CIPA (ADULTS) CIPI (INFANTS)

K992932 · Dmc Medical, Ltd. · DWF · Jun 7, 2000 · Cardiovascular

Device Facts

• Record ID: K992932
• Device Name: CIPA (ADULTS) CIPI (INFANTS)
• Applicant: Dmc Medical, Ltd.
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the myocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.

Device Story

Cardiac Insulation Pad is a thin, pliable, crosslinked, closed-cell polyolefin foam pad; designed to be cut to conform to heart anatomy. Used during heart surgery to cover posterior cardiac wall or myocardium. Functions as thermal barrier to isolate myocardium from warmer adjacent tissues (descending thoracic aorta, liver, pericardial tissues); prevents cold-induced injury to left phrenic nerve during local cardiac cooling. Surgeon-operated; pad includes PVC locator tape for easy removal post-procedure. Available in adult and infant sizes.

Clinical Evidence

Evidence based on literature reviews. Guinn GA et al. (1990) reported prevention of left-sided diaphragmatic paralysis in 52 of 58 patients. Esposito RA and Spencer FC (1987) reported prevention of diaphragm paralysis in 83% of patients using a pericardial insulation pad. Data supports the efficacy of the insulation pad in protecting the phrenic nerve from cold injury.

Technological Characteristics

Material: Crosslinked, closed cell polyolefin foam. Form factor: Thin, pliable pad, cut-to-fit. Sizes: Adult and infant. Accessory: PVC locator tape for removal. Non-electronic, passive thermal insulation device.

Indications for Use

Indicated for patients undergoing heart surgery requiring myocardial cooling; intended to reduce undesirable myocardial re-warming and protect the left phrenic nerve from cold injury. Available in adult and infant sizes.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Cardiac Insulation Pad by Shiley, Inc. (K781990)

Submission Summary (Full Text)

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K992932

## 510(k) Summary

- Company: DMC medical limited Unit 9 Distribution Centre Shannon Free Trade Zone Shannon, County Clare, Ireland
- Tradename: Cardiac Insulation Pad
- Classification: Class II
- Description: The Cardiac Insulation Pad is a thin, pliable, foam pad which can be cut to conform to the shape of the heart. The pad covers the posterior cardiac wall or the mvocardium. When the surgeon is finished using the pad, it can be easily removed by pulling the PVC locator tape. The cardiac pad is available in two sizes; adult and infant.

The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium. In addition, it protects the left phrenic nerve from cold injury during local cooling of the heart.

- Material: Crosslinked, closed cell polyolefin foam
- Indications: The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the mvocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.
- Performance Data: In a study conducted by Guinn GA et al in "Phrenic nerve injury during coronary artery bypass" (Texas Heart Institute Journal 1990;17:48-50), it was shown that the cardiac insulation pad prevented left-sided diaphragmatic paralysis in 52 of 58 patients. In a study conducted by Esposito RA, Spencer, FC, in "The effect of pericardial insulation on hypothermic phrenic nerve injury during open heart surgery" (Annals of Thoracic Surgery, 43:3; 1987;303-308), it was shown that a pericardial insulation pad prevented diaphragm paralysis in 83% of the patients. Thus it was concluded that the cardiac insulation pad protects the phrenic nerve from the cold during heart surgery where the heart is cooled.
- Substantial Equivalence: The device is substantially equivalent to the Cardiac Insulation Pad by Shiley, Inc. (currently Sorin Biomedica , Irvine, California), per K781990 cleared on 12/04/78.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2000

Ms. Charmaine Henderson Director of Regulatory Affairs DMC Medical Limited 511 Catalina Road Fullerton, CA 92835

K992932 Re: RJ232 -Pads Regulatory Class: II (two) Product Code: DWF March 31, 2000 Dated: Received: April 10, 2000

Dear Ms. Henderson:

We have reviewed your Section 510(k) notification of intent to market we have reviewed your babove and we have determined the devices are che devices rerorialent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrobare) of regaring to May 28, 1976, the enactment date of the Interstate commerce prior of to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordante aron. You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls co che general of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they 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 requirements, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Please note: this response to your premarket notification Register. submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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## Page 2 - Charmaine Henderson

Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, please contact the Office of Compliance Also, please note the regulation entitled, at [phone]. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Ruinn E. Haneym

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE ENCLOSURE

K992932 510k:

Cardiac Insulation Pad for Adults Device: Cardiac Insulation Pad for Infants

Indications for Use:

The cardiac insulation pad is indicated for use in patients undergoing heart The cardiac insulation pat is indication indesireble re-warming of the surgery where there is a need to reduce andoclination of the may of the local cooling of the heart.

Prescription use

Burim E. Haveymm

(Division Sign-Off)Over the Counter Use
Division of Cardiovascular, Respiratory,
vascular, Respiratory,
and Neurological Devices
510(k) Number

Division of Cardiov
Division Sign Off)
Hovascular, Respirato
and Neurological Devices

DERA
6/7/00