The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

Device Description

The compressible sleeve is a garment used for compressing patient's lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed compressible limb sleeve. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often seen for novel devices or software.

Here's an analysis based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Functional and Safety Characteristics	No significant difference in functional and safety characteristics between new and reprocessed devices.	Data indicates no significant difference in functional and safety characteristics between new and reprocessed devices.	This is the overarching acceptance criteria for demonstrating substantial equivalence. Specific metrics for "functional and safety characteristics" are not detailed in this summary.
Technological Characteristics	Substantially equivalent in materials, design, and intended use to the sleeves as originally distributed.	The reprocessed sleeves are substantially equivalent (in materials, design, and intended use) to the sleeves as originally distributed.	This is a declaration of equivalence rather than a specific performance metric.

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

Test Set Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," which implies a sample was used, but the size of this sample is not provided.
Data Provenance: The study was "conducted at Medical Device Services, Inc." It appears to be a bench test conducted by the manufacturer, rather than a clinical study with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the way they would be for patient-centric studies.

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

Not Applicable. This submission describes bench testing for a physical medical device (a reprocessed limb sleeve), not a diagnostic algorithm that requires expert interpretation for ground truth. The "ground truth" here would relate to the functional and safety specifications of the device itself, likely assessed through engineering tests and measurements.

4. Adjudication Method for the Test Set

Not Applicable. As this is bench testing and not an expert-based ground truth establishment, adjudication methods like 2+1 or 3+1 are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This is not an AI-powered diagnostic device, and therefore, an MRMC study is not applicable. The device is a reprocessed compressible limb sleeve.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not an algorithm, so standalone performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this comparative bench testing would be the functional and safety specifications of the original new device (Kendall Model 6325 SCD Sequential Compression System). The reprocessed devices were tested against how the original, new devices are expected to perform. This likely involved quantitative measurements of parameters like inflation pressure, cycle times, air leakage, material integrity, and biocompatibility (though the latter isn't explicitly detailed in the summary).

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for an AI/ML algorithm.

Summary

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

K012979 - response to questions from FDA dated November 16, 2001 510(k) Notification for Compressible Limb Sleeve

510(k) Summary

1.	Submitter:	Medical Device Services, Inc. (MDS)144 West Bringham Road, Building ESt. George, UT 84790Tel: 435-652-3073Fax: 435-652-3087
2.	Contact:	Ron Fames President

i Medical Device Services, Inc.
August 31, 2001 3. Date prepared:
Sleeve, Limb, Compressible Device trade name: র্বা

Compressible Sleeve Common name:

Kendall Model 6325 SCD Sequential Compression System 5. Predicate device: K942664

The compressible sleeve is a garment used for compressing patient's 6. Description: lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.

7. Intended Use:

The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

1. Technological comparison to predicate device:
  The technological characteristics of the reprocessed sleeves are substantially equivalent (in materials, design, and intended use) to the sleeves as originally distributed.

ல். Noncritical test summary:

Comparative bench testing of new Kendall SCD Sequential Compression Device to reprocessed Kendall SCD Sequential Compression Devices was conducted at Medical Device Services, Inc. The data indicates no significant difference in functional and safety characteristics between new and reprocessed devices.

1. Conclusion: The reprocessed Kendall SCD is substantially equivalent to the legally marketed predicate device.
  Note: The 510(k) Summary has been modified.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.

Public Health Service

MAY 0 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Eames President Medical Devices Services, Inc. 144 West Bringham Road, Building E St. George, UT 84790

Re: K012979

Trade Name: Medical Devices Services Reprocessed Compressible Lim Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 20, 2002 Received: March 21, 2002

Dear Mr. Eames:

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.

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

Page 2 - Mr. Ron Eames

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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 510(k) premarket notification. The FDA 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, 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.

D. D. Tillman, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(As required by ODE for all 510(k) received after Jan. 1, 1996.)

510(k) Number:

Device Name:

Compressible limb sleeve

Indications For Use:

The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

(Do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012979

Prescription Use
(Per 21 CFR 801.109) ℵ

Over-The-Counter Use

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).