HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861

K080424 · Hygia Health Services, Inc. · NLF · May 28, 2008 · Cardiovascular

Device Facts

• Record ID: K080424
• Device Name: HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
• Applicant: Hygia Health Services, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring. This device is intended for prescription use.

Device Story

Hygia Health Services reprocesses used Masimo LNCS pulse oximeter sensors for reuse. Sensors consist of a dual-wavelength LED and an optical photodiode housed in an adhesive pad. The LED emits red and infrared light in alternating pulses, controlled by the host oximeter instrument. The photodiode detects light absorption by functional arterial hemoglobin and generates a current signal interpreted by the oximeter to calculate and display SpO2 and pulse rate. The device operates non-invasively without tissue penetration, electrical contact, or heat transfer. Used in clinical settings where the host oximeter is deployed; operated by healthcare professionals. Reprocessing includes cleaning and functional testing to ensure performance equivalent to original sensors.

Clinical Evidence

Clinical testing demonstrated that the reprocessed devices, when used with the Masimo Radical SET pulse oximeter, perform as intended and are safe and effective. Additional evidence includes non-clinical functional testing, cleaning validation, and biocompatibility testing.

Technological Characteristics

Dual-wavelength LED and photodiode sensor; adhesive pad housing; cable with pin connector. Operates via optical absorption measurement of arterial hemoglobin. Non-invasive, no electrical contact or heat transfer to patient.

Indications for Use

Indicated for continuous non-invasive SpO2 and pulse rate monitoring in patients requiring such monitoring. Intended for prescription use.

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)
• Masimo LNCS Pulse Oximeter Sensors (K051212)
• Hygia Health Service's Reprocessed Nellcor Pulse Oximeter sensors (K041867)

Submission Summary (Full Text)

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## 510K Summary

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MAY 2 8 2008

K080424

| Submitter: | Hygia Health Services, Inc.<br>434 Industrial Lane<br>Birmingham, Alabama 35211<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jerome James<br>Director of R&D<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date: | February 12, 2008 |
| Trade or<br>Proprietary Name: | Hygia Health Services Reprocessed Sensors |
| Common Name: | Oximeter, Reprocessed |
| Classification: | 21 CFR 870-2700-Oximeter<br>NLF |
| Equivalent Device: | Corresponding Masimo LNCS Pulse Oximeter Sensors legally<br>marketed under various 510(k) premarket notifications and Hygia<br>reprocessed Nellcor Pulse Oximeter sensors |
| | Masimo 510(k) K041815<br>Masimo 510(k) K051212<br>Hygia Health Service's 510(k) K041867 |
| Device Description: | The Hygia Health Services reprocessed pulse Oximeter sensors are<br>non-invasive sensors used to provide continuous SpO2 monitoring and<br>pulse rate. The sensors contain a dual wavelength light emitting diode<br>(LED), and an optical photodiode sensor which are housed in a pad<br>which attaches to the patient using adhesive material. The LED emits<br>red and infrared light in alternate pulses, governed by the Oximeter<br>instrument. The photodiode sensor responds to the light and generates<br>a current that is interpreted by the Oximeter instrument. The Oximeter<br>instrument interprets the different amounts of each light type (red and<br>infrared) from the |
| | output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. |
| Indications for Use: | The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate. |
| Technological<br>Characteristics: | The predicate device and the Hygia reprocessed device contain dual wavelength LED and a photodiode. The LED and photodiode are encased in a pad which attaches to the patient using adhesive material. The sensors are connected to a cable and they terminate in a pin connector. |
| | Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use. |
| Testing: | Functional testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective. |
| | Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective. |
| Conclusion: | Based on the assessment of clinical testing, non-clinical functional testing, cleaning validation, and biocompatibility testing performed, Hygia Health Services concludes that the Hygia Health Services reprocessed pulse Oximeter sensors are substantially equivalent to the Masimo LNCS predicate sensors. |

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# 510K Summary of Safety & Effectiveness (Con't)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font. The eagle is black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 2 8 2008

Mr. Jerome James Director of R&D Hygia Health Services, Incorporated 434 Industrial Lane Birmingham, Alabama 35211

Re: K080424

Trade/Device Name: Hygia Health Services Reprocessed Sensors | Adult Pulse Oximeter Sensor (HHS-1859); Adult-N Pulse Oximeter Sensor (HHS-1862); Pediatric Pulse Oximeter Sensor (HHS-1860); Infant Pulse Oximeter Sensor (HHS-1861)]

Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: April 28, 2008 Received: April 29, 2008

Dear Mr. James:

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 -- Mr. James

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,

Clus

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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## Indications For Use

Applicant:

Hygia Health Services, Inc.

510 (k):

K

Device Name:

Hygia Health Services Reprocessed Sensors

Indications for Use:

The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring.

This device is intended for prescription use.

inhal

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

510(k) Number: K080924

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#### List of Models

:

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| Sensor Model | Intended Oximeter | Hygia Catalog # |
|---------------------------------|--------------------|-----------------|
| Adult Pulse Oximeter sensor | Masimo Radical SET | HHS 1859 |
| Adult-N Pulse Oximeter Sensor | Masimo Radical SET | HHS-1862 |
| Pediatric Pulse Oximeter Sensor | Masimo Radical SET | HHS-1860 |
| Infant Pulse Oximeter Sensor | Masimo Radical SET | HHS-1861 |

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