JOBST READY-TO-WEAR ARM SLEEVES

K991570 · Beiersdorf-Jobt, Inc. · DWL · Aug 20, 1999 · General Hospital

Device Facts

• Record ID: K991570
• Device Name: JOBST READY-TO-WEAR ARM SLEEVES
• Applicant: Beiersdorf-Jobt, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Aug 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Jobst Ready-To-Use Arm Sleeve may be used under the direction of a healthcare professional to manage the flowing conditions: Edema Mild to moderate lymphedema Phlebitis Post-thrombotic syndrome Vascular Malformations Hypertrophic scars

Device Story

JOBST Ready-To-Wear Compression Arm Sleeves are circular knit garments composed of spandex and nylon yarns. Designed for management of lymphatic and venous conditions; device provides gradient compression via large elastic yarns acting circumferentially on the limb. Sizing is determined by circumferential measurements of the wrist, forearm, and mid-upper arm. Used in clinical or home settings under direction of healthcare professional. By forcing fluid into the deep venous system and assisting lymphatic return, the sleeve aids in managing edema, lymphedema, phlebitis, post-thrombotic syndrome, vascular malformations, hypertrophic scars, and post-liposuction recovery. Device serves as a non-invasive therapeutic support.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and established clinical use of predicate devices.

Technological Characteristics

Circular knit compression garment; materials: spandex and nylon yarns. Provides gradient compression via circumferential elastic tension. Dimensions based on standardized circumferential measurements of the arm. Non-powered, passive medical support stocking.

Indications for Use

Indicated for patients requiring management of edema, mild to moderate lymphedema, phlebitis, post-thrombotic syndrome, vascular malformations, hypertrophic scars, and post-liposuction care. Contraindicated for patients with significant arterial insufficiency, cutaneous infections, acute dermatitis, wet dermatosis, or conditions where venous/lymphatic return is undesirable.

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-Custom garments
• SIGVARIS 902/503 Arm Sleeves

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

This submission covers JOBST Ready-To-Wear Compression Arm Sleeves, which fall under the device classification of medical support stockings (21 CFR §880.5780). They are equivalent to the preamendment Jobst-Custom garments, and the SIGVARIS 902/503 Arm Sleeves, which are used for the same indications.

While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the SIGVARIS 902 and JOBST Ready-To-Wear Arm Sleeves are circular knit with spandex and nylon yarns.

The sizing of the Ready-To-Wear Arm Sleeves is based on circumferential measurements of the wrist, forearm and mid-upper arm and is limited to people whose arm dimensions fall within the specified ranges. The Jobst-Custom garments are sized based on measurements taken every inch and a half. They can be made to fit a wider range of limb dimensions and a wider range of compression as needed by the individual patient.

Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps to force fluid into the deep venous system and helps in the return of lymphatic fluid. Consequently, they can be used to manage the same indications. i.e. CVI, edema, lymphedema, phlebitis, post-thrombotic syndrome and vascular malformations. These products can also be used to manage hypertrophic scars and post liposuction for the arms. The contraindications for these products are also the same, i.e. significant arterial insufficiency, cutaneous infections, dermatitis in the acute phase, wet dermatosis and conditions in which venous and lymphatic return is not desired.

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

Date: May 4, 1999

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1999

Mr. Angelo Pereira Manager, Requlatory Affairs Beiersdorf-Jobt, Incorporated 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633

Re : K991570 Jobst Ready-To-Wear Arm Sleeves Trade Name: Regulatory Class: II Product Code: DWL Dated: July 30, 1999 Received: August 02, 1999

Dear Mr. Pereira:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## _Page 2 - Mr. Pereira

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed or babbuance device 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro reguration (broces), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small ander the maj be obertisits toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Prescription Use

(Per 21 CFR 801.109)

## K991570

Device name: Jobst Ready-To-Wear Arm Sleeve

Indications For Use.

Over-the-Counter

Jobst Ready-To-Use Arm Sleeve may be used under the direction of a healthcare professional to manage the flowing conditions:

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Edema Mild to moderate lymphedema Phlebitis Post-thrombotic syndrome Vascular Malformations Hypertrophic scars

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over The Counter Use

Patricio Rucetti

(Division Sign-Off) Division of Dental, and General Hosp 5 1 0(k) Number