(388 days)
The Bodyflow -P2CH is a powered muscle stimulator intended for
- Increased local blood circulation
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
The Bodyflow®-P2CH is a device which delivers muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by permanently installed, rechargeable batteries.
This document describes the 510(k) premarket notification for the Bodyflow-P2CH, a powered muscle stimulator. The information provided heavily focuses on the device's regulatory classification, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1): No specific quantitative criteria listed, but general safety related to electrical leakage current, electrode and lead wire safety, output current, and power density. | The Bodyflow-P2CH "passed all of the applicable test" for electrical leakage current, electrode and lead wire safety, output current, and power density. |
| Electromagnetic Compatibility (IEC 60601-1-2): No specific quantitative criteria listed. | The Bodyflow-P2CH "passed all of the applicable test". |
| Safety of Nerve and Muscle Stimulators (IEC 60601-2-10): No specific quantitative criteria listed. | The Bodyflow-P2CH "passed all of the applicable test". |
| Output Specifications, Device Design, Waveforms, and Programmability (for substantial equivalence to predicate device) | Demonstrated to be "substantially equivalent" to predicate device (Physiomed's LymphaVision, K003896). The specific parameters of equivalence are not itemized. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a study involving human or animal subjects that would typically have a test set with a sample size. The performance testing appears to be limited to bench testing for electrical and safety standards. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided as the submission describes bench testing for safety and electrical standards, not a diagnostic or treatment effectiveness study requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes bench testing, not a study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on regulatory compliance through bench testing and substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study in the context of an algorithm or AI is not applicable to this device. The Bodyflow-P2CH is a physical medical device (powered muscle stimulator), not an AI/algorithm-driven system.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing described is derived from compliance with international electrical and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical performance evaluation.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a powered muscle stimulator, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
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. Section 5: 510(k) Summary: K100862
The following information is provided as required by 21 CFR § 807.87 for the Bodyflow -P2CH 510(k) premarket notification for and in accordance with FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s", June 9, 1999.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Bodyflow P2CH is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
| Applicant: | Physiomed Elektromedizin AGHutweide 10 |
|---|---|
| D-91220 Schnaittach / Laipersdorf | |
| Phone: +49 9126-25 87 - 17 | |
| Facsimile: +49 9126 - 25 87-717 | |
| Registration Number: 3002892330 | |
| Date of submission: | March 8, 2010 |
| Proprietary Name: | Bodyflow®-P2CH |
| Common Name: | Powered Muscle Stimulator |
| Classification Status: | 21 CFR 890.5850 |
| Product Code: | IPF |
| Panel: | Physical Medicine |
| Predicate Device: | Physiomed's LymphaVision, K003896, is substantially equivalent, for |
| the purpose of this 510(k), to other devices that have received 510(k) | |
| clearance for similar indications for use. |
The Bodyflow®-P2CH is a device which delivers muscle stimulation by Device Description: applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by permanently installed, rechargeable batteries.
page 16 of 49
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Intended Use: As prescribed by a physician for the following:
- Increased local blood circulation
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Discussion of performance testing: Based on the output measurements, calculations, and safety testing/inspection; the Bodyflow -P2CH is safe with respect to electrical leakage current, electrode and lead wire safety, as well as output current and power density. Testing performed in accordance with the accepted FDA requirements of IEC 60601-1 Medical Electrical Equipment . Part 1: General Requirements for Safety, IEC 60601-1-2, Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility-Requirements and Test and IEC 60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators, found the Bodyflow -P2CH passed all of the applicable test.
Technological Characteristics and Substantial Equivalence
Output specifications, device design, waveforms and programmability demonstrated the Bodyflow® -P2CH to be substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Birgit Schmid Physiomed Elektromedizin AG Hutweide 10 D-91220 Schnaittach / Laipersdorf Germany
APR 2 1 2011
Re: K100862
Trade/Device Name: Bodyflow-P2CH Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: IPF Dated: April 12, 2011 Received: April 14, 2011
Dear Ms. Schmid:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 – Birgit Schmid
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
A.S. B- Drik
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
Indications for Use
510(k) Number: K100862
Device Name: Bodyflow®-P2CH
Indications For Use: The Bodyflow -P2CH is a powered muscle stimulator intended for
- Increased local blood circulation
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
Over-The-Counter
(Part 21 CFR 801 Subpart D)
(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)
(DWi (Dyvision Sign of Surgical, Orthopedic, Divisionative Devices
510(k) Number K100862
Page I of 1
§ 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).