The StarTrack Infant Graphics Monitor's intended use is the measurement and display of breathing flow, volume and pressure as delivered trough the patient's endotracheal tube. The intended patient population comprises neonatal and pediatric patients requiring an endotracheal tube <5.0mm I.D. and/or who do not exceed a peak breathing flow of 30 L/Min directly through the ET tube. The intended environments of use comprise Hospital, Hospital-type and Intra-Hospital Transport environments. The device is for prescription use only. Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities such as Surgicenters, Sub-acute Centers and Special Nursing Facilities, outside of the hospital transport includes transport with a patient within the hospital or hospital-type facility.

Device Description

The StarTrack Infant Graphics Monitor, StarTrack is contained in a rectangular metal enclosure measuring 9.25 inches wide by 6 inches high by 5.7 inches deep and weighing 7.2 Ibs. A front panel LCD screen enables the presentation of graphics, numeric breath data and alarm settings. User-selectable graphics screens present Flow and Volume vs Time. Pressure and Volume vs Time, Flow and Pressure vs Time, Flow / Volume Loop and Pressure / Volume Loop. Numeric breath data are Expiratory Tidal Volume, Expiratory Minute Volume, ET Tube Leak, Breath Rate and Dynamic Compliance. Alarm Settings are High Minute Volume, Low Minute Volume, High ET Tube Leak, High Breath Rate and Breath Interval. StarTrack also provides visual and audible indicators. Alarms are divided into two categories: patient-related alams and system-related alarms. A patient alarm causes a flashing bell to display next to the violated alarm setting. This is accompanied by an audible sound and the flashing Patient-Related Alarm LED. When the alarm condition is corrected, the audible sound ceases and the bell and LED stop flashing. These displays will turn off when the operator presses the Visual Reset button. Patient-related alarms can be silenced for sixty seconds by pressing the Alarm Silence button. System-related alarms concem problems with the hardware, such as the sensor, sensor cable and the StarTrack electronics. System-related alarms have both visual and audible indicators. The audible indicators cannot be silenced. The System-Related alarms are Sensor Disconnect, Sensor Defect, Sensor Contaminated, AC Power Loss and System Failure.

AI/ML Overview

The provided document is a 510(k) summary for the StarTrack Infant Graphics Monitor, a device intended for measuring and displaying breathing flow, volume, and pressure in neonatal and pediatric patients.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study conducted:

1. A table of acceptance criteria and the reported device performance:

The document states: "Safety and environmental testing to accepted industry standards has been conducted as well as in-vitro testing to confirm the accuracy of StarTrack." However, specific numerical acceptance criteria for accuracy (e.g., ±X% accuracy for flow or volume) and the reported device performance against these criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "in-vitro testing," which implies that the testing was performed in a laboratory setting, not on human subjects. No information is provided regarding the specific sample size for the in-vitro test set, data provenance (country of origin), or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Since the testing was "in-vitro," there would typically be no human experts involved in establishing a "ground truth" in the way a clinical study would. Ground truth in this context would likely be established by a reference standard measurement device. The document does not specify the type or number of reference devices used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As it was an in-vitro study, adjudication methods typically used in clinical trials involving expert interpretation are not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document describes a physical medical device (monitoring spirometer), not an AI-powered diagnostic imaging or interpretation system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document states that the StarTrack uses "substantially the same software algorithm for determining airway flow values as used on the predicate device." While this confirms an algorithm is involved, the primary study mentioned is "in-vitro testing to confirm the accuracy of StarTrack," which represents standalone performance of the device itself (including its integrated algorithm and hardware) against a reference standard. There is no explicit mention of an "algorithm only" test separate from the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For "in-vitro testing," the ground truth would typically be established by a highly accurate and calibrated reference measurement instrument or system (e.g., a highly precise flow and volume simulator or standard). The document does not specify the exact type of reference ground truth used.

8. The sample size for the training set:

The document indicates that the StarTrack's embedded software contains "substantially the same software algorithm for determining airway flow values as used on the predicate device, the Bear Medical Systems Neonatal Volume Monitor, model NVM-1, K890724." This suggests that the algorithm was likely developed and "trained" (if machine learning was involved, which is unlikely for a 1998 device measuring basic physiological parameters) in conjunction with the predicate device. However, no information on the sample size for a training set is provided. Given the device's function, it's more probable that the algorithm is based on physiological principles and calibrated parameters rather than a machine learning training set in the modern sense.

9. How the ground truth for the training set was established:

As above, without a specific "training set" being described, the method for establishing ground truth for training is not available. If the algorithm is based on the predicate device, the initial development and validation of that predicate device would have established its internal ground truth and calibration methods.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and mentions "in-vitro testing" for accuracy. However, it lacks granular details regarding the specific acceptance criteria, quantitative performance results, sample sizes, and detailed methodology typically found in comprehensive study reports for device validation. This is common for 510(k) summaries, which aim to provide a high-level overview rather than a full study protocol and results.

Summary

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3274

DEC 9 1998

Section 16, 510(k) Summary

Section 16.a Date Summary Prepared

30 November 1998

Section 16.b Company Information

Establishment:

Official Correspondent:

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588

David A.C. Green Manager, Requiatory Affairs Nelicor Puritan Bennett Inc. 2200 Faraday Avenue Carlsbad, CA 92008 (760) 603-5978 (direct phone) (760) 603-5907 (fax)

Section 16.c Name of Device

Proprietary:

Common/Usual:

StarTrack Infant Graphics Monitor

Volume Monitor

Classification:

Monitoring Spirometer(§868.1850/73BZK)

Section 16.d Equivalent Devices

Substantial equivalence to the following legally marketed predicate device with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for the predicate device and the StarTrack Infant Graphics Monitor, StarTrack. Safety and environmental testing to accepted industry sfandards has been conducted as well as in-vitro testing to confirm the accuracy of StarTrack. The predicate device is as follows:

Bear Medical Systems Neonatal Volume Monitor, model NVM-1, K890724.

Section 16.e Device Description

The StarTrack Infant Graphics Monitor, StarTrack is contained in a rectangular metal enclosure measuring 9.25 inches wide by 6 inches high by 5.7 inches deep and weighing 7.2 Ibs.

A front panel LCD screen enables the presentation of graphics, numeric breath data and alarm settings. User-selectable graphics screens present Flow and Volume vs Time. Pressure and Volume vs Time, Flow and Pressure vs Time, Flow / Volume Loop and Pressure / Volume Loop. Numeric breath data are Expiratory Tidal Volume, Expiratory Minute Volume, ET Tube Leak, Breath Rate and Dynamic Compliance. Alarm Settings are High Minute Volume, Low Minute Volume, High ET Tube Leak, High Breath Rate and Breath Interval.

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StarTrack also provides visual and audible indicators. Alarms are divided into two categories: patient-related alams and system-related alarms. A patient alarm causes a flashing bell to display next to the violated alarm setting. This is accompanied by an audible sound and the flashing Patient-Related Alarm LED. When the alarm condition is corrected, the audible sound ceases and the bell and LED stop flashing. These displays will turn off when the operator presses the Visual Reset button. Patient-related alarms can be silenced for sixty seconds by pressing the Alarm Silence button.

System-related alarms concem problems with the hardware, such as the sensor, sensor cable and the StarTrack electronics. System-related alarms have both visual and audible indicators. The audible indicators cannot be silenced. The System-Related alarms are Sensor Disconnect, Sensor Defect, Sensor Contaminated, AC Power Loss and System Failure.

Section 16.f Intended Use

StarTrack is intended for prescription use only for the measurement and display of breathing flow, volume and pressure as delivered from a ventilator through the patient's endotracheal tube. StarTrack is not an Apnea Monitor. The intended patient population comprises neonatal and pediatric patients who require an endotracheal tube <5.0mm I.D. and/or do not exceed a peak breathing flow of 30 L/Min directly through the ET tube. The intended environments of use comprise Hospital tvpe and Intra-Hospital Transport environments. Hospital use typically covers such areas as general care floors. operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities such as Surgicenters, Sub-acute Centers and Special Nursing Facilities, outside of the hospital. Intra-hospital transport includes transport with a patient within the hospital or hospital-type facility.

Section 16.g Technological Characteristics

StarTrack's function is to monitor the status of the patient's airway flow. volume and pressure as delivered from a ventilator through the endotracheal (ET) tube in infants. A heated wire anemometer sensor located in series with the patient airway measures flow in the constant temperature mode. Two heated wires within the airway flow sensor enable the determination of flow direction as well as flow magnitude. Current passing through the heated wires maintains a constant sensor resistance and, thus, a constant sensor temperature. As flow changes, the heat loss changes and thus the heating current changes. Knowledge of this current value enables the determination of a corresponding airway flow.

StarTrack also has the capability of displaying proximal pressure information. A pressure transducer resides within StarTrack. The operator can select either StarTrack's pressure transducer or the Infant Star Ventilator's pressure transducer or the Operator can disable pressure monitoring altogether.

The embedded software contains substantially the same software algorithm for determining airway flow values as used on the predicate device, the Bear Medical Systems Neonatal Volume Monitor, model NVM-1, K890724.

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Section 16.h Certification Statement

In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:

Nellcor Puritan Bennett Inc., believes that all data and information submitted in this Premarket Notification are truthful and accurate and no material fact has been omitted.

David A.e. Green.

David A. C. Green Manager, Regulatory Affairs for Nelicor Puritan Bennett Inc.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The design features a staff with a serpent coiled around it, representing healing and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 1998

Mr. David A. C. Green Nellcor Puritan Bennett Inc. 2200 Faraday Avenue Carlsbad, CA 92008

Re: K983274 StarTrack Infant Graphics Monitor Regulatory Class: II (two) Product Code: 73 BZK September 16, 1998 Dated: Received: September 17, 1998

Dear Mr. Green:

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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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. David A. C. Green

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

Enclosure

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Page

510(k) Number (if known):	K983274
Device Name:	StarTrack Infant Graphics Monitor

Indications For Use:

(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) $\checkmark$

Over-The-Counter Use

(Optional Format 1-2-96)

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

510(k) Number K963274

Regulation Number and Section

§ 868.1850 Monitoring spirometer.

(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).