(293 days)
Not Found
No
The device description focuses on pneumatic compression and timing regulation, with no mention of AI or ML terms or functionalities. The performance studies are based on pressure/timing graphs and safety/EMC testing, not AI/ML performance metrics.
Yes
The device is intended to treat conditions like intermittent claudication, rest pain, diabetic foot, and arterial ulcers by increasing blood flow to the limb, which are therapeutic actions.
No
The device description indicates that the ArtAssist device is a pneumatic compression device that applies pressure to limbs to increase blood flow. Its stated purpose is therapeutic (treating conditions like intermittent claudication, rest pain, diabetic foot, etc.) by improving blood flow, not to diagnose a condition.
No
The device description explicitly details hardware components including a pump controller, air pump, air reservoir, electrical power supply, pressure regulation, timing regulation, safety circuitry, limb cuffs with air bladders, and tubing. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed (intermittent claudication, rest pain, diabetic foot, etc.) are all related to treating conditions affecting the limbs and improving blood flow. These are clinical treatments, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a pneumatic compression device that applies pressure to the limbs. This is a physical therapy or treatment device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff
Product codes
JOW
Device Description
The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequences. There is a pump controller that contains a housing, an air pump, an air reservoir, electrical power supply, pressure regulation, timing regulation and safety circuitry. A set of limb cuffs contains air bladders that fill and apply pressure. A tubing set delivers the air from the pump controller to the limb cuffs.
The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Pressure/timing graphs obtained in the laboratory demonstrate substantial equivalence to the predicate device. The device has been tested to safety requirements (UL 60601-1) and EMC requirements (IEC 60601-1-2)
Key Metrics
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
FEB 1 0 2014
Image /page/0/Picture/1 description: The image shows the logo for ACI Medical. The logo has the text "ACI MEDICAL" in bold, with the words "innovate, engineer, deliver" in a smaller font underneath. The logo is surrounded by a curved line on the left and right sides.
ACI Medical, LLC 1857 Diamond St. San Marcos, CA 92078 USA Tel. 760.744.4400 Fax 760.744.4401 ed@acimedical.com
510(k) SUMMARY
510(k) owner's name: ACI Medical, LLC 1857 Diamond St. San Marcos, CA 92078 Tel. 760 744 4400 Fax 760 744 4401 Contact name: Ed Arkans Prepared: February 7, 2014
- Trade name ArtAssist .
- Common name Compressible limb sleeve or Pneumatic compression . device
- . Classification name - Compressible limb sleeve (21 CFR 870.5800, Product Code JOW)
The legally marketed devices to which our firm is claiming equivalence is the ArtAssist device (K942530).
Device description
The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequences. There is a pump controller that contains a housing, an air pump, an air reservoir, electrical power supply, pressure regulation, timing regulation and safety circuitry. A set of limb cuffs contains air bladders that fill and apply pressure. A tubing set delivers the air from the pump controller to the limb cuffs.
The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.
1
Intended use of the device
Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff
Summary of the technological characteristics
The device has the same technological characteristics as the predicate device except that it has been modified to include changes in the control mechanism from mechanical pressure regulation to electronic type and from discrete electronics to microcontroller based.
Performance data
Pressure/timing graphs obtained in the laboratory demonstrate substantial equivalence to the predicate device. The device has been tested to safety requirements (UL 60601-1) and EMC requirements (IEC 60601-1-2)
Conclusions drawn from testing
The laboratory test results demonstrate that the device performs as well as the predicate device since it applies equivalent pressures and timing and is therefore as effective as the predicate device. The risk analysis, safety and EMC tests performed demonstrate the device is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2014
ACI Medical, LLC c/o Mr. Ed Arkans 1857 Diamond St. San Marcos, CA 92078
Re: K131146
Trade Name: ArtAssist Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 24, 2013 Received: December 27, 2013
Dear Mr. Arkans:
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. Iisting 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 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
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Page 2 - Mr. Ed Arkans
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours,
M.A. Hillenbrand
for
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
Device Name: ArtAssist 510(k) number: K131146
Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff
Prescription Use:_ YES (Part 21 CFR 801 Subpart D)
M. Azbilliem