REPROCESSED PULSE OXIMETER SENSORS

K102560 · Sterilmed, Inc. · NLF · Feb 18, 2011 · Cardiovascular

Device Facts

• Record ID: K102560
• Device Name: REPROCESSED PULSE OXIMETER SENSORS
• Applicant: Sterilmed, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 consist of sensor, integrated cable, and plug; connects to external pulse oximeter. Device uses optical method to measure light absorption of functional arterial hemoglobin; two LEDs act as light sources and one photodiode acts as receiver. Sensor positioned with LEDs and photodiode opposing across tissue. Device provides continuous, noninvasive, self-calibrated measurements of SpO2 and pulse rate. Used in clinical settings; operated by healthcare professionals. Output displayed on external pulse oximeter to assist clinicians in patient monitoring and decision-making regarding oxygenation status.

Clinical Evidence

In vivo clinical studies conducted on adult volunteers and neonatal subjects to demonstrate SpO2 accuracy of reprocessed sensors. Bench testing included SpO2 and pulse rate accuracy (normal and low perfusion) using simulated testers, accuracy under varying environmental conditions, and structural integrity testing.

Technological Characteristics

Optical sensor with two LEDs and one photodiode. Sterilization via ethylene oxide (ISO 11135, USP <71>). Packaging validated per ASTM D4169 and ASTM F88. Shelf life validated per ASTM 1980-99. Biocompatibility testing per ISO 10993-7.

Indications for Use

Indicated for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring in adult and neonatal patient populations.

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)

Submission Summary (Full Text)

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

FEB 1 8 2011

## II. SUMMARY AND CERTIFICATION

## 510(k) Summary A.

| Submitter: | SterilMed, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Garrett Ahlborg<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 763-488-3483<br>Fax: [phone] |
| Date Prepared: | September 3, 2010 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Name: | Oximeter, Reprocessed<br>Classification Number: Class II, 21 CFR 870.2700 |
| Product Code: | NLE |

| Predicate Devices: | The SterilMed reprocessed pulse oximeter sensors are substantially equivalent to the Masimo LNCS® pulse oximeter sensors (K041815, K051212, & K060143). |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | SterilMed's reprocessed pulse oximeter sensors consist of a sensor, integrated sensor cable, and a sensor plug which connects to the Pulse Oximeter. These devices feature a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate.<br><br>Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and any 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 arterial oxygen saturation (SpO2) and pulse rate monitoring. |
| Functional and Safety Testing: | Representative samples of reprocessed pulse oximeter sensors were tested to demonstrate appropriate functional characteristics by utilizing the necessary bench testing and in vivo clinical validations. Process validation testing was performed to validate the sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced. |
| Summary of Non-clinical Tests Conducted: | Specific non-clinical tests included: sterilization validation (ISO 11135, USP <71>), ethylene oxide residual testing (ISO 10993-7), bioburden testing, packaging validation (ASTM D4169, ASTM F88) and shelf life validation (ASTM 1980-99). In addition, validation of functional performance (bench testing) was performed and included the following tests: SpO2 and pulse rate accuracy (normal and low perfusion) using a simulated tester, SpO2 and pulse rate accuracy under varying environmental conditions, and physical tests to verify structural integrity after reprocessing. |
| Summary of Clinical Tests Conducted: | In vivo clinical studies were conducted on both adult volunteers and neonatal subjects to demonstrate SpO2 accuracy of the reprocessed sensors. |
| Conclusion: | The reprocessed pulse oximeter sensors are substantially equivalent to the Masimo pulse oximeter sensors.<br><br>This conclusion is based upon the devices' similarities in functional performance and design (principles of operation), materials, clinical validation results, indications for use and methods of construction. |

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Garrett Ahlborg Regulatory Affairs Manager SterilMed, Incorporated 11400 7310 Avenue North Suite 100 Maple Grove, Minnesota 55369

FEB 18 201

Re: K102560

Trade/Device Name: Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: February 14, 2011 Received: February 15, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Enclosure

Please be advised that FDA is 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony D. Watson

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

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

Image /page/3/Picture/0 description: The image shows the logo for "SterilMed, INC." in a bold, sans-serif font. Below the company name, in a smaller font, are the words "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The text is black and the background is white.

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)

Aum Cottle 2/18/11
(Division Sign-Off)

(Divisi (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Devices

510(k) Number: K112568

Page 1 of 1

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.