JOBST TRAVEL SOCKS

K032325 · Bsn-Jobst, Inc. · DWL · Aug 28, 2003 · General Hospital

Device Facts

• Record ID: K032325
• Device Name: JOBST TRAVEL SOCKS
• Applicant: Bsn-Jobst, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Aug 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Jobst Travel Socks are indicated for the following conditions: Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers.

Device Story

Jobst Travel Socks are compression stockings designed for long-distance travelers. Device applies 15-20mmHg gradient compression at the ankle via elastic yarns acting circumferentially on the limb. Mechanism of action involves reducing capillary leakage, preventing blood pooling, and improving blood flow to reduce risk of deep vein thrombosis (DVT) and superficial thromboembolisms. Socks are manufactured on circular knit machines using nylon, spandex, and cotton yarns. Sizing is based on calf circumference, ankle circumference, and shoe size. Device is intended for over-the-counter use by travelers to manage leg discomfort and prevent venous complications associated with prolonged immobility.

Clinical Evidence

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

Technological Characteristics

Medical support stocking (21 CFR 880.5780); circular knit construction; materials include nylon, spandex, and cotton yarns; provides 15-20mmHg gradient compression at the ankle.

Indications for Use

Indicated for long-distance travelers to help prevent edema, leg discomfort, and deep vein thrombosis.

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

• Jobst Anti-Em/GP stocking (K955138)

Submission Summary (Full Text)

{0}------------------------------------------------

K032325

AUG 2 8 2003

## 510(k) Summary Of Safety and Effectiveness

This submission covers the indication that compression stockings in the 15-20mmHg range and higher, such as the JOBST Travel Socks, help prevent deep vein thromboses (DVT). These products fall under the device classification of medical support stockings (21 CFR §880.5780). The Jobst Travel Socks are equivalent to the Jobst Anti-Em/GP stocking (K955138), which is indicated for use for the individuals subjected to long periods of immobility.

Both products are manufactured on circular knit machines. Both products are made of nylon and spandex yarns and provide compression at the ankle of approximately 15-20mmHg. However, the JOBST Travel Socks also have cotton varns for added comfort. While both products are sized based on calf circumference, sizing information based on ankle circumference and shoe size will also be provided with the JOBST Travel Socks, for the convenience of the traveler.

Compression is provided for these products by elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage, prevent pooling of blood and improve blood flow. Consequently, they act prophylactically to help reduce the risk of developing deep vein thromboses (DVT) and superficial thromboembolisms.

The product being submitted is substantially equivalent to the predicate product in the materials used, mode of action, and indications for use and can be considered as safe and effective as the predicate product.

Date: August 27, 2003

Prepared by: Angelo R. Pereira BSN-JOBST. Inc. 5825 Carnegie Boulevard Charlotte, NC 28209 Phone: [phone]

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

AUG 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Angelo Pereira Manager, Regulatory Affairs BEN-JOBST Incorporated 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633

Re: K032325

Trade/Device Name: Jobst Travel Socks Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: July 25, 2003 Received: July 28, 2003

Dear Mr. Pereira:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{2}------------------------------------------------

## Page 2 -Mr. Pereira

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Raoser

Susan Runner, DDS. MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K032325

## 510(k) Number

Page 1 of 1

Device name: Jobst Travel Socks

Indications For Use:

Over-the-Counter

Jobst Travel Socks are indicated for the following conditions:

Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers.

## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over The Counter Use_________________

Patricia Cucurete

510(k) Number: *K032325*