(127 days)
The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.
The BODYTRONIC 200 is based on light reflection rheography. A small quantity of infrared light is radiated into the legs just above the ankles, and the reflected light is measured. On the basis of the quantity of reflected light over a defined period, conclusions can be drawn about the flow of blood in the veins.
The provided text describes the 510(k) Premarket Notification for the Bauerfeind BODYTRONIC 200, a photoelectric plethysmograph. However, it does not contain any information about acceptance criteria, device performance metrics, or experimental studies performed to prove the device meets specific acceptance criteria.
The document focuses on establishing substantial equivalence to a predicate device (Elcat vasoquant VQ1000 D-PPG) based on intended use and technological characteristics, and compliance with various international standards related to electrical safety, EMC, usability, software life-cycle, risk management, biocompatibility, and photobiological safety.
Therefore, I cannot provide the requested information from the given text. The text primarily details:
- Device Description: The BODYTRONIC 200 uses light reflection rheography to measure blood flow in leg veins.
- Intended Use: Measurement of leg vein function.
- Predicate Device: Elcat vasoquant VQ1000 D-PPG (K944395).
- Regulatory Information: Classification as Class II, Product Code JOM, under 21 CFR 870.2780.
- Standards Compliance: Listing of various IEC and ISO standards the device complies with.
- FDA Premarket Notification Outcome: FDA's determination of substantial equivalence.
Without a study report or performance data, I cannot fill out the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies.
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510(k) Premarket Notification BODYTRONIC 200
Section 5: 510(k) Summary
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the BODYTRONIC 200 510(k) premarket notification.
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 BODYTRONIC 200 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device.
| Applicant: | Bauerfeind AGTriebeser Strasse 16D-07937 Zeulenroda-TriebesPhone: +49 36628 661350Facsimile: +49 36628 663153Registration Number: 8010507 |
|---|---|
| Date of Preparation: | December 20, 2012 |
| Proprietary Name: | BODYTRONIC 200 |
| Common Name: | Plethysmograph, Photoelectric |
| Classification Status: | 21 CFR 870.2780 |
| Product Code: | JOM |
| Panel: | Cardiovascular |
Predicate Device
Bauerfeind's BODYTRONIC 200 is substantially equivalent, for the purpose of this 510(k), to Elcat vasoquant VQ1000 D-PPG (K944395).
Device Description
The BODYTRONIC 200 is based on light reflection rheography. A small quantity of infrared light is radiated into the legs just above the ankles, and the reflected light is measured. On the basis of the quantity of reflected light over a defined period, conclusions can be drawn about the flow of blood in the veins.
BF 510k BODYTRONIC200 Section-05 A
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Image /page/1/Picture/1 description: The image shows the logo for "BAUERFEIND" in bold, black letters, with a stylized symbol to the left. Below the logo, the text "Section 5: 510(k) Summary" is printed in a smaller, regular font. The logo and text are aligned to the left.
510(k) Premarket Notification BODYTRONIC 200
Intended Use
The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.
Technological Characteristics and Substantial Equivalence
The BODYTRONIC 200 in accordance to the following international standards:
- · IEC 60601-1 Electrical Safety
- · IEC 60601-1-1 Medical Electrical Systems
- IEC 60601-1-2 Electromagnetic Compatibility
- · IEC 60601-1-6 Usability
- · IEC 62304 Software Life-Cycle
- · ISO 14971 Risk Management
- · ISO 10993-1 Biocompatibility
- · IEC 62471 Photobiological safety of lamps and famp systems
- · IEC 62133 Safety requirements for portable sealed secondary cells
- · IEC 60950-1 Information technology equipment
The BODYTRONIC 200 is substantially equivalent to its predicates because it has the same intended use and similar technological characteristics.
Both the BODYTRONIC 200 and its predicates are intended for the measurement of the leg vein function.
BF_510k_BODYTRONIC200_Section-05_A
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 26, 2013
Bauerfeind Ag Ines Exner Triebeser Strasse 16 Zeulenroda-triebes, 07937 GM
Re: K 123921
Trade/Device Name: Bodytronic 200 Regulation Number: 21 CFR 870.2780 Regulation Name: Plethysmograph, Photoelectric Regulatory Class: Class II Product Code: JOM Dated: January 21, 2013 Received: February 20, 2013
Dear Ines Exner:
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
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Page 2 - Ines Exner
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.
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/MedicalDevices/Safety/ReportaProblem/default.htmfor 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen-PEaris -S
for
Bram D. Zuckerman, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Premarket Notification BODYTRONIC 200
Section 4: Indication for Use Statement
Indications for Use 510(k) Number (if known): not yet assigned Device Name: BODYTRONIC 200 Indications for Use: The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function. Prescription Use AND/OR Over-The-Counter Use × (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) า P. Faris -S 04.26 12:21:11
BF_510k_BODYTRONIC200_Section-04_A
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).