MODIFICATION TO AVANT 9600 PULSE OXIMETER

K040589 · Nonin Medical, Inc. · DQA · Jun 3, 2004 · Cardiovascular

Device Facts

• Record ID: K040589
• Device Name: MODIFICATION TO AVANT 9600 PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 may also be used in patient transport, sleep laboratories, and EMS environments. The Avant™ 9600 is intended for continuous monitoring and / or spot-checking of patients during both no motion and motion conditions, for patients who are well or poorly perfused.

Device Story

Portable tabletop pulse oximeter; measures SpO2 and pulse rate via compatible oxygen sensors. Device processes sensor signals to calculate functional oxygen saturation and pulse rate; displays values on LED screen. Includes adjustable audible/visual alarms for pulse rate, SpO2, and perfusion; features low battery alarms, real-time/print-on-demand data outputs, patient security mode, and nurse call options. Used by clinicians in hospitals, home care, subacute settings, transport, sleep labs, and EMS. Powered by AC adapter or internal rechargeable NiMH battery. Output allows clinicians to monitor patient status continuously or via spot-checks, facilitating clinical decision-making regarding oxygenation and hemodynamic stability.

Clinical Evidence

The device underwent both bench and clinical testing to demonstrate functional characteristics and substantial equivalence to the predicate device.

Technological Characteristics

Portable tabletop pulse oximeter; LED display; powered by 12 VDC AC adapter or internal 7.2-volt rechargeable NiMH battery. Features include audible/visual alarms, data output ports, and nurse call functionality. Noninvasive sensing principle.

Indications for Use

Indicated for adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, subacute environments, patient transport, sleep labs, and EMS. Used for continuous monitoring or spot-checking SpO2 and pulse rate in motion/no-motion conditions and varying perfusion states.

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

• Avant 2120 (K031487)

Submission Summary (Full Text)

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# JUN - 9 2004

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# SUMMARY AND CERTIFICATION

#### 510(k) Summary A.

| Submitter: | Nonin Medical, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John R. Dalpee<br>Director of Regulatory Affairs<br>Nonin Medical, Inc.<br>2605 Fernbrook Lane N.<br>Plymouth, MN 55447-4755 |
| Date Prepared: | May 24, 2004 |
| Trade Name: | Avant™ 9600 Pulse Oximeter |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | The Avant™ 9600 is substantially equivalent to the Avant<br>2120 (K031487), which is also manufactured by Nonin<br>Medical. |
| Device Description: | The Avant™ 9600 Digital Pulse Oximeter is a portable<br>tabletop device designed for continuous noninvasive<br>measurement, display, and recording of functional oxygen<br>saturation of arterial hemoglobin (SpO2) and pulse rate<br>using one of a range of compatible oxygen sensors. The<br>Avant™ 9600 is intended for prescription use with adult,<br>pediatric, infant, and neonatal patients in hospitals, medical<br>facilities, home care, and subacute environments. It may<br>also be used in patient transport, sleep laboratories, and<br>EMS environments.<br><br>The Avant™ 9600's display uses light-emitting diodes<br>(LED) components to present patient's SpO2 and pulse rate<br>values, as well as alarm limit and volume settings. The<br>Avant™ 9600 can be powered internally with a 12 VDC<br>1.5A AC adapter or with an integral sealed 7.2-volt<br>rechargeable NiMH battery pack.<br><br>The Avant™ 9600 includes adjustable audible and visual<br>pulse rate, oxygen saturation, and perfusion alarms. It also<br>includes a variety of advanced features, including low |

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| | battery alarms, real-time and print-on-demand data outputs,<br>a patient security mode, and nurse call options. |
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| Intended Use: | The Nonin® Avant™ 9600 Digital Pulse Oximeter is a<br>portable, tabletop device indicated for use in<br>simultaneously measuring, displaying, and recording<br>functional oxygen saturation of arterial hemoglobin (SpO2)<br>and pulse rate of adult, pediatric, infant, and neonatal<br>patients in hospitals, medical facilities, home care, and<br>subacute environments. It may also be used in patient<br>transport, sleep laboratories, and EMS environments. The<br>Avant™ 9600 is intended for continuous monitoring and /<br>or spot-checking of patients during both no motion and<br>motion conditions, for patients who are well or poorly<br>perfused. |
| Functional and<br>Safety Testing: | Nonin's Avant™ 9600 Pulse Oximeter has successfully<br>undergone both bench and clinical testing in order to<br>demonstrate that it has appropriate functional<br>characteristics and is substantially equivalent to the<br>predicate device. |
| Conclusion: | The Avant™ 9600 Pulse Oximeter is substantially<br>equivalent to the predicate device in terms of functional<br>design and principles of operation. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2004

Mr. John R. Dalpee Director Regulatory Affairs Nonin Medical, Incorporated 2605 Fernbrook Lane, North Plymouth, Minnesota 55447-4755

Re: K040589

R040389
Trade/Device Name: Modification for the Avant™ Model 9600 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 11, 2004 Received: May 12, 2004

Dear Mr. Dalpee:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasin be (27) be device is substantially equivalent (for the referenced above and have decemined are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conninetee proct to that have been reclassified in accordance with the provisions of Amendinents, or to devices that have oact (Act) that do not require approval of a premarket the Federal Pool, Drug, and Connelly , therefore, market the device, subject to the general approval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the Fiel. "The girling 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 If your device is classified (500 above) was a controls. Existing major regulations affecting (PMA), it may of subjoct to sach adam feederal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nonements concerning your device in the Federal Register.

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Page 2 -Mr. 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 complies with other requirements mean that 177A has made a deceminations administered by other Federal agencies. of the Act of ally I ecclai statutes and regar-seens, including, but not limited to: registration You must comply with an the Hotel Ing (21 CFR Part 801); good manufacturing practice and listing (21 CFR I at 807), laoomig (21 CFR (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Partitle A requirents as set form in the quality of 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) This icter will anow you to organ made of substantial equivalence of your device to a premits in the results in the Print mainly of 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), If you desire specific at the for for your 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 may outain 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,

Chiu, I-Ling, Ph.D.

Chiu Lin, Ph.D. 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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## Indications for use Statement

510(K) Number: 040589

Device Name:

## Nonin Medical, Inc. Avant™ 9600

## Indications for Use:

The Nonin® Avant™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated The Nomin - Availt - - 900 Digitary, displaying, and recording functional oxygen 101 ase in sifilultaneously measuring and pulse rate of adult, pediatric, infant, and saturation of arterial nemogloom (Bp of) allis post It may also be used in patient transport, sleep laboratories, and EMS environments. The n thay arso be used in patient aransports, and / or spot-checking of patients A valle - 7000 is intended for some conditions, for patients who are well of poorly perfused. હ

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auu Sulom

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:***_***

Prescription use AND/OR Over-The-Counter
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)