic ultrasound, not an AI-driven diagnostic imaging system. There are no "human readers" or "AI assistance" involved in its stated function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed (electrical safety, EMC, temperature rise, 21 CFR 1050.1 compliance) is based on established engineering standards and regulatory requirements, not clinical outcomes or pathology.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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DEC - 8 2000

1000 STARBENE 510K NOTIFICATION SW ULTRASOUND

510(k) SUMMARY ( As required by 210 CFR 807.92)

Trade Name :

Common / Classification Name :

Marketed by:

SW ULTRASOUND

Ultrasonic Diathermy

STARBENE David Luque 519 5000- Cordoba Argentina 54-351-4240051 T.E: FAX: 54-351-4240052

Dated Prepared : Additional Information : April 23rd , 1999 September 17TH , 1999

Contact:

Miss Judith Niztzschmamn International Regulations Department

A- LEGALLY MARKETED PREDICATE DEVICE

The SW ULTRASOUND LINE equipment is substantially equivalent to the following devices marketed:

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K991616
20F3

STARBENE 510K NOTIFICATION SW ULTRASOUND

B- DEVICE DESCRIPTION

The SW Ultrasound Line 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 .

C- INTENDED USE

The SW Ultrasound Line is intended for use in applying therapeutic deep heat for selected medical conditions.

INDICATIONS FOR USE

INDICATIONS FOR ULTRASOUND USE

Ultrasound therapy 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 ( 21 CFR 890.5300)

D- TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the SW Ultrasound device are the same as those of the predicate device.

E- TESTING

Starbene carried out testing to address the following issues

1- Electrical safety
2- Electromagnetic compatibility
3- Temperature rise in a phantom during SW Ultrasound procedures
4- Temperature rise in a phantom using the predicate devices
5- Compliance with the 21 CFR 1050.1

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K99 1613
3 OF 3

STARBENE 510K NOTIFICATION SW ULTRASOUND

E- CONCLUSIONS

The SW Ultrasound Line has the same intended use and target population as the predicate device.

Starbene has demonstrated through its performance tests on the SW Ultrasound Line equipment and its comparison with those of the predicate device that the SW Ultrasound device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a double helix-like design, representing the structure of DNA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 8 2000

Ms. Judith Niztzschmamn STARBENE International Regulations Department David Luque 519 Cordoba, Pvcia, Cordoba, Argentina

Re: K991613

Trade Name: SW Ultrsound, Models 331, 311, 333 Regulatory Class: II Product Code: IMI Dated: September 15, 2000 Received: September 22, 2000

Dear Ms. Judith Niztzschmamn:

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 vour device can be found in the Code of Federal Regulations, 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 action. In addition, FDA may publish further announcements 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.

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.

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Page 2 -- Ms. Judith Niztzschmamn

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,

Mark N. 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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Page 1 of 1

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510(k) Number (if known ) _K991613

Device Name: SW ULTRASOUND

Indications For Use:

IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR ION THEFULL LONSE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991613
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 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.