. 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 .

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:

1. COMBI Digital
1. COMBI Trend
1. COMBI Max

AI/ML Overview

This document describes the regulatory submission for the CEC Electronica S.R.L. COMBI 8 MAX, a powered muscle stimulator. The information provided heavily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study and its findings cannot be fully addressed from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for the device's clinical performance, nor does it present device performance data from a clinical study against such criteria. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices by comparing technological characteristics and intended use.

Acceptance Criteria (Explicitly Stated in the Document)	Reported Device Performance (as described for COMBI 8 MAX)
Intended Use identical to predicate devices.	COMBI 8 MAX has the same intended uses as the predicate devices (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles, maintaining/increasing range of motion, and for TENS waveform: relief of chronic/intractable pain, adjunctive treatment of post-surgical/post-traumatic acute pain).
Fundamental scientific technology identical to predicate devices.	The device is a multi-wave pulse generator that produces various wave types (Russian currents, TENS, interferential, impulses, direct current) through skin contact electrodes, similar to predicate devices. Technological characteristics were provided and compared.
Modifications relative to predicate devices do not introduce any new hazards and do not affect mitigations and CAPA.	The submission asserts that modifications are adequately described and do not introduce new hazards.
Compliance with recognized standards (e.g., electrical safety).	The device is in compliance with IEC 60601-2-10 (1987-12) for medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators.
Labeling compliant with FDA guidance.	Device labeling was prepared according to Attachment II - Labeling guidance.
Software validation performed using FDA guidance.	Software validation was performed using the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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

No clinical test set is described. The submission relies on a comparison of technological characteristics to predicate devices. There is no mention of a patient-based test set, its sample size, or its provenance.

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

Not applicable, as no clinical test set with a ground truth established by experts is described. The "ground truth" in this context refers to the technological specifications and safety standards defined by regulatory bodies and previous predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this submission.

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

Not applicable. The COMBI 8 MAX is a physical medical device, not an algorithm. Its performance is inherent in its design and ability to generate specific electrical pulses based on pre-programmed settings and user interaction.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this submission is established through regulatory standards, predicate device characteristics, and the documented scientific understanding of electrical stimulation for therapeutic purposes. It's based on:

FDA Guidance Documents: Such as the "Guidance Document for Powered Muscle Stimulator 510(k)s."
Recognized Standards: Like IEC 60601-2-10.
Predicate Device Compliance: The assumption that the predicate devices (K984114, K062354, K960969) are safe and effective.
Scientific Principles: The understanding of how various electrical waveforms affect muscle and nerve tissues.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that would require a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary of the Study (Based on Provided Information):

The submission for the COMBI 8 MAX is a 510(k) premarket notification aiming to demonstrate substantial equivalence to predicate devices. The "study" described is primarily a regulatory and technical comparison study, not a clinical efficacy trial in the traditional sense for this specific 510k submission.

The applicant provided:

A comparison of the device's technological characteristics (wave types, channels, outputs) to those of the predicate devices.
An assertion that the intended use is identical to the cleared predicate devices.
Documentation of compliance with relevant recognized standards (e.g., IEC 60601-2-10 for electrical safety).
Evidence that labeling and software validation procedures followed FDA guidance.

The "proof" that the device meets "acceptance criteria" (which are largely regulatory and technical in this context) is therefore based on this comprehensive comparison and adherence to established guidelines, demonstrating that it is as safe and effective as existing legally marketed devices without raising new questions of safety or effectiveness. There is no mention of a specific clinical trial conducted for this 510(k) submission to prove clinical efficacy against predefined acceptance criteria. Instead, the assumption of efficacy and safety is derived from its substantial equivalence to already approved devices.

Summary

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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.

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Device Definition

The COMBI family by CEC, is a line of multi-wave pulse generators, intended for medical purposes.

Three different configurations of Multiwave Generator devices comprise the COMBI product line:

1. COMBI Digital
1. COMBI Trend
1. 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.

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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.

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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.

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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.

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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

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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
---------------	--

Regulation Number and Section

§ 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).