ZOLL M SERIES SPO2 OPTION

• K Number: K982992
• Device Name: ZOLL M SERIES SPO2 OPTION
• Manufacturer: ZOLL MEDICAL CORP.
• Date Cleared: 1999-03-11 ( 196 days)
• Product Code: MKJ
• Regulation Number: 870.5310

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 Description

Not Found

Predicate Devices

Not Found

Reference Devices

K/DEN numbers are not found in the provided text.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related concepts, and the device description is not available to provide further clues.

Therapeutic

No
The device is a continuous monitoring device for physiological parameters (oxygen saturation and pulse rate), not a therapeutic device.

Diagnostic

Yes
The device is used for "continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate," which are physiological parameters used to assess a patient's health status and aid in diagnosis. Monitoring is a key aspect of diagnostics.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components: "ZOLL M Series Pulse Oximeter" and "LNOP® Series of Sensors".

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use describes the device as a "continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate". This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples.
  • Detecting or measuring substances in biological samples.
  • Providing information for diagnosis, monitoring, or screening based on analysis of biological samples.

Pulse oximeters are considered medical devices, but they fall under a different regulatory category than IVDs. They are devices that directly measure physiological parameters from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

74 MKJ

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

pediatric and neonatal patients

Intended User / Care Setting

hospital and pre-hospital environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Summary

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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](https://510k.innolitics.com/search/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)