(113 days)
Not Found
No
The summary describes a pneumatic compression system with different treatment options and a "Venous Obstruction Detection software module." While it has software, there is no mention of AI, ML, or any characteristics typically associated with these technologies (e.g., training data, complex algorithms for pattern recognition or prediction). The software module appears to be for a specific detection function rather than a learning or adaptive system.
Yes
The device is intended for various therapeutic purposes, including preventing DVT, enhancing blood circulation, diminishing pain and swelling, reducing wound-healing time, and treating several medical conditions such as ulcers and chronic venous insufficiency.
No
The device is described as a "prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs," and its intended uses are therapeutic (e.g., preventing DVT, enhancing circulation, reducing pain/swelling, healing ulcers). While it mentions a "Venous Obstruction Detection software module" in the performance studies, the primary function and indications for use listed are for treatment and prevention, not for diagnosing a condition.
No
The device description explicitly states it is a "pneumatic compression system designed to apply sequential compression to the lower limb" and includes a "control unit" and "cuff sleeve," indicating it is a hardware device with software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ActiveCare+SFT® System Function: The ActiveCare+SFT® System is a pneumatic compression system that applies external pressure to the lower limbs. It works by physically manipulating blood flow and reducing swelling.
- Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely external and mechanical.
The intended uses and device description clearly indicate that it is a therapeutic device used to treat conditions related to circulation and swelling, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare+SFT® System is intended 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.
Product codes
JOW
Device Description
The ActiveCare+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
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 series of performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare+SFT® System does not raise any new questions of safety and efficacy. These tests include:
- Software verification and validation ■
- . Lab tests /Performance testing:
Lab 003- Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module.
Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare+SFT® System is substantially equivalent to the cleared ActiveCare+SFT® System without raising new safety and/or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 1 2 2011
510(K) SUMMARY
Medical Compression Systems (DBN) Ltd
ActiveCare+SFT® System
7.1.1 Applicant's Name:
Medical Compression Systems (DBN) Ltd. 2 Ha'Ilan Street, PO Box 75, Or Akiva 30600, Israel Tel: +972 (4) 6266630 Fax: +972 (4) 6266640 E-mail: medical@mcsmed.com
7.1.2 Contact Person:
Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma(a)gmail.com
7.1.3 Date Prepared:
January 10, 2011
7.1.4 Trade Name:
ActiveCare+SFT® System (ActiveCare®++)
7.1.5 Classification Name:
Sleeve, Limb, Compressible
7.1.6 Classification:
Class II; Product Code JOW: Regulation No. 870.5800 Panel: Cardiovascular Devices
7.1.7 Predicate Devices
Medical Compression Systems (DBN) Ltd. ActiveCare+SFT® System, previously cleared as ActiveCare®++ under K060146.
1
7.1.8 Device Description:
The ActiveCare+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
7.1.9 Intended Use:
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare+SFT® System is intended 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.
7.1.10 Contraindications:
The ActiveCare+SFT® System should not be used in the following cases: fresh preexisting DVT, pulmonary embolism, leg gangrene, recent skin graft, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable
7.1.11 Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the ActiveCare+SFT® System complies with the voluntary standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4 and ISO 14971.
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7.1.12 Performance Data & Substantial Equivalence
The ActiveCare+SFT® System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Medical Compression Systems (DBN) Ltd.'s ActiveCare+SFT® System, previously cleared under K060146.
The difference between the modified and the cleared ActiveCare+SFT® system is that the new model incorporates a modified software module designed to collect and correlate data already being measured by the device to detect possible conditions that may be indicative of the development of venous flow obstruction in the treated legs of those patients receiving the prophylaxis treatment (i.e., Venous Obstruction Detection software module).
A series of performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare+SFT® System does not raise any new questions of safety and efficacy. These tests include:
- Software verification and validation ■
- . Lab tests /Performance testing:
Lab 003- Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module.
Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare+SFT® System is substantially equivalent to the cleared ActiveCare+SFT® System without raising new safety and/or effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
MAY 1 2 2011
Medical Compression Systems (DBN) Ltd. c/o Ms. Orly Maor Company Consultant 25 A Sirkin Street Kfar Saba ISRAEL 44421
Re: K110159
Trade/Device Name: ActiveCare+SFT® System Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: April 1. 2011 Received: April 5, 2011
Dear Ms. Maor:
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 Foond, Or to 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 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 contractly and 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 devine (1) 1) 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.
4
Page 2 – Ms. Orly Maor
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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 STATEMENT
510(k) Number (if known):_K110159
ActiveCare+SFTT® System Device Name:
Indications for Use:
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare+SFT® System is intended 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.
Prescription Use _ र (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)
(Division Siin-Off)
Division of Cardiovascular Devices
510(k) viber K110 1597-10