(48 days)
Not Found
No
The description details a pneumatic compression device with various pre-set compression options. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML. The "Not Found" entries for AI/ML mentions and training/test sets further support this conclusion.
Yes
The device's "Intended Use / Indications for Use" section explicitly lists several medical conditions it aims to prevent, treat, or alleviate, such as preventing DVT, diminishing pain and swelling, treating ulcers, and reducing edema. These are all therapeutic applications.
No
The device description and intended use indicate that the ActiveCare®++ System is a therapeutic device designed to apply compression to lower limbs for treatment and prevention of various conditions, not for diagnosing them.
No
The device description explicitly details hardware components such as a control unit, battery operation, mains operation, and pneumatic compression sleeves (foot, calf, thigh). It is a physical device that applies pressure.
Based on the provided information, 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. They are used to diagnose, monitor, or screen for health issues.
- Device Description and Intended Use: The ActiveCare®++ System is a pneumatic compression device that applies pressure to the lower limbs. Its intended uses are all related to physical therapy and circulation enhancement, not the analysis of biological samples.
- Lack of Mention of Biological Samples: The description and intended use do not mention the collection or analysis of any biological samples.
- Mechanism of Action: The device works by applying external pressure, not by analyzing substances within the body.
Therefore, the ActiveCare®++ System falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ 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®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), 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 sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf 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
A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:
- Electrical and electromagnetic testing
- Software verification and validation
- Performance testing of the output parameters and pressure profile
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:
- Electrical and electromagnetic testing
- Software verification and validation
- Performance testing of the output parameters and pressure profile
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023573, K012994, K002287, K993758
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
2006 MAR 8
510(K) SUMMARY Medical Compression Systems (DBN) Ltd ActiveCare®++ 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: mcs@mcsmed.com
7.1.2 Contact Person:
Dorit Winitz, Ph. D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th Floor, 7 Jabotinsky Street Ramat Gan 52520, Israel Tel: +972-3-612-3281 Fax: +972-3-612-3282 dorit@ebms.co.il
7.1.3 Date Prepared:
January, 2006
7.1.4 Trade Name:
ActiveCare®++ System
7.1.5 Classification Name:
Sleeve, Limb, Compressible
7.1.6 Classification:
Class II; Product Code JOW; Regulation No. 870.5800 Panel: Cardiovascular
7.1.7 Predicate Devices
Medical Compression Systems (DBN) Ltd. Systems (ActiveCare® System, incured - Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758.
1
7.1.8 Device Description:
The ActiveCare®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), 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 sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.
7.1.9 Intended Use:
The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare®++ 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®++ System should not be used in the following cases: fresh pre-existing DVT, pulmonary embolism, leg gangrene, recent skin grafi, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable
2
8.11 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®++ System complies with the voluntary standards such as IEC 60601-1, IEC 60601-2 and AAMI / ISO 14971-1.
8.11 Performance Data & Substantial Equivalence
The ActiveCare®++ 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 Systems (ActiveCare® System, previously named WizAir Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758.
The principle changes between the devices include:
- The software programming language was changed from Assembler to ■ ANSI C.
- A capability to synchronize the compression cycles with the respiratory 배 related. natural phasic venous flow, was added
- The user interface of the Control Unit was modified to include a Liquid 트 Crystal Display (LCD).
- I A Compliance status indicator was added.
- A new calf sleeve, the TripleActive, was added. 트
A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:
- Electrical and electromagnetic testing 트
- Software verification and validation 트
- Performance testing of the output parameters and pressure profile ■
Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare®++ System is substantially equivalení to the cleared ActiveCare® Systems (WizAir Compression System, Wizair DVT or ProAir 3000 Systems), without raising new safety and/or effectiveness issues.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2006
BioMedical Strategy (2004) Ltd. c/o Dorit Winitz, Ph.D. Company Consultant Moshe Aviv Street, 34th Floor 7 Jabotinsky Street Ramat Gan 52520, Israel
Re: K060146
Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 16, 2006 Reccived: January 19, 2006
Dear Dr. Winitz:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the
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Page 2 - Dorit Winitz, Ph.D.
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 (240) 276-0120. Also, please note the regulation extilled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
Sincerely yours,
Dona R. Victner
1 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K06014-6
ActiveCare®++ System Device Name:
Indications for Use:
The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ 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 _ ਵ (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 12 Johner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K060146