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 Description

The DM Sleeve™ consists of a cotton and nylon fabric, which is fitted to the extremity. The DM Sleeve™ applies non-gradient pressure to move interstitial fluid into venous and lymphatic channels. The DM Sleeve™ applies pressure by means of foam protrusions.

AI/ML Overview

This medical device submission for the Dr. Emily Iker's DM Sleeve™ does not contain the detailed performance study information typically found in submissions for AI/ML-driven devices or those requiring rigorous clinical validation for efficacy.

The provided information indicates a lack of specific acceptance criteria based on quantitative performance metrics and, consequently, lacks a study designed to prove the device meets such criteria in terms of clinical effectiveness. The submission focuses primarily on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, and safety.

Here's an analysis based on the provided text, addressing your points as much as possible, and highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Retain size and shape after washing (Safety)	"In all instances, the DM Sleeve™ functioned as intended and the results observed were as expected."
No specific performance criteria related to clinical efficacy (e.g., pressure application effectiveness, reduction in lymphedema, etc.) mentioned.	No quantitative data regarding clinical efficacy is reported.

Missing Information: There are no reported acceptance criteria related to the device's efficacy in managing lymphedema, phlebitis, or vascular malformations. The "performance data" solely addresses safety and integrity after washing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The "safety testing to assure that the product retained its size and shape after washing" does not mention how many sleeves were tested.
Data Provenance: Not specified. It's presumably laboratory testing of the device itself, not human clinical data.

3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set

Number of Experts: Not applicable. The "ground truth" for maintaining size/shape after washing would be an objective measurement or visual inspection by technical staff, not clinical experts.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "safety testing" described is a simple material test, not a complex clinical assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret results, often to assess the impact of AI assistance. The DM Sleeve™ is a physical compression device and does not involve human interpretation in this manner.
Effect size of human readers with vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Not applicable. The DM Sleeve™ is a physical device, not an algorithm. Its "performance" in the 510(k) refers to its physical integrity.

7. Type of Ground Truth Used

Type of Ground Truth: For the "safety testing," the ground truth was the objective observation of the physical state of the sleeve (size and shape retention) after washing, against an unstated expectation of desired integrity. This is a technical/material ground truth, not a clinical one.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. The DM Sleeve™ is a physical medical device. It is not an AI/ML algorithm that requires a training set. The "design" of the sleeve would be based on engineering principles and existing knowledge of compression garments, not machine learning.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Overall Conclusion:

This 510(k) submission for the DM Sleeve™ is very light on "performance data" in the clinical sense. It primarily relies on substantial equivalence to predicate devices (D.R. Medical Controlled Pressure Garments, Jobst Elvarex Compression Garments, and Jobst Ready-To-Wear Arm Sleeves). The "Performance Data" section explicitly states: "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."

This type of submission indicates that the FDA considered the device's mechanism of action (applying pressure via fabric and foam protrusions) and intended use (managing lymphedema, etc.) to be sufficiently similar to already approved devices, such that extensive new clinical efficacy studies were not required for market clearance. The "proof" is largely by analogy and a simple safety check.

Summary

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

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 (202) 637-5794 Phone: Facsimile: (202) 637-5910

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: (310) 829-7472 Facsimile: (310) 829-2282

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).

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

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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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.

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

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{4}------------------------------------------------

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

Regulation Number and Section

§ 880.5780 Medical support stocking.

(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. 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.(2)
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 system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.