The Altus Medical optional infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Altus Medical optional infrared handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

The optional infrared handpiece consists of:

an "umbilical" cable and connector, that is permanently attached to the hand piece A body and is semi-permanently attached to the laser system (detachable by positive action from the user) that houses:
electrical cables (to support the thermoelectric coolers associated with the chilled A sapphire window, to provide power and an electrical drive current to the IR quartz lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
a supply and return water line (to remove the heat generated by the infrared lamp and A thermoelectric cooler);
the hand piece internals described above; and A
the hand piece shells housing the internals and connecting to the umbilical. A
The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
This optional infrared handpiece is for use specifically with the Altus Medical CoolCilide Xeo laser system previously cleared on K023954.

AI/ML Overview

This 510(k) premarket notification describes the Altus Medical Optional Infrared Handpiece, which is intended to provide topical heating for temporary pain relief and muscle relaxation. The document asserts that the device is substantially equivalent to existing infrared heat lamps.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or quantitative performance metrics for the Altus Medical Optional Infrared Handpiece. Instead, it relies on a qualitative comparison to predicate devices, asserting "substantial equivalence" in technological characteristics and safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not report any specific test data or studies involving human subjects or a test set. The submission is based on a comparison to existing predicate devices and an assertion that no new questions of safety or effectiveness are raised.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific test set or study is described, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

As no test set or study is described, there is no information about an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention any MRMC comparative effectiveness study. The submission focuses on device characteristics and equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is not an AI algorithm. It is a physical medical device (an infrared handpiece). Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this submission.

7. Type of Ground Truth Used

Given that no specific studies or test data are provided, there is no explicit ground truth (e.g., expert consensus, pathology, outcomes data) mentioned in relation to the Altus Medical Optional Infrared Handpiece's performance. The "ground truth" for the substantial equivalence claim appears to be the established safety and effectiveness of the identified predicate devices.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI algorithm, the concept of a "training set" does not apply.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI algorithm, this question does not apply.

Summary of the Study and Acceptance Criteria:

The 510(k) submission for the Altus Medical Optional Infrared Handpiece relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a new clinical study with defined acceptance criteria and performance data.

The "acceptance criteria" here are implicitly that the device's technological characteristics, indications for use, and potential risks/benefits are comparable to those of the predicate devices. The study proving this is a qualitative comparison of technical specifications and intended use against the identified predicate devices:

K001056 Olympic Warm-up by Olympic Medical
K022609 PW820 Patient Warmer by Fisher & Paykel
K023621 BioFlex Professional Therapy System by Meditech International
K024179 Thermapulse by Palomar Medical Technologies, Inc.

The document asserts that the infrared handpiece shares "the same general indications for use" and relevant "technological characteristics" such as lamp type, timer, wattage, power, wavelength, protective enclosure, spot size, skin contact, cooling, and energy, with its predicate devices. Through this comparison, Altus Medical concludes that "there are no new questions of safety or effectiveness raised by the introduction of this device."

Summary

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FEB 17 2004.

Premarket Notification 510(k) Submission Infrared Handpiece to be used with the previously cleared CoolGlide Aesthetic Laser

K033768
1 of 3

Attachment 17 510(k) Summary for the Optional Infrared Handpiece

I. General Information

Submitter:	Altus Medical, Inc.821 Cowan RoadBurlingame, CA 94010
Contact Person:	Kathy Maynor
Telephone:	650-259-5586
Fax:	650-552-9787
Summary Preparation Date:	November 18, 2003

II. Names

Altus Medical Optional Infrared Handpiece Device Proprietary Name: Infrared Lamp -- product code 89 ILY; class II; 890.5500 Primary Classification Name:

Infrared lamp Common Name:

III. Predicate Devices

K001056 Olympic Warm-up by Olympic Medical ●
K022609 PW820 Patient Warmer by Fisher & Paykel ●
K023621 BioFlex Professional Therapy System by Meditech International .
K024179 Thermapulse by Palomar Medical Technologies, Inc. .

Product Description/Technological Characteristics IV.

The optional infrared handpiece consists of:

an "umbilical" cable and connector, that is permanently attached to the hand piece A body and is semi-permanently attached to the laser system (detachable by positive action from the user) that houses:
electrical cables (to support the thermoelectric coolers associated with the chilled A sapphire window, to provide power and an electrical drive current to the IR quartz lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
a supply and return water line (to remove the heat generated by the infrared lamp and A thermoelectric cooler);

Premarket Notification 510(k) Submission

Infrared Handpiece to be used with the previously cleared CoolGlide Aesthetic Laser

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K033768

2 of 3

the hand piece internals described above; and A
the hand piece shells housing the internals and connecting to the umbilical. A

The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.

This optional infrared handpiece is for use specifically with the Altus Medical CoolCilide Xeo laser system previously cleared on K023954.

V. Statement of Intended Use

Rationale for Substantial Equivalence VI.

The optional infrared handpiece shares the same general indications for use, and therefore is substantially equivalent to the currently marketed infrared heat lamps. The relevant technological characteristics of the Altus Medical optional infrared handpiece compared to the predicate devices include:

Lamp type: Equivalent to the Olympic Medical Warm-Up lamp from Olympic Medical Timer: Equivalent to the Thermapulse device from Palomar Technologies Total electrical wattage: Substantially equivalent to the Olympic Medical Warm-Up Lamp

Power: Equivalent to the Thermapulse device from Palomar Technologies

Wavelength: Substantially equivalent to the BioFlex Professional Therapy System from Meditech International and the PW820 Patient Warmer from Fisher & Paykel

Protective Enclosure: Equivalent to the Thermapulse from Palomar Technologies

Equivalent to the BioFlex Professional Therapy System from Meditech Spot Size: Interntional

Skin contact: Equivalent to the BioFlex Professional Therapy System

Cooling: Substantially equivalent to the PW820 Patient Warmer

Energy: Substantially equivalent to the Bioflex Professional Therapy System and the PW820 Patient Warmer

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K033768

3 of 3

Electrical Requirements: Equivalent to the PW820 Patient Warmer the BioFlex Delivery device: Substantially equivalent to the Thermapulse and Professional Therapy System

Safety and Effectiveness Information VII.

Technologically, the optional infrared handpiece is substantially equivalent to the listed I colliologically, the options the risks and benefits for the CoolGlide optional infrared handpiece are comparable to the predicate devices.

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device.

VIII. Conclusion

The optional infrared handpiece was found to be substantially equivalent to the currently marketed infrared heat lamps. The optional infrared handpiece shares similar indications marketu mirared neat lampe. The openting functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2004

Altus Medical, Inc. c/o Mr. Morten S. Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K033768

Trade/Device Name: Optional Infrarcd Handpiece for CoolGlide Lasers Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: January 30, 2004 Received: February 2, 2004

Dear Mr. Christensen:

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 Mcdical 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 adultcration.

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 madc 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 CHR 1000-1050.

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Page 2 - Mr. Morten S. Christensen

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) 594-4659. 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.

Miriam C. Provost

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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Attachment 2 Indications For Use Statement as Requested by FDA

510(k) Number (if Known): K033768

Device Name: Optional Infrared Handpiece for CoolGlide Lasers

Indications For Use:

(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)

in A. R.

Over-The-Counter Use ... .........

(Optional Format 1-2-96

Division of General, Restorative, and Neurological Devices

510(k) Number K0633768

Premarket Notification 510(k) Submission Infrared Handpiece to be used with the previously cleared CoolGlide Aesthetic Laser

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.