Preventing deep vein thrombosis (DVT)
Enhancing blood circulation
Diminishing post-operative pain and swelling
Reducing wound healing time
Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
Treatment of chronic venous insufficiency
Reducing edema

Device Description

The Cirvo Compression System is a light-weight, mobile, sequential compression device (SCD) placed around the calf that sequentially compresses the calf to augment blood flow. SCD's are used in both the hospital and home setting. most commonly to prevent deep vein thrombosis (DVT), heal venous leg ulcers (VLU) and reduce swelling. The Cirvo Compression System includes three components: the Cirvo sequential compression device, an AC charger and a smart device app.
The Cirvo compression unit generates compression cvcles using a small motor to sequentially cycle the compression unit on the calf. The Cirvo sequential compression device is placed around the lower leg using a detachable shin guard with self-aligning magnets, with the padded compression unit aligned on the calf. Proper fitting is achieved by adjusting a pair of hook and loop straps. The Cirvo compression system continuously monitors and maintains the prescribed compression therapy, records the duration of therapy session as well as compliance with the prescribed therapy. Therapy can be initiated and stopped using either the app interface on a smart device or using the capacitive touch sensor on the compression unit. Patients can track their progress with the app and can opt in to have text reminders sent to reinforce compliance with their therapy and notifications sent to their physician. All data is saved and transmitted using high-level, AES-128 encryption.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Cirvo Compression System," structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed clinical efficacy trials often described in scientific publications. As such, information regarding clinical studies, AI performance metrics, ground truth establishment, and specific multi-reader multi-case studies might be limited or absent.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the Cirvo Compression System K190976 states that "All testing met pre-established acceptance criteria." However, it does not explicitly detail the quantitative acceptance criteria for each test performed. It lists the types of tests conducted and concludes that they were successful. Therefore, the table below reflects what is implied as meeting the acceptance criteria based on the narrative.

Acceptance Criteria Category (Implied)	Reported Device Performance
Bench Testing
Device strap tensile strength	Successfully passed
Device buckle to cord tensile strength	Successfully passed
Simulated use performance	Successfully passed
Reliability performance	Successfully passed
Packaging integrity	Successfully passed
Software Testing
Battery power supervisor software	Compliant with FDA/IEC 62304 "moderate level of concern"
Mobile application client software	Compliant with FDA/IEC 62304 "moderate level of concern"
Signal board software	Compliant with FDA/IEC 62304 "moderate level of concern"
Security verification	Successfully verified
Electrical Safety Testing
IEC 60601-1:2006 (Basic safety)	Compliant
IEC/EN 60601-1-2:2007 (EMC)	Compliant
FCC Part 15 & Part 18	Compliant
Industry Canada ICES-003 Issue 5	Compliant
Coexistence with intentional radiators	Successfully demonstrated
Therapy Parameters
Pressure Delivered (40-60 mmHg)	Maintained "prescribed compression therapy" (Implied)
Therapy Duration Monitoring	Continuously monitored (Implied as functional)
Compliance with Therapy Monitoring	Continuously monitored (Implied as functional)

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

The document does not provide specific sample sizes for the "test set" in the context of clinical data. The performance testing described (bench, software, electrical safety) uses equipment and methods, but doesn't refer to a "test set" of patients or data in the way an AI/clinical study might. The data provenance is not applicable in the context of device performance testing; it's about the device itself and its components.

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

This information is not provided in the document. The testing described is primarily engineering and regulatory compliance, not typically involving human expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of performance testing documented here.

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

No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and performance testing, not on comparative clinical effectiveness with or without AI assistance. The device is a "sequential compression device," not an AI diagnostic or assistive tool in the MRMC sense.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone physical compression system with software components. The software is part of the control system and user interface. The performance testing "without human-in-the-loop" would essentially be the bench testing and software verification, which were indeed performed. However, this is not a diagnostic algorithm in the typical sense of standalone AI performance.

7. Type of Ground Truth Used

For the engineering tests, the "ground truth" would be established by:

Industry Standards: IEC, FCC, Industry Canada standards for electrical safety and electromagnetic compatibility.
Design Specifications: Internal design requirements for tensile strength, pressure delivery, duration tracking, etc.
FDA Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" and IEC 62304 for software.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the performance testing described.

8. The Sample Size for the Training Set

This information is not applicable as the document does not describe the development of a machine learning or AI model that would require a "training set" of data in the common sense. The software is described as being developed in accordance with validation principles, but not trained on a data set.

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

This information is not applicable as there is no described training set.

Summary

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July 12, 2019

Radial Medical, Inc. % Mark Smutka Regulatory Consultant 10984 Northseal Square Cupertino, California 95014

Re: K190976

Trade/Device Name: Cirvo Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 2, 2019 Received: June 14, 2019

Dear Mark Smutka:

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.

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

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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 mediation-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 Fernando Aguel Assistant Director 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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Indications for Use

510(k) Number (if known) K190976

Device Name Cirvo Compression System

Indications for Use (Describe)

The Radial Medical Cirvo Compression System is indicated for use in:

· Preventing deep vein thrombosis (DVT)
Enhancing blood circulation
· Diminishing post-operative pain and swelling
· Reducing wound healing time
· Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
· Treatment of chronic venous insufficiency
· Reducing edema

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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Premarket Notification 510(k) Summary

510(k) Number: K190976

Applicant Information:

Date Prepared:	May 2, 2019
Name:	Radial Medical, Inc.Address: 2500 Grant RoadMountain View, CA 94040
Contact Person:	Mark Smutka, Consultantmsmutka@comcast.net
Mobile Number:	(408) 981-7531

Device Information:

Trade Name:	Cirvo Compression System
Common Names:	Compression Sleeve
Classification Name(s):	Compressible Limb Sleeve
Product Code/ Regulation:	JOW / 21 CFR 870.5800
Classification:	Class II

Predicate Device:

Radial Medical Compression System 510(k) #K181651 ●

Device Description:

The Cirvo compression unit generates compression cvcles using a small motor to sequentially cycle the compression unit on the calf. The Cirvo sequential compression device is placed around the lower leg using a detachable shin guard with self-aligning magnets, with the padded compression unit aligned on the calf. Proper fitting is achieved by adjusting a pair of hook and loop straps. The Cirvo compression system continuously monitors and maintains the prescribed compression therapy, records the duration of therapy session as well as compliance with the prescribed therapy. Therapy can be initiated and stopped using either the app interface on a smart device or using the capacitive touch sensor on the compression unit. Patients can track their progress with the app and can opt in to have text reminders sent to reinforce compliance with their therapy and notifications sent to their physician. All data is saved and transmitted using high-level, AES-128 encryption.

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Indications for Use:

The Radial Medical Compression System is indicated for use in:

Preventing deep vein thrombosis (DVT) ●
o Enhancing blood circulation
Diminishing post-operative pain and swelling ●
o Reducing wound healing time
Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and ● diabetic leg ulcers
Treatment of chronic venous insufficiency ●
Reducing edema. ●

Summary Comparison to Predicate:

The following table provides a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and substantially equivalent technological characteristics that do not raise different questions of safety or effectiveness.

Key Attributes	Predicate Device	Subject Device
Name	Radial Medical CompressionSystem	Cirvo Compression System
K Number	K181651	K190976
Indication for Use	The Radial MedicalCompression System isindicated for use in:● Preventing deep veinthrombosis (DVT)● Enhancing bloodcirculation● Diminishing post-operative pain andswelling● Reducing woundhealing time● Treatment andassistance in healing:stasis dermatitis;venous stasis ulcers;arterial and diabeticleg ulcers	The Cirvo CompressionSystem is indicated for usein:● Preventing deep veinthrombosis (DVT)● Enhancing bloodcirculation● Diminishing post-operative pain andswelling● Reducing woundhealing time● Treatment andassistance in healing:stasis dermatitis;venous stasis ulcers;arterial and diabeticleg ulcers

Comparison to Predicate and Reference Devices

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	Treatment of chronic venous insufficiency Reducing edema	Treatment of chronic venous insufficiency Reducing edema
Target Population	Patients requiring compression therapy.	Patients requiring compression therapy.
Where Used	Hospital, physician office, and home	Hospital, physician office, and home
Anatomical Site	Calf	Calf
User	Physician and patient	Physician and patient
Sterility	Non-sterile	Non-sterile
Use	Single patient use	Single patient use
Power Source	Rechargeable battery	Rechargeable battery
Pressure Delivered	40 – 60 mmHg	40 – 60 mmHg
Mechanical Properties	2 servo motors	1 servo motor
Charging Method	Wireless inductive charging unit using 12V power adapter	Direct plug-in charging using 12V power adapter

Summary of Performance Testing

Functional and performance testing was successfully completed on the subject device using the same methods and similar equipment as the predicate device to evaluate the minor modifications to the Cirvo Compression System. All testing met pre-established acceptance criteria.

Bench Testing

The following testing was performed to verify the relevant performance specifications of the Cirvo Compression System:

Device strap tensile test ●
Device buckle to cord tensile test ●
Simulated use testing ●
Reliability testing ●
Packaging test ●

Software Testing

Radial Medical followed the FDA Guidance Document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff?' (January, 2002) to classify the software

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as a "moderate level of concern". The software has been prepared in accordance with the FDA guidance document as well as IEC 62304. Testing included:

Battery power supervisor software testing o
o Mobile application client software testing
Signal board software testing ●
Security verification testing ●

Electrical Safety Testing

Electrical safety testing was performed to demonstrate compliance with the following standards:

o IEC 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance FDA recognition number:19-4
IEC/EN 60601-1-2:2007. Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). FDA recognition number: 19-2
FCC Part 15 and Part 18 FCC Part 15, Subpart C (15.209), FCC Part 15, Subpart C ● (15.207), RSS-210 Issue 9, FCC Part 18 (Consumer Device), FCC Part 15, Subpart B, and Industry Canada ICES-003 Issue 5

In addition, coexistence testing with intentional radiators was successfully completed.

Conclusion

Testing described in this 510(k) consisted of verification of design input requirements and product specifications. Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Ciryo Compression System has been shown to be substantially equivalent to the legally-marketed predicate device.

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).