(112 days)
Not Found
No
The summary describes a physical compression garment and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the management of medical conditions such as lymphedema, edematous conditions, phlebitis, and vascular disorders by applying pressure to the extremities, which clearly defines it as a therapeutic device.
No
The device is described as a garment used to apply pressure to extremities for managing lymphedema, edematous conditions, phlebitis, and vascular disorders. Its function is to prevent pooling of blood and fluid, which is a therapeutic rather than a diagnostic action.
No
The device description clearly states it is a physical garment made of nylon and spandex, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply pressure to the extremities for managing conditions like lymphedema, edema, phlebitis, and vascular disorders. This is a physical intervention applied to the body, not a test performed on samples taken from the body.
- Device Description: The device is a compression garment made of fabric. This is a physical device, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, the VenoTrain curaflow compression garments are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
Product codes (comma separated list FDA assigned to the subject device)
DWL
Device Description
The VenoTrain curaflow compression garments help to prevent pooling of blood and fluid in the extremities by applying controlled pressure. The VenoTrain garments are flat knit using yarns made of nylon and spandex and then sewn together.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities
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
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
OCT - 4 2011
Bauerfeind AG
K1116667
510(k)
510(k) Premarket Notification VenoTrain curaflow
Section 5: 510(k) Summary
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the VenoTrain curaflow 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 VenoTrain curaflow 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 submission: | June 1, 2011 |
| Proprietary Name: | VenoTrain curaflow |
| Common Name: | Medical Support Stocking |
| Classification Status: | 21 CFR 880.5780 |
| Product Code: | DWL |
| Panel: | General Hospital |
Predicate Devices
Bauerfeind's VenoTrain curaflow is substantially equivalent, for the purpose of this 510(k), to Torbot Vascular Compression Garments (K061411) and Elvarex compression garments (K963573).
Device Description
The VenoTrain curaflow compression garments help to prevent pooling of blood and fluid in the extremities by applying controlled pressure. The VenoTrain garments are flat knit using yarns made of nylon and spandex and then sewn together.
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Bauerfeind AG
Section 5: 510(k) Summary
Intended Use
The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
Technological Characteristics and Substantial Equivalence
The VenoTrain curaflow is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics.
Both the VenoTrain curaflow and its predicates are intended to apply pressure, by elastic yarns that act circumferentially on the extremity, to manage lymphedema and other edematous conditions, phlebitis, and vascular disorders.
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ines Exner Head of Quality and Regulatory Affairs Bauerfeind AG Triebeser Strasse 16 Zeulenroda-Triebes Germany 07937
_ 4 2011 ೧೮-೧
Re: K111662
Trade/Device Name: VenoTrain curaflow Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: Class II Product Code: DWL Dated: September 16, 2011 Received: September 21, 2011
Dear Ms. 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.
3
Page 2 – Ms. Exner
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any l'ederal 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.goy/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bauerfeind AG
Section 4: Indication for Use Statement
Section 4: Indication for Use Statement
Indications for Use
2 ماها (11)510(k) Number (if known): not yet assigned K (11)2
Device Name: VenoTrain curaflow
Indications for Use: The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Rill C. Chyp 10/3/11
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111662
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