The intended use of the CERAGEM-C Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the Ceragem-C Thermal Massager provides radiant infrared heat for,
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
relaxation of muscles

Device Description

The CERAGEM-C Thermal Massager is an electrically powered motorized multi-functional physical therapy table. Its intended use is to provide muscle relaxation therapy by delivering heat and soothing The massage function is delivered by massage rollers mounted on an independent carriage massage. underneath a pad on the table torso section. The heat function is delivered by two components (1) heated jade massage rollers mounted together on the moving carriage and (2) heated Epoxy Carbon Panels. In both cases, the radiant infrared heat is emitted. Together, the massage action and heated pressure points apply light pressure as well as radiant infrared heat to the user.

AI/ML Overview

The Ceragem-C Thermal Massager is not a device that would require AI performance metrics or a clinical study in the traditional sense, as it is a physical therapy device. The provided text is a 510(k) summary for a medical device that aims to demonstrate substantial equivalence to a predicate device, not to prove performance against specific acceptance criteria using a study with AI.

However, I can extract the "acceptance criteria" through the lens of regulatory compliance and the "study" as the comparison made to the predicate device.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance (in the context of regulatory equivalence):

Acceptance Criteria (Regulatory)	Reported Device Performance (as demonstrated for equivalence)
Same intended use	The CERAGEM-C Thermal Massager has the same intended use as the predicate device (Migun HY5000 Thermassage Energy Product).
Same indications for use	The CERAGEM-C Thermal Massager has the same indications for use as the predicate device: muscle relaxation therapy, temporary relief of minor muscle/joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles.
Same intended population	The CERAGEM-C Thermal Massager has the same intended population.
Similar functional and performance characteristics	Both devices use massage rollers and heat. The CERAGEM-C emits topical radiant infrared heat (5-20 microns) from jade rollers (heated by light bulbs), similar to the predicate.
No new safety or effectiveness issues raised by new components	The addition of three Epoxy Carbon Panels does not raise new safety or effectiveness issues as the temperature never exceeds the maximal temperature of the predicate device.
Compliance with established safety standards (e.g., electrical)	The CERAGEM-C and the predicate device both have and meet UL 60601-1:1997, CAN/CSA C22.2 No. 601.1-M90, EN 60601-1 (1990), IEC 60601-1, and IEC 60601-2-38 (1996).

Since this is a 510(k) submission for a non-AI physical therapy device, the following points are not applicable or do not have direct analogues in the provided text:

Sample sizes used for the test set and the data provenance: Not applicable. No test set data in the conventional sense was used for performance evaluation of an AI algorithm. Equivalence was established via comparison to a predicate device and adherence to safety standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set was established in this context.
Adjudication method: Not applicable. There was no need for adjudication as it was not an AI performance study measuring agreement.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The device is a physical therapy massager, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: Not applicable in the context of an AI study. The "ground truth" in this regulatory context is the established safety and effectiveness of the predicate device and compliance with recognized safety standards.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary

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JUL 2 8 2004

510(k) SUMMARY XI.

Pursuant to 513(i)(3)(A) of the Food, Drug and Cosmetic Act, Ceragem Co., Ltd is required to submit with this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Ceragem Co., Ltd. chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Submitter's Name	CERAGEM Co., Ltd.177-14, Osaejdabg-ri, Seongger-eup, Cheonan-si,Chungcheongnam-do, KoreaContact Person: Kevin ParkTel: 213.480.7851
Date Prepared:	December 31, 2003
Proprietary Name:	CERAGEM-C Thermal Massager
Classification Name:	Multi-Function Therapy Table (Class II), 21 CFR 890.5880
Predicate Device:	Migun HY5000 Thermassage Energy Product (K032449)Migun Medical Instrument Co., Ltd.

Product Description:

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Statement of Intended Use Compared to Predicate Device:

The intended use of the CERAGEM-C Thermal Massager is the same as the above-identified predicate device. It is intended to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the CERAGEM-C Thermal Massager provides radiant infrared heat for,

¢ temporary relief of minor muscle and joint pain, and stiffness
0 the temporary relief of minor joint pain associated with arthritis
¢ the temporary increase in local circulation where applied
◊ relaxation of muscles

Discussion of Technological Characteristics:

Both the CERAGEM-C Thermal Massager and the predicate device use massage rollers and heat to provide muscle relaxation therapy - The CERAGEM-C emits topical radiant infrared heat in the range of 5-20 microns from the jade massage rollers, heated by light bulbs located inside the rollers. The ,在第一次 predicate device also emits topical heat through light bulbs located in the jade massage rollers in the range of 5-20 microns. Both the CERAGEM-C device and the predicate provide the massage compone by attaching the jade rollers to a carriage mounted under a padded cushion that traverses the torso CERAGEM-C device also transmils heat through the three Epoxy Carbon Panels. While the predicate device does not include Epoxy Carbon Panels, the maximal heat of the CERAGEM-C remains that of the predicate. Additionally both the CERAGEM-C and the predicate device have and meet the following standards:

Underwriters Laboratories Standard UL 60601-1:1997 200 Edition, "Medical Electrical Equipment, 1. Part 1: General Requirements for Safety" including Amendments 1 and 2:

CAN/CSA C22.2 No. 601.1-M90, "Medical Equipment Part 1: General Requirements for Safety," 2. including C22.2 No. 601.1 S1-94, Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90.

EN 60601-1 (1990), "Medical Electrical Equipment Part 1, General Requirements for Safety" including Amendments A1 and A2;

IEC 60601-1, 200 Edition (1998) "Medical Equipment- General Requirements for Safety + A1:91 4. and A2:95"; and

IEC 60601-2-38, 1st Edition (1996) "Medical Electrical Equipment - Part 2: Particular 5. Requirements for the Safety of Electrically Operated Beds."

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Image /page/2/Picture/0 description: The image shows the word "CERAGEM" in bold, black letters. The letters are slightly slanted to the right. There is a circled R symbol to the right of the word.

Conclusion:

Based on comparison of the CERAGEM-C Thermal Massager to the predicate device, we conclude that the CERAGEM-C Thermal Massager has the same intended use, indications for use, and intended population, and similar functional and performance characteristics. The addition of the three Epoxy Carbon Panels does not raise new safety or effectiveness issues since the temperature never exceeds the maximal temperature of the predicate device. Other visual distinctions do not impact safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 2004

Ceragem Company, Ltd. c/o Ms. Suzan Onel Kirkpatrick and Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036

Re: K040031

Trade/Device Name: Ceragem-C Thermal Massager Regulation Number: 21 CFR 890.5880 Regulation Names: Multi-function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: April 28, 2004 Received: April 29, 2004

Dear Ms. Suzan Onel:

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

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Page 2 - Ms. Suzan Onel

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 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,

Mark A. 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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CERAGEM®

Page ol

510(k) Number (if known): CERAGEM-C Thermal Massager Device Name:

Indications For Use:

� temporary relief of minor muscle and joint pain, and stiffness

◊ the temporary relief of minor joint pain associated with arthritis

0 the temporary increase in local circulation where applied

0 relaxation of muscles

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Manh M

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

(Optional Format 3-10-98)

510(k) Number_K 040 o 3/

Regulation Number and Section

§ 890.5880 Multi-function physical therapy table.

(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).