HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N

K041867 · Hygia Health Services, Inc. · NLF · Sep 10, 2004 · Cardiovascular

Device Facts

• Record ID: K041867
• Device Name: HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
• Applicant: Hygia Health Services, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.

Device Story

Reprocessed pulse oximeter sensors; non-invasive; attach to patient via adhesive. Device contains dual-wavelength LED (red/infrared) and optical photodiode. LED emits light in alternate pulses governed by external oximeter instrument; photodiode generates current based on light absorption of functional arterial hemoglobin. Instrument interprets current to display SpO2 and pulse rate. Used in clinical settings; operated by healthcare professionals. Reprocessing restores functionality of previously used sensors; no tissue penetration, electrical contact, or heat transfer to patient.

Clinical Evidence

Bench testing only. Evidence includes functional testing, cleaning validation, and biocompatibility testing to demonstrate that reprocessed sensors perform equivalently to original predicate sensors.

Technological Characteristics

Dual-wavelength LED and photodiode sensor; adhesive pad housing; cable with pin connector. Non-invasive optical sensing principle. No tissue penetration, electrical contact, or heat transfer. Reprocessed device maintains original design specifications.

Indications for Use

Indicated for patients requiring continuous non-invasive SpO2 monitoring and pulse rate measurement.

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 OxiMAX (various 510(k)s)
• Oxisensors (various 510(k)s)
• Hygia Health Service's 510(k) 012715
• Nellcor Puritan Bennett, Inc. (K012891)
• Nellcor Puritan Bennett, Inc. (K863784)

Submission Summary (Full Text)

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## 510K Summary of Safety & Effectiveness

2041867

| Submitter: | Hygia Health Services, Inc.<br>434 Industrial Lane<br>Birmingham, Alabama 35211<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mrs. Tracy Wood Comas<br>Chief Operating Officer<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date: | July 7, 2004 |
| 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 Mallinckrodt, Inc., Nellcor OxiMAX and<br>Oxisensors legally marketed under various 510(k) premarket<br>notifications<br>Hygia Health Service's 510(k) 012715<br>Nellcor Puritan Bennett, Inc. 510(k) K012891<br>Nellcor Puritan Bennett, Inc. 510(k) K863784 |
| Device Description: | The Hygia Health Services reprocessed pulse Oximeter sensors are<br>non-invasive sensors used to provide continuous SpO2 monitoring<br>and pulse rate. The sensors contain a dual wavelength light<br>emitting diode (LED), and an optical photodiode sensor which are<br>housed in a pad which attaches to the patient using adhesive<br>material. The LED emits red and infrared light in alternate pulses,<br>governed by the Oximeter instrument. The photodiode sensor<br>responds to the light and generates a current that is interpreted by<br>the Oximeter instrument. The Oximeter instrument interprets the<br>different amounts of each light type (red and infrared) from the |
| | output of the photodiode and interprets the information and<br>displays a reading. The sensor operates without any type of tissue<br>penetration, electrical contact, or heat transfer to the patient. The<br>sensors use optical means to determine the light absorption of<br>functional arterial hemoglobin. |
| Indications for Use: | The sensor is indicated for use as a non-invasive method to provide<br>continuous SpO2 monitoring and pulse rate. |
| Technological<br>Characteristics: | The predicate device and the Hygia reprocessed device contain<br>dual wavelength LED and a photodiode. The LED and photodiode<br>are encased in a pad which attaches to the patient using adhesive<br>material. The sensors are connected to a cable and they terminate<br>in a pin connector. |
| | Biocompatibility and performance/functional testing demonstrate<br>that the devices are equivalent and are safe and effective for their<br>intended use. |
| Testing: | Functional testing, cleaning validation, and biocompatibility<br>testing demonstrates that the reprocessed devices perform as<br>intended and are safe and effective. |
| Conclusion: | Based on the assessment of functional testing, cleaning validation,<br>and biocompatibility testing performed, Hygia Health Services<br>concludes that the Hygia Health Services reprocessed pulse<br>Oximeter sensors are substantially equivalent to the Mallinckrodt,<br>Inc., Nellcor predicate sensors. |

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

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SEP - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy Wood Comas Chief Operating Officer Hygia Health Services, Incorporated 434 Industrial Lane Birmingham, Alabama 35211

Re: K041867

Trade/Device Name: Hygia Health Services Reprocessed Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: July 7, 2004 Received: July 19, 2004

Dear Ms. Wood Comas:

This letter corrects our substantially equivalent letter of July 19, 2004.

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. Wood Comas

Please be advised that FDA's issuance of a substantial equivalence determination does not i Ticast be auvisod that I DT of issuains on that your device complies with other requirements mean that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of any I ederal bita reguirements, including, but not limited to: registration 1 ou must comply with and are reseling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), laooling (21 CFR Part 820); and if requirements as set form in the quality sign ---------------------------------------------------------------------------------------------------------------------------------21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section This letter will anow you to continue marketing your destantial equivalence of your device to 510(k) promative notificate 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), IT you desire specific advice for your do at [phone]. Also, please note the regulation in 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 may obtain 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,

Chiu 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: Hygia Health Services Reprocessed Sensors

| Nellcor Oxisensor II |
|------------------------------------|
| D-20 |
| I-20 |
| Nellcor OxiMax |
| MAX-A with event history |
| MAX-AL with event history |
| MAX-N with event history |
| MAX-P with event history |
| MAX-I with event history |
| MAX-A with event history disabled |
| MAX-AL with event history disabled |
| MAX-N with event history disabled |
| MAX-P with event history disabled |
| MAX-I with event history disabled |

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