(215 days)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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
The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors. The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only. The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
The provided text is a 510(k) summary for the Ceragem Automatic Thermal Massager, Model CGM-MB-1901. This type of document is for medical devices that are deemed substantially equivalent to a legally marketed predicate device. It focuses on demonstrating that the new device is as safe and effective as the predicate, rather than proving efficacy from scratch with extensive clinical trials like a PMA would require.
Therefore, the information regarding acceptance criteria and studies proving the device meets those criteria in the context of efficacy, particularly for AI/Machine Learning devices, is not present in this document. This document details engineering and safety/performance testing relevant to mechanical and thermal devices, not AI performance. Specifically:
- Acceptance Criteria for AI/ML Performance: Not applicable/not defined as this isn't an AI/ML device.
- Study Proving Device Meets Acceptance Criteria: The studies described ("skin temperature study," "usability study," "EMC and electrical safety testing," "cytotoxicity test," "skin irritation & sensitization tests," and "firmware validation tests") are all related to the physical, electrical, and material safety and performance of a thermal massager, not the accuracy or performance of an AI algorithm.
Let's break down what is available in the document related to testing, even though it doesn't fit the typical "acceptance criteria for an AI device" framework:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a thermal massager):
| Acceptance Criteria (Inferred for a Thermal Massager) | Reported Device Performance (from "Performance Tests (Non-clinical)") |
|---|---|
| Skin Temperature Control: Maintain skin temperature between 40-45°C during treatment. | "[The] skin temperature study was performed to verify that the subject device maintained skin temperature between 40-45 degree C during the intended treatment." (Conclusion: supported substantial equivalence) |
| Usability: Lay users can operate the device with the provided User Manual. | "The usability study was performed to validate that the lay users can use the subject device only with the User Manual provided." (Conclusion: supported substantial equivalence) |
| Electrical Safety & EMC: Compliance with relevant standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11). | "The EMC and electrical safety testing were conducted on the subject device in accordance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11." (Conclusion: supported substantial equivalence) |
| Biocompatibility (New Materials): Absence of cytotoxicity, skin irritation, and sensitization for patient-contacting materials. | "The cytotoxicity test per ISO 10993-5 and skin irritation & sensitization tests per ISO 10993-10 were performed to evaluate the safety of the new materials which contact the patients." (Conclusion: supported substantial equivalence) |
| Software/Firmware Functionality: Firmware works as intended. (Level of concern: Moderate) | "The level of concern for the subject device SW is moderate and the validation tests were performed to verify that the firmware works as intended." (Conclusion: supported substantial equivalence) |
| Heating Performance (Abdominal Vibration Projector): Able to heat skin to 40-45°C within 15-20 minutes and maintain this temperature. | "Similar to the predicate device, the subject device was able to heat skin to 40-45 degree C within 15-20 minutes. During the intended treatment the subject device maintained skin temperature between 40-45 degree C." |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for these performance and safety tests (e.g., number of subjects in the skin temperature or usability study, number of material samples for biocompatibility).
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/in-house testing) with a potential small human component for skin temperature and usability. They are not referred to as retrospective or prospective clinical studies in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The studies described are engineering, safety, and basic human factor (usability) tests, not diagnostic accuracy studies requiring expert readers to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring reader adjudication for diagnostic accuracy.
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:
- No, an MRMC study was not done. This device is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI/ML device. "Standalone performance" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth in the typical AI/ML sense (e.g., confirmed disease status) is not relevant. The "ground truth" for the tests performed would be:
- Skin Temperature: Measured temperature readings.
- Usability: Observation of user interaction and completion of tasks using the manual.
- Electrical Safety/EMC: Compliance with standard thresholds and test procedures.
- Biocompatibility: Laboratory results showing absence of toxic or irritating reactions.
- Firmware: Expected functional outputs/behaviors.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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March 2, 2021
Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620
Re: K202113
Trade/Device Name: Ceragem Automatic Thermal Massager, Model CGM-MB-1901 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: December 14, 2020 Received: December 21, 2020
Dear Priscilla Chung:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202113
Device Name
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
Indications for Use (Describe)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(K202113)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Feb 18, 2020
1. 510K Applicant / Submitter:
CERAGEM Co, Ltd. 10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu, Cheonan-si, Chungcheongnam-do 31041 Republic of Korea
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Proprietary Name: Ceragem Automatic Thermal Massager, Model CGM-MB-1901 .
- Regulation Number: 21 CFR 890.5880
- Regulation Name: Multi-Function Physical Therapy Table .
- Regulatory Class: Class II
- Product Code: JFB ●
4. Predicate Device
Automatic Thermal Massager, Model CGM MB-1101 (K140592) by Ceragem International, Inc.
5. Description:
The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary
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relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only.
The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
8. Indications for Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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
9. Substantial Equivalence Discussion:
9.1. Comparison Chart
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | CGM MB-1901 | CGM MB-1101 |
| Automatic Thermal Massager | Automatic Thermal Massager | |
| Manufacturer | CERAGEM Co, Ltd. | CERAGEM Co, Ltd. |
| 510(k) Number | K202113 | K140592 |
| Rated Voltage | 100-127Vac 50/60Hz | 100-127Vac 50/60Hz |
| Home Use | Yes | Yes |
| Style | Flood Model (Massage Bed) | Flood Model (Massage Bed) |
| Components | Main Mat | Main Mat |
| Supporting Mat | Lower Mat | |
| Remote Control | Remote Control | |
| 3-Sphere projector | 3-Sphere projector | |
| Abdominal Vibration Projector | 9-Sphere projector | |
| Power cord | Power cord | |
| Outer fabric | Outer fabric | |
| Head cushion | Head cushion | |
| Projector Cover | Projector Cover |
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| Remote Control | Yes | Yes | |||
|---|---|---|---|---|---|
| Operation Method | Auto / Manual | Auto / Manual | |||
| Infrared Emission Spectrum | Ceramic : 5~20µm | Jade : 5~20µm | |||
| Epoxy Carbon Panel : 5~20 µm | Epoxy Carbon Panel : 5~20 µm | ||||
| HeatingDevice | Voltage | 24V | 24V | ||
| Power | 18W | 15W | |||
| Temperature Range | 1. Internal: 30°C - 65°C(86°F - 149°F)2. External, Main, Auxiliary: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) | |||
| Distance of the InternalProjector | 710mm | 710mm | |||
| Intensity Level | 1 | 1 | |||
| Extra Overheating Protection | Yes | Yes | |||
| Moving Device | Geared DC Motor | Geared DC Motor | |||
| Limit Detector | Limit Switch | Limit Switch | |||
| Temperature Sensor | Thermistor | Thermistor | |||
| Control Method | Microcontroller | Microcontroller | |||
| Tugging Method | Wire-Chain | Wire-Chain | |||
| Material | Main/SupportingFrame | Steel, ABS | Steel, ABS | ||
| Outer Fabric | Polyester, Cotton, Rayon,Polyurethane | Polyester, Cotton, Rayon,Polyurethane | |||
| Main Mat /Supporting MatCover | NylonPolyurethane | Polyethylene | |||
| Projectors | InternalProjector | 1 Ceramic Ball in the Middle 4Ceramic Rollers(Total of 5) | 1 Jade Ball in the Middle 4 JadeRollers(Total of 5) | ||
| ExternalProjectors | Three (3) Ceramic HeadsProjectorNine (9) Ceramic Heads Projector | Three (3) Jade Heads ProjectorNine (9) Jade Heads Projector | |||
| Mat Dimensions | 1.When spread out:700mmx2040mmx450mm(±5mm)2.When folded:700mmx1250mmx450mm(±5mm) | 1.When spread out:700mmx2016mmx450mm(±5mm)2.When folded:700mmx1258mmx450mm(±5mm) | |||
| Weight | Main/Supporting body :52kg(±2kg) | Main body : 23kg(±2kg)Sliding support : 14kg(±2kg)Frame : 16kg(±2kg) | |||
| Mode | Mode A | Mode 1 | |||
| Mode 1 | Mode 2 | ||||
| Mode 2 | Mode 3 | ||||
| Mode 3 | Mode 4 | ||||
| Mode 4 | Mode 5 | ||||
| Mode 5 | Mode 6 | ||||
| Mode 6 | Mode 7 | ||||
| Mode 7 | Mode 8 | ||||
| Mode 8 | Mode 9 | ||||
| Mode 9 | Semi-Automatic Mode | ||||
| Mode 10 | Manual Mode | ||||
| Mode 11 |
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| Semi-Automatic Mode | |
|---|---|
| Semi-Automatic Master Mode | |
| Manual Mode | |
| Manual Master Mode | |
| Abdominal Vibration ProjectorMode |
9.2. Substantial Equivalence Discussion
The subject device is similar to the predicate device in the indications for use, principle of operation, and technological characteristics. The performance specifications are nearly the same, yet the subject device has more choosing options. For example, the intensity level specification is the same between the subject device and the predicate device, but the subject device divided the range into 9 options instead of 6 to better meet user's intensity preferences. The same thing applies to the massage mode that the overall massage specification is the same, but the subject device offers more variety of the massage patterns and options.
The major difference is the material of the internal heating element has changed. We have performed the skin temperature to validate the performance of the heating massage and the test results support that the subject device is substantially equivalent to the predicate device. Another difference is that the subject device has upgraded the 9-Sphere projector to have vibration feature for massage effect. So, we have changed the term for this component to Abdominal Vibration Projector. This vibration function is just an additional feature and still the main function of this projector is heating. The skin temperature test result supported that the Abdominal Vibration Projector performs as well as the predicate device. Similar to the predicate device, the subject device was able to heat skin to 40-45 degree C within 15-20 minutes. During the intended treatment the subject device maintained skin temperature between 40-45 degree C.
10. Performance Tests (Non-clinical)
- The skin temperature study was performed to verify that the subject device maintained ● skin temperature between 40-45 degree C during the intended treatment.
- The usability study was performed to validate that the lay users can use the subject device ● only with the User Manual provided.
- . The EMC and electrical safety testing were conducted on the subject device in accordance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11.
- . The cytotoxicity test per ISO 10993-5 and skin irritation & sensitization tests per ISO 10993-10 were performed to evaluate the safety of the new materials which contact the patients.
- The level of concern for the subject device SW is moderate and the validation tests were ● performed to verify that the firmware works as intended.
The test results of all the tests supported that it is substantially equivalent to the predicate
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device.
11. Conclusions:
Based on the information provided in this premarket notification, CERAGEM Co, Ltd. concludes that the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is substantially equivalent to the predicate device as described herein in.
§ 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).