DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES

K030417 · Philips Medical Systems · LDD · May 9, 2003 · Cardiovascular

Device Facts

• Record ID: K030417
• Device Name: DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
• Applicant: Philips Medical Systems
• Product Code: LDD · Cardiovascular
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.

Device Story

Disposable sterile internal defibrillation paddles designed for intra-thoracic surgical procedures; used to deliver electrical therapy to the heart. Available in switched and switch-less configurations in three sizes. Operated by physicians in operating room settings. Device connects to existing defibrillator/monitor systems to facilitate manual defibrillation. Single-use design eliminates need for reprocessing/sterilization between patients, reducing cross-contamination risk. Output is electrical energy delivered to the heart to terminate arrhythmias. Clinical benefit includes safe, effective, and sterile delivery of defibrillation energy during open-chest surgery.

Clinical Evidence

Bench testing only. Performance of the disposable paddles was compared to current reusable internal paddles to demonstrate substantial equivalence.

Technological Characteristics

Disposable, sterile, single-use internal defibrillation paddles. Available in switched and switch-less versions in three sizes. Designed for use with existing defibrillator/monitor systems. No software or electronic processing components; purely mechanical/electrical interface for energy delivery.

Indications for Use

Indicated for manual defibrillation during intra-thoracic surgical procedures. For use by or on the order of a physician.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Predicate Devices

• CodeMaster XL+ Defibrillator/Monitor, Philips Medical Systems (M1742A, M1743A, M1744A, M1785A, M1786A, M1787A)

Submission Summary (Full Text)

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# Date Summary Prepared

January 31, 2003

# Submitter's Name and Address

Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

#### Contact Person

Peter Ohanian Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099 Telephone: [phone] Facsimile: [phone]

#### Device Name

| Proprietary Name: | Disposable Sterile Internal Defibrillation Paddles |
|-----------------------|----------------------------------------------------|
| Common Name: | Internal Defibrillation Paddles |
| Classification Names: | Low-Energy Internal Defibrillator Paddles |

#### Predicate Devices

The legally marketed devices to which Philips Medical Systems claims equivalence for the Disposable Sterile Internal Defibrillation Paddles are as follows:

- CodeMaster XL+ Defibrillator/Monitor, Philips Medical Systems (formally HP) with ● the following internal paddle model numbers:
- 1. M1742A
- 2. M1743A
- 3. M1744A
- 4. M1785A
- 5. M1786A
- 6. M1787A

The design of the proposed Disposable Sterile Internal Defibrillation Paddles is substantially equivalent in safety and performance to the device listed above.

# Device Description

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The Disposable Sterile Internal Defibrillation Paddles are used primarily by physicians in the operating room during intra-thoracic surgical procedures. These paddles are available in both switched and switch-less versions where both versions are available in three different sizes. The paddles are packaged sterile and are single-use only. These paddles will be used in the manner and application as is currently available.

# Intended Use

The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.

# Comparison of Technology Characteristics

The Philips Disposable Sterile Internal Defibrillation Paddles are used for internal defibrillation in the same manner as the internal paddles currently used with the CodeMaster Defibrillator/Monitors.

# Nonclinical Tests Used in Determination of Substantial Equivalence

The testing performed to show substantial equivalence to the CodeMaster internal defibrillation paddles included:

- Bench testing, demonstrating the performance of the Philips Disposable Sterile . Internal Defibrillation Paddles to the current re-useable internal paddles.
# Conclusion from Testing

Based on the results of the testing described above, it is concluded that the Philips Disposable Sterile Internal Defibrillation Paddles perform in the same manner as the current internal defibrillation paddles. The Philips Disposable Sterile Internal Defibrillation Paddles application does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Ohanian Director, Quality and Regulatory Affairs Philips Medical Systems 3000 Minuteman Road, M/S 0222 Andover, MA 01810-1099

Re: K030417

> Trade/Device Name: Disposable Sterile Internal Defibrillation Paddles Regulation Number: 21 CFR 870.5300 Regulation Name: DC-defibrillator (including paddles). Regulatory Class: II Product Code: LDD Dated: February 3, 2003 Received: February 10, 2003

Dear Mr. Ohanian:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Peter Ohanian

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

K. D. Zuker, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use 2.

# 510(k) Number (if known): K030417

Device Name: Disposable Sterile Internal Defibrillation Paddles

Indications For Use: The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

or

Over-The-Counter Use

DeaVTU

510(k) Numbe