JOBST READY-TO-WEAR GAUNTLET

K013852 · Bsn-Jobst, Inc. · DWL · Jan 28, 2002 · General Hospital

Device Facts

• Record ID: K013852
• Device Name: JOBST READY-TO-WEAR GAUNTLET
• Applicant: Bsn-Jobst, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Jobst Ready-To-Wear Gauntlet may be used under the direction of a Healthcare professional to manage the flowing conditions: Edema Lymphedema Hypertrophic scars

Device Story

Jobst Ready-To-Wear Gauntlet is a compression garment designed to manage edema, lymphedema, and hypertrophic scars. The device is constructed using circular knit spandex and nylon yarns, with a thumb piece sewn on in a secondary operation. It provides gradient compression (20-30 mmHg or 30-40 mmHg) via large elastic yarns acting circumferentially on the limb. This compression reduces capillary leakage and improves lymphatic absorption. The device is sized based on palm and wrist measurements. It is intended for use under the direction of a healthcare professional.

Clinical Evidence

Bench testing only. Biocompatibility was assessed using the Fastox Primary Skin Irritation test on rabbits, which showed no evidence of skin irritation. No clinical trials were conducted.

Technological Characteristics

Materials: Spandex and nylon. Construction: Circular knit with sewn-in thumb piece. Compression: Gradient, 20-30 mmHg or 30-40 mmHg. Principle: Circumferential mechanical compression. Form factor: Gauntlet. No software or electronic components.

Indications for Use

Indicated for patients requiring management of edema, lymphedema, or hypertrophic scars under the direction of a healthcare professional.

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

• JUZO Gauntlet

Reference Devices

• Jobst Custom garments (K925154)
• UltraSheer (Ultimate Stockings) (K920444)
• Ready-To-Wear Arm Sleeve (K991570)

Submission Summary (Full Text)

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K013852

### 510(k) Summary of Safety and Effectiveness

This submission covers the JOBST Ready-To-Wear Gauntlet, which falls under the device classification of medical support stockings (21 CFR §880.5780). It is equivalent to the JUZO Gauntlet, which is used for the same indications.

While the JUZO Gauntlet is flat knit and sewn together from fabric made of spandex, viscose and nylon yarns, the JOBST Ready-To-Wear Gauntlet is circular knit with spandex and nylon yarns. The thumb piece is then sewn in place in a second operation.

Both products are available in two compression ranges, 20-30 mmHg and 30-40 mmHq. the compression ranges most often prescribed by physicians for the indications involved. Both products are sized based on the palm and wrist measurements.

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 reduce capillary leakage and improve capillary and lymphatic absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema. These products can also be used to manage hypertrophic scars.

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: November 16, 2001

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

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## BIOCOMPATIBILITY Jobst Ready-To-Wear Gauntlet

The Jobst Ready-To-Wear (RTW) Gauntlet is made of spandex and nylon. These are the same fibers as used in the Jobst Custom garments (K925154) as well as in UltraSheer (Ultimate Stockings -- K920444) and the Ready-To-Wear Arm Sleeve (K991570).

The RTW Gauntlets are dyed in the same dye loads as the UltraSheer stockings and so are exposed to the same dyes and dye chemicals.

Samples of UltraSheer stockings have previously been tested using the Fastox Primary Skin Irritation test. There was no evidence of any skin irritation.

The Fastox test is performed by NAMSA in Northwood, OH using three rabbits per test. The test area is observed at 24, 48 and 72-hour intervals.

Conclusion: Based on the above data it appears unlikely that use of the Jobst RTW Gauntlet will result in any significant skin irritation to the patient.

> Angelo Pereira Manager, Regulatory Affairs BSN-JOBST, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2002

Ms. Angelo R. Pereira Manager of Regulatory Affairs BSN-Jobst, Incorporated 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633

Re: K013852

Trade/Device Name: Jobst Ready-To-Wear Gauntlet Regulation Number: 880.5780 Regulation Name: Compression Garments -- Gauntlet Regulatory Class: II Product Code: DWL Dated: November 16, 2001 Received: November 20, 2001

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.

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.

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#### Page 2 - Mr. Pereira

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and are labeling (21 CFR Part 801); good manufacturing practice allo listing (21 OF RT at 807), abolity 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 I hils icter will and w you to cogin manas 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 11 you doser app 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Confightance wee, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timotly A. Ulatowski Director 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

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## Device name: Jobst Ready-To-Wear Gauntlet

Indications For Use:

Over-the-Counter

Jobst Ready-To-Wear Gauntlet may be used under the direction of a Healthcare professional to manage the flowing conditions:

Edema Lymphedema Hypertrophic scars

Patricia Cicerale

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 10/385

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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