UUHC's reprocessing methods do not change the intended use of the compression sfeeve devices (CSDs) from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.

Device Description

The description of UUHC's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that UUHC's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a nonsterile product that has not been reprocessed. The studies summarized in section 9,0 Safety and Efficacy and the comparison tables in section 5 demonstrate that UUHC's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.

Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

AI/ML Overview

The provided 510(k) summary for UUHC's Reprocessed Compression Sleeve Devices describes a submission for substantial equivalence to legally marketed predicate devices (Kendall K94664 and K890938 Compression Sleeve Predicate Devices). This type of submission focuses on demonstrating that the reprocessed device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease state or clinical outcome.

Therefore, the "acceptance criteria" here are essentially showing that the reprocessed device does not perform worse than the predicate device across several key attributes. The "study" refers to the testing performed to demonstrate this equivalence.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance
Functional Equivalence: No functional characteristic changes that would pose substantial equivalency differences from the predicate devices after reprocessing multiple times.	Functional Testing: "The results of this test indicated that the CSDs can be reprocessed several times through the reprocessing steps with no functional characteristic changes that would pose any substantial equivalency differences from the predicate devices."
Intermediate Disinfection Capability: The pasteurization procedure is fully capable of and qualified for intermediate disinfection of the CSDs.	Intermediate Disinfection: "Based on test results the pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs."
Seal Strength: Seal strength, even if reduced after reprocessing, must not affect the function of the product in a simulated functional use test.	Seal Strength: "The seal strength of the samples reprocessed were reduced slightly due to reprocessing. The reduction of strength did not affect the function of the product in a simulated functional use test."
Biocompatibility/Toxicological Characteristics: Reprocessed CSDs can be used on patients without posing any new biocompatibility or toxicological hazard compared to the predicate device.	Biocompatibility/Toxicological Characteristics: "Based on test results, we conclude that the CSDs can be reprocessed and may then be used on the patient without posing any new biocompatibility or toxicological hazard to the patient."
Cleaning Efficacy: The cleaning process must effectively remove contaminants, ensuring no new safety or efficacy issues over the predicate device.	Cleaning Efficacy: "Based on test results, we conclude that the cleaning efficacy of the washer was capable or meeting the required cleaning efficacy end-point and that the cleaned reprocessed CSDs pose no new safety or efficacy issues to the patient over the predicate device."
Overall Safety and Efficacy: The reprocessed device is substantially equivalent in physical, performance, and safety characteristics to the predicate.	Substantial Equivalency: "The performance data and the safety data indicated that UUHC's Reprocessed CSDs were technically substantially equivalent. The reprocessed device was tested for biocompatibility and performance and they were substantially equivalent in all required categories to the predicate device."
Intended Use: The reprocessing methods do not change the intended use of the CSDs from that of the predicate devices.	Intended Use: "UUHC's reprocessing methods do not change the intended use of the CSDs from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices."

2. Sample size used for the test set and the data provenance

The document states that the devices can be reprocessed "as many as eleven (11) times" and that "the CSDs can be reprocessed several times". It also mentions "the seal strength of the samples reprocessed." However, specific sample sizes for each test (functional, disinfection, seal strength, biocompatibility, cleaning efficacy) are not provided in this summary. The provenance of the data is from UUHC's internal testing as part of their 510(k) submission. This is a prospective set of tests conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission is not clinical in nature in the sense of diagnosing a disease, but rather demonstrating the safety and effectiveness of a reprocessed medical device through bench testing. Therefore, there is no concept of "ground truth" derived from expert consensus like in an imaging study. The "ground truth" for each test is the objective measurement against established standards or the performance of the predicate device. The experts involved would be the engineers, microbiologists, and other technical specialists who conducted the tests and interpreted the results according to validated protocols. Their qualifications are not specified in the summary but would be relevant to the specific testing performed (e.g., a microbiologist for disinfection testing, material scientist for seal strength).

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings or diagnoses.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for a reprocessed physical medical device (compression sleeve), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the various tests was based on:

Objective measurements and engineering specifications: For functional performance, seal strength, and cleaning efficacy, tests would have compared physical properties and cleanliness against predefined acceptable ranges or against the performance of new predicate devices.
Microbiological standards: For intermediate disinfection, the "ground truth" would be the demonstrated reduction in microbial load to meet specific disinfection levels.
Biocompatibility standards: For biocompatibility, the "ground truth" would be passing assays and tests against established ISO standards (e.g., ISO 10993).
Intended Use of Predicate Devices: For intended use, the "ground truth" is the established indications for use of the original, legally marketed predicate devices.

Essentially, the ground truth is the performance of the predicate device and relevant industry/regulatory standards for medical device safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning model; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary

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K031189

OCT 1 6 2003

510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(K) number is:

Device Name:

Proprietary Name: UUHC'S Reprocessed Compression Sleeve Devices

Common/Usual Name: Compressible Limb Sleeve Device

Classification:

Class II per 21 CFR 870,5800 Panel Number: Panel 70 Product Code: JOW

Predicate Device:

The UUHC'S Reprocessed CSD is substantially equivalent to the legally marketed Kendall K94664 and K890938 Compression Sleeve Predicate Devices.

Device Description:

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flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.

Because the Kendall CSD is placed on the patient's intact skin, it falls under the Spaulding Non-Critical device classification. The CSD procedure is considered a safe, non invasive, less expensive and simple alternative to anti-coagulant drug therapy and it is one of the least expensive, yet most effective non invasive systems available for the prevention of venous thrombosis.

Intended Use:

UUHC's reprocessing methods do not change the intended use of the CSDs from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.

Technical Characteristics:

The technical characteristics of UUHC's reprocessed device and the Kendall predicate Device are substantially equivalent. UUHC's reprocessed devices' seal strength after several reprocessing cycles was reduced from the predicate device. Also the elongation of UUHC's reprocessed device was slightly greater than the predicate device. This is to be understood since the materials would naturally loose a little strength due to the reprocessing procedures.

Also, UUHC's Reprocessed CSDs are pasteurized and passed an intermediate level of disinfection testing whereas the predicate device is non-sterile: which may be considered a technological advantage of the reprocessed device over the predicate device.

Substantial Equivalency:

The performance data and the safety data indicated that UUHC's Reprocessed CSDs were technically substantially equivalent. The only difference between the predicate device and the reprocessed device was that the seal strengths were slightly less in the reprocessed device. This did not affect the safety and efficacy of the reprocessed device compared to the predicate device. In addition the reprocessed device is pasteurized and the predicate device is sold non-sterile. This difference did not affect the safety and efficacy of the reprocessed device.

The reprocessed device was tested for biocompatibility and performance and they were substantially equivalent in all required categories to the predicate device.

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Conclusion:

The following conclusions can be drawn from reviewing the safety and efficacy data of the 510(K):

Functional Testing:

The results of this test indicated that the CSDs can be reprocessed several times through the reprocessing steps with no functional characteristic changes that would pose any substantial equivalency differences from the predicate devices.

Intermediate Disinfection:

Based on test results the pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs.

Seal Strength:

The seal strength of the samples reprocessed were reduced slightly due to reprocessing. The reduction of strength did not affect the function of the product in a simulated functional use test.

Biocompatibility/Toxicological Characteristics:

Based on test results, we conclude that the CSDs can be reprocessed and may then be used on the patient without posing any new biocompatibility or toxicological hazard to the patient.

Cleaning Efficacy:

Based on test results, we conclude that the cleaning efficacy of the washer was capable or meeting the required cleaning efficacy end-point and that the cleaned reprocessed CSDs pose no new safety or efficacy issues to the patient over the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

University of Utah Hospital and Clinics c/o Mr. Jack Speer Jack Speer and Associates, Inc. 1800 East, 900 South Salt Lake City, UT 84108

Re: K031189

Reprocessed Compression Sleeve Devices Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II (two) Product Code: JOW Dated: July 17, 2003 Received: July 18, 2003

Dear Mr. Speer:

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.

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Page 2 - Mr. Jack Speer

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), 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) you may obtain. 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Dias Mallis

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number

Unknown

Device Name:

Reprocessed Compression Sleeve Devices

University of Utah Hospital and Clinics (UUHC) reprocessing Indications for Use: methods do not change the intended use of the compression sfeeve devices (CSDs) from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.

Wanda Charley
(Signature of Verifier)

Richard Lee

Elias Maller

Cardiovascular Devices

510(k) Number_ K031189

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).