DM SLEEVE

K021102 · Emily Iker M.D., A.P.C. · DWL · May 8, 2002 · General Hospital

Device Facts

• Record ID: K021102
• Device Name: DM SLEEVE
• Applicant: Emily Iker M.D., A.P.C.
• Product Code: DWL · General Hospital
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of: Lymphedema and other edematous conditions, phlebitis, and vascular malformations.

Device Story

DM Sleeve™ is a compression garment designed to manage lymphedema, edematous conditions, phlebitis, and vascular malformations. Device applies non-gradient pressure to extremities to facilitate movement of interstitial fluid into venous and lymphatic channels. Construction utilizes cotton and nylon fabric fitted to the extremity, incorporating foam protrusions to exert pressure. Device is intended for clinical or home use. Healthcare providers or patients use the sleeve to provide therapeutic compression, potentially reducing edema and improving patient comfort. Safety testing confirmed retention of size and shape after washing.

Clinical Evidence

Bench testing only. Testing focused on safety and performance, specifically verifying that the device retained its size and shape after washing. Results indicated the device functioned as intended.

Technological Characteristics

Compression garment composed of cotton and nylon fabric. Applies non-gradient pressure via integrated foam protrusions. Designed for extremity fitting. No electronic components, energy sources, or software.

Indications for Use

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

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

• D.R. Medical Controlled Pressure Garments (K001300)
• Jobst Elvarex Compression Garments (K963573)
• Jobst Ready-To-Wear Arm Sleeves (K991570)

Submission Summary (Full Text)

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Koz1102

## MAY 0 8 2002

## 510(k) SUMMARY

## Dr. Emily Iker's DM Sleeve™

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 [phone] Phone: Facsimile: [phone]

Jonathan S. Kahan Contact Person:

April 4, 2002 Date Prepared:

## Name of Device and Name/Address of Sponsor

Emily Iker, M.D., A.P.C. 2021 Santa Monica Boulevard Suite 620E Santa Monica, CA 90404 Phone: [phone] Facsimile: [phone]

### Common or Usual Name

Compression Sleeve

### Classification Name

Medical Support Stocking

#### Predicate Devices

D.R. Medical Controlled Pressure Garments (K001300), Jobst Elvarex Compression Garments (K963573), and Jobst Ready-To-Wear Arm Sleeves (K991570).

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### Intended Use

The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of:

## Lymphedema and other edematous conditions, phlebitis, and vascular malformations.

## Technological Characteristics and Substantial Equivalence

The DM Sleeve™ is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Both the DM Sleeve™ and its predicates are intended to apply pressure to the extremities to manage lymphedema and other edematous conditions, phlebitis, and vascular malformations.

The DM Sleeve™ has very similar components as its predicate devices and very similar technological characteristics. Like the Jobst Elvarex Compression Garments (K963573), the DM Sleeve™ consists of a cotton and nylon fabric, which is fitted to the extremity. The DM Sleeve™ and the D.R. Medical Controlled Pressure Garments (K001300) apply non-gradient pressure to move interstitial fluid into venous and lymphatic channels. The DM Sleeve™ applies pressure by means of foam protrusions, while the Jobst Ready-To-Wear Arm Sleeves (K991570) use spandex and nylon. However, both devices raise the same issues of safety and effectiveness, and are therefore substantially equivalent.

### Performance Data

The DM Sleeve™ underwent safety testing to assure that the product retained its size and shape after washing. In all instances, the DM Sleeve™ functioned as intended and the results observed were as expected.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Emily Iker , M. D., A.P.C C/O Mr. Jonathan S. Kahan Hogan & Hartson, LLP 555 Thirteenth Street Washington, DC 20004

AY 0 8 2002

Re: K021102

Trade/Device Name: DM Sleeve™ Regulation Number: 880.5780 Regulation Name: Regulatory Class: II Product Code: DWL Dated: April 4, 2002 Received: April 4, 2002

Dear Mr. Kahan:

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. Kahan

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), 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 mis letter will and w you to cognizations of substantial equivalence of your device to 310(t) promatited 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = of its of Compilar over, 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 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,

Timothy 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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Kozlloz

# INDICATIONS FOR USE FORM

510(k) Number (if known):__K

DM Sleeve™ Device Name:

Indications for Use: The DM Sleeve™ is intended to be used to apply pressure to the thous for Ober indicated for use in the management of:

Lymphedema and other edematous conditions, phlebitis, and vascular malformations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Patricio Cucurella

(Division Sign-Off) (Division Sign-Only)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Devices and General Hospital Bosho2