ZOLL M SERIES ETCO2 OPTION

K993036 · Zoll Medical Corp · MKJ · Feb 28, 2000 · Cardiovascular

Device Facts

• Record ID: K993036
• Device Name: ZOLL M SERIES ETCO2 OPTION
• Applicant: Zoll Medical Corp
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 28, 2000
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Pediatric

Intended Use

The ZOLL M Series EtCO2 option with Novametrix technology and Capnostal® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.

Device Story

ZOLL M Series EtCO2 option integrates Novametrix technology and Capnostal® sensor into existing M Series monitor/defibrillator platform; provides continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate. Used in clinical settings including transport, anesthesia, and ventilator support; operated by healthcare professionals. Device processes signals from Capnostal® sensor to calculate CO2 levels and respiratory rate; output displayed on M Series screen for real-time patient assessment. Enables clinicians to monitor ventilation status and airway integrity; facilitates timely clinical intervention for respiratory distress or equipment failure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Integrates Novametrix technology and Capnostal® sensor for mainstream CO2 monitoring. Designed for adult, pediatric, and neonatal patient populations. Operates as an option module for the ZOLL M Series monitor/defibrillator. Connectivity via proprietary sensor interface.

Indications for Use

Indicated for continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in adult, pediatric, and neonatal patients requiring ventilator support, transport, or anesthesia.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2000

Mr. Paul Dias ZOLL Medical Corporation 32 Second Avenue Burlington, MA 01803-4420

K993036 Re : ZOLL M Series EtCO2 Option Regulatory Class: III (three) мкј, ССК Product Code: Dated: December 1, 1999 December 2, 1999 Received:

Dear Mr. Dias:

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 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). 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 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 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. Paul Dias

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/dsma/dsmamain.html".

Sincerely yours,

Christy Luman for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1992636 510 (k) NUMBER (IF KNOWN) :

DEVICE NAME : ZOLL M Series EtCO2 Option

INDICATIONS FOR USE:

The ZOLL M Series EtCO2 option with Novametrix technology and Capnostal® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.

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Office of Device Evaluation (ODE) Concurrence of CDRH, cremon Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K993034 OR Over-The-Counter-Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)