(149 days)
Not Found
No
The description focuses on a simple mechanical system with microprocessor control for intermittent compression, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described as being intended "for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation," indicating a therapeutic purpose.
No
The device is described as a mechanical system for improving blood circulation through intermittent compression, not for diagnosing conditions. Its intended use focuses on prevention and reduction of complications of poor circulation, not on identifying a disease or condition.
No
The device description explicitly states it is a "mechanical system" with physical components like a Control Unit, Straps, Disposable Sleeve, and Charger, and describes a mechanical action (straps pulling the sleeve). While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation." This describes a therapeutic or preventative action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "mechanical system" that applies "intermittent compression to the calf." This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The FlowMedic™ FM220 System does not fit this description. It is a medical device used for physical therapy or prevention.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, calf, patient's limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K 042217
7-1 510(k) Summary
:
1
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
2
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 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.
3
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.
4
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.
5
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
6
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