ZOLL M SERIES SPO2 OPTION

K982992 · Zoll Medical Corp · MKJ · Mar 11, 1999 · Cardiovascular

Device Facts

• Record ID: K982992
• Device Name: ZOLL M SERIES SPO2 OPTION
• Applicant: Zoll Medical Corp
• Product Code: MKJ · Cardiovascular
• Decision Date: Mar 11, 1999
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Pediatric

Intended Use

The ZOLL M Series Pulse Oximeter with Masimo SET® technology and the LNOP® series of sensors are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for pediatric and neonatal patients, in a hospital and pre-hospital environment.

Device Story

The ZOLL M-Series Defibrillator SpO2 Option integrates Masimo SET® pulse oximetry technology into an existing defibrillator platform. The device utilizes LNOP® sensors to acquire photoplethysmographic signals from the patient. The Masimo SET® algorithm processes these signals to derive arterial oxygen saturation (SpO2) and pulse rate, specifically designed to maintain accuracy during patient motion and low perfusion. The output is displayed on the device monitor for clinical review by healthcare providers in hospital or pre-hospital environments. This information assists clinicians in assessing patient oxygenation status and heart rate, facilitating timely clinical interventions. The device is intended for use on pediatric and neonatal populations.

Clinical Evidence

No clinical data provided. The submission relies on a hazards analysis, literature searches of the National Library of Medicine (MEDLINE) regarding safety and effectiveness of defibrillators and pacemakers, and the manufacturer's historical design experience.

Technological Characteristics

The device integrates Masimo SET® pulse oximetry technology and LNOP® sensors. It functions as an add-on module to the ZOLL M-Series defibrillator. The system provides continuous noninvasive monitoring of SpO2 and pulse rate. It is designed for use in hospital and pre-hospital environments. The device is subject to FDA device tracking requirements.

Indications for Use

Indicated for continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate in pediatric and neonatal patients in hospital and pre-hospital settings, including during patient motion.

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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K982992

3/11/99

## Summary of Safety and Effectiveness

### Defibrillators

The types of safety and effectiveness problems associated with advisory defibrillators are summarized below:

The five most frequently reported problems that were MDR-related:

1. Non-clearable message prompts (e.g. "check electrode", "motion detected", etc.)

- 2. Device shutdown resulting in inability to defibrillate.
3. Inappropriate rhythm analysis resulting in either a false positive or false negative.

- 4. Inappropriate activation of alarms. ("check patient" falsely indicating patient in shockable rhythm)
- 5. Failure to analyze rhythm

This list is based on the analysis of all MDRs related to AEDs which was presented by Kimberly Trautman of the FDA Office of Compliance at the FDA Meeting with Manufacturers of Automatic External Defibrillators September 23, 1994.

From the perspective of overall complaints (as opposed to strictly MDRs), ECRI presented the results of a questionnaire regarding total number of complaints. This list is part of the same record as Kimberly Trautman's presentation is found. Copies of ECRI's and Ms. Trautman's discussion contained in the Federal Record are included in this section for convenience. ECRI's list is summarized below:

- Tape Deck or other data recording device. 1.
- 2. Service Messages
- 3. Check electrode or motion detection message
- 4. Inappropriate rhythm analysis
- 5. Won't analyze charge, or discharge
- 6. Won't power up
- 7. Monitor/display
- 8. Miscellaneous
- 9. Battery
- 10. Device shuts off

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The top 5 MDRs from 1996, in order of frequency, associated with ZQLL Advisory and Semi-automatic Defibrillators are as follows:

- Non-clearable message prompts 1
- ECG signal problems 2.
- Video display 3.
- Device shutdown 4.
- Inappropriate analysis న.

Also, a literature search of the National Library of Medicine (MEDLINE) was conducted. Copies of the abstracts from this literature search are contained on pages 2-35 to 2-79.

### Pacemakers

The types of safety and effectiveness problems associated with pacemakers are summarized below. This information was obtained from the DIOGENES database.

The five most frequently reported problems that were MDR-related:

- 1. Failure to pace (i.e. no output, very low output, failure to power up, pacing inhibited)
- 2. Failure to achieve or maintain electrical capture
- 3. Pacer current or rate out of specification
- 4. Miscellaneous
- 5. Unclear or Undefined malfunction.

The top 5 MDRs from 1996, in order of frequency, associated with ZOLL Pacemakers are as follows:

- 1. Unable to capture
- 2. No pacer output
- 3. User received unintended pacer pulse (user error)
- 4. Pacer current or rate out of specification
- 5. Unable to adjust pacer rate.

Also, a literature search of the National Library of Medicine (MEDLINE) was conducted (1996 to present). Copies of the abstracts from this literature search are contained on pages 2-80 to 2-142.

This Class III Summary, in conjunction with the Hazards Analysis included in Section 8 of this 510(k), indicates that ZOLL Medical Corporation is fully cognizant of the types of safety and effectiveness problems associated with this type of device. This knowledge, combined with over ten years of experience in

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designing and manufacturing similar types of devices, has led the company to make every effort to ensure that the proposed design minimizes the potential for similar problems.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 1999

Ms. Maura McGuire Zoll Medical Corporation 32 Second Avenue Burlington, MA 01803-4420

K982992 Re: Kool M-Series Defibrillator SpO2 Option Regulatory Class: III (three) Product Code: 74 MKJ December 18, 1998 Dated: Received: December 22, 1998

Dear Ms. McGuire:

We have reviewed your Section 510(k) notification of intent to market We have reviewed your beceion one have determined the device is the device reletenced above and wo nave and to use stated in the substantially equivalence (ased predicate devices marketed in enclosure) to regally marketed productions werket the enactment the device interstate commerce prior co nay as therefore, market the device, Medical Device Amendments. Tourmay choneses the Federal Food, Drug, subject to the general concrols provisions of the Act.
and Cosmetic Act (Act). The general contine listing of dovices, of and Cosmetic Act (ACC). The general contraction, listing of devices, good include requirements for annual Ling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device 15 Classisse (bet Approval) it may be subject to such Controls) of Class III (Fremaines inprovilations affecting your device 200 additional Collections. Thirding major every - Title 21, Parts 800 ound in the code or reasured determination assumes compliance to 895. co 893. A substancially equirements, as a set with the Current Courtem Regulation (QS) for Medical Devices: rorth in the Quarter Byood... and that, through periodic QS General regulacion (2) ori railure, such assumptions. Failure to comply with Inspections, FBA will versily oil regulatory action. In addition, the Che GMF Legulation may reads on (FDA) may publish further announcements rood and bray namevice in the Federal Register. Please note: this concerning your actroor submission submission does not affect any response to your premarked noor section 531 through 542 of the Act for obilgation you might have and diation Control provisions, or other Federal Laws or Regulations.

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# Page 2 - Ms. Maura McGuire

On August 16, 1993 the Final Rule for Device Tracking was published in on August 16, 1975 the Final 3442-43455 (copy enclosed). Be advised che rederal Region 519(e) of the Act as amended by the Safe Medical chat under beceren. Car(o) is identified the above device as a device Devices Acc of 1990 reli nas ause the device is subject to tracking, which required to adopt a method of tracking that follows the you are requred to distribution chain and then identifies and follows devices through one eive them. The specific requirements of the the patients who receive them. The open of the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described inis recei will arrow you co co icention. The FDA finding of substantial in your blog.), proc device to a legally marketed predicate device equivalence or your device and thus, permits 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 regulacion (ir orn parlace contact the Office of Compliance at GraghoSere actrics , For questions on the promotion and (Jul) 354 4622. Thursdanaly advertising or your action not the regulation entitled, "Misbranding (301) 39 4007. In107 personitication"(21 CFR 807.97). Other general by reference to promosibilities under the Act, may be obtained fillolmation of Small Manufacturers Assistance at its toll free rrom the Britision of [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Page 1 of 1

510(k) NUMBER (IF KNOWN): `K982992`
DEVICE NAME: `ZOLL Mseries Defibrillator SpO2 Option`
INDICATIONS FOR USE:

The ZOLL M Series Pulse Oximeter with Masimo SET® technology and the LNOP® The ZOLL IN BORGS For the continuous noninvasive monitoring of arterial Senes of Seasons are malestic pulse rate during both no motion and patient motion oxygen saturation (0p02) and part on motion conditions for pediatric and neonatal patients, in a hospital and pre-hospital environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

: 1/2 di

OR

Over-The-Counter-Use (Optional Format 1-2-96)