NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR

K013319 · Nonin Medical, Inc. · DQA · Jan 3, 2002 · Cardiovascular

Device Facts

• Record ID: K013319
• Device Name: NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 spot-checking and / or continuous monitoring of patients. Its functions may be used separately or simultaneously. 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. 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 Story

Portable monitor combining pulse oximetry and oscillometric NIBP. Pulse oximetry: red/infrared light transmission through tissue; ratio of absorption determines functional oxygen saturation. NIBP: oscillometric step deflate technique; internal pump inflates cuff; microprocessor analyzes pressure fluctuations during deflation. Used in hospitals/subacute settings by clinicians for spot-checking or continuous monitoring. Data memory playback feature allows transfer to computer for analysis. Provides SpO2, pulse rate, and blood pressure readings to assist clinical decision-making and patient monitoring.

Clinical Evidence

No clinical data generated by the applicant. NIBP module supplier (SunTech Medical Instruments) performed clinical testing per AAMI SP10, comparing system to manual readings; device satisfactorily passed.

Technological Characteristics

Portable monitor; oscillometric NIBP; pulse oximetry via red/infrared light absorption. Standards: AAMI SP10, EN60601-1, EN60601-2-30, IEC 601-1-2, EN1060-1, EN1060-3. Microprocessor-controlled deflation. Memory storage for data transfer.

Indications for Use

Indicated for adult, pediatric, infant, and neonatal patients (SpO2/pulse rate) and adult/pediatric patients (NIBP) in hospitals, medical facilities, and subacute environments. NIBP contraindicated for neonates. Arm circumference 18-42 cm required for NIBP.

Regulatory Classification

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.

Predicate Devices

• MTS Option for the ESCORT® II Monitor (K970763)
• Model 9303 Neonatal / Adult Vital Signs Monitor (K982776)
• OSCAR 2 (K003004)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

1 October 2001 Date prepared:

#### (2) Name of Device

| | Device Trade Name: NONIN® Model 2120 Pulse Oximeter and<br>Noninvasive Blood Pressure (NIBP) Monitor |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common /<br>Classification Name: | Pulse Oximeter with Noninvasive Blood Pressure |
| Device Class: | Class II; 74 DQA, 870.2700; 74 DXN, 870.1130.<br>No performance standards have been established<br>under Section 514 of the Food, Drug and Cosmetic<br>Act 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.

17

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 | <div> <span style="text-decoration: overline;">✓</span> </div> | OR | Over-The-Counter Use | <span style="text-decoration: overline;"></span> |
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|------------------|----------------------------------------------------------------|----|----------------------|--------------------------------------------------|

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K013319 |
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