(108 days)
The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
-
Temporary relief of minor joint pain associated with arthritis.
-
The temporary increase in local circulation where applied.
-
Relaxation of muscle.
The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:
- (1) Main assembly
- (2) 5-Ball Projector
- (3) Remote Control
- (4) Accessories
Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.
This document is a 510(k) Premarket Notification from Nuga Medical Co., Ltd. for their device, the N5-1. The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not to present a study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy in the way an AI/software device typically would.
Therefore, many of the details requested in your prompt (such as acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or not provided in this regulatory document. This submission focuses on comparing the N5-1's design, technological characteristics, and intended use to a previously cleared predicate device to show that it does not raise new questions of safety or effectiveness.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The intended use of the N5-1 should be substantially equivalent to the predicate device, providing muscle relaxation and topical heating for: - Temporary relief of minor muscle and joint pain and stiffness. - Temporary relief of minor joint pain associated with arthritis. - Temporary increase in local circulation where applied. - Relaxation of muscle. | The N5-1's intended use is identical to the predicate device (NM-7000): "to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. - Temporary relief of minor joint pain associated with arthritis. - The temporary increase in local circulation where applied. - Relaxation of muscle." |
| Technological Characteristics Equivalence (General) | Design, function, and technical characteristics should be similar to the predicate device and not raise new safety/effectiveness concerns. | The N5-1 is stated to be similar to the predicate device (NM-7000) with regard to design, function, and technical characteristics. Key differences (music player, size, components, mode set-up) are explicitly stated not to raise new safety and effectiveness issues. |
| Material (Internal/External Projector) | Ceramic material for heating elements. | Both the N5-1 and the predicate device use Tourmanium ceramic for the emission source, and ceramic for the internal and external projector materials. |
| Temperature Range | 40 - 60°C (104 - 140°F) | Both the N5-1 and the predicate device operate within the temperature range of 40 - 60°C (104 - 140°F). |
| Safe Working Load | 170 kg | Both the N5-1 and the predicate device have a safe working load of 170 kg. |
| Electrical Safety | Compliance with AAMI ES60601-1. | The N5-1 "complies with the electrical safety ... requirements established by the standards AAMI ES60601-1". |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | The N5-1 "complies with the ... electromagnetic compatibility requirements established by the standards ... IEC 60601-1-2". |
| Software Validation | Software designed and developed according to a software development process, verified and validated, and in accordance with FDA guidance for "MODERATE level of concern software." | Software was designed and developed according to a software development process and was verified and validated. It is deemed "MODERATE level of concern software." |
| Biocompatibility | No direct patient contact for device parts (no biocompatibility testing needed). | The N5-1 "does not contain any parts which be contacted with the body of patient directly." Therefore, biocompatibility testing was not performed based on this criteria. |
2. Sample size used for the test set and the data provenance:
- This document is for a physical therapy device, not an AI/software device that processes data for diagnosis or treatment decisions. Therefore, there is no "test set" in the context of data for an algorithm.
- The safety and performance are evaluated through engineering tests (electrical safety, EMC) and comparison to a predicate device. Clinical studies were explicitly stated as not being necessary or performed.
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 "test set" in the context of an algorithm's performance requiring ground truth established by experts.
4. Adjudication method for the test set:
- Not applicable.
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. This is not an AI-assisted diagnostic or therapeutic device that requires human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical therapy device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of an AI/software device's performance. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., AAMI ES60601-1, IEC 60601-1-2) and demonstrating substantial equivalence to a legally marketed predicate device with the same intended use and similar technological characteristics.
8. The sample size for the training set:
- Not applicable. There is no AI training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI training set.
Summary of the Study:
The document describes a non-clinical study primarily focused on demonstrating substantial equivalence to a predicate device (K111329, NM-7000) for regulatory clearance. This is done by comparing:
- Intended Use: The N5-1's intended use is identical to the predicate device.
- Technological Characteristics: The N5-1 is shown to have similar design, function, and technical characteristics (e.g., emission source, temperature range, safe working load) to the predicate device. Minor differences are identified and argued not to raise new safety or effectiveness concerns.
- Performance via Standards Compliance: Electrical safety and electromagnetic compatibility (EMC) were tested against recognized standards (AAMI ES60601-1 and IEC 60601-1-2, respectively). The device "complies" with these standards.
- Software Validation: The device's software (classified as "MODERATE level of concern") was designed, developed, verified, and validated according to a software development process and FDA guidance.
- Biocompatibility: No biocompatibility testing was performed as the device does not have direct patient contact.
Conclusion: Based on this comparison and compliance with engineering standards, NUGA MEDICAL Co., Ltd. concludes that the N5-1 is substantially equivalent to the predicate device. No clinical studies were deemed necessary or performed for this submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
Nuga Medical Co., Ltd Jong Soo Lee Vice President 185. Jiraeul-ro. Jijeong-myeon Wonju, Gangwon-do 220-821 Republic of Korea
Re: K153054 Trade/Device Name: N5-1 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB, ILY, ISA Dated: January 4, 2016 Received: January 5, 2016
Dear Jong Soo Lee:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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,
Michael J. Hoffmann -A
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) K153054
Device Name NS-I
Indications for Use (Describe)
The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
-
Temporary relief of minor joint pain associated with arthritis.
-
The temporary increase in local circulation where applied.
-
Relaxation of muscle.
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
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
February 4, 2016
Submitter's Information [21 CFR 807.92(a)(1)] 2.
| Name of Sponsor: | NUGA MEDICAL Co., Ltd. |
|---|---|
| Address: | 185, Jiraeul-ro, Jijeong-myeon, Wonju-si,Gangwon-do, Korea |
| Contact Name: | Jong Soo Lee/Vice President |
| Telephone No.: | +82 33 730 0001 |
| Fax No.: | +82 33 730 0008 |
| Email Address: | oky7800@nuga.kr |
| Registration Number: | 300200626518 |
| Name of Manufacturer: | Same as Sponsor |
| Address: | Same as Sponsor |
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
| Trade Name: | N5-1 |
|---|---|
| ------------- | ------ |
- Common Name: Personal Heating Therapeutic Device ●
- Classification:
| Classification Name | 1. Multi-Function Physical Therapy Table2. Massager, Therapeutic, Electric3. Lamp, Infrared, Therapeutic Heating |
|---|---|
| Classification Panel | Physical Medicine |
| Classification Regulation | 21 CFR 890.5880, 21 CFR 890.5660 and21 CFR 890.5500 |
| Product Code | 1. JFB2. ISA3. ILY |
| Device Class | II |
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Image /page/4/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a stylized graphic of three figures in pink on the left, followed by the text "NUGA BEST" in blue. The "BEST" portion of the text has a trademark symbol next to it.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate device within this submission is shown as follow;
- 510(k) Number: K111329
- Applicant: NUGA MEDICAL Co., Ltd. ●
- Common Name: Personal Heating Therapeutic Device ●
- Device Name: NM-7000
There are no significant differences between the N5-1 and the predicate device that would adversely affect the use of the product. It is substantially equivalent to both device in design, operational principles, functions and technological characteristics.
5. Description of the Device [21 CFR 807.92(a)(4)]
The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:
- (1) Main assembly
- (2) 5-Ball Projector
- (3) Remote Control
- (4) Accessories
Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.
6. Intended Use [21 CFR 807.92(a)(5)]
The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
- -Temporary relief of minor muscle and joint pain, and stiffness.
- -Temporary relief of minor joint pain associated with arthritis.
- -The temporary increase in local circulation where applied.
- -Relaxation of muscle.
General Information
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Image /page/5/Picture/0 description: The image shows the logo for Nuga Best. The logo consists of a pink circular graphic with white figures inside, followed by the text "NUGA BEST" in blue. The word "BEST" has a trademark symbol next to it.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The N5-1 is based on a technical feature comparison, the subject device was found to be similar to predicate device with regard to design, function, and technical characteristics.
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K111329 |
| Common name | Personal HeatingTherapeutic Device | Personal HeatingTherapeutic Device |
| Model | N5-1 | NM-7000 |
| Manufacturer | NUGA MEDICAL Co., Ltd. | NUGA MEDICAL Co., Ltd. |
| Intended Use | The intended use of the N5-1 is to provide patientswith muscle relaxationtherapy by delivering heatand soothing massage.Additionally, it providestopical heating for;-Temporary relief of minormuscle and joint pain, andstiffness.- Temporary relief of minorjoint pain associated witharthritis.- The temporary increase inlocal circulation whereapplied.- Relaxation of muscle. | The intended use of theNM-7000 is to providepatients with musclerelaxation therapy bydelivering heat andsoothing massage.Additionally, it providestopical heating for;- Temporary relief of minormuscle and joint pain, andstiffness.- Temporary relief of minorjoint pain associated witharthritis.- The temporary increase inlocal circulation whereapplied.- Relaxation of muscle. |
| Emission Source | Tourmanium ceramic | Tourmanium ceramic |
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Image /page/6/Picture/0 description: The image contains the logo for NUGA BEST. The logo consists of a circular graphic on the left and the text "NUGA BEST" on the right. The circular graphic is pink and appears to depict three stylized figures with their arms raised. The text "NUGA BEST" is in a bold, sans-serif font and is colored blue. A small trademark symbol is located to the upper right of the word BEST.
| Design | |||
|---|---|---|---|
| Component | Main assembly (Mat),Auxiliary Heating Part,5-ball Projector,Remote controller | Mat,Auxiliary mat,5-ball Projector,9-ball Projector,Remote controller,Leg heater | |
| Accessory | Outside cover,Projector cover,User manual | Outside cover,Projector cover,User manual | |
| Material | InternalProjector | Ceramic | Ceramic |
| ExternalProjector | Ceramic | Ceramic | |
| Technical Specification | |||
| Temperature | 40 - 60°C (104 - 140°F) | 40 - 60°C (104 - 140°F) | |
| Mode set-up | Manual Mode and AutoMode 1/2 | Manual Mode 1/2 and AutoMode 1/2/3/4 | |
| SafeWorking Lode | 170 kg | 170 kg |
The key differences between both devices are (1) the music player function on the remote controller, (2) the size of the main assembly, (3) the list of components (with or without the 9-ball projector and the leg heater), and (4) Mode set-up, and which do not raise any new safety and effectiveness issues.
Non-Clinical Test Summary:
-
- Electrical Safety, Electromagnetic Compatibility and Performance:
The N5-1 complies with the electrical safety and electromagnetic compatibility requirements established by the standards AAMI ES60601-1 and IEC 60601-1-2.
- Electrical Safety, Electromagnetic Compatibility and Performance:
-
· Testing to confirm compliance with the safety requirements of standard AAMI ES60601-1
-
· Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2
General Information
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Image /page/7/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a stylized image of three people holding hands in a circle on the left, and the words "NUGA BEST" in blue on the right. The logo is simple and modern, and it is likely used to represent a company or organization that is focused on health and wellness.
-
- Software Validation:
The N5-1 contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
- Software Validation:
Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005;
-
- Clinical Test Summary:
No clinical studies were considered necessary and performed.
- Clinical Test Summary:
-
- Biocompatibility
The N5-1 does not contain any parts which be contacted with the body of patient directly. Therefore the biocompatibility test has not been performed.
- Biocompatibility
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.
When compared to the predicate device (K111329), the N5-1 and the predicate are similar, with respect to indications for use and design, function, and technical characteristics.
Conclusion [21 CFR 807.92(b)(3)] 9.
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification NUGA MEDICAL Co., Ltd., concludes that the N5-1 is substantially equivalent to predicate device as described herein.
§ 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).