RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20

K063661 · Renu Medical, Inc. · NLF · May 25, 2007 · Cardiovascular

Device Facts

• Record ID: K063661
• Device Name: RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
• Applicant: Renu Medical, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Both the ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor® II and Reprocessed Nellcor™ 1-20 Oxysensor8 II are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Nellcor™ Oximeter system. The Model D-20 is used for infants from 10 to 50 kg. The Model I-20 is used for infants from 3 to 20 Kg. Both sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.

Device Story

Reprocessed pulse oximetry sensors (D-20 and I-20) function as transducers for Nellcor oximeter systems. Device consists of two LEDs and one photodiode in a laminated envelope with adhesive bandage for patient attachment; cable with multi-pin connector interfaces with oximeter. Device transmits electrical signals to patient and returns modified signals to oximeter for analysis. Used in clinical settings for non-invasive monitoring of SpO2 and pulse rate. Healthcare providers use oximeter display to assess patient oxygenation status and make clinical decisions. Reprocessing restores original device functionality.

Clinical Evidence

Substantial equivalence supported by bench testing, clinical performance data, and non-clinical performance data. Specific metrics not provided in summary.

Technological Characteristics

Transducer containing two LEDs and one photodiode; laminated envelope; adhesive bandage; cable with multi-pin connector. Designed to meet EN 60601-1, EN 60601-1-2, and biocompatibility standards ISO 10993-10/EN 30993-1.

Indications for Use

Indicated for continuous non-invasive arterial oxygen saturation and pulse rate monitoring. D-20: patients 10-50 kg. I-20: patients 3-20 kg.

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

• Nellcor™ D-20 Oxysensor® II (K063661)
• Nellcor™ I-20 Oxysensor® II (K063661)

Submission Summary (Full Text)

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

## Section 13 Premarket Notification

510 (k) Summary

MAY 2 5 2007

Submitters Name and Address: ReNu Medical 9800 Evergreen Way Everett, WA 98024 9820 4 Phone: [phone] Fax: [phone]

FDA Registration Number: 3034520

Contact Person: L. Bruce Pierson Chief Operating Officer

Date Summary Prepared: August 15, 2006

Trade or Proprietary Name(s): ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor" II. ReNu Medical Reprocessed Nellcor 10 I-20 Oxysensor" II

Common Name: Oxisensor

Classification: Oximeter (21 CFR 870.2700)/ NLF

Equivalent Device(s)

The ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor8 II and Nellcor™ I-20 Oxysensor II are substantially equivalent to the Nellcor™ D-20 Oxysensor® II and Nellcor™ I-20 Oxysensor8 II (respectively)

#### Device Description:

The ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor® II and Reprocessed Nellcor™ I-20 Oxysensor II are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.

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

Image /page/1/Picture/0 description: The image shows a handwritten number, "1063661". The numbers are written in a simple, slightly slanted style. The handwriting appears to be clear and legible.

### Intended Use

Both the ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor® II and Reprocessed Nellcor™ 1-20 Oxysensor8 II are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Nellcor™ Oximeter system. The Model D-20 is used for infants from 10 to 50 kg. The Model I-20 is used for infants from 3 to 20 Kg. Both sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.

Technological Characteristics of the ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor II and Reprocessed Nellcor M 1-20 Oxysensor II Compared with the Nellcor M D-20 Oxysensor II and Nellcor M I-20 Oxysensor® II

The predicate devices and the ReNu Medical Reprocessed devices contain identical components (LED, photodiode, laminated envelope, cable, and connector.) The means of patient attachment (adhesive bandage) is identical.

#### Summary of Comparison Tests

Based on an assessment consisting of bench testing, clinical performance data, and non-clinical performance data the ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor II and Reprocessed Nellcor™ I-20 Oxysensor® II function in a manner that is Substantially Equivalent to that of the predicate devices.

#### Safety and Standards

The ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor® II and Reprocessed Nellcor™ 1-20 Oxysensor \$11 are designed to meet the following safety standards.

- EN 60601-1 �
- EN60601-1-2 .
- Biocompatibility ISO10993-10 1995 EN 30993-1

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized representation of three human figures, which are meant to symbolize the department's mission of protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. L Bruce Pierson Chief Operating Officer ReNu Medical, Incorporated 9800 Evergreen Way Everett, Washington 98204

MAY 2 5 2007

Re: K063661

Trade/Device Name: ReNu Reprocessed Nellcor Oxysensor, D-20 and I-20 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: May 22, 2007 Received: May 23, 2007

Dear Mr. Pierson:

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 Eederal Register.

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

#### Page 2 - Mr. Pierson

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/industry/support/index.html.

Sincerely yours.

Soyite y. Michael DMD.

Chiu Lin, Ph.D. 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

510(k) Number (if known): _____________

Device Name: ReNu Reprocessed Nellcor D-20 AND I -20 Oxysensor

Indications for Use:

D-20 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 10 and 50 kg

I-20: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 3 and 20 kg

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Center for Devices and Radiological Health / CDRH

ා වියුග-ටිෆ්) tion of Anesthesiology, General Hospital, Scion Control, Dental Devices

MK) Number: K06366/