Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.

Device Description

The Restep Deep Vein Thrombosis (DVT) System, consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves.

Note: Only the compression sleeves (garments) are the subject of this submission, the pump is not included in the scope of this submission.

AI/ML Overview

This document describes the 510(k) submission for Ascent Healthcare Solutions' Reprocessed Restep Compression Sleeves. The submission focuses on demonstrating substantial equivalence to predicate devices for these reprocessed sleeves, which are part of a Deep Vein Thrombosis (DVT) prevention system.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state numerical acceptance criteria in the format of a table with thresholds and reported values for specific performance metrics. Instead, it describes types of tests conducted to demonstrate that the reprocessed sleeves perform "as originally intended."

Area of Performance	Acceptance Criteria (Implied)	Reported Device Performance
Safety	Biocompatibility requirements met	Biocompatibility testing conducted.
	Effective reprocessing and decontamination	Validation of reprocessing conducted, including removal of adherent visible soil and decontamination.
Effectiveness/Functionality	Appropriate function of components	Each individual compression sleeve tested for appropriate function of its components prior to packaging and labeling.
	Performance equivalent to original intended use	Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.

2. Sample size(s) used for the test set and the data provenance:

The document does not specify the sample sizes used for the biocompatibility, reprocessing validation, or function tests. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be bench and laboratory-based.

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

This information is not applicable. The studies described are not clinical studies that would involve expert review for ground truth establishment. They are bench and laboratory tests.

4. Adjudication method for the test set:

This information is not applicable as there is no mention of a test set requiring adjudication in the context of clinical expert review.

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 information is not applicable. The device is a reprocessed medical device (compression sleeves), not an AI-powered diagnostic tool, and therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. The device is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests (biocompatibility, reprocessing validation, function tests) would be defined by established engineering, materials science, and microbiology standards for safety and functionality of medical devices. For example:

Biocompatibility: Adherence to ISO standards (e.g., ISO 10993) or FDA guidance for medical device biocompatibility.
Reprocessing Validation: Demonstrated removal of soil and inactivation of microorganisms to acceptable levels.
Function Test: Meeting predefined specifications for pressure, fit, and integrity as per the original device's design.

8. The sample size for the training set:

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable.

Summary

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

K101087 pg 1 of 2

SECTION 5: 510(k) SUMMARY

、

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044	JUL 1 6 2010
Contact:	Amanda BabcockSr. Regulatory Affairs Specialist480.763.5300 (o)863.904.2312 (f)ababcock@ascenths.com
Date of preparation:	April 15, 2010
Name of device:	Trade/Proprietary Name: Reprocessed Restep CompressionSleevesCommon or Usual Name: Compression SleeveClassification Name: Compressible Limb Sleeve
Predicate DevicesK090308	510(k) TitleRestep DVT System	ManufacturerStortford Medical LLC
Device description:	The Restep Deep Vein Thrombosis (DVT) System, consists ofthe Restep pump and compatible leg and foot compressiongarments. The system is a lightweight, portable, prescriptivepneumatic compression device that helps to stimulate blood flowin the deep veins of the legs through the use of pneumaticallycontrolled single chamber pressure cuffs, actuated by anelectronically controlled pump unit and solenoid valves.
	Note: Only the compression sleeves (garments) are the subjectof this submission, the pump is not included in the scope of thissubmission.
Indications for Use:	Intermittent Pneumatic Compression (IPC) is indicated for usefor the prevention of deep vein thrombosis due to the presenceof risk factors for thrombus formation during orthopedic, trauma,urologic, neurology, critical care, general medicine, obstetrics,and general surgery.
Technologicalcharacteristics:	The design, materials, and intended use of ReprocessedCompression Sleeves are identical to the predicate devices.The mechanism of action of Reprocessed Compression Sleevesis identical to the predicate devices in that the same standardmechanical design, size, and materials are utilized. There areno changes to the claims, intended use, clinical applications,patient population, performance specifications, or method of

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

K101087 pg 2 of 2

Ascent Healthcare Solutions' In addition, operation. reprocessing of Compression Sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations.

Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves. This included the following tests:

Biocompatibility .
Validation of reprocessing ●
Function test(s) ●

Performance testing t demonstrates that Reprocessed Compression Sleeves perform as originally intended.

Conclusion: Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Restep Compression Sleeves) are safe, effective, and substantially equivalent to the predicate devices as described herein.

{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 consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line drawing. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

July 1 6 2010

Ms. Amanda Babcock Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

Re: K101087

Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: April 15, 2010 Received: April 19, 2010

Dear Ms. Babcock:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Amanda Babcock

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dona R. Vahner

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

Enclosure

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

K101087

SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed Restep Compression Sleeves

Indications For Use:

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 Device Evaluation (ODE)

Duna R. Vohmer.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Kio 1087

{5}------------------------------------------------

. Page 4 - Ms. Amanda Babcock

K101087

Applicant: Ascent Healthcare Solutions 10232 S 51st Street Phoenix, AZ 85044 Contact Individual: Amanda Babcock, Senior Regulatory Affairs Specialist Ph: (480)763-5376 Fax: (863)904-2312 Email: ababcock@ascenths.com

Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve

Device Name: Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves

Manufacturer	Models
Restep	RCG-10 Calf Garment (up to 22")
Restep	RCG-30 Thigh Garment (up to 32")
Restep	RCG-60 Bariatric Garment (up to 27")
Restep	RCG-210 Foot Garment (universal size)

Indications for Use (IFU)

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).