ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION

K011865 · Zoll Medical Corp · DSK · Jul 31, 2001 · Cardiovascular

Device Facts

• Record ID: K011865
• Device Name: ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION
• Applicant: Zoll Medical Corp
• Product Code: DSK · Cardiovascular
• Decision Date: Jul 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial pressures using invasive transducers with 5uV/V/mmHg sensitivity for use with critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only. The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.

Device Story

ZOLL M Series IBP and Temperature options are add-on modules for the ZOLL M Series monitor/defibrillator. IBP option processes signals from invasive pressure transducers (5uV/V/mmHg sensitivity) to display arterial, venous, and intracranial pressures. Temperature option processes signals from YSI 400-compatible sensors to display patient temperature. Used in critical care and transport environments by clinicians. Provides real-time physiological data to support clinical decision-making and patient monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modules integrate with ZOLL M Series monitor/defibrillator. IBP module: invasive pressure transducer interface (5uV/V/mmHg). Temperature module: YSI 400-compatible sensor interface. Class II device (21 CFR 870.1110).

Indications for Use

Indicated for adult and pediatric patients requiring invasive arterial, venous, or intracranial pressure monitoring and temperature monitoring in critical care or transport settings. Contraindicated for neonatal patients.

Regulatory Classification

Identification

A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 2001

Mr. Paul Dias Director, Quality Assurance and Regulatory ZOLL Medical Corporation 32 Second Avenue Burlington, MA 01803-4420

Re: K011865

Trade Name: ZOLL M Series IBP Option ZOLL M Series Temperature Option Regulation Number: 21 CFR 870.1110 Regulatory Class: II (two) Product Code: 74 DSK Dated: June 12, 2001 Received: June 14, 2001

#### 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 provision, 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 ( fecting 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

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## Page 2 - Mr. Paul Dias

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 response to your premarker notheaters the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematket I his letter will anow you to begill marketing your device to a legally marketed nothication. The PDA imania of backan.com 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 If you desire specific advice to your do rise contact the Office of Compliance at additionally 809.10 for m vitto diagnostions on the promotion and advertising of your device, [phone]. Addinonally, for questions on are parties of Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, TMIsoranding by relearles to premained from the Division of Small
information on your responsibilities under the Act 12011 412 6507 - at its information on your responsionnes analy under [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dak Vill

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

Enclosure

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# Section 6 - Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ZOLL M Series IBP and Temperature Option Device Name:

### Indications for Use:

#### IBP

The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial Trie ZOLL M Series TD "Option is Indication For resimitivity for resting patients in
pressures using invasive transducers with 5uV/V/mmHg sensitivity for use with and pressures using finasive transducers with our rimming sommercy.
critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only.

#### Contraindications:

The ZOLL M Series IBP option is not indicated for use on neonatal patients.

#### TEMPERATURE

The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.

#### Contraindications:

The ZOLL M Series Temperature option is not indicated for use on neonatal patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ca. Ve. Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K011863

Prescription Use (Per 21 CFR 801.109

or

Over-The-Counter-Use

(Optional Format 1-2-96)