The provided text describes a 510(k) submission for a reprocessed medical device, the ReNu Medical Reprocessed ALP®1 Calf Garment. It focuses on demonstrating substantial equivalence to predicate devices and the impact of reprocessing.

Based on the provided text, the following information can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall design	Identical
Materials	Identical
Energy source	Identical
Mode of operation	Identical
Performance techniques	Identical
Reprocessing methodology	Identical
Biocompatibility	Reprocessing does not affect biocompatibility
Performance after reprocessing	Bench testing conducted to ensure reprocessing did not compromise performance
Safety after reprocessing	Validation information provided to demonstrate device safety is not impacted by reprocessing

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

Sample Size: Not explicitly stated. The text mentions "Bench testing was conducted" but does not give a specific number of units tested.
Data Provenance: Not explicitly stated. Given the context of a 510(k) submission from a US company (Everett, WA), it is highly likely the testing was conducted in the US. The testing appears to be internal (bench testing) rather than clinical.

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

This section is not applicable as the study described is a bench study comparing a reprocessed device to its original and predicate devices, not a study involving human interpretation or subjective assessment of medical conditions by experts. The "ground truth" here refers to the physical and functional properties of the device.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. There is no human interpretation requiring adjudication.

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

This section is not applicable. The device is a physical medical device (compression sleeve), not an AI diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This section is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for the acceptance criteria was based on the physical and performance characteristics of the predicate devices and the original (unreprocessed) ALP™1 Calf Garment. The goal was to demonstrate that the reprocessed device remained "identical" in key aspects and that reprocessing did not compromise its safety or performance.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is a physical device re-processing validation, not an AI or machine learning model development.

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

This section is not applicable for the same reason as point 8.

Summary

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

Ko5/227

510 (k) Summary

Submitters Name and Address: ReNu Medical 9800 Evergreen Way Everett, WA 98024 Phone: 425-353-1110 Fax: 425-353-1110

FDA Registration Number: 3034520

Contact Person: L. Bruce Pierson Chief Operating Officer

Date Summary Prepared: 3-12-05

Trade or Proprietary Name(s): ReNu Medical Reprocessed ALP®1 Calf Garment (up to 18" calf circumference)

APR

6 2006

Common Name:

Sleeve, Limb, Compression

Product Code:

JOW

Panel

Cardiovascular 870.5800

Classification:

Class II

Equivalent Device(s)

Re Nu Medical Reprocessed Kendall Impad - 510(k) # K031559 Re Nu Medical Reprocessed Huntleigh Flowtron - 510(k) # 031559

Device Description:

The ReNu Medical Reprocessed (up to 18" calf circumference)

CONFIDENTIAL

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

Intended Use

· Prevent deep vein thrombosis and resulting pulmonary embolism.
Intra-operative compression therapy. .

Technological Characteristics of the ReNu Medical Reprocessed Healthcare Service and Supply ALP™ 1 Calf Garment.

The predicate devices and the ReNu Medical ALP®1 Sequential Compression Sleeve are identical in overall design, materials, energy source, mode of operation, performance techniques, and reprocessing methodology.

Summary of Comparison Tests

Bench testing was conducted to ensure that reprocessing did not compromise the performance of the device.

Biocompatability

Reprocessing does not affect the biocompatibility of the device.

Process Validation:

Validation information has been provided as part of this submission to demonstrate that the device safety and. performance is not impacted by subsequent reprocessing

Image /page/1/Picture/11 description: The image shows the word "CONFIDENTIAL" in bold, uppercase letters. The word is slightly tilted, with the left side appearing lower than the right. The text is dark against a lighter background, making it stand out.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2006 APR

ReNú Medical c/o Mr. L. Bruce Pierson Chief Operating Officer 9800 Evergreen Way Everett, WA 98204-2780

Re: K051227

ReNu Reprocessed ALP®1 Calf Garment (up to 18" calf circumference) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 23, 2005 Received: January 11, 2006

Dear Mr. Pierson:

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.

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

Page 2 - Mr. L. Bruce Pierson

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 (240) 276-0120. 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Bhimmarfor

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

Enclosure

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

Indications for Use

510(k) Number (if known):

Device Name: ReNu Reprocessed ALP®1 Calf Garment (up to 18" calf circumference)

Indications for Use:

The ReNu Medical Reprocessed ALP®1 is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:

Prevent deep vein thrombosis and resulting pulmonary embolism. .

Precautions and Contraindications:

Sleeves may not be recommended for patients with the following:

Any local leg condition in which sleeves would interfere: dermatitis, gangrene, . recent skin graft, untreated infected wounds.
Congestive heart failure. .
Severe arteriosclerosis or other ischemic vascular disease. .
. Pulmonary edema.
Known or suspected deep vein thrombosis or phlebitis. .

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Btmuna

Page 1 of

Division Slan-Offi Division of Cardlovascular Devices 510(k) Number

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).