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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the VenoTrain curaflow medical support stocking. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria and study design are not present in the provided document. The 510(k) process for this type of device often relies on demonstrating that the new device has the same intended use and similar technological characteristics to legally marketed predicate devices, rather than requiring extensive clinical performance studies with defined acceptance criteria for a new clinical claim.

Here's an breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Not present in the document. The document states: "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." It also states: "The VenoTrain curaflow is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics." This indicates that general principles of compression, rather than specific numerical acceptance criteria, are being used.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not present. No specific test set or associated data is described, as the submission relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not present. No ground truth establishment is described for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not present. No test set or adjudication process 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 medical support stocking, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not present. No ground truth is described for a performance study.

8. The sample size for the training set

Not applicable/Not present. Training sets are typically for AI/machine learning models, which this device is not.

9. How the ground truth for the training set was established

Not applicable/Not present.

Summary based on the provided text:

The provided 510(k) summary focuses entirely on demonstrating substantial equivalence of the VenoTrain curaflow to existing predicate devices (Torbot Vascular Compression Garments (K061411) and Elvarex compression garments (K963573)).

Acceptance Criteria/Performance Study: The document does not describe specific acceptance criteria or a study designed to prove the device meets them. Instead, the "acceptance" is based on the new device having the "same intended use and very similar technological characteristics" as the predicates.
Intended Use: The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in the management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
Technological Characteristics: The garments are flat knit using yarns made of nylon and spandex, and then sewn together, applying controlled pressure. This is deemed "very similar" to the predicates.

Summary

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OCT - 4 2011

Bauerfeind AG

K1116667
510(k)

510(k) Premarket Notification VenoTrain curaflow

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 AGTriebeser Strasse 16D-07937 Zeulenroda-TriebesPhone: +49 36628 661350Facsimile: +49 36628 663153Registration 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

Page 5-1

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Bauerfeind AG

Section 5: 510(k) Summary

Intended Use

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.

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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.

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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

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Bauerfeind AG

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

Page 1 of 1

Regulation Number and Section

§ 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.