(105 days)
Not Found
No
The description focuses on standard therapeutic ultrasound and neuromuscular stimulation functionalities controlled by a microprocessor and user interface, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly lists therapeuticapplications such as pain relief, reduction of muscle spasm, and increase of blood flow for both Therapeutic Ultrasound and Neuromuscular Stimulation.
No
Explanation: The device is described as a therapeutic ultrasound and muscle stimulator system intended for pain relief, reduction of muscle spasm, increased blood flow, and muscle re-education. Its stated uses are for treatment and rehabilitation, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a system console, control and display panel, electrodes, ultrasound applicators, acoustic gel, and cables. It is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed uses are all therapeutic applications (pain relief, muscle spasm reduction, blood flow increase, range of motion improvement, muscle re-education, etc.). These are treatments applied to the body, not tests performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a system for delivering therapeutic ultrasound and muscle stimulation. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD-related information: The document does not include any information typically found in IVD submissions, such as details about sample types, analytical methods, diagnostic performance metrics (sensitivity, specificity, etc.), or clinical studies focused on diagnosis or monitoring.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's purpose is to directly treat conditions through physical modalities.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IMG, IMI, IPF, LIH
Device Description
The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
- · A system console including software and control electronics;
- · A control and display panel;
· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.
The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment.
The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.
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
Physiotherapy clinics
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)
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.
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.
Not Found
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
EXHIBIT 1
DEC 9 2005
510(K) SUMMARY
This summary of 510(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) number is:________________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
Alfa Tech Medical Systems Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam Israel
Date Summary Prepared: 8 August 2005
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 DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System
- b. CLASSIFICATION NAME: Ultrasound and Muscle Stimulator
-
- Common or Usual Name: Ultrasound Diathermy/Powered Muscle Stimulator
Page 1 of 6
1
Predicate Devices Information: 4.
- . Mettler Electronics Corp., Sonicator Plus 930, Model ME 930 (K013192)
- ડ. Device Description: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
- · A system console including software and control electronics;
- · A control and display panel;
· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.
The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment.
The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.
6. Intended Use: (Same as those for predicate device)
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
2
Comparison to Predicate Devices: 7.
Comparison of technological characteristics to legally marketed predicate devices is given in the tables below:
Table 1. Comparison of general characteristics to legally marketed predicate
| Item for comparison | Description | Comments | |
|---|---|---|---|
| Claimed device | Predicate device | ||
| 510K # | Pending FDA 510(k) approval | K013192 | |
| Device Name | DU857 Dual Frequency | ||
| Ultrasound Therapy and | |||
| Muscle Stimulator System | Sonicator Plus 930 | ||
| Manufacturer | AlfaTech Medical Systems | ||
| Ltd. | Mettler Electronics | ||
| Intended use | Therapeutic Ultrasound and | ||
| Neuromuscular Stimulation | Therapeutic Ultrasound and | ||
| Neuromuscular Stimulation | |||
| Target population | Patients who need | ||
| physiotherapy treatment | Patients who need | ||
| physiotherapy treatment | |||
| Design | The concept is to combine | ||
| two kinds of physiotherapy | |||
| units in one device | The concept is to combine | ||
| two kinds of physiotherapy | |||
| units in one device | |||
| Materials | Metal enclosure | Metal enclosure | |
| Performance | Use friendly interface, easy to | ||
| operate | Use friendly interface, easy to | ||
| operate | |||
| Sterility | Sterilization is not used | Sterilization is not used | |
| Biocompatability | Yes | Yes | |
| Mechanical Safety | Compliant with mechanical | ||
| safety requirements of IEC | |||
| 60601-1, IEC 60601-2-5, IEC | |||
| 60601-2-10 safety standards | Compliant with mechanical | ||
| safety requirements of | |||
| UL2601-1, CSA C22.2 NO | |||
| 601.1-M90, IEC 60601-2-5, | |||
| IEC 60601-2-10 safety | |||
| standards | Mechanical safety | ||
| requirements of IEC60601-1 | |||
| and UL2601-1 are the same | |||
| except additional | |||
| requirements of UL2601-1 | |||
| cl.55 for polymeric covers. | |||
| These requirements are not | |||
| applicable for DU857 System | |||
| because such materials are | |||
| not used. | |||
| Chemical Safety | No chemical hazards | No chemical hazards | |
| Human Factors | For analysis see Risk | ||
| Management file | |||
| Energy delivered | The delivered energy is | ||
| limited according to | |||
| requirements of collateral IEC | |||
| 60601-2-5, IEC 60601-2-10 | |||
| safety standards | The delivered energy is | ||
| limited according to | |||
| requirements of collateral IEC | |||
| 60601-2-5, IEC 60601-2-10 | |||
| safety standards | The maximum DU857 | ||
| intensities in ultrasound and | |||
| electrotherapy treatment are | |||
| less than used in Sonicator | |||
| Plus 930, see table 2 | |||
| Compatibility with | |||
| environment and other | |||
| devices | The system is used inside | ||
| buildings. Interaction with | |||
| other devices is not | |||
| performed | The system is used inside | ||
| buildings. Interaction with | |||
| other devices is not | |||
| performed | |||
| Used at: (hospital, | |||
| home, ambulances) | Physiotherapy clinics | Physiotherapy clinics | |
| Standards met | IEC 60601-1, IEC 60601-2-5, | ||
| IEC 60601-2-10 | UL2601-1, CSA C22.2 NO | ||
| 601.1-M90, IEC 60601-2-5, | |||
| IEC 60601-2-10 | |||
| Electrical Safety | IEC 60601-1, IEC 60601-2-5, | ||
| IEC 60601-2-10 | UL2601-1, CSA C22.2 NO | ||
| 601.1-M90, IEC 60601-2-5, | |||
| IEC 60601-2-10 | |||
| Thermal Safety | IEC 60601-1, IEC 60601-2-5, | ||
| IEC 60601-2-10 | UL2601-1, CSA C22.2 NO | ||
| 601.1-M90, IEC 60601-2-5, | |||
| IEC 60601-2-10 | |||
| Radiation Safety | N/A | N/A | |
| Item for comparison | Claimed device | Predicate device | |
| 510K # | K013192 | ||
| Device Name | DU857 Dual Frequency Ultrasound | ||
| Therapy and Muscle Stimulator System | Sonicator Plus 930 | ||
| Manufacturer | AlfaTech Medical Systems Ltd. | Mettler Electronics | |
| Power Source | AC line | AC line | |
| Input: | 90-132VAC, 50-60Hz,4A; 207-264VAC, | ||
| 50Hz, 2A | 90-240VAC, 50-60Hz, 2.3A Nom | ||
| Classification | Protective Class I Equipment | Protective Class I Equipment | |
| Year 2000 Compliant | Yes | Yes | |
| Weight (lbs) | 165 | 10 | |
| Dimensions (in.) HxW xL | 67 in (H) x 26 in (W) x 35 in (D) | 6 in (H) x 12 in (W) x 12 in (D) | |
| Housing materials | Aluminum chassis | Aluminum chassis with ABS cover | |
| Construction | Folded into a specially designed cart | Folded into a box shape and seams | |
| welded & ground flush and a stylized ABS | |||
| cover screwed onto metal box | |||
| Operating temperature | +50°F to +86°F | ||
| +10°C to +30°C | +50°F to +104°F | ||
| +10°C to +40°C | |||
| Humidity | Operating, 30% to 75% Relative Humidity | ||
| at 86°F | |||
| Nonoperating, 20 to 80% Relative | |||
| Humidity, noncondensing | Operating, 30% to 75% Relative Humidity | ||
| at 104°F | |||
| Nonoperating, 5 to 95% Relative | |||
| Humidity, noncondensing | |||
| Storage temperature | 32°F to 113°F | ||
| 0°C to 45°C | -40°F to 167°F | ||
| -40°C to 75°C | |||
| Timer Accuracy | $\pm$ 5 seconds for all times range | $\pm$ 0.5 minutes for times less than 5 minutes | |
| $\pm$ 10% for times from 5 to 10 minutes | |||
| $\pm$ 1.0 minute for times greater than 10 | |||
| minutes | |||
| Maximum Treatment Time | 30 minutes - ultrasound or combination | ||
| therapy | |||
| 30 minutes - electrical stimulation | 30 minutes - ultrasound or combination | ||
| therapy | |||
| 60 minutes - electrical stimulation | |||
| Treatment Timer | Treatment time counts down to zero when | ||
| a time is set, or up to 30 minutes when no | |||
| time is set. The digital timer indicates the | |||
| remaining or elapsed treatment time | |||
| during the "Hold" period. | Treatment time counts down to zero when | ||
| a time is set, or up to 60 or 30 minutes | |||
| when no time is set. The digital timer | |||
| indicates the remaining or elapsed | |||
| treatment time during the "Hold" period. | |||
| Item for comparison | Neuromuscular Stimulation | ||
| 510K # | K013192 | ||
| Standards | |||
| UL544 | No | No | |
| UL2601-1-UL | No | Yes | |
| CUL | No | No | |
| CSA C22.2 NO 601.1- | |||
| M90 | No | Yes | |
| IEC 60601-1 | Yes | No | |
| IEC 60601-2-10 | Yes | Yes | |
| FCC Part 15-B | Yes | Yes | |
| EN-55011 (CISPR-11) | Yes | Yes | |
| FDA, 21 CFR 1050.10 | Yes | Yes | |
| MDD 93/42EEC, Annex II | Yes | Yes | |
| Timer settings | 1-30 minutes $\pm$ 1% | 1-60 minutes $\pm$ 5% | |
| Automatic Shut Off | Yes | Yes | |
| Number of output modes | 1 | 3 | |
| Channel(s) | 2 | 2 | |
| Synchronous | 1&2 | 1&2 | |
| Reciprocal | No | Yes | |
| Other | No | Yes | |
| Computerized Software | |||
| Provided | Yes | N/A |
3
Table 2. Comparison of technological characteristics to legally marketed predicate
Page 4 of 6
:
4
| Constant Current | No | Yes | |||
|---|---|---|---|---|---|
| Constant Voltage | No | No | |||
| Max Output Current (mA) | 0-36±10% mA RMS, max., | ||||
| 1Kohm load, Muscle Stimulator mode | 0-65±10% mA RMS, max., | ||||
| 1Kohm load, Muscle Stimulator mode | |||||
| N/A | 0-50±10% mA RMS, max., | ||||
| 1Kohm load, premodulated and medium | |||||
| frequency modes | |||||
| N/A | 0-99±10% mA peak, max., | ||||
| 1Kohm load, biphasic mode | |||||
| N/A | 0-2500±10% mA peak, max., | ||||
| 1Kohm load, high volt mode | |||||
| N/A | 10-990±10 μA peak, | ||||
| 1Kohm load, microamp mode | |||||
| Max output Voltage (V) | 0-36±30% volts RMS, | ||||
| 1Kohm load, Muscle Stimulator mode | 0-65±10% volts RMS, | ||||
| 1Kohm load, Muscle Stimulator mode | |||||
| N/A | 0-50±10% volts RMS, | ||||
| 1Kohm load, premodulated and medium | |||||
| frequency modes | |||||
| N/A | 99±10% volts peak, | ||||
| 1Kohm load, biphasic mode | |||||
| N/A | 0-500±10% volts peak, | ||||
| 1Kohm load, high volt mode | |||||
| N/A | 1.0±10% volt peak, | ||||
| 1Kohm load, microamp mode | |||||
| Frequency range | 4800-5050 Hz ±1%(Interferential mode) | 4000-4250 Hz ±1%(Interferential and | |||
| Premodulated modes) | |||||
| 2500 Hz ±2%(Medium frequency mode) | |||||
| Electrodes | ME2221 | ME2221 | |||
| Waveforms & Channels | |||||
| All Channels | Interferential | Premodulated, Medium Frequency, | |||
| Biphasic | |||||
| Channel 1 & 2 | Muscle Stimulator | Muscle Stimulator | |||
| Channel 1 | Muscle Stimulator | Combination Therapy and all others | |||
| Channel 2 | Muscle Stimulator | All | |||
| Output Displays | Two simultaneously, amber channel | ||||
| active indicators | Two simultaneously, amber channel | ||||
| active indicators | |||||
| Channel Isolation | Yes | Yes | |||
| Line Current Isolation | Yes | Yes | |||
| Automatic Overload Trip | Yes | Yes | |||
| Current/Voltage level | 50 mA RMS, Muscle Stimulator mode | ||||
| N/A | 70 mA RMS, Muscle Stimulator mode | ||||
| 55 mA RMS, premodulated and medium | |||||
| frequency mode | |||||
| Automatic No Load Trip | Yes | Yes | |||
| Patient Override | None | None | |||
| Control Method | On/Off | On/Off or hold | |||
| Max Leakage Current | |||||
| (μΑ) | |||||
| Chassis |