The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Device Description

The FlowMedic™ FM220 System is a small, battery operated, microprocessor controlled, portable and simple mechanical system, intended for the improvement of blood circulation in the lower extremities through the application of intermittent compression to the calf.

The FlowMedic™ FM220 System consists of the following basic components:

FlowMedic™ FM220 System Control Unit and Straps
FlowMedic™ FM220 System Disposable Sleeve
Charger

The anatomical concave-convex shaped Control Unit is directly mounted on a pre-positioned Sleeve on the calf. Upon Control Unit activation, the straps are periodically pulled into the Control Unit base and subsequently pull the underneath sleeve, generating an intermittent compressive pressure on the patient's limb.

AI/ML Overview

The FlowMedic™ FM220 System is a mechanical system intended to improve blood circulation in the lower extremities. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices and testing performed. However, it does not contain specific acceptance criteria, performance metrics, or details of a clinical study with human subjects, making it impossible to complete the table or answer many of the subsequent questions.

Here's an analysis of what can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific performance criteria for safety and effectiveness are not provided in the 510(k) summary.	The 510(k) summary states that "Tests results indicated that the FlowMedic™ FM220 System performs according to its specifications and share very similar operational characteristics, including applied pressure output, pressure duration and frequency, with its predicate devices." No quantitative data or specific thresholds are given.

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

The document mentions "a set of in vitro (bench) performance testing and side by side comparison to the predicate devices." No sample size for a test set (e.g., number of patients, limbs, or cases) is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). This indicates that the primary testing for this 510(k) submission was likely bench testing, not human clinical trials.

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

This information is not provided. Given the nature of the testing described (in vitro bench testing), it's unlikely that experts were used to establish "ground truth" in the way they would be for image interpretation or diagnosis.

4. Adjudication method for the test set

This information is not provided.

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

No MRMC study was described or performed. The device is a mechanical system, not an AI-powered diagnostic tool, so this type of study would not be applicable.

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

This information is not explicitly stated in terms of a "standalone" study for an algorithm. However, the "in vitro (bench) performance testing" is essentially standalone testing of the device's mechanical and operational characteristics.

7. The type of ground truth used

For the in vitro (bench) testing, the "ground truth" would be the actual physical measurements of parameters like pressure output, pressure duration, and frequency, as measured by calibrated instruments. This is not explicitly detailed but inferred from the type of testing described for a mechanical device.

8. The sample size for the training set

No information about a training set is provided, as the testing described is primarily bench testing for substantial equivalence, not a machine learning model.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The 510(k) summary for the FlowMedic™ FM220 System (K042217) focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific clinical efficacy with new, quantitative acceptance criteria via a clinical trial for this specific product.

The study described to support the device's performance and safety involved:

Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
Software verification and validation testing.
A set of in vitro (bench) performance testing and side-by-side comparison to the predicate devices.
Hazard analysis including risk level and solutions performed in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software.

The results of this testing "indicated that the FlowMedic™ FM220 System performs according to its specifications and share very similar operational characteristics, including applied pressure output, pressure duration and frequency, with its predicate devices."

The acceptance criteria implicitly used in this submission are that the FlowMedic™ FM220 System demonstrates similar safety and operational characteristics to its predicate devices, as demonstrated through the listed engineering and bench tests, without raising new safety or effectiveness concerns. The specific quantitative acceptance criteria or detailed methodologies for these tests are not provided in this summary.

Summary

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K 042217

7-1 510(k) Summary

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510(K) SUMMARY

FlowMedic (USA) Inc.

510(k) Number K0422 17

Applicant's Name:

Flowmedic (USA) Inc. 40 Ramland Road South, Suite 10 Orangeburg, NY 10962, USA (845) 359-2250 (phone) (845) 359-2251 (fax)

Contact Person:

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910

And/Or

Dorit Winitz Ph.D Biomedical Strategy Ltd. 11 Menachem Begin Street. Ramat Gan 52521, Israel Tel: +972-3-6123281 Fax: +972-3-6123282

Date Prepared:

July 2004

Trade Name:

FlowMedic™ FM220 System

Classification Name:

Sleeve, Limb, Compressible

Classification:

Product Code: JOW Regulation No: 870.5800 Class: II Panel: Cardiovascular

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Predicate Devices:

The ArterialFlow™ System (Aircast, Inc), cleared under 매 K024019
트 The ArtAssist® Model AA-1000 (ACI Medical, Inc.), cleared under K942530
트 WizAir DVT™ (Medical Compression Systems (DBN) Ltd.), cleared under K012994

Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the FlowMedic™ FM220 System complies with the following voluntary standards:

트 IEC 60601-1 (1988) + A1 (1991) + A2 (1995)
IEC/EN 60601-1-2 (2001) E
IEC 60601-1-4 (1996) + A1 (1999)
EN 1441 (1997) ■
l ISO 14971 (2000)

Intended Use / Indication for Use:

The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Device Description:

The FlowMedic™ FM220 System consists of the following basic components:

1. FlowMedic™ FM220 System Control Unit and Straps
1. FlowMedic™ FM220 System Disposable Sleeve
1. Charger

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Substantial Equivalence:

The FlowMedic™ FM220 System and its predicate devices share the same intended use and similar materials and design. In addition, the mode of operation and delivery of therapy is similar in all the devices. A comprehensive testing program was developed and performed in order to verify that the FlowMedic™ FM220 System does not raise any new safety and effectiveness issues in comparison to its predicate devices. This includes the following testing and activities:

Electrical safety and electromagnetic compatibility testing 에 according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards
Software verification and validation testing .
프 A set of in vitro (bench) performance testing and side by side comparison to the predicate devices
Hazard analysis including risk level and solutions performed 트 in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software

Tests results indicated that the FlowMedic™ FM220 System performs according to its specifications and share very similar operational characteristics, including applied pressure output, pressure duration and frequency, with its predicate devices.

In conclusion, FlowMedic (USA) Inc. believes that the FlowMedic™ FM220 System is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

FlowMedic (Israel) Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, LLP 555 13th Street, N.W. Washington, DC 20004-1109

K042217 Re: FlowMedic™ FM220 System Regulation Number: 21 CFR 868.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: November 19, 2004 Received: November 19, 2004

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becalent be device is substantially equivalent (for the indications ferenced uboro and harrsviro legally marketed predicate devices marketed in interstate for ass suated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of they 20, 2017 11:37 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 I ou may, ateres, include requirements for annual reguirements 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 If your de roo 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.

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Page 2 - Mr. Jonathan S. Kahan

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Duna R. Lochner

Image /page/5/Picture/5 description: The image shows a portion of a document with the text "Bram D. Zuc", followed by "Director", "Division of", and "Office of". The text is aligned to the left and appears to be part of a formal document or letterhead. There is also a signature above the name.

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

Enclosure

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Indications for Use Statement

510(k) Number (if known):____________________________________________________________________________________________________________________________________________________

Device Name: FlowMedic™ FM220 System

Indications for Use:

The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Prescription Use V (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Vachner

Division Sign-Off) ് vision of Cardiovascular Devices

10(k) Number K042217

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).