VANGUARD REPROCESSED PULSE OXIMETER SENSORS

K012344 · Vanguard Medical Concepts, Inc. · NLF · Oct 4, 2002 · Cardiovascular

Device Facts

• Record ID: K012344
• Device Name: VANGUARD REPROCESSED PULSE OXIMETER SENSORS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

Device Story

Vanguard reprocesses used pulse oximeter sensors; process includes cleaning, reworking, replacing patient-contacting tape, inspecting, testing, repackaging, and sterilizing. Sensors consist of red/infrared LEDs and photosensor; applied to patient finger, foot, or hand. Device functions by emitting light across vascular bed; photosensor detects absorption changes based on oxygenated/deoxygenated hemoglobin ratios. Output is processed by compatible pulse oximeter to calculate pulse rate and arterial oxygen saturation. Used in clinical settings; operated by healthcare professionals. Reprocessing restores device to OEM specifications, enabling continued clinical use and patient monitoring.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation, functional/performance testing, and biocompatibility testing to demonstrate equivalence to OEM sensors.

Technological Characteristics

Components: red and infrared LEDs, photosensor, taping system. Principle: optical absorption spectrophotometry. Connectivity: compatible with standard pulse oximeters. Sterilization: validated process. Reprocessing involves replacement of all patient-contacting materials.

Indications for Use

Indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate 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

• Nellcor Oxisensor II Sensors (Mallinckrodt, Inc.)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Ms. Heather Crawford Director, Regulatory Affairs Vanguard Medical Concepts, Incorporated 5307 Great Oak Drive Lakeland, Florida 33815

Re: K012344

Trade/Device Name: Vanguard Reprocessed Pulse Oximeter Sensors (Models D-25, D-25L, N-25, D-20 and I-20) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF, DQA Dated: May 19, 2004 Received: May 21, 2004

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of August 4, 2006.

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 (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 Eederal Register.

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Page 2 - Ms. Crawford

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 continue 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 yours,

Chin-Lin, Ph.D.

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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## List of Models: Vanguard Reprocessed Pulse Oximeter Sensors

100 million in the state

:

| Nellcor Oxisensor II |
|----------------------|
| D-20 |
| D-25L |
| D-25 |
| N-25 |
| I-20 |

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## 510(k) Summary of Safety & Effectiveness, Continued

| Device<br>Description | Oximeter sensors are used with compatible pulse oximeters to noninvasively<br>continually monitor oxygen saturation and pulse rate. The primary<br>components of the sensors are light-emitting diodes (red and infrared LED)<br>and a photosensor. These components are embedded within a taping system<br>to wrap the sensor around a patient's finger, foot or hand so that the LED and<br>photosensor are directly opposite each other. As light is emitted and received<br>across the vascular bed, the rates of absorption at the two wavelengths vary<br>depending upon the ratios of oxygenated and deoxygenated hemoglobin<br>within the blood. The pulse oximeter detects the changes in absorption and<br>utilizes an algorithm to calculate the corresponding pulse rate (beats/minute)<br>and percent arterial oxygen saturation. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vanguard receives previously used oximeter sensors from healthcare<br>facilities; cleans, reworks, (replaces the tape [all patient-contacting<br>materials]), inspects, tests, repackages and sterilizes the devices; and returns<br>them to the healthcare facility. |
| Technological<br>Characteristics | The Vanguard reprocessed oximeter sensors are essentially identical to<br>the currently marketed OEM sensors. No changes are made to the currently<br>marketed device's specifications and they possess the same technological<br>characteristics. Biocompatibility and performance/functional testing<br>demonstrate that the devices are equivalent and continue to be safe and<br>effective for their intended use. |
| Test Data | Sterilization validations, and functional/performance and biocompatibility<br>testing demonstrates that the reprocessed devices perform as intended and are<br>safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>reprocessed pulse oximeter sensors are substantially equivalent to the<br>predicate devices, Mallinckrodt, Inc., Nellcor Oxisensor® II Sensors,<br>under the Federal Food, Drug and Cosmetic Act. |

Nellcor, Nellcor Puritan Bennett and Oxisensor are registered trademarks of Mallinckrodt, Inc.

:

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## Indications for Use

2012344 510(k) Number:

Device Name: Vanguard Reprocessed Pulse Oximeter Sensors

Indications for Use:

The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseV (Per 21 CFR 801.109)

OR

Over-The-Counter Use ---------------------------------------------------------------------------------------------------------------------------------------------------------

(Optional Format 1-2-96)

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Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices

510(k) Number: K012344