REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

K092101 · Nonin Medical, Inc. · DQA · Oct 21, 2009 · Cardiovascular

Device Facts

• Record ID: K092101
• Device Name: REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Nonin's Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Device Story

8000SX is a fingertip transmittance pulse oximetry sensor; utilizes molded silicone boot housing identical optics and cable as predicate Model 8000AA. Available in three sizes (Small, Medium, Large) based on finger height. Device connects to Nonin branded pulse oximeters to acquire photoplethysmographic signals. Used in clinical settings (OR, recovery, critical care, ER, long-term care) and home/mobile environments. Healthcare providers or patients use the sensor to monitor oxygen saturation and pulse rate; output facilitates clinical assessment of patient perfusion and oxygenation status.

Clinical Evidence

Bench and clinical testing performed to demonstrate compliance with ISO 9919:2005 (Accuracy of Operating Data) and IEC 60601-1:1998/ISO 10993-1:2003 (Biocompatibility).

Technological Characteristics

Fingertip transmittance sensor; molded silicone boot construction. Compatible with Nonin pulse oximeters. Three sizes: Small (0.3-0.5 inch finger height), Medium (0.4-0.75 inch), Large (0.5-1.0 inch). Biocompatibility per ISO 10993-1:2003.

Indications for Use

Indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients, including those 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

• Nonin Model 8000AA (K080255, K063752, K040589, K052669, K050056, K002690, K031487)
• Envitec SoftTip Reusable Sensor (K992215)

Submission Summary (Full Text)

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

Kosziciol.

## 510(k) Summary

Submitter:

Contact Person:

Nonin Medical, Inc.

July 9, 2009

74 DQA

Oximeter Sensor

Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Inc. 13700 1st Ave. North Plymouth, MN 55441-5443

OCT 2 1 2009

Date Prepared:

Trade Name:

Product Code:

Classification Name: and Number:

Class II, 21 CFR 870.2700

Predicate Device(s):

Device Description:

Nonin's 8000AA sensor as cleared in the following 510(K) submissions: Model 7500 (K080255 cleared on May 23, 2008), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K040589 cleared on June 3, 2004), Model 4000 (K052669 cleared on December 23, 2005), Model 2500A (K050056 cleared on June 21, 2005), Model 2500 (K002690 cleared on October 11, 2000), Model 2120 (K031487 cleared on March 22, 2004).

Envitec's SoftTip Reusable Sensor (Small, Medium and Large), cleared under K992215, 29 March 2000.

The 8000SX is a fingertip transmittance sensor comprised of a molded silicone boot that contains identical sensor optics and cable as the currently marketed Model 8000AA. The 8000SX sensor comes in three sizes, Model 8000SL (Large) for finger heights between 0.5 inches and 1.0 inch, Model 8000SM (Medium) for finger heights between 0.4 inches and 0.75 inches, and Model 8000SS (Small) for finger heights between 0.3 inches and 0.5 inch The sensors are compatible with all Nonin branded pulse oximeters.

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

Nonin's Model 8000SX Reusable Sensors are indicated for Intended Use: non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. lt is intended for use in environments including operating room, surgical recovery, critical care, emergency room, longterm care, home use and mobile environments Functional and Nonin's Model 8000SX sensor have successfully undergone Safety Testing: both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility. Conclusion: The Model 8000SX sensor is substantially equivalent to Nonin's Model 8000AA and Envitec's SoftTip sensors when

used with Nonin branded Pulse Oximeters monitors.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans. The eagle is a stylized design with three lines representing its wings and a simple outline for its body.

Food and Drig Administration 10903 New Hampshire Avenne Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441

OCT 2 1 2009

Re: K092101

Trade/Device Name: Nonin Medical, Inc. Model 8000SX Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 18, 2009 Received: September 21, 2009

Dear Ms. Roth:

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 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.

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

Page 2 - Ms. Roth

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours

1 for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use Statement

| 510(k) Number (if known) | K092101 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Nonin Medical, Inc. Model 8000SX Sensor Series |
| Indications for Use | Nonin's Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments. |

Prescription Use X (Part 21 CFR 801 Subpart D)

사용 제품 : 10 :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schullte
(Division Sign-Off)

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

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

¯1º(½) Numher: