AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100

K052669 · Nonin Medical, Inc. · DQA · Dec 23, 2005 · Cardiovascular

Device Facts

• Record ID: K052669
• Device Name: AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 23, 2005
• 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 of patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

Device Story

Wireless pulse oximetry system comprising tabletop display unit (Avant 4000) and wrist-worn patient module (Avant 4100). System measures arterial oxyhemoglobin saturation (SpO2) and pulse rate via red/infrared light absorption through tissue. Bluetooth wireless technology transmits SpO2, pulse rate, and plethysmographic data from wrist module to display unit, replacing point-to-point cabling. Operates within 30-foot radius. Display unit features LED indicators for SpO2, pulse rate, and alarms; powered by AC adapter or internal NiMH battery. Patient module powered by AA batteries. ISP2+ software processes signals to mitigate motion artifact. Used in clinical settings by healthcare providers to monitor patient oxygenation status; provides real-time data and alarms to assist in clinical decision-making and patient management.

Clinical Evidence

Successful bench and clinical testing performed to demonstrate functional features and substantial equivalence to predicate devices.

Technological Characteristics

Wireless pulse oximeter; Bluetooth 1.1 connectivity (Generic Access Profile, Serial Port Profile); ISP2+ signal processing software; LED display; NiMH battery (display) and AA battery (module) power; 30-foot wireless range; 128-bit SAFER+ encryption/authentication.

Indications for Use

Indicated for adult, pediatric, and infant patients for spot-checking or continuous monitoring of SpO2 and pulse rate during motion or no-motion conditions, including patients who are well or poorly perfused.

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 4000 Pulse Oximetry System (K041156)

Submission Summary (Full Text)

{0}------------------------------------------------

K 052669

## DEC 2 3 2005

# SECTION 2. SUMMARY AND CERTIFICATION

#### 510(k) Summary A.

| Submitter: | Nonin Medical, Inc. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lori M. Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Avenue North<br>Plymouth, MN 55441-5443 |
| Date Prepared: | October 17, 2005 |
| 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 4000 Pulse Oximetry System<br>manufactured by Nonin Medical, Inc. that was cleared by<br>the FDA under K041156 on 06/09/04. |
| 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 determines arterial<br>oxyhemoglobin saturation (SpO2) by measuring the<br>absorption of red and infrared light passed through the<br>tissue. Changes in absorption caused by pulsation of blood<br>in the vascular bed are used to determine arterial saturation<br>and pulse rate. Using Bluetooth® wireless technology, the<br>system allows functional oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate, and plethysmographic data<br>to be transmitted from the wrist worn (4100) module to a<br>compatible Bluetooth-enabled device tabletop monitor<br>(4000).<br>Bluetooth wireless technology is used in the Avant, Model<br>4000 Pulse Oximetry System to transmit data from the<br>4100 Patient Module to the 4000 Display Unit. The<br>technology allows replacement of simple point-to-point |

{1}------------------------------------------------

cabling. The low power radio (used in the Avant System) covers 30 feet (spherical radius) with a total bandwidth of 1 Mbps, and a theoretical 720 kbps data payload. The Bluetooth radio is highly immune to noise and simple to implement on silicon and software. In order to achieve robust connections, Bluetooth employs several techniques: very fast frequency hopping, several layers of checks and Cyclical Redundancy Checks (CRCs), packet retransmission, and relatively short data packets. Bluetooth offers the features of robust security and authentication, using the SAFER+ algorithm with 128 bit keys for secure encryption and authentication. The Avant Model 4000 has been tested and verified to meet the specifications of the Bluetooth revision 1.1 and is listed by the Bluetooth SIG (Special Interest Group). It implements the Generic Access Profile (GAP) and Serial Port Profiles and fully implements security and authentication. The Avant Model 4000 System has also been granted Federal Communications Commission (FCC) authorization.

Nonin's system eliminates the connection from the wristworn oximeter module (4100) to the display unit (4000), giving patients increased ability to move freely without being hindered by cables. Nonin's patient module uses a class II Bluetooth radio with a battery life of approximately 120 hours and a range of approximately 30 feet (spherical radius). The display unit has a minimum operating life of 18 hours with a fully charged battery. When the AC adaptor is plugged into the display unit, power is divided between operating the device and charging the battery pack. The display unit can also be used continuously with the AC adaptor.

The Avant 4000 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Avant™ 4000 can be powered with a 12 VDC AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Avant 4100 patient module is powered with two 1.5volt AA batteries.

The Avant 4000 System includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, event markers, and real-time and printon-demand data outputs.

{2}------------------------------------------------

| | The Model 4000 System contains ISP2+ software. The improved signal processing software addresses the complaints about the effects of motion artifact on pulse oximeters by better identifying a valid pulse. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 of patients during both no motion and motion conditions, and for patients who are well or poorly perfused. |
| Functional and<br>Safety Testing: | Nonin's Avant 4000 Pulse Oximetry System has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate devices. |
| Conclusion: | Nonin's Avant Model 4000 is substantially equivalent to the Avant® Model 4000 Pulse Oximetry System manufactured by Nonin Medical, Inc. and cleared by the FDA under K041156 on 06/09/04. |

,

00000

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

DEC 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 15t Avenue North Plymouth, Minnesota 55441-5443

Re: K052669

K032007
Trade/Device Name: Avant® Model 4000 Pulse Oximetry System Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 26, 2005 Received: September 30, 2005

Dear Ms. Roth:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your because 310(x) process.
The referenced above and have determined the device is substantially equivalent (for the referenced above and have determined the to heeficate devices marketed in the election in indications for use stated in the cholosares to regions interstate commerce prior to May 20, 1770, the children in accordance with the provisions of Amendments, of to devices that have been rockessions and require approval of a prematice the spenses the Federal Food, Drug, and Cosment 710 (110) annaket the device, subject to the general approval application (1 Mr.). Tou may) and controls provisions of the Act include controls provisions of the ret. "The gentires, good manufacturing practice, requirements for annual reasons

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see a6070) into exartires. Existing major regulations affecting (PMA), it may be subject to such additional controllar sames given in the Roderal your device can be found in the Code of Peacharing
addition, FDA may publish further announcements concerning your device in the Eederal Register.

{4}------------------------------------------------

Page 2 - Ms. Roth

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA \$ issualice of a substantal. Shownloss with other requirements
mean that FDA has made a determination that your devices Federal egencies mean that FDA nas made a decemination that 70 and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered to posistration of the Act or any rederal statues and registements, including, but not limited to: registration
You must comply with all the Act st requirements, including and manufacturing You must comply with an the Act 3 requirements are 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Fall 807), labeling (21 CFR Party of 2017) - 11:47
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, and if requirements as set forth in the quality systems (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)
10 a This letter will anow you to begin matically your artial equivalence of your device to a premarket notification. The PDA miding of substants on 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 Patt 801), If you desire specific atvice for your device at [phone]. Also, please note the regulation please contact the Office of Comphanes as (210) - 10 - 10 Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 Creen the entitled, "Misoranding by renemes to premation on your responsibilities under the tall for may obtain other general miormation on Jour Popper Assistance at its toll-free Division of Binan 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snotte Y. Michael Evans.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use Statement

510(K) Number: (If known)

Device Name:

Avant® Model 4000 Pulse Oximetry System

### Indications for Use:

The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in
t (SpO) and The Nonin® Avant® Model 4000 Digital I use Oxinola J-25ecial Memoglobin (SpC)) and measuring and displaying functional oxygen statution of cated for spot-checking and / or
pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checki pulse rate of adult, pediatic, and infallt pations. "It is marcares and no motion conditions, and for continuous a no are well or poorly perfused.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aue Safion

K052669