The Wheaton Franciscan Huntleigh Reprocessed Compression Sleeve is recommended for use in whom The Wheath Flanciscan Trancisco Compression Compresses of the prevention of deep vein external compression theraly using the riaming. I to the presence of risk factors for thrombus formation. Intrathromoosis and resuming pumitonaly indicated, sometimes adjunctively with medical measures, during operative compression therepy d general surgery, particularly in patients over the age of 40.

Device Description

Huntleigh's compression sleeve device (CSD) is an SUD component of Huntleigh's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin with a bladder that is attached to a pneumatic compression device called a controller and it 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 (see diagrams in appendix 6). The sleeves are constructed with cells running the length of the patient's thigh or calf that are sequentially inflated and deflated 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.

Because the Huntleigh 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.

The description of WFSI's Reprocessed Compression Sleeves is substantially equivalent to the above described Huntleigh CSD. The primary descriptive difference between the two products is that WFSI's Reprocessed Compression Sleeves have been reprocessed as several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile product that has not been reprocessed.

AI/ML Overview

The provided text describes the reprocessing and re-marketing of compression sleeve devices (CSDs) by WFSI, asserting their substantial equivalence to Huntleigh's predicate CSDs. This is a medical device submission, primarily focused on regulatory approval rather than a traditional research study with specific acceptance criteria and performance metrics in the way a diagnostic algorithm or new drug might be evaluated.

Here's a breakdown of the requested information based on the provided text, recognizing that some points may not be directly applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate device)	Reported Device Performance (WFSI Reprocessed CSDs)
Functional Testing	No substantial equivalency differences in pressure deflation, bladder leakage, or burst strength.	"no functional pressure deflation, bladder leakage or burst strength characteristic changes that would pose any substantial equivalency differences from the predicate devices."
Intermediate Disinfection	Capable of effective intermediate disinfection.	"pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs." (Note: this is a technological advantage over the non-sterile predicate).
Biocompatibility/Toxicological Characteristics	No new biocompatibility or toxicological hazards.	"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	Capable of meeting required cleaning efficacy endpoint.	"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."
Seal Strength	Equivalent to predicate new device.	"reduced from the predicate device." (Acknowledged, but deemed acceptable for substantial equivalence).
Elongation	Equivalent to predicate new device.	"slightly greater than the predicate device." (Acknowledged, but deemed acceptable for substantial equivalence).

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

The document does not explicitly state a specific "sample size" for a test set in the way a clinical trial or algorithm validation would. Instead, it refers to:

"Functional Testing": Implies a set of reprocessed CSDs were tested. The number of CSDs or repetitions of the reprocessing cycles isn't specified. It mentions they "can be reprocessed several times."
"Intermediate Disinfection": Tests were performed on reprocessed CSDs.
"Biocompatibility/Toxicological Characteristics": Tests were performed on reprocessed CSDs.
"Cleaning Efficacy": Refers to the cleaning efficacy of the "washer," implying tests were done on CSDs after reprocessing.

The data provenance is internal to WFSI, generated during their reprocessing and testing procedures. It is prospective in the sense that they performed these tests specifically to support this 510(k) submission, rather than analyzing existing data. The country of origin is not explicitly stated but assumed to be the USA, given the FDA submission.

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

This type of information is not applicable to this submission. The "ground truth" here is established through engineering and laboratory testing against established physical, chemical, and biological standards and comparison to the predicate device's characteristics. There's no subjective interpretation by human experts (like radiologists or pathologists) to establish ground truth for performance metrics in this context.

4. Adjudication Method for the Test Set

This is not applicable as there is no subjective assessment or multiple expert opinions requiring adjudication for the type of testing performed (e.g., burst strength, disinfection efficacy, cytotoxicity).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human performance, often with or without AI assistance, in interpreting medical images or making diagnostic decisions. The WFSI submission is for a physical medical device (compression sleeves) and its reprocessing, requiring engineering and laboratory validation, not human interpretation studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. This submission is about a reprocessed physical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the WFSI Reprocessed CSDs is based on:

Physical performance standards: E.g., pressure deflation, bladder leakage, burst strength, seal strength, elongation (compared to new predicate device and manufacturing specifications).
Chemical/Biological performance standards: E.g., intermediate disinfection efficacy (meeting defined reduction targets for microorganisms), cleaning efficacy (meeting defined residuals targets), and biocompatibility/toxicological characteristics (meeting ISO standards or equivalent for medical devices).
Comparison to the predicate device: The fundamental "ground truth" for substantial equivalence is demonstrating that the reprocessed device performs comparably to the original, legally marketed predicate device (Huntleigh K881632 Compression Sleeve).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of an AI or algorithm as this submission is for a physical medical device. Manufacturing and reprocessing processes are typically validated through process validation, which involves testing a certain number of units or batches, but this isn't analogous to an AI training set.

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

This question is not applicable as there is no "training set" in this context.

Summary

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FEB 1 3 2004

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: WFSI'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 WFSI Reprocessed CSD is substantially equivalent to the legally marketed Huntleigh K881632 Compression Sleeve Predicate Devices.

Device Description:

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several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile 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 WFSI's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Huntleigh's CSDs.

WFSIs reprocessing methods does not change the intended use of the compression sleeve devices (CSDs) from the intended use of, Huntleigh's K881632 model AC500/550 predicate devices. Both WFSI's reprocessed device and Huntleigh'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.

The technical characteristics of WFSI's reprocessed device and the Huntleigh predicate Device are substantially equivalent. WFSI's reprocessed devices' seal strength after several reprocessing cycles was reduced from the predicate device. Also the elongation of WFSI'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, WFSI'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. The performance data and the safety data indicated that WFSI's Reprocessed CSDs were technically substantially equivalent to the Huntleigh CSD. The only difference is that the reprocessed CSDs were a slightly different color and the reprocessed CSDs were intermediate disinfected and the predicate devices were non sterile.

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

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 pressure deflation, bladder leakage or burst strength characteristic changes that would pose any substantial equivalency differences from the predicate devices.

Intermediate Disinfection:

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

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 circular and features the department's name around the perimeter. In the center of the circle is an emblem of an eagle with three wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Wheaton Franciscan Services, Inc. c/o Mr. Jack Speer Jack Speer & Associates, Inc. 1800 East 900 South Salt Lake City, UT 84108

Re: K033615

WFSI'S Reprocessed Compression Sleeve Devices Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Slecve Regulatory Class: Class II (two) Product Codc: JOW Dated: October 17, 2003 Received: November 17, 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. 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 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.

Sincerely yours,

Duna R. Lochner

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

ններ Աստերոիդների սրունն Vy Mis 1 11:

510(k) Number (if known): K033615 Reprocessed Compression Sleeve Devices Device Name:

Indications For Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K 0

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).