TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM

{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 - 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 {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 comparison | Claimed device | Predicate device 2 | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K # | K052340 | K024307 | | Device Name | TNN-DU810 Non-Invasive<br>Subdermal Therapy System, | Dermosonic Non-Invasive Subdermal<br>Therapy System | | Intended use | Therapeutic vacuum Massager,<br>Ultrasonic Diathermy and<br>neuromuscular stimulation,<br>including: temporarily improvement<br>local blood circulation and<br>temporarily reduction the<br>appearance of cellulite | Therapeutic vacuum Massager and<br>Ultrasonic Diathermy, including:<br>temporarily improvement local blood<br>circulation and temporarily reduction the<br>appearance of cellulite | | Design | 1 model<br>2 ultrasound applicators<br>4 conductive electrodes<br>1 vacuum treatment roller head | 1 model<br>1 ultrasound applicators<br>3 vacuum treatment roller head | | Specifications | Ground current leakage <40<br>micamp. | Not specified | | Performance | Use friendly interface, easy to<br>operate | Use friendly interface, easy to operate | | Frequency | 1 MHz±5%<br>3 MHz±5% | 1 MHz±3%<br>3 MHz±3% | | Modes | Continuous | Continuous<br>Pulsed - 5% duty cycle<br>Pulsed - 10% duty cycle<br>Pulsed - 20% duty cycle | | Maximum Intensity | 1.5 W/cm² | 2 W/cm² | | Maximum Treatment<br>Time | 30 minutes - ultrasound<br>30 minutes - electrical stimulation<br>40 minutes - suction treatment | 30 minutes - ultrasound therapy<br>99 minutes - suction treatment | | Classification | Protective Class I Equipment | Protective Class I Equipment | | Type of applied part | BF type | BF type | | Vacuum treatment<br>mode | Continuous or pulsed | Continuous or pulsed | | Depression level | Pulse mode -820 mbar maximum<br>continuous mode- 125-210mbar | Pulse mode -820 mbar maximum<br>continuous mode- 125-210mbar | | Vacuum treatment<br>roller head | 61.452 - Dermasonic | 61.452 - Dermasonic | | | Each of the two components of the<br>system (ultrasound+<br>Neuromuscular Stimulation) and<br>the Therapeutic Massager function<br>independently and have no<br>connection between them. | Each of the two components of the system<br>(ultrasound) and the Therapeutic Massager<br>function independently and have no<br>connection between them. | | Relaxation time | 0.36, 0.72, 1.08 or 1.44 sec | 0.36, 0.72, 1.08 or 1.44 sec | | Suction time | 0.36, 0.72, 1.08, 1.44, 1.80. 2.16,<br>2.52, 2.88 or 3.24 sec | 0.36, 0.72, 1.08, 1.44, 1.80. 2.16, 2.52, 2.88<br>or 3.24 sec | | Vacuum Pressure | 55, 80, 105, 125, 145, 160.185, 210, 240, 260, 260, 280, 310, 330, 365,440, 510, 615, 715 or 820 Mbar | 55, 80, 105, 125, 145, 160.185, 210, 240, 260, 260, 280, 310, 330, 365,440, 510, 615, 715 or 820 Mbar | | Air Flow | 3500 l/hour | 3500 l/hour | | Treatment time -<br>therapeutic vacuum<br>massager | 1 to 99 minutes | 1 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 - 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 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