(461 days)
Not Found
No
The document describes a multi-wave pulse generator with various pre-determined electrical pulses and waveforms. There is no mention of AI, ML, or any adaptive or learning capabilities in the device description or intended use. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for various medical purposes such as relaxation of muscle spasms, pain relief, and prevention of disuse atrophy, which are therapeutic applications.
No
The document describes the device as a multi-wave pulse generator "intended for medical purposes" for therapeutic uses such as muscle relaxation, prevention of atrophy, increasing circulation, and pain relief. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description explicitly states it is a "line of multi-wave pulse generators" and "deliver the predetermined electrical pulses through skin contact adhesive electrodes," indicating it is a hardware device that generates and delivers electrical pulses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The COMBI pulse generators are described as devices that deliver electrical pulses through skin contact electrodes for therapeutic purposes (muscle stimulation, pain relief, etc.). They are applied externally to the body and do not analyze samples taken from the body.
- Intended Use: The listed intended uses are all related to physical therapy and pain management, not diagnostic testing of biological samples.
Therefore, the COMBI pulse generators fall under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses:
COMBI 4/8 DIGITAL, COMBI TREND 4/8
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- . Increasing local blood circulation
- Muscle re-education .
- . Immediate post-surgical stimulation of calf muscles to prevent venous
- thrombosis .
- Maintaining or increasing range of motion. .
COMBI 4/8 MAX
- . Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- . Increasing local blood circulation
- . Muscle re-education
- . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion. .
For TENS waveform:
- Relief of chronic, intractable pain .
- Adjunctive treatment of post surgical or post traumatic acute pain .
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, LIH
Device Description
The COMBI family by CEC, is a line of multi-wave pulse generators, intended for medical purposes.
The COMBI generators are capable of producing different wave types, such as: three Russian currents (1:1, 2:1, 4:1), symmetric TENS, and symmetric in burst mode: asymmetric TENS, and asymmetric in burst mode; bipolar interferential; three types of impulses, rectangular, triangular, exp + direct current.
The devices deliver the predetermined electrical pulses through skin contact adhesive clectrodes, connected to up to four or eight independent body channels, depending on the specific model. (The prefixes 4 and 8 designate the number of channels, respectively).
Three different configurations of Multiwave Generator devices comprise the COMBI product line:
-
- COMBI Digital
-
- COMBI Trend
-
- COMBI Max
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)
Not Found
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
11070888
JUL - 9 2008
SECTION 2: 510K SUMMARY
Date of application: March 2007 Applicant's name: CEC Electronica S.R.L. Argentina Tel/Fax: +54351422492 Contact person: Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: +972 (4) 994-0337 Fax: +972 (4) 994-4224 e-mail: benny.A@arazygroup.com
Product Information
Common name: Powered Muscle Stimulator Trade name: COMBI 8 MAX Product Codes: IPF, GZJ and LIH Regulation Numbers and Descriptions: 890.5850 - Powered muscle stimulator (IPF) 882,5890 - Transcutaneous electrical nerve stimulator for pain relief (GZJ) Interferential Current Therapy (LIH - Pre-Amendment, unclassified) Panel Code: 89 Classification Advisory Committee: Physical Medicine Establishment Registration Number: to be assigned
Information on devices to which substantial equivalence is claimed:
| 510K # | Trade or propriety name | Manufacturer | Class |
|---|---|---|---|
| K984114 | SYS STYM 294 | Mettler Electronics Corp. | II |
| K062354 | Vectra Genisys | Chattanooga Group | II |
| K960969 | Galva 5-T | Zimmer Elektromedizin Gmbh | II |
Technological characteristics, for each output mode, were provided and compared to the predicate devices, in compliance with the guidelines included in FDA Guidance Document for Powered Muscle Stimulator 510(k)s.
1
Device Definition
The COMBI family by CEC, is a line of multi-wave pulse generators, intended for medical purposes.
The COMBI generators are capable of producing different wave types, such as: three Russian currents (1:1, 2:1, 4:1), symmetric TENS, and symmetric in burst mode: asymmetric TENS, and asymmetric in burst mode; bipolar interferential; three types of impulses, rectangular, triangular, exp + direct current.
The devices deliver the predetermined electrical pulses through skin contact adhesive clectrodes, connected to up to four or eight independent body channels, depending on the specific model. (The prefixes 4 and 8 designate the number of channels, respectively).
Three different configurations of Multiwave Generator devices comprise the COMBI product line:
-
- COMBI Digital
-
- COMBI Trend
-
- COMBI Max
The following table gives a summary of the waveforms featured by each one of the three device configurations:
| Russian 1:1 | Russian 1:1, 2:1 ,4:1 | TENS sym. & asym. | Tetrapolar Interferential | Bipolar Interferential | Rect. & Square Impulses | Direct Current | |
|---|---|---|---|---|---|---|---|
| COMBI Digital | ✓ | ✓ | |||||
| CMBI Max | ✓ | ✓ | ✓ | ✓ | |||
| COMBI Trend | ✓ | ✓ | ✓ |
For more details regarding the device physical and performance sharacteristics please refer to Section 4 of the submission.
2
Intended Use
Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses:
COMBI 4/8 DIGITAL, COMBI TREND 4/8
- . Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation ●
- Muscle re-education .
- Immediate post-surgical stimulation of calf muscles to prevent venous .
- thrombosis .
- Maintaining or increasing range of motion. .
COMBI 4/8 MAX
- Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation ●
- Muscle re-education ●
- Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis
- Maintaining or increasing range of motion. .
For TENS waveform:
- . Relief of chronic, intractable pain
- Adjunctive treatment of post surgical or post traumatic acute pain .
Declaration of Conformity
The COMBI 8 MAX device is in compliance with the following FDA recognized standard:
- IEC 60601-2-10 (1987-12) Medical electrical equipment Part 2: イ
Particular requirements for the safety of nerve and muscle stimulators
A full statement of Declaration of Conformity to recognized standards is included in the submission.
3
Summarv
The attached documents contain the information required in accordance with FDA regulations at 21 C.F.R. Part 807.87. As indicated above, throughout the submission preparation the Guidance document for Powered Muscle Stimulator 510(K)'s was used to address the risks associated with the device.
In particular, the Technological Characteristics were written according the attachment II of the guidance, the Instructions for Use were written by taking into consideration all the precautions and contraindications that appear in the guidance. The device labeling was prepared according the attachment II- Labeling guidance. The standard indication for use for powered muscle stimulators was adopted from the guidance. The software validation was performed by using the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The COMBI product line, subject of this submission, constitutes a safe, reliable and effective medical device meeting all the declared requirements of its intended use. The device presents no adverse health effect or safety risks to patients when used as intended.
We trust that the information provided in this SE file will be sufficient to enable FDA to find the COMBI product line substantially equivalent to the predicate devices as:
The intended use is identical to that of the cleared predicate device.
イ The fundamental scientific technology is identical to that of the cleared predicate device.
The modification relative to the cleared predicate device does not introduce any new hazards and does not affect the mitigations and CAPA. These modifications as compared with the predicate device are described in the Substantial Equivalence to Cleared Device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CEC Electronica S.R.L. % Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M.P. Migav 20187 Israel
JUL - 3 2008
K070888 Re: Trade/Device Name: Combi 8 Max Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: June 19, 2008 Received: June 26, 2008
Dear Mr. Arazy:
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. Ilsting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Mr. Benny Arazy
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 3: INDICATIONS FOR USE
510(k) Number: K070888
Device Name: COMBI 8 MAX
Indication for Use:
Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses:
COMBI 4/8 DIGITAL, COMBI TREND 4/8
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- . Increasing local blood circulation
- Muscle re-education .
- . Immediate post-surgical stimulation of calf muscles to prevent venous
- thrombosis .
- Maintaining or increasing range of motion. .
COMBI 4/8 MAX
- . Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- . Increasing local blood circulation
- . Muscle re-education
- . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion. .
For TENS waveform:
- Relief of chronic, intractable pain .
- Adjunctive treatment of post surgical or post traumatic acute pain .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X OR Over-(Division Site Use Off) |
|---|---|
| ------------------ | ------------------------------------------------------------------------- |
Division of General, Restorative,
(Per 21 CFR 801. and Neurological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |