AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001

K041156 · Nonin Medical, Inc. · DQA · Jun 9, 2004 · Cardiovascular

Device Facts

• Record ID: K041156
• Device Name: AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checking and / or continuous monitoring.

Device Story

Wireless pulse oximetry system comprising tabletop display unit (Avant 4000) and wrist-worn patient module (Avant 4100); utilizes Bluetooth technology to eliminate cables between module and display. Measures SpO2 and pulse rate noninvasively; displays values via LEDs; includes audible/visual alarms for pulse rate, oxygen saturation, and perfusion. Powered by AC adapter or internal NiMH battery (display) and AA batteries (module). Used in clinical settings for spot-checking or continuous monitoring; provides real-time data output and event markers. Enables patient mobility by removing physical tethering to display unit; assists clinicians in monitoring patient status and making clinical decisions based on oxygenation and pulse rate trends.

Clinical Evidence

Bench and clinical testing performed to demonstrate functional features and substantial equivalence to predicate devices. No specific performance metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Wireless pulse oximetry system; Bluetooth connectivity; LED display; NiMH rechargeable battery (display) and AA battery (module) power sources. Class II device (21 CFR 870.2700).

Indications for Use

Indicated for spot-checking and/or continuous monitoring of functional oxygen saturation (SpO2) and pulse rate in adult, pediatric, and infant patients.

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® Model 2120 Pulse Oximeter (K013319)
• Wireless Medicine LifeSync™ System (K030765)

Submission Summary (Full Text)

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JUN - 9 2004

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# SECTION 2. 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: | April 30, 2004 |
| Trade Name: | Avant® Model 4000 Digital Pulse Oximetry System |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | Nonin's Avant® Model 4000 is substantially equivalent to<br>the Avant® Model 2120 Pulse Oximeter manufactured by<br>Nonin Medical, Inc. that was cleared by the FDA under<br>K013319 on 1/03/02, and the Wireless Medicine<br>LifeSync™ System (K030765). |
| Device Description: | The Avant Model 4000 Digital Pulse Oximetry System is a<br>wireless pulse oximeter that includes a portable, tabletop<br>display unit (Avant 4000) and a wrist-worn patient module<br>Avant (4100). The System is designed for spot-checking<br>and / or continuous noninvasive measuring and displaying<br>of functional oxygen saturation of arterial hemoglobin<br>(SpO2), and pulse rate.<br><br>The Avant 4000 System is intended for use with adult,<br>pediatric, and infant patients.<br><br>The Avant 4000 display uses light-emitting diodes (LED)<br>components to present patient's SpO2 and pulse rate values,<br>as well as alarm limit and volume settings. The Avant 4000<br>can be powered with a 12 VDC AC adapter or with an<br>integral sealed 7.2-volt rechargeable NiMH battery pack.<br>The Avant 4100 patient module is powered with two 1.5<br>volt AA batteries. |
| | The Avant 4000 System includes adjustable audible and<br>visual pulse rate, oxygen saturation, and perfusion alarms.<br>It also includes a variety of advanced features, including<br>low battery alarms, event markers, real-time and print-on-<br>demand data outputs. |
| | Incorporating Bluetooth® Technology in the Avant 4000<br>eliminates the connection from the wrist worn oximeter<br>module to the display unit giving patients increased ability<br>to move freely without being hindered by cables. |
| Intended Use: | The Nonin® Avant® Model 4000 Digital Pulse Oximetry<br>System is indicated for use in measuring and displaying<br>functional oxygen saturation of arterial hemoglobin (SpO2)<br>and pulse rate of adult, pediatric, and infant patients. It is<br>indicated for spot-checking and / or continuous monitoring. |
| Functional and<br>Safety Testing: | Nonin's Avant 4000 Pulse Oximetry System has<br>successfully undergone both bench and clinical testing in<br>order to demonstrate that it has appropriate functional<br>features and is substantially equivalent to the predicate<br>devices. |
| Conclusion: | Nonin's Avant Model 4000 is substantially equivalent to<br>the Avant® Model 2120 Pulse Oximeter manufactured by<br>Nonin Medical, Inc. and cleared by the FDA under<br>K013319 on 1/03/02. |
| | Previously cleared Bluetooth predicate device: Wireless<br>Medicine LifeSync™ System (K030765). |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2004

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

Re: K041156

Trade/Device Name: Avant® Model 4000 Digital Pulse Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 30, 2004 Received: May 3, 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 approvisions 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 (1 wr 1, it is a 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. 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Free of arryly 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 premiance noticate 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), 11 you dontact 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 maj somal 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,

Culs

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: __

KO41156

Device Name:

### Nonin Medical, Inc. Avant® Model 4000

#### Indications for Use:

The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in The Norm - Avail@ Model 1900 Digixianal oxygen saturation of arterial hemoglobin (SpO2) and measuring and ulsplaying funchenal ofty getients. It is indicated for spot-checking and / or continuous monitoring.

Cindyschum

(Division Sign Off) Division of Anesthesiology. General Hospital Infection Control, Dental Device 510(k) Number.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)