The DINAMAP® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital or ground transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

Device Description

The DINAMAP Pro Monitor, Series 100, 200, 300, 400 is a prescription device intended for use only by health care professionals. Four configurations of the monitor - all with an integrated printer - will offer the following vital signs parameters: . DINAMAP Pro Series 100: Non-Invasive Blood Pressure and Pulse Rate - DINAMAP Pro Series 200: Non-Invasive Blood Pressure and Monitor/Predictive Oral/Rectal . Temperature - . DINAMAP Pro Series 300: Non-Invasive Blood Pressure and Nellcor® Pulse Oximetry and Pulse Rate - . DINAMAP Pro Series 400: Non-Invasive Blood Pressure and Pulse Rate; Monitor/Predictive Oral/Rectal Temperature; and Nellcor® Oxygen Saturation and Pulse Rate (Pulse Oximetry) This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. The device uses the same technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DINAMAP® Pro Monitor, Series 100, 200, 300, 400, based on the provided text:

Acceptance Criteria and Device Performance for DINAMAP® Pro Monitor

1. Table of Acceptance Criteria and Reported Device Performance

This device combines multiple physiological monitoring functionalities. The acceptance criteria and performance are detailed for each major component: Non-Invasive Blood Pressure (NIBP), Oxygen Saturation (SpO2), and Temperature.

Feature Area	Acceptance Criteria	Reported Device Performance
NIBP	Compliance with ANSI/AAMI SP10-1992 and SP10A-1996 for: - Labeling (4.1) - Stability (4.2.4, excluding 4.2.1, 4.2.2, 4.2.3 and including 4.2.4.1 Voltage Range; 4.2.4.2 Life) - Safety (4.3, including 4.3.1.1 Maximum Cuff Pressure; 4.3.1.2 Cuff Deflation; 4.3.2 Electrical Safety; 4.3.3 Conductive Components) - Performance (4.4, including 4.4.1 Pressure Indicator Accuracy; 4.4.3 Battery-Powered Devices) - Environmental performance as per November 1993 Draft Reviewer Guidance.	The new device met the requirements of ANSI/AAMI SP10 and SP10A for the specified sections. It passed all bench tests related to stability, safety, and performance. Clinical accuracy for the NIBP algorithm was established in adult, pediatric, and neonatal populations during prior studies for predicate devices (DINAMAP MPS Select NIBP Module) which use the same NIBP algorithm, software, processor family, operating system, and accessories.
Oxygen Saturation (SpO2)	Met Nellcor sensor specifications for accuracy against arterial blood oxygen saturation co-oximeter measurements across a range of oxygen saturation (100% down to 70%). This includes performance in low perfusion/low signal conditions.	Co-Oximeter Correlation Study: Pooled results for all three subjects indicated that the three new devices met sensor specifications. Non-Invasive Controlled Hypoxia Study: The oxygen saturation parameter of the new devices met oxygen saturation with all Nellcor sensors. Bench Testing: The new devices met the acceptance criteria for Saturation Comparison Verification, Low Perfusion/Low Signal Saturation, and Pulse Rate Comparison studies.
Temperature	Monitor Mode/Probe Accuracy: Liquid-bath testing according to ASTM E 1112 - 86 (Reapproved 1991), Table 1 maximum error ranges, relative to a mercury-in-glass thermometer. Predictive Mode Accuracy: Liquid-bath testing to establish equivalence with Alaris Medical Systems IVAC® 2080 Measurement (using a Critikon-developed procedure), relative to an IVAC 2080 Measurement System, within ASTM E 1112 - 86 (Reapproved 1991) Table 1 maximum error ranges. Clinical Accuracy: Mean difference < 1.0ºF (clinically significant difference definition).	Liquid-bath testing: Demonstrated the ability of the new device to determine monitor mode temperatures relative to a mercury-in-glass thermometer and predictive mode temperatures relative to an IVAC 2080 Measurement System within the maximum error ranges specified in Table 1 of ASTM E 1112 - 86 (Reapproved 1991). Clinical Study: Mean difference of 0.13ºF with an S.D. of 0.31, which is well within acceptance criteria of 2.0ºF (even though the internal definition was < 1.0ºF).

2. Sample Size and Data Provenance

NIBP:
- Clinical Study for Accuracy (predicate device): The text states accuracy was established in "adult, pediatric, and neonatal populations." It references the DINAMAP MPS Select NIBP Module, but does not provide specific sample sizes for these populations in the current document.
- Data Provenance: Not explicitly stated, but the studies were for a U.S. market device, so likely at U.S. clinical sites. The studies for the predicate device would have been prospective clinical trials.
SpO2:
- Co-Oximeter Correlation Study: 3 healthy subjects.
- Non-Invasive Controlled Hypoxia Study: 35 subjects.
- Data Provenance: Not explicitly stated, but conducted by Nellcor Puritan Bennett, Inc. (NPB), a U.S. company. Likely prospective studies.
Temperature:
- Clinical Study: 78 subjects (adult and pediatric).
- Data Provenance: In-house study conducted by Critikon. Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

The document primarily references standards (ANSI/AAMI, ASTM) and reference devices (co-oximeter, mercury-in-glass thermometer, IVAC 2080 Measurement System) for establishing ground truth, rather than human experts making subjective assessments for the purpose of algorithm validation directly.
For NIBP, the ground truth would have been established by invasive arterial blood pressure measurements (gold standard for NIBP validation) during the predicate device trials. The document doesn't specify the number or qualifications of clinicians involved in those ground truth measurements, but it would have been standard clinical practice.
For SpO2, arterial blood oxygen saturation co-oximeter measurements serve as the ground truth. These are objective measurements; no human experts are mentioned for establishing this ground truth.
For Temperature, mercury-in-glass thermometers and the Alaris Medical Systems IVAC® 2080 Measurement System served as the reference standards for ground truth. Again, these are objective measurement devices, not subjective assessments by human experts.

4. Adjudication Method

NIBP, SpO2, Temperature: The validation relies on comparisons against established objective reference standards and devices (e.g., co-oximeters, mercury thermometers, invasive BP for NIBP in predicate). Therefore, there is no mention of an adjudication method involving multiple human experts for subjective assessment as would be common in image interpretation studies. The "adjudication" is inherent in the comparison of the device reading to the objective reference standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not explicitly mentioned or performed for this device. The studies described are focused on standalone device accuracy against objective standards, not on how human readers interact with or improve using AI assistance, as this is a vital signs monitor, not an AI-driven interpretive system.

6. Standalone Performance Study

Yes, standalone performance studies were done for all parameters.
- NIBP: Accuracy was established for the NIBP algorithm itself, which is incorporated into the device. The clinical study for accuracy, although done on a predicate, validates the algorithm in a standalone manner.
- SpO2: Clinical and bench tests directly evaluated the accuracy of the oxygen saturation parameter of the new device against reference standards.
- Temperature: Both monitor and predictive modes were tested for accuracy against reference standards in liquid baths and clinically against a mercury-in-glass thermometer.

7. Type of Ground Truth Used

NIBP: For the predicate device studies, the ground truth for NIBP accuracy would have been invasive arterial blood pressure measurements.
SpO2: Arterial blood oxygen saturation co-oximeter measurements (objective laboratory measurements).
Temperature: Mercury-in-glass thermometer and the Alaris Medical Systems IVAC® 2080 Measurement System (objective reference devices/standards).

8. Sample Size for the Training Set

This device is a traditional physiological monitor, not an AI/machine learning device in the modern sense that typically relies on "training sets." The NIBP algorithm is based on established oscillometric principles. Therefore, there is no specific "training set" sample size mentioned or applicable in the context of an AI/ML model for this type of device. The algorithm and device were likely developed and refined using R&D data, but not in the format of a distinct "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit "training set" in the AI/ML sense, this question is not directly applicable. The underlying principles and algorithms for NIBP, SpO2, and temperature are based on well-understood physiological measurements and engineering principles, validated against established medical standards and reference measurements. Development of these algorithms would involve extensive testing and refinement against known accurate measurements, but not in a "ground truth for training set" paradigm.

Summary

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FEB 2 4 2000

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K992638

510(k) Summary

August 3, 1999

Device Identification

Dinamap® Pro Monitor, Series 100, 200, 300, 400

Submitted by

Critikon Company, L.L.C., 4110 George Road, Tampa, Florida 33634

Contact Person

Tom English, Director, Regulatory Affairs and Clinical Services, Critikon Company LLC, Tampa, FL

Common Name

Physiological or Vital Signs Monitor, Patient Monitor includes:

Non-Invasive Blood Pressure and Pulse Rate .
Pulse Oximetry and Pulse Rate .
Temperature, Predictive and Monitor Mode .

Classification Name	Product Code	21 CFR
System, Measurement, Blood Pressure, Noninvasive	DXN	870.1130
Computer, Blood Pressure	DSK	870.1110
Alarm, Blood Pressure	DSJ	870.1100
Oximeter	DQA	870.2700
Oximeter, Ear	DPZ	870.2710
Thermometer, Clinical Electronic	FLL	880.2910
Recorder, Paper Chart	DSF	870.2810

Indications for use

Device Description

. DINAMAP Pro Series 100: Non-Invasive Blood Pressure and Pulse Rate
DINAMAP Pro Series 200: Non-Invasive Blood Pressure and Monitor/Predictive Oral/Rectal . Temperature
. DINAMAP Pro Series 300: Non-Invasive Blood Pressure and Nellcor® Pulse Oximetry and Pulse Rate
. DINAMAP Pro Series 400: Non-Invasive Blood Pressure and Pulse Rate; Monitor/Predictive Oral/Rectal Temperature; and Nellcor® Oxygen Saturation and Pulse Rate (Pulse Oximetry)

This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. The device uses the same technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97).

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Clinical and Bench Testing

Non-Invasive Blood Pressure (NIBP)

For NIBP performance, Critikon used ANSI/AAMI SP10-1992: "Electronic or automated sphygmomanometers" and ANSI/AAMI SP10A-1996: Amendment to ANSI/AAMI SP10-1992: American National Standard for Electronic or Automated Sphygmomanometers.

The following requirements of ANSI/AAMI SP10 and SP10A were met:

. Labeling (4.1)
Stability (4.2.4, environmental requirements, 4.2.1, 4.2.2, and 4.2.3 were not included) .
. Safety (4.3)
. Performance (4.4)

To evaluate environmental performance, Critikon met the requirements contained in the November 1993 Draft Reviewer Guidance for Premarket Notification Submissions of the Anesthesiology and Respiratory Devices Branch of the Division of Cardiovascular, Respiratory, and Neurological Devices.

Clinical Study for Accuracy - Overall System Efficacy:

Accuracy of the NIBP algorithm was established in the adult, pediatric, and neonatal populations with the ANSI/AAMI SP10 clinical study for the DINAMAP MPS Select NIBP Module used in the DINAMAP MPS Select Multiparameter System and the DINAMAP MPS Select Portable Monitor (K955113 cleared 8/15/96).

The NIBP parameter of the new monitor has the same NIBP algorithm that calculates blood pressure from measured oscillations as the DINAMAP MPS™ Select™ Multiparameter System (K955) 13 cleared 815/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97),

Moreover, the NIBP parameter of the new monitor has the same intended use and labeling claims as the DINAMAP MPS Select NIBP Module; the same software runs in the same processor family under the same operating system as the predicate device; and the same accessories - air hoses and blood pressure cuffs.

Bench Testing, ANSI/AAMI SP10

With the exception of the environmental performance, the new device was subjected to the remainder of ANSI/AAMI SP 10 bench testing requirements, including:

. Stability: 4.2.4.1 Voltage Range; and 4.2.4.2 Life
. Safety Requirements: 4.3.1.1 Maximum Cuff Pressure; 4.3.1.2. Cuff Deflation; 4.3.2 Electrical Safety; and 4.3.3 Conductive Components
. Performance Requirements: 4.4.1 Pressure Indicator Accuracy; and 4.4.3 Battery-Powered Devices.

The new device passed all tests.

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Oxygen Saturation (SpO2)

Nellcor Puritan Bennett, Inc. (NPB) conducted studies (two clinical and three bench) to demonstrate the accuracy of the pulse oximetry parameter to the new device with Nellcor FE101 hardware, BE3050 software and the Nellcor sensor line.

Clinical Studies

Two clinical studies were performed to evaluate the accuracy of the new device's derived oxygen.

Co-Oximeter Correlation Study -- compared oxygen saturation measurements obtained with three new devices with . arterial blood oxygen saturation co-oximeter measurements obtained from three healthy subjects. Breathedown progressed in five plateaus from 100% to 70% in increments of approximately 5%. After data collection at the lowest plateau was complete, the subjects were rapidly re-saturated to 100%. Pooled results for all three subjects indicated that the three new devices met sensor specifications.
. Non-Invasive Controlled Hypoxia Study - compared oxygen saturation measurements obtained with three new devices with arterial blood oxygen saturation pulse oximeter measurements obtained from 35 subjects across the full Nellcor sensor line.

The oxygen saturation parameter of the new devices met oxygen saturation with all Nellor sensors.

Bench Testing

The following three bench tests were performed:

. Saturation Comparison Verification Study
Low Perfusion/Low Signal Saturation Study .
. Pulse Rate Comparison Study

In all cases the new devices met the acceptance criteria

Temperature

Temperature tests performed were:

To establish monitor mode or probe accuracy, liquid-bath testing according to ASTM E 1112 86 (Reapproved 1991); . Standard Specification for Electronic Thermittent Determination of Patient Temperature was followed.
. To establish predictive mode accuracy; liquid-bath testing was conducted to establish equivalence between the new device and the Alaris Medical Systems IVAC® 2080 Measurement according to a Critikon-developed procedure.

Bench Testing

To determine clinical accuracy, Critikon conducted an in-house study comparing temperatures obtained from 78 subjects using the new device and a mercury-in-glass thermometer. The ability of two new devices to accurately read resistance was confirmed before and after liquid-bath testing. Four probes were then tested with the two new devices over the operational temperature range - both in monitor and predictive modes. Test results demonstrated the ability of the new device to determine monitor mode temperatures relative to a mercury-in-glass thermometer and predictive mode temperatures relative to an IVAC 2080 Measurement System within the maximum error ranges specified in Table 1 of ASTM E 1112 - 86 (Reapproved 1991).

Clinical Studies

Temperature data was collected orally from 78 adult and pediative temperature was obtained from the test device and compared to a reference mercury-in-glass thermometer temperature reading collected over a three-minute period. A clinically significant difference was defined as a mean difference > 1.0 F. Data analysis showed a mean difference of 0.13ºF, with a S.D. of 0.31 - well within acceptance criteria of 2.0ºF.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2000

Mr. Thomas English Critikon Company, L.L.C. 4502 Woodland Corporate Boulevard 33614 Tampa, FL

Re: K992638 Dinamap® Pro Series Monitor, Models 100, 200, 300, 400 Monitor Regulatory Class: II (two) Product Code: MW I Dated: November 23, 1999 November 26, 1999 Received:

Dear Mr. English:

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 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 requlation may result in 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. Thomas English

This letter will allow you to beqin 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,

Material test results

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: DINAMAP® Pro Series 100, 200, 300, 400 Monitor

Indications for Use:

The DINAMAP® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs parameters include noninvasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Rita B. Campbell

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

510(k) Number K992636

Prescription Use (per 21 CFR 801.109

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

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).