(127 days)
No
The summary describes a device based on light reflection rheography and does not mention AI, ML, or any related concepts.
No
The device is a diagnostic tool that measures leg vein function to draw conclusions about blood flow; it does not provide any therapy or treatment.
Yes
The device is described as a photoelectric plethysmograph intended for the measurement of leg vein function, indicating its purpose is to diagnose or assess a physiological function.
No
The device description explicitly states it uses hardware components (infrared light radiation and measurement of reflected light) to perform its function.
Based on the provided information, the BODYTRONIC 200 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The BODYTRONIC 200 directly measures a physiological function (blood flow in veins) within the living body using light reflection. It does not analyze samples like blood, urine, or tissue.
- The intended use describes measuring leg vein function. This is a physiological measurement, not a diagnostic test performed on a specimen.
- The device description details a non-invasive measurement technique. It uses infrared light shone onto the skin, not a process involving the analysis of bodily fluids or tissues.
Therefore, the BODYTRONIC 200 falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.
Product codes
JOM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light reflection rheography (uses infrared light)
Anatomical Site
legs just above the ankles
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)
Reference Device(s)
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
§ 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).
0
Image /page/0/Picture/2 description: The image shows the Bauerfeind logo. The logo consists of a stylized "B" symbol on the left, followed by the word "BAUERFEIND" in bold, sans-serif font. A registered trademark symbol is present to the upper right of the word "BAUERFEIND".
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 AG
Triebeser Strasse 16
D-07937 Zeulenroda-Triebes
Phone: +49 36628 661350
Facsimile: +49 36628 663153
Registration 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
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three wavy lines that represent snakes.
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