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 Description

The Hygia Health Services reprocessed pulse Oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and 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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Hygia Health Services Reprocessed Sensors, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. However, it indicates the overall performance goal is substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (Safety)	Testing demonstrates safety and effectiveness.
Performance/Functional Equivalence	Functional testing demonstrates that the reprocessed devices perform as intended.
Clinical Performance (SpO2 monitoring and pulse rate)	Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective.
Cleaning Validation	Cleaning validation demonstrates safety and effectiveness.
Substantial Equivalence to Predicate	Hygia Health Services concludes that the Hygia Health Services reprocessed pulse Oximeter sensors are substantially equivalent to the Masimo LNCS predicate sensors based on all testing.

2. Sample Size for Test Set and Data Provenance

The 510(k) summary does not specify the sample size used for the clinical or functional testing. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment

The 510(k) summary does not provide information on the number of experts used to establish ground truth or their qualifications. Given the nature of a reprocessed medical device, the "ground truth" would likely be the performance of new, original equipment manufacturer (OEM) sensors, but no details are given on how this comparison was rigorously established.

4. Adjudication Method for the Test Set

The 510(k) summary does not mention any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. The device is a pulse oximeter sensor, which provides objective measurements (SpO2 and pulse rate) rather than relying on interpretation by human readers. Therefore, such a study would not be applicable.

6. Standalone Performance Study (Algorithm Only)

The device itself is a reprocessed sensor, meaning it's a hardware component rather than a standalone algorithm. While the sensor outputs data that an oximeter algorithm interprets, the document focuses on the sensor's performance. The "clinical testing" mentioned likely evaluates the sensor's ability to provide accurate readings when used with an oximeter, implying a form of standalone performance evaluation for the sensor's output. However, it's not an "algorithm-only" study in the typical AI/software sense.

7. Type of Ground Truth Used

The ground truth implicitly used for this device's performance evaluation would be the performance of legally marketed, new (non-reprocessed) OEM pulse oximeter sensors, specifically the Masimo LNCS Pulse Oximeter Sensors. The goal is to demonstrate that the reprocessed sensors perform equivalently. The document states that "Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective," which implies comparison against expected, accurate readings.

8. Sample Size for the Training Set

The product is a reprocessed physical medical device (sensor), not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size does not apply here. The reprocessed sensors are evaluated for their equivalence to new sensors after processing, not "trained" on data.

9. How Ground Truth for the Training Set Was Established

As established above, the concept of a "training set" is not applicable to this device.

Summary

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510K Summary

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MAY 2 8 2008

K080424

Submitter:	Hygia Health Services, Inc.434 Industrial LaneBirmingham, Alabama 35211Phone: (205) 314-3920Fax: (205) 314-3959
Contact:	Jerome JamesDirector of R&DPhone: (205) 314-3920Fax: (205) 314-3959Email: jerry.james@hygia.net
Date:	February 12, 2008
Trade orProprietary Name:	Hygia Health Services Reprocessed Sensors
Common Name:	Oximeter, Reprocessed
Classification:	21 CFR 870-2700-OximeterNLF
Equivalent Device:	Corresponding Masimo LNCS Pulse Oximeter Sensors legallymarketed under various 510(k) premarket notifications and Hygiareprocessed Nellcor Pulse Oximeter sensors
	Masimo 510(k) K041815Masimo 510(k) K051212Hygia Health Service's 510(k) K041867
Device Description:	The Hygia Health Services reprocessed pulse Oximeter sensors arenon-invasive sensors used to provide continuous SpO2 monitoring andpulse rate. The sensors contain a dual wavelength light emitting diode(LED), and an optical photodiode sensor which are housed in a padwhich attaches to the patient using adhesive material. The LED emitsred and infrared light in alternate pulses, governed by the Oximeterinstrument. The photodiode sensor responds to the light and generatesa current that is interpreted by the Oximeter instrument. The Oximeterinstrument interprets the different amounts of each light type (red andinfrared) 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.
TechnologicalCharacteristics:	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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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):

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

and the comments of the comments of the country of

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

the submit and the submit of the subscription in the subject of

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).