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.

AI/ML Overview

This 510(k) summary does not contain sufficient information to describe the acceptance criteria or a study that proves the device meets those criteria in the format requested. The document is a regulatory submission for premarket notification of a medical device, the "Circulator Boot," seeking substantial equivalence to existing devices. It focuses on device description, indications for use, and a comparison to predicate devices, but lacks detailed performance data or a study report with specific acceptance criteria.

Specifically, the following information is missing from the provided text to complete the requested table and study description:

A table of acceptance criteria and the reported device performance: The document mentions that the new model has "increased accuracy of timing and easier user interface" compared to the old model, with the new model being "accurate to within +/- 0.002 seconds" versus the old model's "+/- 0.05 seconds." This is a performance specification, but not a formally defined acceptance criterion that would be part of a study design to demonstrate safety and effectiveness. There are no other performance metrics or acceptance criteria provided.
Sample size used for the test set and the data provenance: No information on any test set size or data origin is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth experts is provided.
Adjudication method: No information on an adjudication method is provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe an MRMC study.
Standalone performance study: While it mentions improved timing accuracy, it does not describe a formal standalone performance study with detailed methodology, metrics, and acceptance criteria.
Type of ground truth used: No information on ground truth is provided.
Sample size for the training set: No information on a training set is provided, as this is not an AI/ML device in the modern sense.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Summary of available information related to performance:

The document primarily focuses on establishing "substantial equivalence" of the "Circulator Boot" to legally marketed predicate devices, as required for a 510(k) submission. The only performance-related detail provided is:

Improved Timing Accuracy: The new Circulator Boot model is accurate to within +/- 0.002 seconds, whereas the original model varied timing by as much as +/- 0.05 seconds. This indicates a technical improvement but is presented as a feature rather than the result of a formal study proving specific acceptance criteria.

Without more detailed information, it is impossible to complete the requested output.

Summary

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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:

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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 fromCirculatorBoot
Cardiassist	Water pressure applied from grointo midcalf timed with heartbeat tomaximize coronary blood flow.	Blocks blood flow into the legs andblocks venous and lymphatic flowout of the lower leg.
Jobst Extremity pump	Treatment of lymhpedematous statesassociated with venous insufficiencyor blockage of the lymphaticsystem. Cloth boots of variouslengths are inflated for variousperiods of time to intermittentlypump fluid from the legs.	soft cloth boots are used. Inflation isonly in late diastole so that arterialblood flow into the leg is notblocked.
Circulator Boot (original model)	Essentially the same use as the newmodel without the increasedaccuracy of timing and easier userinterface.	Old model monitor without themore accurate timing. Old modelcould vary timing by as much as +/-0.05 seconds, new model is accurateto within +/- 0.002 seconds.

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Regulation Number and Section

§ 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.