VENOTRAIN CURAFLOW

K111662 · Bauerfeind AG · DWL · Oct 4, 2011 · General Hospital

Device Facts

• Record ID: K111662
• Device Name: VENOTRAIN CURAFLOW
• Applicant: Bauerfeind AG
• Product Code: DWL · General Hospital
• Decision Date: Oct 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

VenoTrain curaflow is a medical support stocking designed to prevent blood and fluid pooling in extremities. Device applies controlled, circumferential pressure to limbs via elastic properties of flat-knit fabric. Constructed from nylon and spandex yarns. Used in clinical or home settings to manage lymphedema, edema, phlebitis, and vascular disorders. Provides therapeutic benefit by reducing fluid accumulation through mechanical compression.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Flat-knit compression garment; materials: nylon and spandex yarns; mechanism: circumferential elastic pressure application; form factor: extremity stocking.

Indications for Use

Indicated for patients requiring extremity compression for management of lymphedema, edematous conditions, phlebitis, and vascular disorders.

Regulatory Classification

Identification

Medical support stocking to prevent the pooling of blood in the legs: 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. Medical support stocking for general medical purposes: 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.

Special Controls

*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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Torbot Vascular Compression Garments (K061411)
• Elvarex compression garments (K963573)

Submission Summary (Full Text)

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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<br>Triebeser Strasse 16<br>D-07937 Zeulenroda-Triebes<br>Phone: [phone]<br>Facsimile: [phone]<br>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.

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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 [phone] or [phone] 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

#### 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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