CHASE PHRENIC NERVE PAD

K971021 · Chase Medical, Inc. · DWF · Aug 12, 1997 · Cardiovascular

Device Facts

• Record ID: K971021
• Device Name: CHASE PHRENIC NERVE PAD
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.

Device Story

The CHASE Phrenic Nerve Pad is a passive surgical accessory used during open-heart surgery. It consists of a heart-shaped, 1/8-inch closed-cell foam pad with an 18-inch silicone tail. The device is placed by a surgeon within the thoracic cavity to provide thermal insulation, protecting the heart from heat transfer from adjacent organs and tissues. It is a single-use, sterile device.

Clinical Evidence

Bench testing only. Evidence includes package integrity testing (ASTM F1140-88), shipping and distribution vibration/drop testing per National Safe Transit Association standards, and accelerated aging studies supporting a two-year shelf life.

Technological Characteristics

Materials: Closed-cell foam (1/8 inch) and silicone tail. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar. Form factor: Heart-shaped pad with 18-inch tail.

Indications for Use

Indicated for patients undergoing open-heart surgery to provide thermal insulation of the heart from surrounding warmer organs and tissues.

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

• Medtronic/DLP Phrenic Nerve Pad (K890707)

Submission Summary (Full Text)

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K971021

AUG 12 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE PHRENIC NERVE PAD

### I. General Information

A. Generic Name: Phrenic Nerve Pad
B. Trade Name of Device: CHASE Phrenic Nerve Pad
C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX
D. Pre-market Notification Number: Not assigned

### II. Indication for Use:

The CHASE Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.

### III. Device Description

The CHASE Phrenic Nerve Pad consists of a heart shaped, 1/8 inch, closed cell piece of foam with an 18 inch silicone tail.

### IV. Device Classification:

Class I device

### V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the Medtronic/DLP Phrenic Nerve Pad (K890707).

### VI. Other Safety and Effectiveness Data:

Materials: All material are identical to the predicate device.
Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶

## Functional Testing

All functional characteristics of the CHASE Phrenic Nerve Pad are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.

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# SUMMARY OF SAFETY AND EFFECTIVENESS

Package Integrity: Tyvek/Polymylar passed burst test per ASTM F1140-88

Shipping & Distribution Testing: Per National Safe Transit Ass. vibration and drop tests

Accelerated Aging: Two year shelf life

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Bert Davis
President
Chase Medical, Inc.
1876 Firman Drive
Richardson, Texas 75081

AUG 12 1997

Re: K971021
Chase Phrenic Nerve Pad
Regulatory Class: II (Two)
Product Code: 74 DWF
Dated: June 30, 1997
Received: June 30, 1997

Dear Mr. Davis:

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.

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Page 2 - Mr. Bert Davis

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

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Page ______ of ______

510(k) Number (if known): 5971021/51

Device Name: ________________________________________________________________________

Indications For Use: ________________________________________________________________________

# CHASE MEDICAL, INC.

# PHRENIC NERVE PAD

Intended Use: ________________________________________________________________________

The Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

_________________________
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number: K971021

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)