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 Radial Medical Compression System (RMCS) is a light weight, mobile, sequential compression device (SCD) placed around the lower leg. The device is designed to provide sequential compression to the calf to augment blood flow. The system includes three components: the Cirvo sequential compression device, an inductive charging cradle and a smart device app (i.e. tablet or smartphone). The RMCS records the amount and duration of compression received during a therapy session as well as compliance with the prescribed therapy. Identified patient data, and compiled, de-identified data will be shared with the treating physician to facilitate clinical decision making.
The Cirvo uses a mechanical system to sequentially compress the leg utilizing four tension zones tensioned in series. A circumferential sleeve of polyester material is placed around the calf, held in place using hook and loop straps. During the compression cycle, a reduction in the effective circumference of the sleeve exerts a radially inward force on the calf. The device has a compression cycle time of 6 seconds and a physician-determined dwell time between compression cycles. The range of compression cycle pressures of the Cirvo is 40-60 mmHg.

AI/ML Overview

The provided text describes the Radial Medical Compression System (RMCS) and its clearance via a 510(k) pathway, demonstrating substantial equivalence to a predicate device. However, the information provided does not include the details typically found in a study proving an AI/device meets acceptance criteria using a test set with ground truth established by experts and adjudication methods, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisted by AI.

The document outlines performance testing for a medical device (a sequential compression system) for therapeutic purposes, not an AI or diagnostic device that would require the establishment of ground truth for a test set, expert consensus, or specific acceptance criteria around diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot directly answer your prompt's specific requirements regarding acceptance criteria and a study proving an AI device meets those criteria, as the provided text describes a mechanical medical device and its validation for FDA clearance, which focuses on device performance, safety, and substantial equivalence to a predicate.

However, I can extract the closest analogous information from the provided text regarding the device's performance testing and clinical evaluation.

Based on the provided text, here's an attempt to extract relevant details, acknowledging that it's for a mechanical device and not an AI/diagnostic system as implied by the prompt's structure:

The Radial Medical Compression System (RMCS) is a light-weight, mobile, sequential compression device (SCD) designed to provide sequential compression to the calf to augment blood flow. Its clearance was based on demonstrating substantial equivalence to a legally marketed predicate device (Vasculaire Compression System, K122609).

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for diagnostic performance (as would be typical for an AI device) but rather functional and safety performance specifications. The "performance" assessment is primarily comparative and related to its intended physiological effect.

Table 1: Key Performance Attributes and Comparison (Extracted from "Summary Comparison to Predicate" and "Clinical Performance Testing")

Attribute	Acceptance Criteria (Implied / Compared to Predicate)	Reported Device Performance (Radial Medical Compression System)
Pressure Delivered	Within specified physiological range and comparable to predicate. The predicate delivers 50-150 mmHg.	40 – 60 mmHg
Therapy Delivery Mode	Sequential compression of calf from caudal to cranial to augment venous flow. Similar to predicate.	Mechanical system, four tension zones, tensioned in series. Delivered as sequential compression from caudal to cranial.
Clinical Effect	Augment venous flow (measured as peak venous velocity); comparable or superior to baseline and predicate.	- Average 3.5-fold femoral venous flow augmentation (high setting).- Radial device (low/high setting) resulted in higher average peak venous velocities compared to baseline and IPC device (p<0.05).
Safety	No serious safety events or adverse events.	No Adverse Events or safety issues reported in the course of the study.
Biocompatibility	Materials in patient contact are biocompatible (per ISO 10993-1:2009).	Cytotoxicity, irritation, and sensitization testing performed and successfully completed.
Electrical Safety	Compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-2, etc.).	Successfully demonstrated compliance.
Software Validation	Classified as "moderate level of concern," prepared in accordance with FDA guidance and IEC 62304.	Compliant with FDA guidance "General Principles of Software Validation" and IEC 62304.
Human Factors	Usability and safety evaluated, no serious safety events due to use/misuse.	Formative usability testing performed, device meets requirements. FMEA revealed no serious safety events related to use/misuse.

Study Details (Clinical Performance Testing)

The "Clinical Performance Testing" section describes a feasibility study rather than a full-scale clinical trial used for a new AI diagnostic device to establish standalone or human-in-the-loop performance. This study's purpose was to evaluate venous flow augmentation.

1. Sample Size and Data Provenance:
* Test Set Sample Size: 10 subjects.
* Data Provenance: The study was conducted on recruited subjects. The text mentions "an IRB approved study," suggesting prospective data collection, likely within the US, given the FDA submission context. No explicit country of origin is stated beyond the general context of US regulatory approval.

2. Number of Experts and Qualifications:
* This type of study (measuring physiological parameters like peak venous velocity) typically involves trained medical professionals performing the measurements (e.g., ultrasound technicians, physicians). However, the document does not specify the number or qualifications of experts used for data collection or analysis within this feasibility study. There's no "ground truth" adjudicated by multiple experts in the sense of image interpretation for AI.

3. Adjudication Method:
* Not applicable to this type of study. The measurements (peak venous velocity) are quantitative.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, an MRMC study was not done. This study was a physiological measurement study on a medical device, not an AI diagnostic tool involving multiple readers interpreting cases. Therefore, there's no effect size for human readers improving with AI assistance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
* Not applicable in the typical sense for an AI device. The "performance" described is the device's direct physiological effect (venous flow augmentation) when worn by a subject, which is an "algorithm only" type of assessment in that it evaluates the device's physical function. However, it's not an AI algorithm generating a diagnostic output.

6. Type of Ground Truth Used:
* The "ground truth" in this context is the physiologically measured peak venous velocity (cm/s) at specific anatomical sites (popliteal and femoral veins) using an objective measurement method (implied to be Doppler ultrasound, common for such measurements). This serves as the quantitative outcome data.
* It also compared to a baseline measurement and a commercially available portable intermittent pneumatic compression (IPC) device.

7. Sample Size for Training Set:
* Not applicable. This document describes a medical device, not an AI system that undergoes a separate training phase with a distinct training dataset.

8. How the Ground Truth for the Training Set Was Established:
* Not applicable. As above, there's no AI training set or associated ground truth establishment process described.

Summary

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

October 12, 2018

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

Re: K181651

Trade/Device Name: Radial Medical Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 19, 2018 Received: June 22, 2018

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 Actinclude 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel Fernando Aguel - S

for 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

510(k) Number (if known)

K181651

Device Name Radial Medical Compression System

Indications for Use (Describe)

The Radial Medical 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: K181651

Applicant Information:

Date Prepared:	October 4, 2018
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:	Radial Medical 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:

Vasculaire Compression System 510(k) #K122609 ●

Device Description:

The Cirvo uses a mechanical system to sequentially compress the leg utilizing four tension zones tensioned in series. A circumferential sleeve of polyester material is placed around the calf, held in place using hook and loop straps. During the compression cycle, a reduction in the effective circumference of the sleeve exerts a radially inward force on the calf. The device has a compression cycle time of 6 seconds and a physician-determined dwell time between compression cycles. The range of compression cycle pressures of the Cirvo is 40-60 mmHg.

Indications for Use:

The Radial Medical Compression System is indicated for use in:

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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. ●

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 as the predicate device. Although the subject device has different technological characteristics than the predicate device, the differences do not raise different questions of safety or effectiveness.

Key Attributes	Subject Device	Predicate Device
Name	Radial Medical CompressionSystem	Vasculaire Compression System
K Number	K181651	K122609
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 Treatment of chronicvenous insufficiency Reducing edema	The Vasculaire CompressionSystem is indicated 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 Treatment of chronicvenous insufficiency Reducing edema

Comparison to Predicate and Reference Devices

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Target Population	Patients requiring compressiontherapy.	Patients requiring compressiontherapy.
Where Used	Hospital, physician office, andhome	Hospital, physician office, andhome
Anatomical Site	Calf	Calf, or calf and foot
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	50 – 150 mmHg

The primary technical difference between the Cirvo and the predicate device is that the Cirvo uses a mechanical system to sequentially compress the leg using a system of pulleys and cables to tension four zones, tensioned in series, to apply pressure (Figure 1) and the Vasculaire uses a pneumatic pump to inflate a series of four bladder zones in series to apply pressure The therapy delivery mode is the same for both devices, sequentially compressing the calf from caudal to cranial to augment venous flow. The clinical effect of the Cirvo is similar to the effect of the predicate device.

Image /page/5/Picture/2 description: The image shows a medical device with upper and lower compression zones. The upper compression zone is located above the lower compression zone. The device has straps with numbers 1, 2, 3, and 4 on them, which are likely used to adjust the compression level.

Figure 1. Sequential compression mechanism of operation. Cirvo on lower leg. Four pulley zones tensioned in series from zone one to four (numbers) tension lower and upper compression zones via straps resulting in compression (arrows).

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Summary of Performance Testing

Functional and performance testing was successfully completed on the subject device. In addition, the subject device has been investigated with respect to biocompatibility, electrical safety, software validation, human factors and clinical requirements. The Radial Medical Compression System has been tested for electromagnetic compatibility and electrical safety.

Bench Testing

The following testing was performed to verify the performance specifications of the Radial Medical Compression System:

Device strap tensile test ■
Device drive cord tensile test
Device strap weld tensile test
Device hook and loop tensile test
I D-ring chassis strap and T-bar breakaway release tensile test
트 Device shin plate tensile test
트 Simulated use and reliability test
트 Packaging test

In addition, device simulation testing was performed to compare the performance of the Radial Medical Compression System to the predicate device. Bench testing demonstrated that the two devices deliver equivalent pressures.

Biocompatibility

Materials in contact with the patient include the following:

Material	Description	Part#	Material Manufacturer
Velcro (inadvertent contact)	Velcro strap (nylon)	DG15BLTH-S	Hook-and-Loop
Polyester fabric (sealing the foam)	Tek Stretch 4 fabric	TS100BW/4W	Eastex Products, Inc.

Biocompatibility was considered according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Biocompatibility). Cytotoxicity testing, irritation and sensitization testing were performed and successfully completed.

Software

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

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Electrical Safety Testing

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

. 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
IEC 60601-1-6:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC60601-1-11: 2015, Medical electrical equipment Part 1-11: General requirements ● for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. 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.

Human Factors Testing

Radial Medical performed human factors testing for the Radial Medical Compression System. Testing operations were performed according to FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" (Feb. 3, 2016). The usability of the device was also evaluated in compliance with IEC 60601-1-6.

A Use Failure Modes and Effects Analysis (FMEA) was performed to evaluate potential safety issues related to the use or misuse of the device. The analysis revealed that there are no serious safety events that are related to the use or misuse of the product. As part of design testing of the products, formative usability testing was performed to evaluate overall usability and related human factors. The testing evaluated the Radial Medical Compression System performance when used by the intended patient population. The testing shows that the Radial Medical Compression System meets the requirements and expected performance of the intended users. The results also were used as input into the device design.

The device was also shown to be compliant with IEC 60601-1-11 for use in the home healthcare environment.

Clinical Performance Testing

A feasibility study was performed in which ten subjects with CEAP 3-6 venous insufficiency were recruited into an IRB approved study of venous flow augmentation. A baseline summary of subjects' demographics can be found below. Subjects underwent DVT screening and those

1 Provisionally accepted for publication in the Journal of Vascular Surgery

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who passed the DVT screen went on to have measurement of peak venous velocity in cm/s at the popliteal and femoral veins for the following conditions: (1) baseline (2) Radial device in low setting (3) Radial device in high setting. In 5 patients, an additional measurement of peak venous velocity in cm/s at the popliteal and femoral veins was completed while wearing a commercially available portable intermittent pneumatic compression (IPC) device (Tactile Actitouch). A minimum of 3 peak venous velocities were taken for each condition.

Demographic	Average (Range)
Age	56 (33-78)
Weight (lbs)	170 (103-277)
BMI (kg/m²)	26.6 (19.3-40.9)
Height (inches)	66 (61-69)
Gender	63% female

As shown below, both settings of the Radial device resulted in higher average peak venous velocities when compared to both baseline and the IPC device (p<0.05), with an average 3.5-fold femoral venous flow augmentation observed for the Radial device high setting. An average of three-fold increase (range 1 - 6.5-fold increase) in peak femoral venous velocities are reported in the literature for commercially available compression devices.2 No Adverse Events or safety issues were reported in the course of the study.

	Average and range of PeakVenous Flow Augmentationmeasured at Popliteal Vein(cm/s)	Average and range of PeakVenous Flow Augmentationmeasured at Femoral Vein(cm/s)
Baseline	11.1 (1.0-17.5)	13.5 (9.9-16.7)
IPC Device	14.1 (4.5-18.1)	19.2 (13.4-25.1)
Radial - low setting	56.6 (41.1-67.3)	45.5 (30.5-60.1)
Radial - high setting	58.3 (42.9-77.4)	47.1 (32.0-56.3)

Conclusion

Testing described in this 510(k) consisted of verification of design input requirements and product specifications. Clinical input requirements were validated. Side by side bench testing demonstrated that the Radial Medical Compression System is substantially equivalent with respect to device performance. Clinical testing demonstrated that the device is clinically effective, and no safety events were reported in the study.

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Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Radial Medical Compression System has been shown to be substantially equivalent to the legally-marketed predicate device.

2 Labropoulos N, Oh DS, Golts E, Kang SS, Mansour MA, Baker WH. Improved venous return by elliptical, sequential and seamless air-cell compression. Int Angiol.2003 Sep;22(3):317-21

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).