(322 days)
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powered, motorized multi-functional physical therapy table. It is intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two independent carriages. Each carriage has five infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.
The provided document describes the safety and effectiveness of the CHOYANG Thermal Massager (Model: CY-7000) by demonstrating its substantial equivalence to two predicate devices, rather than through a study with specific acceptance criteria and performance metrics for the device itself.
The "study" in this context is a substantial equivalence comparison to legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria. Instead, it asserts that the new device is "as safe and effective as the predicate devices" based on bench and clinical evaluation, and a comparison of technical specifications and intended use. The "reported device performance" is essentially its similarity to the predicates.
| Item | CHOYANG Thermal Massager (New Device) | Predicate Device 1 (HY7000 Thermassage Energy Product) | Predicate Device 2 (CERAGEM-RH1 Automatic Thermal Massager) | Conclusion (Acceptance) |
|---|---|---|---|---|
| Safety Standard Compliance | Complies with EN 60601-1-2 | - | - | |
| Intended Use | To provide patients with muscle relaxation therapy by delivering heat and soothing massage. | To provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating 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 muscle | -(Implicit in classification as "Multi-function physical therapy table" and "Therapeutic massager" as well as the similarity to Predicate 1's use) | Substantially equivalent in primary intended use (muscle relaxation, heat, massage). Differences in secondary infrared claims for Predicate 1 are noted but do not preclude substantial equivalence for the new device's stated indications. |
| Rated input voltage | 120V a.c | 120V a.c | 120V a.c | Equivalent |
| Supply Frequency | 50-60Hz | 50Hz | 60Hz | Functionally equivalent for typical mains power |
| Rated input power | 250W | 269W | 290W | Comparable range, deemed equivalent |
| Degree of protection | Type BF applied part | Type BF applied part | Type BF applied part | Equivalent |
| Ambient temperature | 40~70℃ | 40~70℃ | 30~60℃ | Overlapping and comparable, deemed equivalent |
| Weight | 64Kg | 74Kg | 87Kg | Comparable range, deemed equivalent |
| Safe working load | Max. 150Kg | Max. 150Kg | Max. 140Kg | Equivalent or exceeds predicate |
| Massage roller | Jade | Geranium Cerramic | Jade | Different material from one predicate but similar to other, deemed equivalent in function |
| Mode Set-Up | Auto Mode, Semi-Auto Mode | Auto Mode, Semi-Auto Mode | Auto Mode, Semi-Auto Mode | Equivalent |
| Remote Buttons | Rubber Pad Type | Rubber Pad Type | Rubber Pad Type | Equivalent |
| Operating time | 36min | 34min | 40min | Comparable range, deemed equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the sense of a dataset used for performance evaluation of an AI/software device. The evaluation is based on bench testing for safety (EN 60601-1-2) and a comparison of specifications and intended use to predicate devices.
- Sample size: Not applicable for a typical test set using patient data. The "sample" is of the device itself (one unit of CY-7000) for bench testing.
- Data provenance: Bench test reports were performed by SGS Testing Korea. The comparison data for predicate devices is from their respective 510(k) submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" derived from expert consensus on a test set of data for this type of device submission. The substantial equivalence is determined by regulatory review based on engineering, safety, and functional comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no expert adjudication process for determining ground truth in a test set.
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 physical thermal massager, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical thermal massager.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/software device. The "ground truth" for the submission is the documented performance, safety standards compliance, and intended use of the predicate devices, against which the new device is compared. The determination of "safe and effective" for the new device is made through this comparison and adherence to relevant standards.
8. The sample size for the training set
Not applicable. This is a physical thermal massager, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a logo with the word "CHOYANG" in a stylized font. The word is positioned to the right of a curved, swooping shape that resembles a crescent or an arc. The logo is set against a white background, and the text and shape are in black.
MAY 2 5 2012
Exhibit 5 510(k) Summary
CHOYANG Thermal Massager (Model: CY-7000)
-
- Submitter and US Official Correspondent
| Submitter: | Choyang Medical Instrument Co., Ltd. |
|---|---|
| Address: | 66-3 Yogwang-ri, Chubu-myeon, Geumsan-gunChungcheongnam-do, 312-943, Korea |
| Tel: +82-41-754-8070~3Fax: +82-41-754-8075 | |
| Contact: Jung Hyun, Quality Assurance ManagerEmail: jh0158@nate.com |
| US Official Correspondent: | Shin Kuk Yoo, Consultant |
|---|---|
| Telephone No.: | 714-313-7442 |
| Fax No.: | 8 01-303-7455 |
| Email: | skyone@LSKBioPartners.com |
2. Establishment Registration Number
The firm will be registered and listed prior to distribution of medical device in United States.
3. Device Information
| Proprietary/Trade Name: | CHOYANG Thermal Massager (Model: CY-7000) |
|---|---|
| Common/Usual Name: | Multi-function physical therapy table, Therapeutic massager |
| Classification Name: | Table, Physical therapy, Multi-function |
| Product Code: | JFB |
| Subsequent Product Code: | ISA |
| Device Class: | Class II per regulation 21 CFR 890.5880, 21 CFR 890.5660 |
4. New or modification
:
This notification is for a new device for the USA market.
12
{1}------------------------------------------------
5. Equivalent Legally Marketed Device
| Predicate #1 | |
|---|---|
| Manufacturer: | Migun Medical Instrument Co., Ltd. |
| Device Name: | HY7000 Thermassage Energy Product |
| 510(k) Number: | K041200 (Decision Date - June 17, 2004) |
| Classification: | Table, Physical Therapy, Multi FunctionJFB (Classification Product Code)Class II per regulation 21 CFR 890.5880 |
Predicate #2
| Manufacturer: | CERAGEM Co., Ltd. |
|---|---|
| Device Name: | CERAGEM-RH1 Automatic Thermal Massager |
| 510(k) Number: | K062476 (Decision Date - Oct. 31, 2006) |
| Classification: | Table, Physical Therapy, Multi Function |
| JFB (Classification Product Code) | |
| Class II per regulation 21 CFR 890.5880 |
ଚ. Description of the Device
The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powe red, motorized multi-functional physical therapy table. It is intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two independent carriages. Each carriage has five infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.
7. Indications for use
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
8. Safety, EMC and Performance Data
The compliance of the CHOYANG Thermal Massager (Model: CY-7000) has been satisfied with the applicable requirements of the EN 60601-1-2. The tests have been performed by SGS Testing Korea.
16
{2}------------------------------------------------
9. Safety and Effectiveness, comparison to Predicate
The results of bench and clinical evaluation indicate that the new device is as safe and effective as the predicate devices.
10. Substantial Equivalence Chart
.
| No | Item | CHOYANG ThermalMassager | HY7000 ThermassageEnergy Product | Ceragem-RH1 AutomaticMassager |
|---|---|---|---|---|
| 1 | 510K Number | None | K041200 | K062476 |
| 2 | Manufacturer | Choyang MedicalInstrument Co., Ltd. | Migun MedicalInstrument Co., Ltd. | CERAGEM Co., Ltd. |
| 3 | Regulation Number | CFR 890.5880, | CFR 890.5880, | CFR 890.5880, |
| 4 | Product code | JFB, ISA | JFB, ISA, ILY | JFB, ISA, ILY |
| 5 | Classification | Class II(21CFR 890.5880) | Class II(21CFR 890.5880) | Class II(21CFR 890.5880) |
| 6 | Rated input voltage | 120V a.c | 120V a.c | 120V a.c |
| 7 | Supply Frequency | 50-60Hz | 50Hz | 60Hz |
| 8 | Rated input power | 250W | 269W | 290W |
| 9 | Degree of protection | Type BF applied part | Type BF applied part | Type BF applied part |
| 10 | Ambient temperature | 40~70℃ | 40~70℃ | 30~60℃ |
| 11 | Weight | 64Kg | 74Kg | 87Kg |
| 12 | Safe working load | Max. 150Kg | Max. 150Kg | Max. 140Kg |
| 13 | Massage roller | Jade | Geranium Cerramic | Jade |
| 14 | Mode Set-Up | Auto ModeSemi-Auto Mode | Auto ModeSemi-Auto Mode | Auto ModeSemi-Auto Mode |
| 15 | Remote Buttons | Rubber Pad Type | Rubber Pad Type | Rubber Pad Type |
| 16 | Operating time | 36min | 34min | 40min |
| 17 | Intended Use | The intended use of theCHOYANG ThermalMassager is to providepatients with muscle | The intended use of the device is to provide patientswith muscle relaxation therapy by delivering heat andsoothing massage. Additionally, the infrared lampsprovide topical heating for; | |
| relaxation | therapy by | - temporary relief of minor muscle and joint pain and | ||
| delivering | heat and | stiffness | ||
| soothing massage. | - the temporary relief of minor joint pain associated | |||
| with arthritis | ||||
| - the temporary increase in local circulation where | ||||
| applied | ||||
| - relaxation of muscle |
{3}------------------------------------------------
11. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the Choyang Medical Instrument Co., Ltd. concludes that the CHOYANG Thermal Massager (Model: CY-7000) is safe and effective and substantially equivalent to the predicate devices as described above.
18
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human figures or elements of a design. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 25 2012
Choyang Medical Instrument Co., Ltd. % LSK BioPartners, Inc. Mr. Shin Kuk Yoo 8 East Broadway, Suite 611 Salt Lake City, Utah 84111
Re: K11941
Trade/Device Name: Choyang Thermal Massager (Model: CY-7000) Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Dated: May 15, 2012 Received: May 17, 2012
Dear Mr. Shin Kuk Yoo:
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
{5}------------------------------------------------
Page 2 - Mr. Shin Kuk Yoo
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 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/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 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.
Euil Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Exhibit 4 Indications for Use
510(k) number (if known):
K111994
Device Name: CHOYANG Thermal Massager (Model: CY-7000)
Indications for Use:
The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vernon H. Clark
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111941
§ 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).