(234 days)
The intended use of the N7-S 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 air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.
The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage.
It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.
The given document is a 510(k) premarket notification for a medical device (N7-S Multi-Function Physical Therapy Table) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document primarily focuses on establishing substantial equivalence to predicate devices (CGM MB-1701 & CGM MB-1702, and N5-1) based on indications for use, technological characteristics, and performance testing for safety and basic functionality (e.g., temperature range, pressure performance of air cell massager).
The sections that might contain information about studies are "Performance Test" and "Clinical Test Summary" (page 14). However, these sections state:
- Performance Test: "A comprehensive performance test was conducted on the subject device, including a pressure performance test of the Air Cell Massager, to substantiate its equivalence to the predicate device A(K220572)." It lists items evaluated such as temperature range, extra overheating protection, temperature sensor function, heating part, skin surface temperature, and pressure performance of the Air cell massager. It concludes that "the subject device met all applicable performance requirements and was substantial equivalent with predicate devices."
- Clinical Test Summary: "No clinical studies are considered necessary and performed."
Therefore, the provided document does not describe: AI/ML acceptance criteria, a study proving an AI/ML device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or how ground truth for training data was established.
The device, N7-S, appears to be a physical therapy table with heat and massage functions, including an air massager. It is not an AI/ML-driven device based on the provided text, and thus, the detailed questions about AI/ML performance metrics are not applicable to this submission.
Without information on AI/ML components or their performance evaluations, I cannot fill out the requested table or provide details on the study's AI/ML specific aspects.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
September 12, 2024
Nuga Medical Co., Ltd. Jun Lee Official Correspondent 185. Jiraeul-ro. Jijeong-myeon Wonju-si, Gangwon-do 26355 Korea. South
Re: K240168
Trade/Device Name: N7-S Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB, IRP Dated: September 3, 2024 Received: September 3, 2024
Dear Jun 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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
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assistance/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,
Lauren E. Woodard -S
for Amber Ballard, PhD 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) K240168
Device Name N7-S
Indications for Use (Describe)
The intended use of the N7-S is to provide patients with muscle relaxation therapy by delivering heatand 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 air massager module of N7-S is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading of tissues by using an inflatable garment.
| 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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Image /page/4/Picture/0 description: The image contains the logo for Nuga Best. The logo consists of a pink circular graphic on the left, followed by the text "NUGA BEST" in blue, bold letters. The circular graphic appears to depict two stylized figures or abstract shapes, also in pink.
510(k) Summary
1. Date Prepared
September 3, 2024
2. Submitter Information & Contact Person
| Name of Manufacturer | NUGA MEDICAL Co., Ltd. |
|---|---|
| Address | 185, Jiraeul-ro, Jijeong-myeon, Wonju-si, Gangwon-do,Republic of Korea |
| Contact Name | Lee Jun Woo/Assistant Researcher |
| Telephone No. | +82-33-730-0001 |
| Fax No. | +82-33-730-0008 |
| Email Address | nuga227@nuga.kr |
3. Trade Name, Common Name, Classification
Common name: Multi-Function Physical Therapy Table Trade name: N7-S
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Table, Physical Therapy, Multi Function | 890.5880 | JFB |
| Massager, Powered Inflatable Tube | 890.5650 | IRP |
As stated in 21 CFR, parts 890.5880, and 890.5650, each of these generic types of devices has been classified as Class II.
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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 on the left, followed by the text "NUGA BEST" in blue, bold letters. The graphic appears to depict three stylized figures in a circle, possibly representing people or movement.
Identification of Predicate Device 4.
The identified predicate devices within this submission are shown as follow:
| Predicate device A | |
|---|---|
| 510(k) Number | K220572 |
| Applicant | CERAGEM Co, Ltd. |
| Regulation Name | Multi-Function Physical Therapy Table |
| Trade Name | Ceragem Automatic Thermal Massager |
| Device Name | CGM MB-1701 & CGM MB-1702 |
| Predicate device B | |
| 510(k) Number | K153054 |
| Applicant | NUGA MEDICAL Co., Ltd. |
| Regulation Name | Multi-Function Physical Therapy Table |
| Trade Name | N5-1 |
| Device Name | N5-1 |
N7-S is an updated version of the predicate device B with an addition of a leg massaging feature. Therefore, it is used as a secondary predicate device.
5. Description of the Device
The N7-S is a multi-function physical therapy device offering muscle relaxation through heat therapy and massage.
It has an internal heating unit (smart module), and this module, equipped with four individual heating elements, delivers targeted heat therapy to the cervical, thoracic, and lumbar vertebrae. An auxiliary heating unit is used for the heating units located on both arms to boost the heating effect. For more focused heat therapy and massage, 9-ball projector, Abdominal heating pad are also available. Additionally, it includes an air massager module that features air compression technology to deliver a relaxing and therapeutic massage.
6. Indications for Use
The intended use of the N7-S 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 air massager module of N7-S is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading and stroking of tissues by using an inflatable garment.
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Image /page/6/Picture/0 description: The image shows the logo for Nuga Best. The logo consists of a pink circular graphic on the left, followed by the text "NUGA BEST" in blue. The word "BEST" is slightly smaller and has a registered trademark symbol next to it.
7. Determination of Substantial Equivalence
7.1. Multi-Function Physical Therapy Table
| Name | Subject device | Predicate device A | Predicate device B | SEdecision |
|---|---|---|---|---|
| DeviceName | N7-S | CGM MB-1701 & CGMMB-1702 | N5-1 | - |
| ProductCode | JFB, IRP | JFB, IRP | JFB, ILY, ISA | - |
| Manufacturer | NUGA MEDICAL Co.,Ltd. | CERAGEM Co, Ltd. | NUGA MEDICAL Co.,Ltd. | - |
| 510(k) No. | - | K220572 | K153054 | - |
| Indicationsfor use | The intended use of theN7-S is to providepatients with musclerelaxation therapy bydelivering heat andsoothing massage.Additionally, it providestopical heating for;- Temporary relief ofminor muscle and jointpain, and stiffness.- Temporary relief ofminor joint painassociated with arthritis.- The temporary increasein local circulation whereapplied.- Relaxation of muscle.The air massager moduleof the N7-S is indicatedfor the temporary reliefof minor muscle achesand pains and fortemporary increase inblood circulation to thetreated areas.The air massager moduleof the N7-S stimulateskneading and stroking oftissues by using aninflatable garment. | The intended use of theCeragem AutomaticThermal Massager, ModelCGM MB-1701 & CGMMB-1702 is to providepatients with musclerelaxation therapy bydelivering heat andsoothing massage.Additionally, it providestopical radiant infraredheat for;- Temporary relief ofminor muscle and jointpain, and stiffness.- Temporary relief ofminor joint pain associatedwith arthritis.- The temporary increasein local circulation whereapplied.- Relaxation of muscle.The Air Massager (OnlyCGM MB-1701) isindicated for the temporaryrelief of minor muscleaches and pains and fortemporary increase inblood circulation to thetreated areas. The Air CellMassager stimulateskneading and stroking oftissues by using aninflatable garment. | The intended use of theN5-1 is to providepatients with musclerelaxation therapy bydelivering heat andsoothingmassage. Additionally,it provides topicalheating for;-Temporary relief ofminor muscle and jointpain, and stiffness.- Temporary relief ofminor joint painassociated witharthritis.- The temporaryincrease in localcirculation whereapplied.- Relaxation of muscle. | Same withPredicatedevice A |
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Image /page/7/Picture/0 description: The image contains the logo for Nuga Best. The logo consists of a stylized graphic of two figures in pink, followed by the text "NUGA BEST" in blue. The word "BEST" is followed by a trademark symbol.
| Name | Subject device | Predicate device A | Predicate device B | SEdecision |
|---|---|---|---|---|
| Components | Main Table | Main Table | Main assembly (Mat) | SimilarwithPredicatedevice A |
| Remote Control | Remote Control | Remote controller | ||
| 9-ball projector | 3-Sphere projector | 5-ball Projector | ||
| Abdominal heat pad | Abdominal VibrationProjector | - | ||
| Power cord | Power cord | - | ||
| Outer fabric | Outer fabric | - | ||
| Headrest | Head cushion | - | ||
| Air Cell Massager | Air Cell Massager | - | ||
| - | Supporting Mat | - | ||
| Projector Cover | Projector Cover | - | ||
| Auxiliary Heating Part | - | Auxiliary Heating Part |
The subject device includes all external components that predicate device A has.
However, the subject device has the following differences:
Abdominal Heat Pad: The Abdominal Heat Pad of the subject device is equivalent to the heating function of the Abdominal Vibration Projector of predicate device A.
The headrest in the subject device corresponds to the head cushion in the predicate device A.
The subject device includes all components that predicate device B has.
Auxiliary Heating Unit: Both the subject device and the predicate device B include an Auxiliary Heating Unit in the Main Table Unit. The two devices use the same heating wire.
The aforementioned minor differences do not affect the safety and effectiveness of the device.
| RemoteControl | Yes | Yes | Yes | Same |
|---|---|---|---|---|
| OperationMethod | Auto / Manual | Auto / Manual | Auto / Manual | Same |
| HeatingDeviceVoltage | 12V | 24V | N/A | Different |
| HeatingDevicePower | 8W | 28.8V | N/A | Different |
There is a difference in the voltage and power of the heating device between the subject device and the predicate devices. However, while having higher voltage and power than equivalent devices may pose a risk, lower values are safe. Additionally, there is no difference in thermal performance compared to predicate devices, and they are substantially equivalent. Therefore, these differences do not affect safety or efficacy.
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| Name | Subject device | Predicate device A | Predicate device B | SEdecision |
|---|---|---|---|---|
| TemperatureRange | - Main Table: 40°C-60°C(104°F-140°F)-Auxiliary: 30°C-60°C(86°F-140°F)-External: 30°C-60°C(86°F-140°F) | -External, Main, Auxiliary:30°C-60°C (86°F-140°F) | -External, Main,Auxiliary:40°C-60°C(104°F-140°F) | MainTable unitsame withpredicatedevice BAuxiliaryandExternalunit samewithpredicatedevice A |
| ExtraOverheatingProtection | Yes | Yes | Yes | Same |
| TemperatureSensor | Thermistor | Thermistor | Thermistor | Same |
| Heating part | Internal projector(Smartmodule) | Internal projector | Internal projector | Same |
| Auxiliary Heating Part9-ball projector | Internal heating element3-Sphere projector | Auxiliary Heating Part5-ball Projector | ||
| Abdominal heat pad | Abdominal VibrationProjector | - | ||
| Mode | 10 Automatic Modes10 Intensive ModesManual ModeProjector ModeAir Massage Mode | Mode A16 ModesIntensive ModeSemi-Automatic ModeSemi-Automatic MasterModeManual ModeManual Master ModeAbdominal VibrationProjector ModeAir Massage Mode | Manual Mode and AutoMode | Similar |
The foundations for both automatic mode and manual mode are the same.
These differences are not sigmificant changes since they are additional features for user convenience and do not raise any questions about safety or effectiveness.
7.2. The air massager
| Name | Subject device | Predicate device A | SE decision |
|---|---|---|---|
| Device Name | N7-S | CGM MB-1701 & CGM MB-1702 | - |
| Product Code | JFB, IRP | JFB, IRP | - |
| Manufacturer | NUGA MEDICAL Co., Ltd. | CERAGEM Co, Ltd. | - |
| Name | Subject device | Predicate device A | SE decision |
| 510(k) No. | - | K220572 | - |
| Output pressurerange | 30~140 mmHg | 48~240 mmHg | Different |
| Air pressurelevel | 8 levels settings:Level 1 : 30 mmHgLevel 2 : 60 mmHgLevel 3 : 80 mmHgLevel 4 : 90 mmHgLevel 5 : 110 mmHgLevel 6 : 120 mmHgLevel 7 : 130 mmHgLevel 8 : 140 mmHg | 9 levels settings:Level 1 : 48mmHgLevel 2 : 72mmHgLevel 3 : 96mmHgLevel 4 : 120mmHgLevel 5 : 144mmHgLevel 6 : 168mmHgLevel 7 : 192mmHgLevel 8 : 216mmHgLevel 9 : 240mmHg | Different |
| The air pressure levels of the subject device are divided into 8 levels whereas the predicate device's air pressurelevels are divided into 9 levels. The minimum and maximum pressure level of the subject is significantly lowerthan the predicate device, so there is no safety issue concerned and as for the efficacy, it remains valid since itsperformance has been demonstrated by the performance testing data included in this submission. | |||
| Mode types | Auto/Manual | Sequential/Peristaltic | Similar |
| Sequential mode of predicate device can be substituted through the Manual mode for each chamber of the subjectdevice, and the Peristaltic mode can be substituted through the function of evenly applying air pressure to eachpart through the Auto mode of the subject device, with the cycle starting accordingly. So, these similarities do notaffect safety and effectiveness. | |||
| Therapy time | 15 or 30 minutes | 18 minutes | Different |
| The predicate device applies a maximum pressure of 240 mmHg for a treatment duration of up to 18 minutes,while the subject device employs a maximum pressure of 160 mmHg for a 30-minute treatment. The extendedtreatment duration does not necessarily impact safety and efficacy. However, despite the lower pressure in thesubject device, the longer treatment time requires caution regarding blood pressure elevation. Consequently,precautions for using the Air Massage Mode are provided in User Manual page 6, taking into consideration thedifferences from the predicate device. | |||
| Deflation time | 4~8s | 1~10s | Different |
| Name | Subject device | Predicate device A | SE decision |
| The deflation time of the subject device falls within the range of the predicate device, so these differences do notimpact safety and efficacy. | |||
| Number ofchambers | 5 Chambers | 4 Chambers | Different |
| Even though the number of chambers in the subject device differs from the predicate device (having one morechamber), the chamber count only determines the applicable treatment site with subtle differences. Moreover,since the "applicable treatment site" and "usage instructions" of the subject device fall within the same range asthe predicate device, these differences do not impact safety and effectiveness. | |||
| Number oftreatment mode | 3 modes | 3 modes | Same |
| Name | Subject device | Predicate device A | SE decision |
| Modes(Visual description) | Image: Single Chamber Mode with numbers 1, 2, 3, 4, 5Single Chamber mode operateswith the chamber marked in red inthe photo above. When the motionstarts, the air pressure graduallyrises to the set level and then thepressure decreases. When thepressure is reduced, the cyclebegins again.Image: Dual Chamber Mode with numbers 1, 2, 3, 4, 5Dual Chamber mode operates withthe chamber marked in red in thephoto above. When the motionstarts, the air pressure graduallyrises to the set level and then thepressure decreases. When thepressure is reduced, the cyclebegins again.Image: Quintuple Chamber Mode with numbers 1, 2, 3, 4, 5Quintuple Chamber mode operateswith the chamber marked in red inthe photo above. When the motionstarts, the air pressure graduallyrises to the set level and then thepressure decreases. When thepressure is reduced, the cyclebegins again. | Image: Predicate device A with numbers 4, 3, 2, 1Mode 1:Starting with the foot chamber andprogressing up the thigh chamber,each section compresses and thepressure gradually rises to the pre-determined air pressure level, thendecompresses and the air pressuredrops. Once the thigh sectiondecompresses, the cycle beginsagain.Mode 2:Starting with the foot chamber andprogressing up the thigh, eachsection compresses, and thepressure gradually rises to the pre-determined air pressure level, holdsthe air until the entire garment iscompressed. All four sections thendecompress simultaneously, and theair pressure drops, then cycle beginsagain.Mode 3:Start between the foot chamber tothe thigh chamber except for No. 4chamber. And No.4 chamber iscompressed while the otherchambers are maintained. After thatall four sections decompresssimultaneously and the air pressuredrops, then cycle begins again. Thissequence is similar to the Mode 2. | Different |
| The subject device allows selecting modes for each specific area, while the predicate device offers a mode | |||
| Name | Subject device | Predicate device A | SE decision |
| Sleeve Material | Oxford and Nylon | Oxford and Nylon | Same |
| Patient contact | Non-conductive attachments | Non-conductive attachments | Same |
| Size andappearance ofsleeves (leg part) | Image: Subject device diagram | Image: Predicate device A diagram | Different |
| One size: 93.6*33.5cm | One size: 28*58.4cm | ||
| Size and appearance of sleeves (leg part): Slight differences of size and appearance of the sleeves do not raiseany safety or efficacy issues. | |||
| Safety Features | Power On/off allows user to stoptherapy session at any time | Power On/off and mode start/pausebutton allows user to stop therapysession at any time | Different |
| The pause function of the predicate device can be replaced with the power-off function in the subject device.This is simply a different type of feature, and both operate as safety features. Therefore, this difference do notraise any concerns regarding safety and efficacy. | |||
| Transportation& Storageenvironment | Temperature: -25°C to 70°CHumidity: 15% to 90%Atmospheric pressure: 700hPa -1060hPa | Temperature: -20°C to 60°CHumidity: 10% to 95%Atmospheric pressure: 500hPa -1060hPa | Different |
| The differences in the Transportation & Storage environment do not impact safety and efficacy. It remains validsince its performance has been demonstrated by the Medical Electrical Safety performance testing data includedin this submission. |
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Image /page/9/Picture/0 description: The image contains the logo for "NUGA BEST". The logo consists of a circular graphic on the left, featuring stylized figures in pink. To the right of the graphic is the text "NUGA BEST" in a bold, blue sans-serif font, with a trademark symbol after the word "BEST".
185, Jiraeul-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Korea
Tel: +82 33 730 0001 / Fax: +82 33 730 0001 / Fax: +82 33 730 0008
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Image /page/10/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a pink circle with two white figures inside, followed by the words "NUGA BEST" in blue, bold letters. The "BEST" portion of the name has a small trademark symbol next to it.
185, Jiraeul-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Korea
Tel: +82 33 730 0001 / Fax: +82 33 730 0001 / Fax: +82 33 730 0008
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Image /page/11/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a pink circle with white figures inside, followed by the words "NUGA BEST" in blue, bold letters. A small trademark symbol appears next to the word BEST.
selection for massaging from the foot to the thigh chamber. However, there is no difference in the way the air pressure drops, and the next cycle begins. Since the treatment area is the same, these differences do not impact safety and effectiveness.
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Image /page/12/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a pink circular graphic on the left and the text "NUGA BEST" in blue on the right. The graphic appears to be two figures reaching towards each other.
Based on the test results submitted in this 510(k), we compared N7-S with two predicate devices, CGM MB-1701, CGM MB-1702 (K220572) and N5-1 (K153054). The comparative analysis revealed differences in components, operating modes, and voltage and power of heating devices. However, based on the submitted test results, these differences do not raise any new or different questions about safety or effectiveness.
The Indications for use of the subject device is similar as Predicate Device A and supported by the IFU of Predicate Device B, and the temperature range of the main table unit is the same as that of Predicate Device B, while the temperature range of auxiliary and external unit is the same as Predicate Device A.
The air massager has been compared with both the subject device and the corresponding parts of predicate device A. When comparing the two devices, the two devices have in indications for use, patient contact, mode types, and sleeve material, while there are minor differences in detailed operational functions such as air pressure level and therapy time. However, these differences do not significantly impact the safety and efficacy of this air massager part, and the performance related to the differences has been confirmed in the performance test data included in this submission.
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Image /page/13/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a pink circular graphic on the left, followed by the text "NUGA BEST" in blue. The graphic appears to depict two stylized figures reaching upwards, and the text is bold and slightly italicized.
In addition, the subject device is equivalent to the predicate devices in terms of indications for user interface, functions, and technical characteristics. Therefore, we conclude that the subject device is substantially equivalent to the predicate device.
Non-Clinical Test Summary
Biocompatibility
The N7-S follows the FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Appendix G, which outlines a least burdensome approach, recommending the inclusion of specific material in premarket submissions in lieu of biocompatibility testing for these devices. In addition, the cover of the headrest component is identical to that which was cleared in Predicate device B.
This device was tested in accordance with the following standards:
-
ES60601-1:2005/(R)2012 A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-
IEC 60601-1-2 Edition 4.1 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
-
IEC TR 60601-4-2 Edition 1.0 Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
*Through the above standard, an Immunity performance test was performed and integrated with IEC 60601-1-2.
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IEC 60601-1-11 Edition 2.0 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance
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IEC 62304:2015 Edition 1.1 Medical device software - Software life cycle processes
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Image /page/14/Picture/0 description: The image contains the logo for NUGA BEST. The logo consists of a pink circular graphic on the left, which appears to depict stylized figures. To the right of the graphic, the words "NUGA BEST" are written in a bold, blue font. The "BEST" portion of the name has a trademark symbol next to it.
Performance Test
A comprehensive performance test was conducted on the subject device, including a pressure performance test of the Air Cell Massager, to substantiate its equivalence to the predicate device A(K220572). The evaluation of the following items revealed that the subject device met all applicable performance requirements and was substantial equivalent with predicate devices.
- Temperature Range
- . Extra Overheating
- Protection
- Temperature Sensor function
- Heating part
- . Skin surface temperature
- . Pressure performance of the Air cell massager
Clinical Test Summary
No clinical studies are considered necessary and performed.
Conclusion
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information and documents provided in this premarket notification NUGA MEDICAL Co., Ltd. concludes that the N7-S is substantially equivalent to predicate devices 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).