ELVAREX

K963573 · Jobst A Beiersdorf Co. · DWL · Oct 16, 1996 · General Hospital

Device Facts

• Record ID: K963573
• Device Name: ELVAREX
• Applicant: Jobst A Beiersdorf Co.
• Product Code: DWL · General Hospital
• Decision Date: Oct 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Elvarex compression garments are medical support stockings used to treat chronic venous insufficiency (CVI), edema, lymphedema, phlebitis and vascular malformations.

Device Story

Elvarex compression garments; custom-fitted medical support stockings. Input: patient limb measurements. Transformation: flat-knit fabric construction using nylon, natural rubber latex, cotton, and spandex; dimensions calculated via LaPlace formula. Output: gradient compression applied circumferentially to limbs. Used in clinical or home settings; prescribed by physicians. Mechanism: compression forces fluid into deep venous system and aids lymphatic return. Benefit: management of edema, lymphedema, and venous conditions.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by established market history in Europe and three-year assessment with no reports of serious injury.

Technological Characteristics

Flat-knit compression garment. Materials: nylon, natural rubber latex, cotton, spandex. Principle: gradient compression via circumferential elastic tension. Dimensioning: LaPlace formula. Classification: 21 CFR 880.5780.

Indications for Use

Indicated for patients with chronic venous insufficiency, edema, lymphedema, phlebitis, and vascular malformations. Contraindicated in patients with significant arterial insufficiency, cutaneous infections, acute phase dermatitis, wet dermatosis, and conditions where venous or lymphatic return is not desired.

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 (preamendment)

Submission Summary (Full Text)

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K963573

Beiersdorf-Jobst, Inc.

OCT 16 1996

5825 Carnegie Blvd.

Charlotte, NC 28209-4633

Phone: [phone]

# 510(k) Summary of Safety and Effectiveness

This submission covers Elvarex compression garments which are classified as medical support stockings (21 CFR §880.5780). The Elvarex garments are equivalent to the preamendment Jobst-Custom garments which are used for the same indications.

While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon yams, the Elvarex garments are flat knit using yams made of nylon, natural rubber latex, cotton and spandex and then sewn together.

Both products use the specific measurements for a patient and calculate the final garment dimensions using the LaPlace formula. Compression is provided for both products by large elastic yams that act circumferentially on the limb. The gradient compression present with both products helps to force fluid into the deep venous system and in the return of lymphatic fluid. Consequently, they can be used to treat the same indications, i.e. CVI, edema, lymphedema, phlebitis and vascular malformations. The contraindications for the two 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.

Elvarex has been on the market for several years in Europe and has an established track record. There have also been no reports of serious injury resulting from its use during the three year period assessed.

The product being submitted is substantially equivalent to the predicate product in the materials used, mode of action, and indications of use. It also has a long history of use and has proven to be as safe and effective as the predicate product.

Date: August 2, 1996

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