The NONIN® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients. Its functions may be used separately or simultaneously.

Pulse Oximeter Intended Use:
The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. It may also be used for spot-checking and / or continuous monitoring of patients.

Blood Pressure Monitor Intended Use:
The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking.

The Model 2120 should be used for patients with arm circumferences of 18-42 cm.

Device Description

The Model 2120 combines Pulse Oximetry and NIBP, utilizing the same fundamental scientific technology and intended use as the predicate devices.

Pulse Oximetry:
The NONIN® Model 2120 Finger Pulse Oximeter passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial blood pressure pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin from this color difference by measuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.

Blood Pressure Measurement:
The NONIN® Model 2120 NIBP uses an oscillometric step deflate technique to determine blood pressure. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Model 2120 has the ability to make blood pressure measurements at predetermined intervals or on demand. The Model 2120 has a Memory playback feature, allowing stored data to be transferred to a computer through data acquisition software for analysis.

AI/ML Overview

The Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor combines pulse oximetry and NIBP functionalities.

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance (NIBP)
NIBP Accuracy (compared to manual readings)	AAMI SP10 Section 4.4.2 criteria: The average difference between the device and reference standard should be ±5 mmHg or less, with a standard deviation of 8 mmHg or less. (This implies that 68% of the readings should be within ±8 mmHg, and 95% within ±16 mmHg of the reference standard).	The NIBP module, supplied by SunTech Medical Instruments, satisfactorily passed the clinical testing according to AAMI SP10, which compared the system to manual readings on patients according to section 4.4.2. (Specific numerical performance values for mean difference and standard deviation are not provided in this summary).
Pulse Oximetry Accuracy	(No specific numerical acceptance criteria for SpO2 or pulse rate are provided in this 510(k) summary, beyond the device utilizing "the same fundamental scientific technology and intended use as the predicate devices.")	(No specific numerical performance values for pulse oximetry are provided in this summary).

2. Sample Size and Data Provenance

Test Set (NIBP): Not explicitly stated, but the NIBP module supplier (SunTech Medical Instruments) performed clinical testing according to AAMI SP10 section 4.4.2. AAMI SP10 generally recommends a minimum of 85 subjects for clinical validation.
Data Provenance (NIBP): Not explicitly stated (e.g., country of origin), but it was a clinical test. The summary does not specify if it was retrospective or prospective, but clinical validation studies are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

NIBP: The NIBP clinical testing, performed according to AAMI SP10 section 4.4.2, compared the device to manual readings. This implies that human observers (likely trained medical professionals) established the ground truth through auscultation (listening with a stethoscope) and a sphygmomanometer. The summary does not specify the number of these "experts" or their qualifications (e.g., years of experience), but AAMI SP10 requires a minimum number of trained observers (usually at least two) whose readings are then averaged or compared.

4. Adjudication Method for the Test Set

NIBP: For the NIBP clinical testing against manual readings, AAMI SP10 dictates a specific protocol for how manual readings are taken and compared to the device readings. This usually involves multiple observers, and the reference standard might be the average of their readings or a comparison against a more invasive, simultaneously obtained reference (though manual readings are often considered the reference in oscillometric device validation). The summary does not explicitly detail the adjudication method beyond "compared to manual readings on patients according to section 4.4.2 of AAMI SP10."

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

No, a MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this 510(k) summary. The device in question is a monitoring device, not an AI diagnostic tool that assists human interpretation of images or other complex data.

6. Standalone Performance

Yes, a standalone performance assessment was effectively done for the NIBP component through the clinical testing according to AAMI SP10. This standard assesses the algorithm's performance against a reference standard (manual blood pressure measurements) without human intervention in the interpretation of the device's output.
For the Pulse Oximeter, while no specific clinical study details are provided, the claim of "same fundamental scientific technology and intended use as predicate devices" implies that its standalone performance would be similar to established oximeters.

7. Type of Ground Truth Used

NIBP: The ground truth used was expert consensus/manual readings. Specifically, it was comparison against manual sphygmomanometer readings, which are the established clinical standard for non-invasive blood pressure measurement and the standard required by AAMI SP10.
Pulse Oximetry: Not explicitly stated, but for pulse oximeters, the ground truth is typically assessed against invasive arterial blood gas (ABG) measurements (co-oximetry) under controlled hypoxia studies, or by demonstrating substantial equivalence to devices that have been validated in such a manner. Given the brevity and focus on NIBP, these details for the oximeter are omitted.

8. Sample Size for the Training Set

The 510(k) summary does not mention a separate training set or its sample size. This is typical for medical devices that are based on established physiological principles and signal processing without explicit machine learning or AI models that require distinct training and test sets in the modern sense. While the core algorithms for NIBP (oscillometric processing) and pulse oximetry were developed and refined, the concept of a "training set" as understood in current AI/ML development is not applicable here.

9. How Ground Truth for the Training Set Was Established

As no explicit "training set" is mentioned in the context of this 510(k), there is no information provided on how ground truth for such a set would have been established. The underlying physiological models and signal processing algorithms would have been developed and refined through general engineering principles and possibly internal testing data, but not a formally described "training set" as submitted for an AI/ML device.

Summary

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Nonin Medical, Inc.

Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor

510(k) Summary

3 October 2001

JAN 0 3 2002

(1) Submitter information

Name:

Address:

Nonin Medical, Inc.

2605 Fernbrook Lane North Plymouth, MN 55447-4755

763-553-9968 Telephone:

Registration Number: 2183646

Richard P. Bennett (Official Correspondent) Contact person:

Nonin Medical, Inc. 2605 Fembrook Lane North Plymouth, MN 55447-4755 Tel: 763-577-3166 Fax: 763-553-7807

1 October 2001 Date prepared:

(2) Name of Device

	Device Trade Name: NONIN® Model 2120 Pulse Oximeter andNoninvasive Blood Pressure (NIBP) Monitor
Device Common /Classification Name:	Pulse Oximeter with Noninvasive Blood Pressure
Device Class:	Class II; 74 DQA, 870.2700; 74 DXN, 870.1130.No performance standards have been establishedunder Section 514 of the Food, Drug and CosmeticAct for Pulse Oximeters.

(3) Legally-marketed predicate devices

MTS Option for the ESCORT® II Monitor, K970763, made by Medical Data Electronics, clearance date, July 14, 1997.

Model 9303 Neonatal / Adult Vital Signs Monitor, K982776, made by CAS Medical Systems, Inc., clearance date, November 2, 1998.

OSCAR 2, K003004, made by SunTech Medical Instruments, clearance date, October 25, 2000.

The NONIN® Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor is substantially equivalent to these devices.

K013319 p.1/3

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(4) Description

The Model 2120 combines Pulse Oximetry and NIBP, utilizing the same fundamental scientific technology and intended use as the predicate devices.

Pulse Oximetry

The NONIN® Model 2120 Finger Pulse Oximeter passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial blood pressure pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin from this color difference by measuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.

Blood Pressure Measurement

The NONIN® Model 2120 NIBP uses an oscillometric step deflate technique to determine blood pressure. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Model 2120 has the ability to make blood pressure measurements at predetermined intervals or on demand. The Model 2120 has a Memory playback feature, allowing stored data to be transferred to a computer through data acquisition software for analysis.

(5) Intended Use

Indications for Use:

The NONIN® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients. Its functions may be used separately or simultaneously.

Pulse Oximeter Intended Use:

The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. It may also be used for spot-checking and / or continuous monitoring of patients.

Blood Pressure Monitor Intended Use:

The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking.

The Model 2120 should be used for patients with arm circumferences of 18-42 cm.

KO13319

p213

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(6) Testing and Validations

(a) Non-clinical Tests

The Model 2120 has passed the following tests and validations:

Electronic or Automated sphygmomanometers. AAMI SP10 .
Medical Electrical Equipment General requirements for Safety EN60601-1 ●
Medical Electrical Equipment Specific requirements for Blood EN60601-2-30 .
- Pressure monitors
Electromagnetic Compatibility ● IEC 601-1-2
Non-invasive sphygmomanometers General Requirements . EN1060-1
Non-invasive sphygmomanometers- Supplementary requirements EN1060-3 . for electro-mechanical blood pressure measuring systems

(b) Clinical tests

Since the Model 2120 NIBP uses the same technology as existing devices, clinical tests are not required. However, the supplier of the NIBP module, SunTech Medical Instruments, performed clinical testing according to AAMI SP10, in which the system was compared to manual readings on patients according to section 4.4.2 of AAMI SP10, and it has satisfactorily passed this test.

(7) Conclusion

The NONIN® Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor is equivalent in safety and efficacy to the legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 3 2002

Mr. Richard P. Bennett Director of Regulatory Affairs Nonin Medical, Inc. 2605 Fembrook Lane North Plymouth, MN 55447-4755

Re: K013319

Trade Name: Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure Monitor Regulation Number: 21 CFR 870.2700 and 870.1130 Regulation Name: Oximeter and Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: 74 DQA & 74 DXN Dated: October 3, 2001 Received: October 5, 2001

Dear Mr. Bennett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Richard P. Bennett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Dallas Teller

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO13319

Special 510(k): Device Modification

'JAN 0 3 2002

Indications for Use Form

510(k) Number (if known):

Device Name: NONIN® Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor

Indications for Use:

The NONIN® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for mospitals, necucal facilities, and success monitoring of patients. Its functions may be used separately or simultaneously.

Pulse Oximeter Intended Use:

The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pediatric, infant, and neonatal patients in Saturator and paiso raities, and subacute environments. It may be used for spotchecking and/or continuous monitoring of patients.

Blood Pressure Monitor Intended Use:

Blood I ressure Monitor intended for noninvasively monitoring the blood The otood pressure of adult and pediatric patients in hospitals, facilities, and pressure or acan allo p. The blood pressure monitor is not intended for use with subacult cliviniones. In over and may be used for spot-checking. The neonates. It is intenses seed for patients with arm circumferences of 18-42 cm.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
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(Per 21 CFR 801.109)

Signature
Division of Cardiovascular & Respiratory Devices

510(k) Number	K013319
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Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).