MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

K041127 · Sterilmed, Inc. · NLF · Sep 23, 2004 · Cardiovascular

Device Facts

• Record ID: K041127
• Device Name: MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
• Applicant: Sterilmed, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required.

Device Story

Reprocessed pulse oximeter sensors (Nellcor Max-A and Max-N models) function as electro-optical sensors. Device utilizes two light-emitting diodes (LEDs) as light sources and one photodiode as a receiver. Positioned on tissue, sensor measures light absorption of functional arterial hemoglobin. Connected via cable to a pulse oximeter monitor, the system provides continuous, non-invasive, self-calibrated measurements of oxygen saturation and pulse rate. Used in clinical settings by healthcare providers to monitor patient status; output assists in clinical decision-making regarding patient oxygenation and cardiovascular status.

Clinical Evidence

No clinical data provided; substantial equivalence is based on functional design, indications for use, principles of operation, and test performance characteristics.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode; non-invasive; cable-connected to pulse oximeter monitor; reprocessed from original Nellcor components.

Indications for Use

Indicated for patients requiring continuous external monitoring of arterial oxygen saturation and pulse rate.

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

• Reprocessed Pulse Oximeter Sensors (K012677)

Submission Summary (Full Text)

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SterilMed, Inc. Special 510(k)

SEP 2 3 2004

Reprocessed Pulse Oximeter Sensors

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# Appendix F

### 510(k) Summary

| Submitter: | SterilMed, Inc.<br>11400 73rd Ave. N<br>Minneapolis, MN 55369<br>ERN: 2134070 |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Bruce Lester<br>VP Research and Develpoment<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 26, 2004 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Name<br>and Number: | 21 CFR 870.2700 |
| Product Code: | NLF |
| Predicate Device<br>Name and 510(k)<br>Number | Reprocessed Pulse Oximeter Sensors<br>K012677 |
| Device Description: | DEVICE DESCRIPTION<br>The subject devices are reprocessed pulse oximeter sensors<br>model numbers Max-A and Max-N Pulse Oximeter Sensors<br>originally manufactured by Nellcor.<br><br>The reprocessed pulse oximeter sensor is an electro-optical<br>sensor that uses an optical means to determine the light<br>absorption of functional arterial hemoglobin. The sensor<br>contains three optical components: two light emitting diodes<br>(LED's) that serve as light sources, and one photodiode, that<br>acts as a light receiver. The oximeter sensor is positioned so<br>that the LED's and photodiode oppose one another across the<br>tissue. The sensor is connected via cable to a pulse oximeter,<br>which provides continuous non-invasive, self-calibrated<br>measurements of both oxygen saturation of functional<br>hemoglobin and pulse rate. Please note that this submission<br>only pertains to the sensor. It does not pertain to the pulse<br>oximeter or connecting cable. |
| Intended Use: | Reprocessed Pulse Oximeter Sensors are used when continuous<br>external monitoring of arterial oxygen saturation and pulse rate<br>is required. |
| Statement of<br>Technological<br>Comparison | The subject reprocessed Pulse Oximeter Sensors have the<br>following similarities to the Reprocessed Pulse Oximeter<br>Sensor which previously received 510(k) clearance:<br>The same indicated use; The same operating principle; The same basic design; The same technical characteristics; The same clinical performance characteristics; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the subject device described in this submission is,<br>in the opinion of SterilMed, substantially equivalent to the<br>predicate device. |
| Conclusion: | The subject reprocessed pulse oximeter sensors are substantially<br>equivalent to the predicate reprocessed pulse oximeter sensors.<br>This conclusion is based upon the fact that this device is<br>substantially equivalent to the predicate device in terms of<br>functional design, indications for use, principles of operation<br>and test performance characteristics. |

04/26/04

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04/26/04

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SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Bruce Lester Vice President Research & Development SterilMed, Incorporated 11400 73rd Avenue, North Minneapolis, Minnesota 55369

Re: K041127

Trade/Device Name: Modification To: Reprocessed Pulse Oximeter Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: July 27, 2004 Received: July 29, 2004

Dear Dr. Lester:

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 - Dr. Lester

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 vours.

Susan Russo
fa 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

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Reprocessed Pulse Oximeter Sensors

Steri Med, Inc. Special 510(k)

## Appendix B

### Indications for Use Statement

| 510(k) Number (if known) | TBD |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Reprocessed Pulse Oximeter Sensors |
| Indications for Use | Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required. |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--|
| Prescription Use <span style="text-decoration: overline;">✓</span><br>(Per 21 CFR 801. 109) | OR | Over-The-Counter Use <span style="text-decoration: overline;">_____</span> | |
| | (Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | |
| 510(k) Number: | K041127 | | |

Appendix B, Page 1

Confidential SterilMed Inc. Snecial S10/k) for Renrocessed Pulse Oximeter Sensors