VANGUARD REPROCESSED PULSE OXIMETER SENSORS

K042316 · Vanguard Medical Concepts, Inc. · NLF · Jan 6, 2005 · Cardiovascular

Device Facts

• Record ID: K042316
• Device Name: VANGUARD REPROCESSED PULSE OXIMETER SENSORS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Jan 6, 2005
• 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

Reprocessed pulse oximeter sensors; used with compatible pulse oximeters for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate. Device consists of red/infrared LEDs and a photosensor embedded in a taping system; applied to patient finger, foot, or hand. LEDs emit light through vascular bed; photosensor detects absorption changes based on hemoglobin oxygenation ratios. Oximeter host unit uses internal algorithm to calculate pulse rate and oxygen saturation. Vanguard Medical Concepts cleans, reworks (replaces patient-contacting tape), inspects, tests, and sterilizes previously used OEM sensors. Used in clinical settings; operated by healthcare professionals. Benefits include continued clinical monitoring capability via reprocessed hardware.

Clinical Evidence

No clinical data. Bench testing performed, including cleaning, sterilization, and packaging validations, as well as performance and biocompatibility testing to ensure safety and effectiveness.

Technological Characteristics

Electro-optical pulse oximeter sensor; utilizes red and infrared LEDs and a photosensor. Components are identical to OEM specifications. Patient-contacting materials (adhesive tape) are replaced during reprocessing. Sterilized via validated processes.

Indications for Use

Indicated for continuous noninvasive arterial oxygen saturation and pulse rate monitoring in patients. Contraindicated for patients with adhesive tape allergies.

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 Puritan Bennett, OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors and Cables (K012891)

Submission Summary (Full Text)

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JAN - 6 2005

K042316

## 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director, Regulatory Affairs<br>[phone]<br>[phone] (facsimile)<br>[e-mail] |
| Date | August 25, 2004 |
| Device | • Trade Name: Vanguard Reprocessed Pulse Oximeter Sensors<br>• Common Names: Pulse oximeter sensor, oximeter sensor, oxygen<br>transducer, O2 transducer<br>• 21 CFR 870.2700 – Oximeter, Reprocessed - Class II<br>• Product Code NLF |
| Predicate<br>Devices | • Nellcor Puritan Bennett, OxiMAX Pulse Oximetry System with N-595<br>Pulse Oximeter and OxiMAX Sensors and Cables (aka "Accessories"),<br>K012891 |
| Indications for<br>Use | The sensor is indicated for use in continuous noninvasive arterial oxygen<br>saturation and pulse rate monitoring. |
| Contra-<br>indications | This device should not be used on patients who exhibit allergic reactions to<br>the adhesive tape. |
| 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.<br>Vanguard receives previously used pulse 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 a healthcare facility. |
| Technological<br>Characteristics | Vanguard Reprocessed Pulse Oximeter Sensors are essentially identical to the<br>original equipment manufacturer (OEM) devices. No changes are made to<br>the electro-optical components; the reprocessed sensors possess equivalent<br>technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance and<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are 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 their<br>predicate devices under the Federal Food, Drug and Cosmetic Act. |

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

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SEP - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042316

Trade/Device Name: Vanguard Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: December 22, 2004 Received: December 27, 2004

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of January 6, 2005.

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 Federal 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 vours.

Cove

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

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| Nellcor OxiMax |
|----------------|
| MAX-A |
| MAX-AL |
| MAX-I |
| MAX-P |
| MAX-N |

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