THE CIRCULATOR BOOT

K971026 · Circulator Boot Corp. · DRN · Aug 14, 1997 · Cardiovascular

Device Facts

• Record ID: K971026
• Device Name: THE CIRCULATOR BOOT
• Applicant: Circulator Boot Corp.
• Product Code: DRN · Cardiovascular
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

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, ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, chronic lymphedema, thrombophlebitis

Device Story

The Circulator Boot is an end-diastolic pneumatic compression device for lower extremity treatment. It consists of a double-walled plastic bag placed over the patient's leg, enclosed within a rigid plastic boot. The system connects to an external air supply and an EKG QRS monitor. The device uses the EKG signal to time pneumatic compression cycles to occur during end-diastole, following an operator-selectable delay. This timing ensures compression does not obstruct arterial blood flow. The device is intended for clinical use to manage conditions like peripheral arterial disease, ulcers, and lymphedema. By timing compression to the cardiac cycle, the device aims to improve circulation and treat ischemic or stasis-related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and design improvements over the predicate device.

Technological Characteristics

End-diastolic pneumatic compression system. Components: rigid plastic boot, double-walled plastic bag, pneumatic valve system, EKG QRS monitor. Energy source: external air supply. Timing accuracy: +/- 0.002 seconds. Operation: EKG-gated pneumatic inflation.

Indications for Use

Indicated for patients with peripheral arterial disease, ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, chronic lymphedema, or thrombophlebitis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• The Circulator Boot (original model) (K792354)
• Jobst Extremity Pump (K882683)
• Cardiassist (K792430)

Submission Summary (Full Text)

{0}

K971026

# 510 (K) Summary

This summary was submitted by:
AUG 14 1997

Richard S. Dillon M.D.
Circulator Boot corp.
150 Mill Creek road
Ardmore PA, 19003

Tel. # (610) -896-6545
Fax # [phone]

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.

11.0

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 14 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, 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 (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 Regulation (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 Federal Register. Please 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.

{2}

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{3}

11.1

# 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
- ischemic lesions
- claudication pain
- necrotizing cellulitis
- venous stasis ulcers
- stasis dermatitis
- chronic lymphedema
- thrombophlebitis


It is classified as:

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 lymphpedematous 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. |