4100 PATIENT OXIMETER MODULE

K043359 · Nonin Medical, Inc. · DQA · Jan 7, 2005 · Cardiovascular

Device Facts

• Record ID: K043359
• Device Name: 4100 PATIENT OXIMETER MODULE
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Nonin® Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device.

Device Story

Wrist-worn pulse oximeter module; measures SpO2, pulse rate, and plethysmographic data. Device utilizes Bluetooth wireless technology to transmit data to compatible external devices. Powered by two AA batteries. Used in clinical or home settings to monitor patient oxygenation status. Healthcare providers or patients view transmitted data on paired Bluetooth-enabled devices to assist in clinical decision-making regarding patient respiratory or cardiovascular status.

Clinical Evidence

The device underwent both bench and clinical testing to demonstrate functional equivalence to the predicate device. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary document.

Technological Characteristics

Wrist-worn pulse oximeter; Class II Bluetooth radio (approx. 30-foot range); powered by two AA batteries (approx. 120-hour continuous use). Measures SpO2, pulse rate, and plethysmographic data via optical sensing.

Indications for Use

Indicated for patients requiring measurement and transmission of functional arterial hemoglobin oxygen saturation (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth-enabled device.

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)

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K043359

JAN - 7 2005

# 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: | December 6, 2004 |
| Trade Name: | Model 4100 Patient Oximeter Module |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | Nonin's Model 4100 Patient Oximeter Module is<br>substantially equivalent to the Avant® Model 4000 Pulse<br>Oximetry System manufactured by Nonin Medical, Inc.<br>that was cleared by the FDA under K041156 on 6/09/04. |
| Device Description: | Nonin's Model 4100 Bluetooth® - enabled wrist-worn<br>Patient Oximeter Module measures and transmits SpO2,<br>pulse rate, and plethysmographic data to a compatible<br>Bluetooth - enabled device. The patient module includes a<br>class II Bluetooth radio with a range of approximately 30<br>feet (spherical range).<br><br>The 4100 Patient Oximeter Module is powered with two<br>AA batteries, which last for approximately 120 hours when<br>used continuously. |
| Intended Use: | The Nonin® Bluetooth® - enabled Model 4100 Patient<br>Oximeter Module is indicated for use in measuring and<br>transmitting functional oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate, and plethysmographic data<br>to a compatible Bluetooth - enabled device. |
| Functional and<br>Safety Testing: | Nonin's Model 4100 Patient Oximeter Module 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>device. |
| Conclusion: | Nonin's Model 4100 Patient Oximeter Module is<br>substantially equivalent to the Avant® Model 4000 Pulse<br>Oximetry System manufactured by Nonin Medical, Inc.<br>and cleared by the FDA under K041156 on 6/09/04. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

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

Re: K043359

Trade/Device Name: Model 4100 Patient Oximeter Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 6, 2004 Received: December 17, 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. 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. 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,

Sutte Michael ms.
Chiu Lin, Ph.D.

for DR. LIN 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

くなってい

510(K) Number:

## K 04335

Device Name:

Nonin Medical, Inc. Model 4100 Patient Oximeter Module

### Indications for Use:

The Nonin Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device.

Sia. G. Semilla
(Division Sign Off)
Division of Anesthesiology, General Hospital
Michael for

hesiology, General Hospital, on Control. Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nonin Medical Inc.

Model 4100 Traditional 510(K): Premarket Notification