(110 days)
K#052340, K#024307
K#013192
No
The description focuses on standard physical therapy modalities (ultrasound, neuromuscular stimulation, therapeutic massager) and their hardware components. There is no mention of AI, ML, or any software features that would suggest intelligent data processing or learning.
Yes
The "Intended Use / Indications for Use" section explicitly lists therapeutic applications for Therapeutic Ultrasound, Neuromuscular Stimulation, and Therapeutic Massager components of the device, all of which aim to treat medical conditions or alleviate symptoms.
No
The Intended Use/Indications for Use section lists therapeutic applications such as pain relief, reduction of muscle spasm, increase of blood flow, and muscle re-education, but no diagnostic purposes.
No
The device description explicitly lists multiple hardware components including a system console, control electrodes, a control and display panel, muscle stimulator electrodes, ultrasound transducers, acoustic gel, and a vacuum treatment roller head. While software is mentioned as part of the system console, the device is clearly a combination of hardware and software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's functions are related to therapeutic ultrasound, neuromuscular stimulation, and therapeutic massage. These are all external, non-invasive treatments applied to the body.
- Intended Use: The intended uses listed are for pain relief, muscle treatment, blood flow increase, and range of motion improvement. None of these involve analyzing biological samples.
- Device Components: The components listed (console, electrodes, transducers, gel, vacuum roller head) are consistent with devices used for physical therapy and massage, not for analyzing biological specimens.
The device's purpose is to provide physical therapy and massage treatments, not to diagnose conditions by analyzing samples from the body.
N/A
Intended Use / Indications for Use
The TNN-DU810 Non-Invasive Subdermal Therapy System is indicated for:
Therapeutic Ultrasound:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase of blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques
Neuromuscular Stimulation:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions
-
- Muscle re-education
-
- Maintaining or increasing range of motion
Therapeutic Massager:
-
- Relieves muscle spasms
-
- Provides temporary relief of minor muscle aches and pains
-
- Temporarily improves local blood circulation
-
- Temporarily reduces the appearance of cellulite
Product codes (comma separated list FDA assigned to the subject device)
IMG, IMG, IMI, IPF, LIH and ISA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed: Performance testing to include: Air Flow Testing, Vacuum Pressure Testing, Timer Testing, etc. Also conducted: Electrical Safety Testing, EMC Testing, Risk Analysis, etc.
Clinical Tests Performed: Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#052340, K#024307
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K#013192
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase of blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques
Neuromuscular Stimulation:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions
-
- Muscle re-education
-
- Maintaining or increasing range of motion
Therapeutic Massager:
-
- Relieves muscle spasms
-
- Provides temporary relief of minor muscle aches and pains
-
- Temporarily improves local blood circulation
-
- 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 | |
| Subdermal Therapy System, | Dermosonic Non-Invasive Subdermal | |
| Therapy System | ||
| Intended use | Therapeutic vacuum Massager, | |
| Ultrasonic Diathermy and | ||
| neuromuscular stimulation, | ||
| including: temporarily improvement | ||
| local blood circulation and | ||
| temporarily reduction the | ||
| appearance of cellulite | Therapeutic vacuum Massager and | |
| Ultrasonic Diathermy, including: | ||
| temporarily improvement local blood | ||
| circulation and temporarily reduction the | ||
| appearance of cellulite | ||
| Design | 1 model | |
| 2 ultrasound applicators | ||
| 4 conductive electrodes | ||
| 1 vacuum treatment roller head | 1 model | |
| 1 ultrasound applicators | ||
| 3 vacuum treatment roller head | ||
| Specifications | Ground current leakage |