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K Number
K063728
Device Name
TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
Manufacturer
ALFA TECH MEDICAL SYSTEMS, LTD.
Date Cleared
2007-04-04

(110 days)

Product Code
IMG,IMI,IPF,ISA,LIH
Regulation Number
890.5860
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Therapeutic Ultrasound:

  1. Pain relief
  2. Reduction of muscle spasm
  3. Localized increase of blood flow
  4. Increase range of motion of contracted joints using heat and stretch techniques

Neuromuscular Stimulation:

  1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
  2. Temporary relaxation of muscle spasm
  3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
  4. Increase of blood flow in the treatment area.
  5. Prevention or retardation of disuse atrophy in post-injury type conditions
  6. Muscle re-education
  7. Maintaining or increasing range of motion

Therapeutic Massager:

  1. Relieves muscle spasms
  2. Provides temporary relief of minor muscle aches and pains
  3. Temporarily improves local blood circulation
  4. Temporarily reduces the appearance of cellulite
Device Description

The TNN-DU810 Non-Invasive Subdermal Therapy System is comprised of the following main components:
A system console including software and control electrodes;
A control and display panel: .
Device accessories including muscle stimulator electrodes (ME2221, Mettler Corp., K#013192) and cables, ultrasound transducers (applicators) (ME7513, Mettler Corp.) acoustic gel (Sonigel, Mettler Corp), and cables. The electrodes. ultrasound transducers and acoustic gel have all been cleared under the Mettler Electronics Corp. 510(k). Also included is a Dermosonic vacuum treatment roller head, cleared under the Dermosonic device. K024307.
The TNN-DU810 device has dual frequencies ultrasound therapy, muscle stimulator systems and therapeutic vacuum massager.
The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The system consists of the Alfatech DU857 device (K#052340) and the Dermosonic Therapeutic Vacuum Applicator, a component cleared in the Dermosonic K#024307 ..
The frequency Ultrasound Therapy, Muscle Stimulator System is identical to the DU857. It is important to note that there is no electric connection between the ultrasound therapy, muscle stimulator system and the therapeutic vacuum massager.
Each of the two components of the system (ultrasound plus neuromuscular stimulation) and the therapeutic massager function independently and have no connection between them.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the TNN-DU810 Non-Invasive Subdermal Therapy System:

Summary of Device Performance and Acceptance Criteria:

The provided document is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically demonstrated by showing substantial equivalence to a legally marketed predicate device, rather than explicit quantitative performance metrics against pre-defined thresholds. The device aims to achieve similar functionality and safety as the predicate devices.

The "acceptance criteria" can be inferred from the comparison table (Table 1) and the overall conclusion of substantial equivalence. The device is 'accepted' if it can demonstrate equivalent characteristics and performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Item for ComparisonAcceptance Criteria (Predicate Device)Reported Device Performance (TNN-DU810)
Intended UseTherapeutic vacuum Massager and Ultrasonic Diathermy, including: temporarily improvement local blood circulation and temporarily reduction the appearance of cellulite.Therapeutic vacuum Massager, Ultrasonic Diathermy and neuromuscular stimulation, including: temporarily improvement local blood circulation and temporarily reduction the appearance of cellulite. (Note: Added neuromuscular stimulation to intended use compared to Predicate 2)
Design1 model, 1 ultrasound applicators, 3 vacuum treatment roller head1 model, 2 ultrasound applicators, 4 conductive electrodes, 1 vacuum treatment roller head
SpecificationsNot specifiedGround current leakage <40 micamp.
Performance (User Interface)Use friendly interface, easy to operateUse friendly interface, easy to operate
Frequency1 MHz±3%, 3 MHz±3%1 MHz±5%, 3 MHz±5% (Note: Slightly wider tolerance than Predicate 2)
Modes (Ultrasound)Continuous, Pulsed - 5% duty cycle, Pulsed - 10% duty cycle, Pulsed - 20% duty cycleContinuous (Note: Fewer pulsed modes than Predicate 2)
Maximum Intensity2 W/cm²1.5 W/cm² (Note: Lower maximum intensity than Predicate 2)
Maximum Treatment Time30 minutes - ultrasound therapy, 99 minutes - suction treatment30 minutes - ultrasound, 30 minutes - electrical stimulation, 40 minutes - suction treatment (Note: Added electrical stimulation time, shorter suction time than Predicate 2)
ClassificationProtective Class I EquipmentProtective Class I Equipment
Type of Applied PartBF typeBF type
Vacuum Treatment ModeContinuous or pulsedContinuous or pulsed
Depression LevelPulse mode -820 mbar maximum, continuous mode- 125-210mbarPulse mode -820 mbar maximum, continuous mode- 125-210mbar
Vacuum Treatment Roller Head61.452 - Dermasonic61.452 - Dermasonic
Component IndependenceEach of the two components of the system (ultrasound) and the Therapeutic Massager function independently and have no connection between them.Each of the two components of the system (ultrasound + Neuromuscular Stimulation) and the Therapeutic Massager function independently and have no connection between them. (Note: Added Neuromuscular Stimulation to independent components)
Relaxation Time0.36, 0.72, 1.08 or 1.44 sec0.36, 0.72, 1.08 or 1.44 sec
Suction Time0.36, 0.72, 1.08, 1.44, 1.80. 2.16, 2.52, 2.88 or 3.24 sec0.36, 0.72, 1.08, 1.44, 1.80. 2.16, 2.52, 2.88 or 3.24 sec
Vacuum PressureRanges from 55 to 820 Mbar (20 distinct values)Ranges from 55 to 820 Mbar (20 distinct values)
Air Flow3500 l/hour3500 l/hour
Treatment Time - Therapeutic Vacuum Massager1 to 99 minutes1 to 99 minutes

Rationale for "Acceptance": The document concludes that the TNN-DU810 device is "substantially equivalent" to the predicate device (K#024307) in design and function, particularly noting the use of the predicate's rollers and vacuum suction components to achieve increased blood flow and temporarily reduce the appearance of cellulite. The FDA accepted this submission (K063728) based on this demonstration of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

  • Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This is a premarket notification based on substantial equivalence, not a clinical trial with a defined test set of patients or images. The "test set" here refers to the performance characteristics compared with the predicate device.
  • Data Provenance: Not applicable. The "data" consists of the device's technical specifications and a comparison to predicate devices, along with non-clinical testing results. There is no mention of patient data, clinical images, or country of origin for such data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

  • Number of Experts: Not applicable. This submission does not involve expert-established ground truth for a clinical test set.
  • Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set:

  • Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

  • MRMC Study: No. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This device's clearance was based on substantial equivalence to predicate devices and non-clinical performance testing, not a comparative effectiveness study involving human readers or AI assistance.
  • Effect Size of AI Improvement: Not applicable.

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

  • Standalone Performance: Not applicable. This device is a physical therapy system, not an AI algorithm.

7. The Type of Ground Truth Used:

  • Type of Ground Truth: Not applicable. In the context of a 510(k) for substantial equivalence, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate devices, as demonstrated through their own prior clearances and regulatory compliance. For the TNN-DU810, the "ground truth" for its performance claims (e.g., vacuum pressure, frequency) would be verified through non-clinical laboratory testing against its own specifications, which are compared to the predicate's specifications.

8. The Sample Size for the Training Set:

  • Sample Size for Training Set: Not applicable. This device does not involve machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set was Established:

  • Ground Truth for Training Set: Not applicable.

{0}------------------------------------------------

APR 4 - 2007

Exhibit #1

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510 (k) numbers is:_

1. Submitter's Identification:

Alfa Tech Medical Systems Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam lsrael

Date Summary Prepared: March 12, 2007

Contact Persons:

Mr. Ilan Feferberg COO Alfa Tech Medical Systems, Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam Israel + 972-3 5049039 Tel: + 972-3 5049039 Fax: E-mail: imft@zahav.net.il

Mr. Yossi Ben David Alfa Tech QA Manager + 972-9 7711018 Tel: + 972-9 7711019 Fax: E-mail: yossi@ordos.co.il

2. Name of the Device:

  • a. TRADE NAME: The TNN-DU810 Non-Invasive Subdermal Therapy System
  • b. CLASSIFIČATION NAME: Ultrasonic Diathermy/Muscle Stimulator/Therapeutic Massager

{1}------------------------------------------------

  • Common or Usual Name: Ultrasound Diathermy/Powered Muscle Stimulator and 3. Therapeutic Massager.
  • Predicate Devices Information: 4.
    • AlfaTech Medical Systems, Ltd. The DU857 Dual Frequency Ultrasound Therapy . and Muscle Stimulator System, K#052340.
    • . Sybaritic Inc., Dermosonic Non-Invasive Subdermal Therapy System, K#024307.

Device Description: 5.

י

The TNN-DU810 Non-Invasive Subdermal Therapy System is comprised of the following main components:

  • . A system console including software and control electrodes;
  • A control and display panel: .
  • Device accessories including muscle stimulator electrodes (ME2221, Mettler . Corp., K#013192) and cables, ultrasound transducers (applicators) (ME7513, Mettler Corp.) acoustic gel (Sonigel, Mettler Corp), and cables. The electrodes. ultrasound transducers and acoustic gel have all been cleared under the Mettler Electronics Corp. 510(k). Also included is a Dermosonic vacuum treatment roller head, cleared under the Dermosonic device. K024307.

The TNN-DU810 device has dual frequencies ultrasound therapy, muscle stimulator systems and therapeutic vacuum massager.

The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.

The system consists of the Alfatech DU857 device (K#052340) and the Dermosonic Therapeutic Vacuum Applicator, a component cleared in the Dermosonic K#024307 ..

The frequency Ultrasound Therapy, Muscle Stimulator System is identical to the DU857. It is important to note that there is no electric connection between the ultrasound therapy, muscle stimulator system and the therapeutic vacuum massager.

Each of the two components of the system (ultrasound plus neuromuscular stimulation) and the therapeutic massager function independently and have no connection between them.

{2}------------------------------------------------

Intended Use: 6.

Therapeutic Ultrasound:

    1. Pain relief
    1. Reduction of muscle spasm
    1. Localized increase of blood flow
    1. Increase range of motion of contracted joints using heat and stretch techniques

Neuromuscular Stimulation:

    1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
    1. Temporary relaxation of muscle spasm
    1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
    1. Increase of blood flow in the treatment area.
    1. Prevention or retardation of disuse atrophy in post-injury type conditions
    1. Muscle re-education
    1. Maintaining or increasing range of motion

Therapeutic Massager:

    1. Relieves muscle spasms
    1. Provides temporary relief of minor muscle aches and pains
    1. Temporarily improves local blood circulation
    1. Temporarily reduces the appearance of cellulite

{3}------------------------------------------------

Comparison to Predicate Devices: 7.

Comparison of technological characteristics to a legally marketed predicate device is given in the table below:

Table 1. Comparison of general characteristics to legally marketed predicate Dermosonic Non-Invasive Subdermal Therapy System:

System.

Item for comparisonClaimed devicePredicate device 2
510K #K052340K024307
Device NameTNN-DU810 Non-InvasiveSubdermal Therapy System,Dermosonic Non-Invasive SubdermalTherapy System
Intended useTherapeutic vacuum Massager,Ultrasonic Diathermy andneuromuscular stimulation,including: temporarily improvementlocal blood circulation andtemporarily reduction theappearance of celluliteTherapeutic vacuum Massager andUltrasonic Diathermy, including:temporarily improvement local bloodcirculation and temporarily reduction theappearance of cellulite
Design1 model2 ultrasound applicators4 conductive electrodes1 vacuum treatment roller head1 model1 ultrasound applicators3 vacuum treatment roller head
SpecificationsGround current leakage <40micamp.Not specified
PerformanceUse friendly interface, easy tooperateUse friendly interface, easy to operate
Frequency1 MHz±5%3 MHz±5%1 MHz±3%3 MHz±3%
ModesContinuousContinuousPulsed - 5% duty cyclePulsed - 10% duty cyclePulsed - 20% duty cycle
Maximum Intensity1.5 W/cm²2 W/cm²
Maximum TreatmentTime30 minutes - ultrasound30 minutes - electrical stimulation40 minutes - suction treatment30 minutes - ultrasound therapy99 minutes - suction treatment
ClassificationProtective Class I EquipmentProtective Class I Equipment
Type of applied partBF typeBF type
Vacuum treatmentmodeContinuous or pulsedContinuous or pulsed
Depression levelPulse mode -820 mbar maximumcontinuous mode- 125-210mbarPulse mode -820 mbar maximumcontinuous mode- 125-210mbar
Vacuum treatmentroller head61.452 - Dermasonic61.452 - Dermasonic
Each of the two components of thesystem (ultrasound+Neuromuscular Stimulation) andthe Therapeutic Massager functionindependently and have noconnection between them.Each of the two components of the system(ultrasound) and the Therapeutic Massagerfunction independently and have noconnection between them.
Relaxation time0.36, 0.72, 1.08 or 1.44 sec0.36, 0.72, 1.08 or 1.44 sec
Suction time0.36, 0.72, 1.08, 1.44, 1.80. 2.16,2.52, 2.88 or 3.24 sec0.36, 0.72, 1.08, 1.44, 1.80. 2.16, 2.52, 2.88or 3.24 sec
Vacuum Pressure55, 80, 105, 125, 145, 160.185, 210, 240, 260, 260, 280, 310, 330, 365,440, 510, 615, 715 or 820 Mbar55, 80, 105, 125, 145, 160.185, 210, 240, 260, 260, 280, 310, 330, 365,440, 510, 615, 715 or 820 Mbar
Air Flow3500 l/hour3500 l/hour
Treatment time -therapeutic vacuummassager1 to 99 minutes1 to 99 minutes

{4}------------------------------------------------

Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence as follows:

Performance testing to include: Air Flow Testing, Vacuum Pressure Testing, Timer Testing, etc. Also conducted: Electrical Safety Testing, EMC Testing, Risk Analysis, etc.

Discussion of Clinical Tests Performed: 9.

Not Applicable

10. Conclusions:

·

The subject TNN-DU810 device is substantially equivalent to the predicate device (K#024307) in design and function, (using the predicate's own rollers and vacuum suction components) thereby achieving increased blood flow and therefore achieving temporary reduction in the appearance of cellulite.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 4 - 2007

Alfa Tech Medical Systems, Ltd. % MDI Consultants, Inc. Ms. Susan D. Goldstein-Faulk Official Correspondent 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K063728

Trade/Device Name: TNN-DU810 Subdermal Therapy System Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, IMG, IMI, IPF, LIH and ISA Dated: March 15, 2007 Received: March 16, 2007

Dear Ms. Goldstein-Faulk:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{6}------------------------------------------------

Page 2 - Ms. Susan D. Goldstein-Faulk

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerso Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Exhibit B

510(k) Number (if known): _

KO63728

1 Page 1 of of of

Device Name: The TNN-DU810 Non-Invasive Subdermal Therapy System

Indications For Use:

Therapeutic Ultrasound:

    1. Pain relief
    1. Reduction of muscle spasm
    1. Localized increase of blood flow
    1. Increase range of motion of contracted joints using heat and stretch techniques

Neuromuscular Stimulation:

    1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
    1. Temporary relaxation of muscle spasm
    1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
    1. Increase of blood flow in the treatment area.
    1. Prevention or retardation of disuse atrophy in post-injury type conditions
    1. Muscle re-education
    1. Maintaining or increasing range of motion

Therapeutic Massager:

    1. Relieves muscle spasms
    1. Provides temporary relief of minor muscle aches and pains
    1. Temporarily improves local blood circulation
    1. Temporarily reduces the appearance of cellulite

Prescription Use × (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
----------------------------------------------------------

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number /<063728

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.