The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

Temporary relief of minor muscle and joint pain stiffness
Temporary relief of minor joint pain associated with arthritis
Temporary increase in local circulation where applied
Relaxation of muscles

Device Description

This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ceragem Automatic Thermal Massager, Model CGM-MB-1101, based on the provided FDA 510(k) summary:

This device does not involve AI/ML technology, so many of the requested fields related to AI performance, ground truth establishment, and expert involvement are not applicable and will be marked as such. The study described is primarily a comparison to a predicate device and adherence to industry standards, rather than clinical performance trials with specific disease outcomes.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are mainly demonstrated through substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "performance" in this context refers to the device's functional specifications being within acceptable limits and similar to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Model CGM-MB-1101)
Intended Use	Same as predicate: Muscle relaxation therapy by delivering heat and soothing massage.	Same intended use.
Indications for Use	Same as predicate: Temporary relief of minor muscle/joint pain/stiffness, arthritis pain, increased local circulation, muscle relaxation.	Same indications for use.
Technological Characteristics	Similar emission source (Jade Projectors), infrared emission spectrum (5-20 microns).	Jade Projectors, 5-20 micron infrared emission spectrum.
Safety - Electrical Standards	UL 60601-1, CAN/CSA-C22.2 No. 601.1-M90, IEC 60601-1:2005, EN 60601-1:2006.	Tested to and meets these standards.
Safety - EMC Standards	IEC 60601-1-2: 2007 (Electromagnetic Compatibility).	Tested to and meets this standard.
Safety - Thermal Regulation	Operating Temperature Range similar to predicate, with maximal heat not exceeding predicate.	Internal: 30°C – 65°C; External, main, Auxiliary: 30°C - 60°C. Predicate: 30°C – 60°C. Max temperature does not exceed predicate.
Safety - Biocompatibility	ISO 10993-10 (Tests for Irritation and Skin Sensitization).	Tested to and meets this standard.
Safety - Risk Management	ISO 14971 (Application of Risk Management).	Tested to and meets this standard.
Software Life Cycle (if applicable)	IEC 62304 (Medical device Software Software Life Cycle Processes).	Tested to and meets this standard.
Performance - Mechanical Components	Geared DC Motor, Limit Switch, Wire-Chain, Ergonomically Molded Polyethylene Rails.	Geared DC Motor, Limit Switch, Wire-Chain, Ergonomically Molded Polyethylene Rails. (Similar to predicate)
Performance - Weight Capacity	Static Weight: 300 pounds (predicate).	298 pounds (subject device declared substantially equivalent).
	Maximum Permissible Weight: 300 pounds (predicate).	298 pounds (subject device declared substantially equivalent).

Study Details

1. Table of Acceptance Criteria and Reported Device Performance

(See table above)

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

Sample Size (Test Set): Not applicable in the context of clinical performance data for efficacy. The "test set" here refers to the device itself being tested for compliance with technical standards and compared against its predicate's specifications. No patient outcome data or imaging data is presented to require a test set sample size.
Data Provenance: The data primarily originates from the manufacturer's engineering specifications, technical testing reports, and a comparison against the previously cleared predicate device (K040031) by the same manufacturer. It is a retrospective analysis of the device's design and technical specifications relative to a predicate, combined with physical testing for safety standards.

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

Not applicable. This is not an AI/ML device that generates diagnoses or interpretations. "Ground truth" in this context would refer to the established engineering standards and the specifications of the predicate device, which are objectively measurable and defined by regulatory bodies and the manufacturer. Experts involved would be engineers and regulatory specialists, but their role is not to establish a "ground truth" for a diagnostic output.

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

Not applicable. This pertains to diagnostic outcomes and expert consensus, which does not apply to this type of device submission. The "adjudication" is essentially the FDA's review of the manufacturer's claims of substantial equivalence and compliance with standards.

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 a non-AI therapeutic device.

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

Not applicable. This is a non-AI therapeutic device.

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

The "ground truth" implicitly used is the established safety and performance standards for similar electromechanical thermal massage devices (e.g., UL, IEC, ISO standards) and the specifications and regulatory clearance of the predicate device (K040031). There is no diagnostic "ground truth" involved.

8. The sample size for the training set

Not applicable. This is a non-AI device; there is no training set.

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

Not applicable. This is a non-AI device; there is no training set or associated ground truth.

Summary

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Public Health Service

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

December 17, 2014

Ceragem International, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K140592

Trade/Device Name: Ceragem Automatic Thermal Massager, Model CGM-MB-1101 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: November 17, 2014 Received: November 17, 2014

Dear E.J. Smith,

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 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

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Page 2 - E.J. Smith

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 of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140592

Device Name

Ceragem Automatic Thermal Massager, Model CGM-MB-1101

Indications for Use (Describe)

Temporary relief of minor muscle and joint pain stiffness
Temporary relief of minor joint pain associated with arthritis
Temporary increase in local circulation where applied
Relaxation of muscles

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

× Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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807.92(c)

510(k) Summary

Sponsor:	Ceragem International, Inc. 807.92(a)(1)
Address:	3699 Wilshire Blvd., 930Los Angeles, CA 90010
Contact Person:	Raymond Chung
Phone:	213-480-7070
Fax:	213-341-2338
Summary Prepared:	November 11, 2014
Device Name:	807.92(a)(2
Trade Name:	Ceragem Automatic Thermal MassagerModel CGM-MB-1101
Common/Usual Name:	Massage Table
Classification Name:	Table, Physical Therapy, Multi-Function
Establishment Registration Number:	2087361
Product Code:	JFB
Device Classification:	Class II
Regulation Number:	21 CFR 890.5880

Manufacturer	Brand Name	510(k) Number
Ceragem International, Inc.	CERAGEM-C Thermal Massager	K040031

Device Description

Indications for Use

Temporary relief of minor muscle and joint pain stiffness -
। Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied
-Relaxation of muscles

807.92(a)(4)

807.92(a)(5)

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12.3 Predicate Product Comparison Chart

807.92(a)(6)

		Predicate Device	Subject Device
Device Brand Name and	Manufacturer	CERAGEM-C Thermal MassagerCeragem International, Inc.	CGM MB-1101Automatic Thermal MassagerCeragem International, Inc.
510(k) Number		K040031
Rated Voltage		AC 120V 60Hz	100-127Vac 50/60Hz
Operation Power		Maximum 280 Watts	360 VA240 Watts]
Home Use		Yes	Yes
Style		Flood Model (Massage Bed)	Flood Model (Massage Bed)
Remote Control		Yes	Yes
Operation Method		Auto / Manual	Auto / Manual
Emission Source		Jade Projectors	Jade Projectors
Infrared Emission Spectrum		Jade: 5 ~ 20Epoxy Carbon Panel: 5 ~ 20	Jade: 5 ~ 20Epoxy Carbon Panel: 5 ~ 20
Heating Lamp	Voltage	12V	24Vdc
	Power	10W	15W
Operating Temperature Range		30°C - 60°C (86°F - 140°F)	1. Internal : 30°C – 65°C(86°F - 149°F)2. External, main, Auxiliary :30°C - 60°C (86°F – 140°F)
Extra Overheating Protection		Yes	Yes
Moving Device		Geared DC Motor	Geared DC Motor
Limit Detector		Limit Switch	Limit Switch
Temperature Sensor		Temperature CoefficientVariable Resistor	Thermistor
Control Method		Microchip's Microcontroller	Microchip's Microcontroller
Tugging Method		Wire-Chain	Wire-Chain
Material	Support Frame	Steel	Steel, ABS
	Massager	Vinyl	Polyester, Cotton, Rayon, Polyurethane
	Cover
	Cover Sheet	Cotton	Oxford
	Rails	Ergonomically MoldedPolyethylene	Ergonomically MoldedPolyethylene
Internal Projector		Ergonomic Tilting Jade Rollers	Ergonomic Tilting Jade Rollers
Jade Heads	InternalProjector	1 Jade Ball in the Middle 4 JadeRollers (Total of 5)	1 Jade Ball in the Middle 4 JadeRollers (Total of 5)
	ExternalProjectors	Three (3) Jade Heads ProjectorNine (9) Jade Heads Projector	Three (3) Jade Heads ProjectorNine (9) Jade Heads Projector

Mat Dimensions		1920mm x 550mm x 130mm76 in x 22 in x 5 in(L x W x H)	1. When spread out: 700mm×2016mm×450mm(±5mm)2. When folded:700mm×1258mm×450mm(±5mm)
Weight		Approximately 38 Kg (84 lb.)	Main body: 23kg(±2kg)
		Sliding support: 14kg(±2kg)Frame: 16kg(±2kg)
Patient Population	Adult	Adult

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12.4 Differences Table

		Predicate Device	Subject Device	Difference
Rated Voltage		AC 120V 60Hz	100-127Vac 50/60Hz	Changed SMPS(switched-modepower supply)
Operation Power		Maximum 280 Watts	360 VA[240 Watts]	Changed SMPS(switched-modepower supply)
Heating Lamp	Voltage	12V	24Vdc	Changed the heatingelement
	Power	10W	15W
Operating Temperature Range		30°C – 60°C (86°F –140°F)	1. Internal : 30°C−65°C(86°F - 149°F)2. External, main,Auxiliary :30°C – 60°C (86°F – 140°F)	Changed internaltemperature range
Temperature Sensor		Temperature CoefficientVariable Resistor	Thermistor	No changes
Material	Support Frame	Steel	Steel, ABS	Added newcomponents
	MassagerCover	Vinyl	Polyester, Cotton, Rayon,Poly urethane	Changed components
	Cover Sheet	Cotton	Oxford	Changed components
	Rails	Ergonomically MoldedPolyethylene	Ergonomically MoldedPolyethylene
Mat Dimensions		1920mm x 550mm x130mm76 in x 22 in x 5 in(L x W x H)	1. When spread out: 700mm×2016mm×450mm(±5mm)2. When folded: 700mm×1258mm×450mm	New design (Slidingin/out structure)
		(±5mm)
Static Weight	300	298 pounds	SubstantiallyEquivalent
Maximum Permissible Weight	300	298 pounds	SubstantiallyEquivalent
Weight	Approximately 38 Kg(84 lb.)	Main body: 23kg(±2kg)Sliding support:14kg(±2kg)Frame: 16kg(±2kg)	Changed design

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12.4 Discussion of Technological Characteristics

807.92(b)(1)

Both CGM MB-1101 and the predicate device use massage rollers and heat to provide muscle relaxation therapy. The CGM MB-1101 emits topical radiant infrared heat in the range of 5-20 microns from the jade massage rollers, heated by lamps located inside the rollers. The predicate device also emits topical heat through lamps located in the jade massage rollers in the range of 5-20 microns. Both the CGM MB-1101 device and the predicate provide the massage component by attaching the jade rollers to a carriage mounted under a padded cushion that traverses the torso. The CGM MB-1101 device also transmits heat through the two Epoxy Carbon Panels and an infrared-rays heating element. While the predicate device does not include Epoxy Carbon Panels, the maximal heat of the CGM MB-1101 remains lower than that of the predicate. Additionally, both CGM MB-1101 and the predicate device have been tested to and meet the following standards:

1. UL 60601-1, 1st Edition, 2006-04-26 (include National Differences for USA)
CAN/CSA-C22.2 No. 601.1-M90 (R2005) (includes National Differences for Canada) 2.
1. IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007)
1. EN 60601-1:2006 + CORR: 2010 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
1. IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General Requirements for Electromagnetic Compatibility
IEC 62304 Medical device Software Software Life Cycle Processes 6.
1. ISO 10993-10 Biological Evaluation of medical Devices Part 10: Tests for Irritation and Skin Sensitization
1. ISO 14971 Medical Devices Application of Risk Management to Medical Devices

12.5 Conclusions

807.92(b)(3)

Based on comparison of the CGM Mb-1101 to the predicate device, we conclude that the CGM MB-1101 has the same intended use, indications for use, and intended population, and similar

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functional and performance characteristics. The addition of the two Epoxy panels and one infrared-rays heating element 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.

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).