These monitors were originally cleared for monitoring respiration, heart rate, optional pulse oximetry and for detecting central apnea in infants in the home and hospital environments. This submission identifies the additional adult/pediatric monitoring mode.

Device Description

The Model 510 Series consists of the Model 510 and the Model 511 monitors. Both monitors are identical in design with the exception that the Model 511 has a numeric display and the Model 510 does not.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative format. The non-clinical testing focused on verifying compliance with standards and the clinical study aimed to assess respiration detection accuracy.

However, based on the non-clinical and clinical testing sections, we can infer some criteria and reported performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with ANSI/AAMI EC-13:1992 sections: - 3.2.1 Operating Condition - 3.2.2 Overload Protection - 3.2.3 Risk Current (isolated patient connection) - 3.2.4 Auxiliary Output Risk Current (isolated patient connection) - 3.2.5 Respiration Lead-Off Sensing and Active Noise Suppression Risk Current - 3.2.6 QRS Detection - 3.2.7 Range/Accuracy of Heart Rate Meter - 3.2.8 Alarm System, Alarm Limit Range	The monitor was tested and found to be in compliance with these applicable requirements.
Validation of software change and regression testing of applicable monitor functions/operations.	Validated through a Software Validation Test Plan, challenging various system capabilities.
Verification of accuracy of heart rate, respiration rate, and percent SpO2.	Verified through the use of a patient simulator during validation and verification phases.
Verification of visual and audible alarm functions (e.g., apnea, HR, RR) with pre-defined and random selected limits.	Alarm functions were repeatedly verified.
Verification of vital operations such as Self-Test functions.	Self-Test functions were verified.
Accuracy of respiration detection in adult/pediatric mode in a clinical setting.	Correlation between the study monitor (510 Series) and a reference monitor (nasal airflow) was consistent with previous findings for the predicate device (infant mode).

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The study population consisted of a "representative distribution" with 62% male and 38% female, and ages ranging from 2 to 74 years. The exact number of subjects is not provided, but they were divided into two groups: Group 1 (Pediatric, age 1-18 years) or Group 2 (Adult, age 19 years and older).
- Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer's address in Wallingford, CT, USA, it's highly probable the study was conducted in the US. The study appears to be prospective as it involved monitoring subjects with the test device and a reference monitor.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: "Recordings were independently scored by the principal investigator." This suggests one principal investigator established the ground truth.
- Qualifications of Experts: The qualifications of the principal investigator are not provided.
Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. Since "recordings were independently scored by the principal investigator," it implies a single point of truth determination, rather than a consensus or adjudication process involving multiple readers.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical study involved the device (Corometrics Model 510 Series) and a reference monitor (nasal airflow), with evaluation by a single principal investigator, not a comparison of human readers with and without AI assistance.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the clinical study essentially represents a standalone performance evaluation of the device's adult/pediatric mode. It compares the device's measurements (specifically respiratory rate detection) against a reference standard (nasal airflow) without human intervention in the interpretation of the device's output during the data collection phase, though a human (principal investigator) then scored the recordings.
Type of Ground Truth Used:
- The ground truth for the clinical study was established by a reference monitor (nasal airflow). This can be considered physiological or "gold standard" data for respiration detection, subsequently scored/analyzed by a principal investigator.
Sample Size for the Training Set:
- The document does not mention a training set sample size. The focus of this 510(k) summary is on the modification to enable an adult/pediatric mode via a software change, building upon an already cleared device. The original infant mode would have had its own development and validation, but details for the adult/pediatric mode's training are not provided here. The software change itself was validated, but details of training data for any potential machine learning components are absent, suggesting the update was likely rule-based or using established signal processing algorithms.
How the Ground Truth for the Training Set Was Established:
- Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.

Summary

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510(k) Summary 10.0 Prepared: 06 February 1997
K962781

[21 CFR § 807.92(a)1] Contact Information

MAR - 6 1997

Maria Vitug Fouts Sr. Regulatory Compliance Specialist

Corometrics Medical Systems, Inc. Address: 61 Barnes Park Road North Wallingford, CT. 06492

203-949-2538 Tel.: 203-284-9465 Fax:

[21 CFR § 807.92(a)2] Device Name and Classification

The proprietary name for the two devices are: Corometrics Model 510 Monitor and Corometrics Model 511 Monitor. Common names include: Model 511 and Model 510 Series.

As with the predicate device, the modified Model 510 and Model 511 are class II devices. Applicable 21 C.F.R. identifications include: 868.2375, breathing frequency monitor; 870.2300, cardiac monitor; and 870.2700, oximeter.

Device	Manufacturer (k Number, SE* Date)
Model 510	Corometrics Medical Systems, Inc.(K943308, 7/25/95)
Model 511	Corometrics Medical Systems, Inc.(K942179, 6/2/95)
EdenTec Model 2000WOption H	EdenTec(K871302, 4/20/87 and K905575,6/20/91)
Nellcor N-180 Pulse Oximeter	Nellcor Puritan Bennett(K913695, 11/13/95)

[21 CFR § 807.92(a)3] Identification of Legally Marketed Devices

*SE - Substantial Equivalence

[21 CFR § 807.92(a)4,5] Device Description & Intended Use

The Model 510 Series consists of the Model 510 and the Model 511 monitors. These monitors were originally cleared for monitoring respiration, heart rate, optional pulse oximetry and for detecting central apnea in infants in the home and hospital environments. Both monitors are identical in design with the exception that the Model 511 has a numeric display and the Model 510 does not. This submission identifies the additional adult/pediatric monitoring mode.

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510(k) Summary 10.0

Continued

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121 CFR § 807.92(a)6) Predicate Device Comparison of Technological Characteristics

The predicate Model 510 Series (Infant Mode) and the proposed Model 510 Series (with Adult/Pediatric Mode enable) uses the same technology for detecting, measuring, and displaying heart rate and respiration rate (including the detection of central apnea). The Model 510 Series measures heart rate based on a three wire electrocardiograph (ECG). The heart rate is calculated from the lead I signal using the R-R interval on a beat-to-beat basis. The respiration method utilized is transthoracic impedance, using the same three wires as the ECG component. This technology is the same as that of the EdenTec predicate device, for both patient populations.

The pulse oximetry mode is based on spectrophotometry and plethysmography techniques developed by Nellcor Puritan Bennett (NPB). Specifically, the Model 510 Series utilizes the same signal processing board and patient accessories as the NPB N-180 Pulse Oximeter.

[21 CFR § 807.92(b)1| Brief discussion of nonclinical tests

Nonclinical testing that was required to demonstrate substantial equivalence focused on the device changes that were the subject of this 510(k) submission: enabling the adult/pediatric mode via a software change. This software change did not affect the mechanical or electrical performance of the monitor; thus electrical and mechanical testing was required to be retested. Nonclinical testing consisted of: {a) validation of the software change and regression testing of applicable monitor functions/operations; and (b) verification of compliance with applicable requirements of ANSI/AAMI EC-13:1992.

The accuracy of heart rate, respiration rate and percent SpO2 were verified in the validation and verification phase through the use of a patient simulator. The visual and audible alarm functions (e.g. apnea, heart rate, respiration rate, etc.) were repeatedly verified with pre-defined and random selected limits. Vital operations such as Self-Test functions were also verified. A software Validation Test Plan, derived from the overall system specifications was used to challenge the various system capabilities.

The monitor was tested and found to be in complicable requirements of ANSI/AAMI EC-13:1992. The applicable requirements to which the monitor was tested include: 3.2.1 Operating Condition, 3.2.2 Overload Protection, 3.2.3 Risk Current (isolated patient connection), 3.2.4 Auxiliary Output Risk Current (isolated patient connection), 3.2.5 Respiration Lead-Off Sensing and Active Noise Suppression Risk Current, 3.2.6 QRS Detection, 3.2.7 Range/Accuracy of Heart Rate Meter, 3.2.8 Alarm System, Alarm Limit Range.

807.92(b)2 Brief discussion of clinical tests

Clinical testing of the adult/pediatric mode was performed as additional verification of the monitor performance in a clinical setting. The primary objective was to assess the accuracy of respiration detection. Subjects monitored in the study were divided into two groups: Group 1 (Pediatric, age 1 - 18 years) or Group 2 (Adult; age 19 years and older). Each patient was dual monitored with the test device and a reference monitor (i.e. nasal airflow). Recordings were independently scored by the principal investigator. Evaluation of the collected data included: comparison of the respiratory rate detection (510 Series vs. nasal airflow); and visual comparison

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510(k) Summary: Corometrics Model 510 Series Monitors

of cardiac, respiratory and airflow waveforms. An analysis of the results demonstrated that the % true and false positive alarms had considerable variation to the electrode placement. The study population consisted of a representative distribution (62% male, 38% female with ages ranging from 2 to 74 years of age). The correlation between the study monitor and the reference device was consistent with previous findings for the predicate Model 510 Series (infant mode).

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1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

807.92(b)3 Conclusions drawn from 807.92(b)1,2

New device testing focused on the software changes required to enable the Adult/Pediatric mode. The specific changes identified in this submission regarded only software and associated labeling changes. It was determined that these changes did not affect the electrical or mechanical performance of the monitor. The original electrical and mechanical performance testing that was submitted with the infant 510(k) submission still applied, and was therefore not repeated.

In summary, the monitor was found to comply with the requirements of the Validation Test Plan and product system specifications. Verification of the monitor performance in clinical testing showed that the correlation between the 510 Series to nasal airflow remain consistent with previous findings for the predicate Model 510 Series (i.e. with infant mode enabled only). These test results along with the labeling and the predicate device comparison of device specifications demonstrate that the modified 510 Series is substantially equivalent to its listed predicate devices.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).