The ASA laser SH1 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Description

The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source. The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end. A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready. Overall weight of the device is 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D). Electrical requirement is 115Vac 50/60Hz, 750VA.

AI/ML Overview

The provided 510(k) summary (K122125) describes the ASA laser SH1, a medical device for topical heating. The study provided focuses on the device's ability to achieve and maintain a specific skin temperature. Here's a breakdown based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Induce skin temperature of 40°C - 45°C	Was able to induce skin temperature between 40°C and 45°C
Maintain temperature for at least 10 minutes	Maintained temperature for at least 10 minutes
Applicable across different skin phototypes	Achieved for all patients (three different skin phototypes)

Study Details

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

Sample Size: Three live human subjects.
Data Provenance: Prospective (clinical study performed), country of origin not explicitly stated but the applicant is El.En. S.p.A. from Italy.

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

Number of Experts: Not applicable. The "ground truth" here is the objective measurement of skin temperature.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Not applicable. The study involved objective temperature measurement, not subjective interpretation 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 not an AI-assisted diagnostic tool and no MRMC study was performed.

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

Not applicable. This is a medical laser device, not an algorithm, and its performance directly involves human subjects for therapeutic effect, not as an "algorithm-only" assessment.

7. The type of ground truth used:

Objective Measurement (Skin Temperature): The "ground truth" was the direct measurement of skin temperature achieved and maintained on human subjects.

8. The sample size for the training set:

Not applicable. This study does not involve an AI algorithm with a training set. The clinical study was a direct performance test on a small cohort of subjects.

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

Not applicable, as there is no training set for an AI algorithm.

Summary of the Study and its purpose for this 510(k):

The clinical study described was a clinical performance trial involving three human subjects with different skin phototypes. The primary purpose of this study was to demonstrate the device's ability to achieve its intended physiological effect (elevating and maintaining tissue temperature within a specific range). This type of study supports the substantial equivalence claim by showing that the device performs as expected and similarly to its predicate device in terms of its therapeutic mechanism. It is important to note that this is a very small study primarily focused on demonstrating direct physiological action rather than complex diagnostic or intervention outcomes.

Summary

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K122/25

510(K) Summary

JAN 2 5 2013

Submitter:

El.En. S.p.A.

via Baldanzese, 17

50041 Calenzano (FI), Italy

Contact:

Paolo Peruzzi

Regulatory Affairs Manager

Phone: +39.055.8826807

E-mail: standards@elen.it

Date Summary Prepared:

Device Trade Name:

Common Name:

Classification Name:

Equivalent Devices:

Device Description:

November 26, 2012

ASA laser SH1

Nd:YAG Laser System

Infrared Lamp

ILY, 21 CFR 890.5500

HILT Family Laser (K051537)

The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source.

The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end.

A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.

Overall weight of the device is 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D).

Electrical requirement is 115Vac 50/60Hz, 750VA.

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Indications for Use:

Comparison:

Nonclinical Performance Data:

Clinical Performance Data:

The ASA laser SH1 is substantially equivalent to its predicate device.

It shares same indication for use, same principle of operation essentially same technological and characteristics and performances.

None

A clinical study has been performed on three live human subjects with three different skin phototypes. The study has shown that ASA laser SH1 is able to induce a skin temperature between 40℃ and 45°C and maintain that temperature for at least 10 minutes for all patients.

The results of clinical performance tests show that ASA laser SH1 system is as safe, as effective and performs as well as its predicate device for the indications for use mentioned above.

Additional Information:

Conclusion:

None

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, represented by flowing lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

EL.EN. Electronic Engineering S.p.A % Mr. Paolo Peruzzi · Regulatory Affairs Manager 17 Via Baldanzese Calenzano, Italy 50041

Re: K122125

Trade/Device Name: ASA laser SH1 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: IL Y Dated: November 27, 2012 Received: November 29, 2012

Dear Mr. Peruzzi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 t 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

January 25, 2013

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Page 2 – Mr. Paolo Peruzzi

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: ASA laser SHI

Indications for Use:

The ASA laser SHI is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Prescriptive Use _ X (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C) ti

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(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence ofCDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.01.25 08:10:41 -05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________ K122125

Regulation Number and Section

§ 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.