REPROCESSED PULSE OXIMETER SENSORS

K092368 · Sterilmed, Inc. · NLF · Nov 3, 2009 · Cardiovascular

Device Facts

• Record ID: K092368
• Device Name: REPROCESSED PULSE OXIMETER SENSORS
• Applicant: Sterilmed, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Nov 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.

Device Story

Reprocessed pulse oximeter sensors; intended for continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate. Device consists of sensor, integrated cable, and plug (LNCS configuration) or sensor, connector extension, and connector (LNOP configuration). Principle of operation: optical measurement of light absorption of functional arterial hemoglobin via two LEDs and one photodiode positioned across tissue. Sensor connects to external pulse oximeter (not included) which performs signal processing and display. Used in clinical settings; operated by healthcare professionals. Reprocessing restores used sensors to original functional specifications; includes visual and functional testing of all units.

Clinical Evidence

Bench testing and in vivo clinical validation performed. Process validation conducted for sterilization and packaging. Manufacturing includes 100% visual and functional testing.

Technological Characteristics

Optical sensor using two LEDs and one photodiode. Configurations: LNCS (integrated cable) and LNOP (connector extension). Connectivity: wired connection to external pulse oximeter. Sterilization: validated reprocessing procedures.

Indications for Use

Indicated for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring in patients requiring such monitoring.

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

• Masimo LNCS pulse oximeter sensors (K041815, K051212, & K060143)
• Masimo LNOP pulse oximeter sensors (K031330)

Submission Summary (Full Text)

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

K092368

**STERILMED, INC.**
Medical Device Reprocessing
Small Equipment & Instrument Repair

510(K) PREMARKET NOTIFICATION SUBMISSION AUGUST 3, 2009 FOR REPROCESSED PULSE OXIMETER SENSORS

## SUMMARY AND CERTIFICATION II.

- 510(k) Summary A.

| Submitter: | SterilMed, Inc. NOV - 3 2009 |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Garrett Ahlborg<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 763-488-3483<br>Fax: [phone] |
| Date Prepared: | August 3, 2009 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Name: | Oximeter, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.2700 |
| Product Code: | NLF |

| Predicate<br>Devices: | The SterilMed reprocessed pulse oximeter sensors are substantially equivalent to the Masimo<br>LNCS® pulse oximeter sensors (K041815, K051212, & K060143) and the Masimo LNOP®<br>pulse oximeter sensors (K031330). |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed's reprocessed Masimo LNCS® Pulse Oximeter Sensors consist of a sensor,<br>integrated sensor cable, and the sensor plug which connects to the Pulse Oximeter. The<br>reprocessed Masimo LNOP® Pulse Oximeter Sensors consist of a sensor (two LED's and a<br>photodiode), connector extension and connector, but do not feature an integrated cable. Both<br>configurations have a sensor that uses an optical means to determine the light absorption of<br>functional arterial hemoglobin. The sensor contains three optical components: two light<br>emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light<br>receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one<br>another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides<br>continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional<br>hemoglobin and pulse rate.<br><br>Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and any<br>other related equipment are not included in the scope of this submission. |
| Intended Use: | The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive<br>arterial oxygen saturation (SpO2) and pulse rate monitoring. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed pulse oximeter sensors were tested to demonstrate<br>appropriate functional characteristics by utilizing the necessary bench testing and an <i>in vivo</i><br>clinical validation. Process validation testing was performed to validate the sterilization<br>procedures as well as device packaging. In addition, the manufacturing process includes visual<br>and validated functional testing of all products produced. |
| Conclusion: | The reprocessed pulse oximeter sensors are substantially equivalent to the Masimo pulse<br>oximeter sensors.<br><br>This conclusion is based upon the devices' similarities in functional design (principles of<br>operation), materials, indications for use and methods of construction. |

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half. Inside the circle is a stylized depiction of an eagle, which is a common symbol of the United States. The eagle is shown in profile, with its wings spread and its head turned to the left.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Garrett Ahlborg Regulaotry Affairs Specialist SterilMed, Incorporated 11400 73rd Avenue North, Suite 100 Minneapolis, Minnesota 55369

NOV - 3 2009

Re: K092368

Trade/Device Name: Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: August 3, 2009 Received: August 5, 2009

Dear Mr. Ahlborg:

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.

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

## Page 2 - Mr. Ahlborg

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Nh fac

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

## Enclosure

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

Indications for Use

510(k) Number (if known):

Device Name: Reprocessed Pulse Oximeter Sensors

Indications for Use:

The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k-092368

Page 1 of 1

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.