(15 days)
Not Found
No
The provided text describes a pneumatic compression device and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the mechanical function and therapeutic benefits of compression.
Yes
The device is described as having "specific therapeutic functions" and is intended for the "treatment of disorders" and "reduction of edema," which are therapeutic actions.
No
The device is described as an intermittent, sequential pneumatic compression device intended for treatment, reduction of edema, and aiding blood flow, not for diagnosis.
No
The intended use describes a "pneumatic compression device" and mentions "localized thermal therapy," which are functions typically performed by hardware components, not software alone. The lack of a device description prevents confirmation, but the described functions strongly suggest a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Compression System is an "intermittent, sequential pneumatic compression device." It applies external pressure to the body to treat conditions related to circulation and edema.
- Intended Use: The intended uses listed are all related to applying physical therapy and pressure to the body for therapeutic purposes (treating vascular/lymphatic insufficiency, reducing edema, aiding blood flow, etc.). None of the intended uses involve analyzing samples taken from the body.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions:
The CMP-001 (Compression Plus) is intended for:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains.
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions
- Aids the blood flow back to the heart .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
The CMP-002 (DVTmax) is intended for:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions
- Decrease the risk of deep venous thrombosis (DVT) .
- Aids the blood flow back to the heart, .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
Product codes
JOW, ILO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The target patient population is adults.
Intended User / Care Setting
The device is intended for home or hospital use
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human figures arranged in a row, with their heads tilted upwards. The figures are connected by a flowing line that represents the department's mission to promote health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 7 2012
Novitas Medical, LLC c/o Mr. William J. Sammons Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 Twinsburg, OH 44087
Re: K121001
Trade/Device Name: Compression System - Models CMP-001 and CMP-002 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW, ILO Dated: March 30, 2012 Received: April 2, 2012
Dear Mr. Sammons:
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. 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
1
Page 2 - Mr. William J. Sammons
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 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.fda.gov/AboutFDA/CentersOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M.A. Hollebe
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4
Indications for Use Statement
510(k) Number (if known):
Device Name: Compression System - Models: CMP-001 and CMP-002
Indications for Use: The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions:
The CMP-001 (Compression Plus) is intended for:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains.
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions
- Aids the blood flow back to the heart .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
The CMP-002 (DVTmax) is intended for:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema
- Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains
- Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions
- Decrease the risk of deep venous thrombosis (DVT) .
- Aids the blood flow back to the heart, .
- Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
3
K121øøi pg 2 of 2
The device is intended for home or hospital use and the target patient population is adults.
Prescription Use _ V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D C)
(21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Miller
(Division Sign-Off) Division of Cardiovascular Devices
K121001 510(k) Number_