MODEL AVANT 2120 PULSE OXIMETER AND NIBP

K031487 · Nonin Medical, Inc. · DXN · Mar 22, 2004 · Cardiovascular

Device Facts

• Record ID: K031487
• Device Name: MODEL AVANT 2120 PULSE OXIMETER AND NIBP
• Applicant: Nonin Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Model Avant™ 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 during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.

Device Story

Portable monitor combining pulse oximetry and NIBP; used in hospitals, medical facilities, and subacute environments. Pulse oximetry: passes red/infrared light through tissue; detects fluctuating signals from arterial pulses; measures ratio of absorbed light to determine functional oxygen saturation. NIBP: uses oscillometric step-deflate technique; internal pump inflates cuff; two valves control deflation; microprocessor analyzes cuff pressure changes during deflation to determine blood pressure. Device supports spot-checking and continuous monitoring; functions used separately or simultaneously. Memory playback feature allows data transfer to computer via acquisition software for analysis. Healthcare providers use displayed values for clinical assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Portable monitor; oscillometric NIBP measurement; pulse oximetry via red/infrared light absorption. Microprocessor-controlled signal analysis. Connectivity via data acquisition software for computer transfer. Powered by internal pump and valves for NIBP. No specific material standards or software architecture details provided.

Indications for Use

Indicated for adult and pediatric patients (arm circumference 18-42 cm) in hospitals, medical facilities, and subacute environments for monitoring SpO2, pulse rate, and blood pressure. Pulse oximetry also indicated for infants and neonates. Not indicated for NIBP use in neonates.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Model Avant™ 2120 Pulse Oximeter and NIBP (K013319)
• Model N-395 Pulse Oximeter (K993637)
• Masimo SET® Radical Pulse Oximeter (K013792)

Submission Summary (Full Text)

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# Special 510(k): Device Modification

MAR 2 2 2004

# Attachment 4

# 510(k) Summary

Nonin Medical, Inc.

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

# 510(k) Summary

9 May 2003

#### (1) Submitter information

| Name: | Nonin Medical, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | 2605 Fernbrook Lane North<br>Plymouth, MN 55447-4755 |
| Telephone: | 763-553-9968 |
| Registration Number: | 2183646 |
| Contact person: | Richard P. Bennett (Official Correspondent) |
| | Nonin Medical, Inc.<br>2605 Fernbrook Lane North<br>Plymouth, MN 55447-4755<br>Tel: [phone]<br>Fax: [phone] |
| Date prepared: | 9 May 2003 |

## (2) Name of Device

| Device Trade Name: | NONIN® Model Avant™ 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

Model Avant™ 2120 Pulse Oximeter and NIBP, K013319, clearance date January 3, 2002, by Nonin Medical, Inc.

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# Special 510(k): Device Modification

Model N-395 Pulse Oximeter with Extension of Motion Performance Claims to cover three additional oximetry sensors, K993637, clearance date November 24, 1999 made by Nellcor Puritan Bennett.

Masimo SET® Radical Pulse Oximeter, K013792, clearance date December 11, 2001, made by Masimo Corporation.

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

### (4) Description

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

#### Pulse Oximetry

The NONIN® Model Avant™ 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 mcasuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.

#### Blood Pressure Measurement

The NONIN® Model Avant™ 2120 NIBP uses an oscillometric stcp 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 Avant™ 2120 has the ability to make blood pressure measurcments 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 Avant™ 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 pulse oximeter is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.

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# Special 510(k): Device Modification

### Pulse Oximeter Intended Use:

The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pcdiatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused.

#### 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.

#### (6) Conclusion

The NONIN® Model Avant™ 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2004

Nonin Medical, Inc. c/o Mr. John R. Dalpee Director of Regulatory Affairs 2605 Fernbrook Lane North Plymouth, MN 55447-4755

Re: K031487

> Trade Name: Model 2120 Avant™ Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: February 16, 2004 Received: February 19, 2004

Dear Mr. Dalpee:

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. John R. Dalpee

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Donna R. LaClair

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

Enclosure

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K03i487/S2

# Indications for Use

510(K) Number: K031487

Device Name: Model 2120 Avant™ Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor

## Indications for Use:

The Nonin® Model Avant™ 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 during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.

Prescription Use
(Per 21 CFR 801.109)

✓

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Duna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 31487