(147 days)
Not Found
No
The device description details a pneumatic compression system triggered by an EKG QRS signal with an operator-selectable delay. There is no mention of AI, ML, image processing, or any learning/adaptive capabilities. The control mechanism is based on a direct physiological signal and a fixed or operator-set parameter, not on complex data analysis or pattern recognition characteristic of AI/ML.
Yes
The "Intended Use / Indications for Use" section clearly lists various medical conditions that the device is designed to treat, such as peripheral arterial disease, chronic lymphedema, and venous stasis ulcers, which are all therapeutic functions.
No
The device description and intended use indicate it is a therapeutic device (pneumatic compression to treat various conditions), not one that diagnoses disease.
No
The device description clearly outlines multiple hardware components including a plastic bag, rigid plastic boot, valve system, air supply, and an EKG QRS monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The Circulator Boot System is a pneumatic compression device that applies external pressure to the leg. It interacts directly with the patient's body, not with specimens taken from the body.
- Intended Use: The intended uses listed are all related to treating conditions affecting the leg and circulatory system through physical compression, not through the analysis of biological samples.
Therefore, the Circulator Boot System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Circulator Boot System - alone or in combination with other drug or device therapies - may be used to treat: peripheral arterial disease, chronic lymphedema, ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, thrombophlebitis.
Product codes
DRN
Device Description
The Circulator Boot is an end diastolic pneumatic compression device made up of several components. A double walled plastic bag is placed over the leg of the patient and then placed inside a rigid plastic "boot". The boot is then attached to a valve system which is connected to an air supply. The valve is also connected to an EKG QRS monitor that times the compression cycle to occur after a variable (operator selectable) delay following the QRS signal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg, lower leg
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)
Not Found
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
§ 870.5225 External counter-pulsating device.
(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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510 (K) Summary
This summary was submitted by:
AUG 1 4 1997
4971026
Richard S. Dillon M.D. Circulator Boot corp. 150 Mill Creek road Ardmore PA, 19003
Tel. # (610) -896-6545 Fax # (610)-896-8959
The contact person is:
Deborah Welker Administrator
This Summary was prepared on 3/11/97
The device name is:
The Circulator Boot
The Circulator Boot description:
The Circulator Boot is an end diastolic pneumatic compression device made up of several components. A double walled plastic bag is placed over the leg of the patient and then placed inside a rigid plastic "boot". The boot is then attached to a valve system which is connected to an air supply. The valve is also connected to an EKG QRS monitor that times the compression cycle to occur after a variable (operator selectable) delay following the QRS signal.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Richard S. Dillion, M.D. Circulator Boot Corporation 150 Mill Creek Road Ardmore, Pennsylvania 19003. .
AUG 1 4 1997 . . .
Re: K971026 The Circulator Boot Regulatory Class: III (Three) Product Code: 74 (DRN) Dated: April 10, 1997 Received: April 29, 1997
Dear Dr. Dillion:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the rederal Register. Flease note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Richard S. Dillion, M.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
incerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use:
The Circulator Boot System - alone or in combination with other drug or device therapies - may be used to treat:
-
peripheral arterial disease ●
chronic lymphedema -
ischemic lesions ●
-
claudication pain .
-
necrotizing cellulitis ●
-
venous stasis ulcers ◆
-
stasis dermatitis .
.
.
the Prys
Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Devices K971026
510(k) Number k9
It is classified as:
thrombophlebitis
A class III device
The Circulator Boot is equivalent to:
| 1. The Circulator Boot ( original model ) | 510(k) # K792354 |
|---|---|
| 2. The Jobst Extremity Pump | 510(K) # K882683 |
| 3. Cardiassist | 510(K) # K792430 |
| Product | Device description | Difference from
Circulator
Boot |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardiassist | Water pressure applied from groin
to midcalf timed with heartbeat to
maximize coronary blood flow. | Blocks blood flow into the legs and
blocks venous and lymphatic flow
out of the lower leg. |
| Jobst Extremity pump | Treatment of lymhpedematous states
associated with venous insufficiency
or blockage of the lymphatic
system. Cloth boots of various
lengths are inflated for various
periods of time to intermittently
pump fluid from the legs. | soft cloth boots are used. Inflation is
only in late diastole so that arterial
blood flow into the leg is not
blocked. |
| Circulator Boot (original model) | Essentially the same use as the new
model without the increased
accuracy of timing and easier user
interface. | Old model monitor without the
more accurate timing. Old model
could vary timing by as much as +/-
0.05 seconds, new model is accurate
to within +/- 0.002 seconds. |
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