ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE

K042302 · Zoll Medical Corp · LDD · Oct 26, 2004 · Cardiovascular

Device Facts

• Record ID: K042302
• Device Name: ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
• Applicant: Zoll Medical Corp
• Product Code: LDD · Cardiovascular
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZOLL Autoclavable Internal Handles are to be used with interchangeable electrodes and a manually operated ZOLL Defibrillator to defibrillation therapy directly to the heart during surgical procedures. When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature. the ZOLL Autoclavable Internal Handles allows the defibrillator to operate only as a manual device. The ZOLL Autoclavable Internal Handles are intended for use by or under the direction of a physician. The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to provide defibrillation therapy directly to the heart during surgical procedures. When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allows the defibrillator to operate only as a manual device. The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician. The ZOLL Autoclavable External Paddles are to be used with manually operated ZOLL M Series Defibrillator products to perform closed chest defibrillation of a patient when sterlization of the paddles is required either before or after the defibrillation event. The ZOLL Autoclavable External Paddles are intended for use by trained personnel and are for use on Adult patients only. The ZOLL Autoclavable External Paddles are intended for use by or under the direction of a physician.

Device Story

Device consists of autoclavable internal handles, internal handles with integrated electrodes, and external paddles for use with ZOLL defibrillators. Internal components deliver defibrillation therapy directly to the heart during surgery; external paddles perform closed-chest defibrillation. Operated by physicians or trained personnel in clinical/surgical settings. When connected to defibrillators with advisory/ECG analysis, device forces manual-only operation mode. Provides physical interface for energy delivery; facilitates sterilization of patient-contact components.

Clinical Evidence

No clinical data provided; device relies on established technological characteristics for defibrillation accessories.

Technological Characteristics

Autoclavable handles and paddles for DC-defibrillator (21 CFR 870.5300). Designed for manual operation with ZOLL defibrillator systems. Materials selected for repeated sterilization cycles. Interface forces manual mode on advisory-capable defibrillators.

Indications for Use

Indicated for adult patients requiring closed chest defibrillation (external paddles) or patients undergoing surgical procedures requiring direct cardiac defibrillation (internal handles/electrodes). Intended for use by or under the direction of a physician or trained personnel.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2004

Zoll Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105

Re: K042302

Re: N042302
Trade Name: Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes and Zoll Autoclavable External Paddles Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator (including paddles) Regulatory Class: II (two) Product Code: LDD Dated: August 24, 2004 Received: August 25, 2004

Dear Mr. Reynolds:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocuril 310(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regars) to regard the Medical Device Amendments, or to conninered prior to May 20, 1978, is accordance with the provisions of the Federal Food, Drug, de necs may been rocussioned in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, mainer 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device r may of vary of 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.

{1}------------------------------------------------

Page 2 - Mr. Sean Reynolds

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease oc advised that 1 Dris issuanted byour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any it call the Act's requirements, including, but not limited to: registration and listing (21 Compry with an the 11th 11th 31equirements)01); good manufacturing practice requirements as set CITY art 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This icter will anow you to ough mainenting of substantial equivalence of your device to a legally premarket notification: "The PDT Intention 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 If you dome specific and Compliance at [phone]. Also, please note the regulation entitled, comace the Ories of Compilance in the the notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on 70% Topsumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimmer for
R. D. Zucherman, M.D.

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K042302

## Device Name: ZOLL Autoclavable Internal Handles, ZOLL Autoclavable Internal Handles with Integrated Electrodes, ZOLL Autoclavable External Paddles

Indications For Use:

The ZOLL Autoclavable Internal Handles are to be used with interchangeable electrodes and a manually operated ZOLL Defibrillator to defibrillation therapy directly to the heart during surgical procedures.

When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature. the ZOLL Autoclavable Internal Handles allows the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles are intended for use by or under the direction of a physician.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to provide defibrillation therapy directly to the heart during surgical procedures.

When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allows the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.

## (continued on next page)

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

oncurrence of CDRH, Office of Device Evaluation (ODE)

R.B. Simmon

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042502

Page 1 of 2

{3}------------------------------------------------

## Indications for Use (continued from previous page)

The ZOLL Autoclavable External Paddles are to be used with manually operated ZOLL M Series Defibrillator products to perform closed chest defibrillation of a patient when sterlization of the paddles is required either before or after the defibrillation event.

The ZOLL Autoclavable External Paddles are intended for use by trained personnel and are for use on Adult patients only.

The ZOLL Autoclavable External Paddles are intended for use by or under the direction of a physician.

K042302
page 2 of 2