MODEL 9600, AVANT PULSE OXIMETER

K023044 · Nonin Medical, Inc. · DQA · Jul 23, 2003 · Cardiovascular

Device Facts

• Record ID: K023044
• Device Name: MODEL 9600, AVANT PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients for Oxygen saturation SpO2 and pulse rate.

Device Story

Portable, tabletop pulse oximeter; measures arterial hemoglobin saturation (%SpO2) and pulse rate via red and infrared light absorption through tissue. Device provides continuous monitoring or spot-checking of patients. Used by clinicians in hospitals, medical facilities, home care, subacute settings, transport, sleep labs, and EMS. Output displayed on device screen; assists healthcare providers in assessing patient oxygenation status and heart rate; facilitates clinical decision-making regarding patient respiratory and cardiovascular health.

Clinical Evidence

Bench testing and safety testing performed to verify performance against design requirements. Hazard analysis and risk assessment conducted. No clinical trial data provided.

Technological Characteristics

Tabletop pulse oximeter; optical sensing principle using red and infrared light absorption. Portable form factor. Software-controlled operation. Complies with 1993 FDA Reviewer Guidance for Premarket Notification Submission for pulse oximeters.

Indications for Use

Indicated for measuring, displaying, and recording functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients. Used in hospitals, medical facilities, home care, subacute environments, patient transport, sleep laboratories, and EMS environments.

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

• Nonin, Model Avant 2120 Pulse Oximeter/Non Invasive Blood Pressure (NIBP) Monitor

Submission Summary (Full Text)

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Ko23044

| SUBMITTER: | Nonin Medical, Inc. |
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| Address: | Nonin Medical, Inc.<br>2605 Fernbrook Lane North<br>Plymouth, MN 55447-4755 |
| Telephone: | 763-553-9968 |
| CONTACT PERSON: | Richard P. Bennett, Director of Regulatory Affairs |
| DATE PREPARED: | August 26, 2002 |
| TRADE NAME: | Nonin® Avant™, Model 9600, Pulse Oximeter |
| COMMON NAME: | Pulse Oximeter |

#### SUBSTANTIALLY EQUIVALENT TO:

The Nonin, Model Avant 2120 Pulse Oximeter/Non Invasive Blood Pressure (NIBP) Monitor

#### DESCRIPTION OF THE DEVICE:

The Model 9600 Pulse Oximeter determines arterial hemoglobin saturation (%SpO2) by measuring absorption of red and infrared (IR) light passed through the tissue. The Model 9600 also measures pulse rate and displays the rate in beats per minute.

#### INDICATIONS FOR USE:

The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals. medical facilities. home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients.

#### INTENDED USE:

The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients for Oxygen saturation SpO2 and pulse rate.

#### SUMMARY OF TESTING:

The Model Avant 9600 Digital Pulse Oximeter has followed (where applicable) the Reviewer Guidance for Premarket Notification Submission of November of 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and Neurological Devices. In addition, Nonin has conducted a Hazard Analysis and Risk Assessment, and developed extensive software/hardware procedures to confirm the performance of the design requirements. Bench and safety testing have been done to verify the performance of the device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or flowing lines.

Public Health Service

JUL 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023044

Trade/Device Name: Model 9600 Avant Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 1, 2003 Received: May 2, 2003

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 vour 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), 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 vours.

Patricia Cucerite/for

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2

# Indications for Use Statement

510(k) Number:

KO236.44

Device Name:

Nonin Medical Inc AVANT™, Model 9600

## Indications for Use:

The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording function of arterial hemoglobin (SpO-3) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 is intended for continuous monitoring and/or spot-checking of patients.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|---------------------|
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Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | R023044 |
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________