The RENU Medical Reprocessed Tri Pulse Compression Garment are to be used as a non-invasive therapeutic method to help prevent Deep Vein Thrombosis (DVT) and resulting pulmonary embolism.

Device Description

The Reprocessed Tri Pulse Compression Garment is a compression garment that is attached to a patient's limb. It is designed to work with the Arjo Flowtron ACS800 Pump and Arjo Flowtron ACS900 Pump only. Each garment is compressed alternately, applying pressure to the patient's limb, to help prevent deep vein thrombosis.

Tri Pulse garments are constructed with a three-chamber bladder enclosed in a polyester garment, which is wrapped around the limb and secured with hook and eye tabs. When connected to the pump, the garment inflates through a single connecting tube to generate a sequential compression effect on the limb.

Reprocessing the Tri-Pulse Compression Garment is conducted by achieving high-level disinfection via thermal disinfection methods. This process is conducted by holding the devices at or above a predetermined specified temperature for a predetermined specified duration.

AI/ML Overview

Although the document describes the regulatory clearance for a reprocessed medical device (Tri Pulse Compression Garment), it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML medical device.

The provided text focuses on:

Device Type: Reprocessed medical device (compression garment)
Regulatory Pathway: 510(k) premarket notification
Substantial Equivalence: Demonstrated through bench testing (cycle verification testing) to ensure reprocessing does not adversely affect the device's performance compared to the OEM predicate device.
Testing Method: Cycle Verification Testing, which involves reprocessing garments multiple times (10 cycles) and performing functional pressure and inflation time readings after each cycle.
Ground Truth: For this type of device, the "ground truth" is adherence to OEM specifications (pressure, inflation time) after reprocessing, not clinical outcomes or expert consensus on image interpretation.
Study Design: Bench testing, not a clinical study involving human subjects or AI algorithms.

Therefore, I cannot extract the following information from the provided text as it pertains to AI/ML device studies:

A table of acceptance criteria and the reported device performance: The document mentions "specifications outlined by the OEM predicate device" and "functional requirements" but doesn't present these in a table format with specific acceptance criteria and reported values for an AI/ML model.
Sample size used for the test set and the data provenance: The document mentions a "sample of devices" being reprocessed "10 times each" for the bench test, but this isn't an AI test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the ground truth for this device is based on physical performance metrics (pressure, inflation time) measured by equipment, not human experts interpreting data.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is the physical performance specifications of the OEM device (pressure and inflation time) after reprocessing.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the provided document does not contain the information needed to answer the prompt regarding AI/ML device acceptance criteria and study details.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 7, 2021

RENU Medical, Inc Darren DeMerritt Director RA/OA 830 80th ST SW Suite 100 Everett, Washington 98203

Re: K203847

Trade/Device Name: Reprocessed Tri Pulse Compression Garment Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: April 8, 2021 Received: April 9, 2021

Dear Darren DeMerritt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Nicole Gillette Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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The item numbers included in the scope of this 510(k) submission are as follows:

Item No	Sleeve Description
RM-TRP10	Flowtron Regular Sequential Calf Garment
RM-TRP20	Flowtron Large Sequential Calf Garment
RM-TRP30	Flowtron Regular Sequential Thigh Garment
RM-TRP40	Flowtron Large Sequential Thigh Garment
RM-TRP60L	Flowtron Bariatric Sequential Calf Garment

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Indications for Use

510(k) Number (if known)

K203847

Device Name

Reprocessed Tri Pulse Compression Garments

Indications for Use (Describe)

The RENU Medical Reprocessed Tri Pulse Compression Garment are to be used as a non-invasive therapeutic method to help prevent Deep Vein Thrombosis (DVT) and resulting pulmonary embolism.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Reprocessed Tri Pulse Compression Garments

Name & Address:	RENU Medical, Inc.830 80th ST SW Suite 100Everett, WA 98203
Telephone:	425-353-1110
Fax:	425-353-9116
Prepared:	December 29, 2020
Contact:	Darren DeMerritt, Director RA/QA
Device Name:	Reprocessed Tri Pulse Compression Garment
Common Name:	Compressible Limb Sleeve

Classification

	Class	Product	Classification
		Code	Regulation
	ll	JOW	21 CFR 870.5800
Classification Name:	Sleeve, Limb, Compressible
Predicate Devices:	12, 2003 (K031559).		RENU Medical Reprocessed Compressible Limb Sleeves, cleared November
	Arjo Huntleigh (K133119).	The following is a reference device:	Tri Pulse Garments cleared February 28, 2014, originally manufactured by
Indications for Use:			The RENU Medical Reprocessed Tri Pulse Compression Garment are to beused as a non-invasive therapeutic method to help prevent Deep VeinThrombosis (DVT) and resulting pulmonary embolism.
Description:	The Reprocessed Tri Pulse Compression Garment is a compression garmentthat is attached to a patient's limb. It is designed to work with the ArjoFlowtron ACS800 Pump and Arjo Flowtron ACS900 Pump only. Eachgarment is compressed alternately, applying pressure to the patient's limb,to help prevent deep vein thrombosis.

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Models:

Model ID:	Device	Features
TRP10, TRP20,TRP30, TRP40and TRP60	Tri Pulse CompressionGarment	Sequential inflation providing activecompression.

Substantial Equivalence:	The equivalence of the Tri Pulse garments is demonstrated usingbench testing to determine that the reprocessing methods do notadversely affect the device from performing to the specificationsoutlined by the OEM predicate device (K133119).
	The bench tested done on the devices was Cycle Verification Testing. Thistest examines the effect of the ReNu reprocessing system on thedurability and functionality of the devices. The purpose of this test is toensure that the Tri-Pulse Compression Garments can withstand thethermal temperatures that they're subject to during a reprocessing hotwater pasteurization cycle.
	During this test, a sample of devices were reprocessed 10 times each andsubject to functional testing after each individual cycle in order to ensurethat each device meets its functional requirements.
	Each device was subject to a pasteurization cycle, then placed aroundPVC to simulate a patient use. Once situated, it was pumped up by anOEM pump and pressure readings were taken to ensure that thecompression garment met its pressure and inflation time requirementsand repeated until the Reprocessed Compression Garment met its cyclelimit. This verification report, document ID #12915, titled, CycleVerification Report, TRP DVT, can be found in section 18.4, SupportingDocuments.
	Additionally, the Reprocessed Tri Pulse Garments are substantiallyequivalent to other reprocessed compression garments andtherefore are able to achieve the same cycle limits of otherpreviously cleared reprocessed compression garments (K031559).
Technologies Summary:	Tri Pulse garments are constructed with a three-chamber bladderenclosed in a polyester garment, which is wrapped around the limband secured with hook and eye tabs. When connected to the pump,

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the garment inflates through a single connecting tube to generate a sequential compression effect on the limb.

Conclusion: The data detailed within submission demonstrates that the device is as safe and effective as the predicate and performs as well as the legally marketed predicate devices, identified in this summary.

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).