REPROCESSED MASIMO PULSE OXIMETER SENSORS by ASCENT HEALTHCARE SOLUTIONS

The devices are reprocessed Low Noise Cabled Sensors (LNCS)® Series - Adult, Pediatric, and Infant SpO2 adhesive sensors. The sensors are disposable devices used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

AI/ML Overview

The provided document states that the Reprocessed Pulse Oximeter Sensors have identical indications for use, technological characteristics, design, materials, and intended use as the predicate devices. Therefore, the acceptance criteria are implicitly that the reprocessed devices perform as "originally intended" by the manufacturer of the predicate devices. The study conducted to prove this involved bench and laboratory testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Maintain original intended performance (safety and effectiveness)	Bench and laboratory testing demonstrated that Reprocessed Pulse Oximeter Sensors perform as originally intended. Key tests included: Biocompatibility, Validation of reprocessing, Function test(s), Packaging Validation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "bench and laboratory testing" and "each individual Pulse Oximeter Sensor is tested," suggesting that a robust testing protocol was followed but does not provide specific numbers for the test set.
Data Provenance: Not explicitly stated. The document does not mention the country of origin of data or whether it was retrospective or prospective. It describes general testing conducted by the applicant, Ascent Healthcare Solutions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. The "ground truth" here is the performance specifications of the original, new device. The testing conducted by Ascent Healthcare Solutions was to verify that the reprocessed devices meet these pre-defined specifications through direct measurement and physical/chemical analysis, not through expert interpretation of clinical data on the reprocessed devices themselves.
Qualifications of Experts: Not applicable, for the reasons above.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing described is objective, physical, and chemical in nature, designed to confirm that the reprocessed devices meet established performance parameters. There is no subjective interpretation requiring an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a reprocessed medical device, and the evaluation focused on its functional equivalence to the original device through bench and laboratory testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is a physical medical sensor, not an algorithm. The performance evaluation is of the sensor itself.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the reprocessed sensors is the performance specifications and characteristics of the original, new predicate devices (Masimo LNCS and SPO2.COM Sensors). The objective was to demonstrate that the reprocessed devices continue to meet these original manufacturer specifications after reprocessing.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a "training set." The device is a reprocessed physical medical device.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary

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JUL 2 9 2008

1081238

SECTION 5: 510(k) SUMMARY

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044
Contact:	Katie BrayRegulatory Affairs Manager(480) 763-5300 (o)(480) 763-6089 (f)kbray@ascenths.com
Date of preparation:	April 29, 2008
Name of device:	Trade/Proprietary Name: Reprocessed Pulse Oximeter Sensors
	Classification Name: Oximeter, Reprocessed
Predicate DeviceK060143 K041815	510(k) TitleLNCS and SPO2.COM SensorsLNCS Oximetry Sensors	ManufacturerMasimo CorporationMasimo Corporation
Device description:	The devices are reprocessed Low Noise Cabled Sensors(LNCS)® Series - Adult, Pediatric, and Infant SpO2 adhesivesensors. The sensors are disposable devices used forcontinuous noninvasive arterial oxygen saturation and pulse ratemonitoring.
Indications for Use:	Reprocessed Pulse Oximeter Sensors are indicated for use incontinuous noninvasive arterial oxygen saturation and pulse ratemonitoring.
Technologicalcharacteristics:	The design, materials, and intended use of Reprocessed PulseOximeter Sensors are identical to the predicate devices. Themechanism of action of Reprocessed Pulse Oximeter Sensors isidentical to the predicate devices in that the same standardmechanical design and size and equivalent materials areutilized. There are no changes to the claims, intended use,clinical applications, patient population, performancespecifications, or method of operation. In addition, AscentHealthcare Solutions' reprocessing of Pulse Oximeter Sensorsincludes removal of adherent visible soil and decontamination.Each individual Pulse Oximeter Sensor is tested for appropriatefunction of its components prior to packaging and labelingoperations.
Performance data:	Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of Reprocessed PulseOximeter Sensors. This included the following tests:

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Biocompatibility
. Validation of reprocessing
. Function test(s)
Packaging Validation .

Performance testing demonstrates that Reprocessed Pulse Oximeter Sensors perform as originally intended.

Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Pulse Oximeter Sensors) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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Public Health Service

JUL 29 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katie Bray Regulatory Affairs Manager Ascent Healthcare Solutions 10232 South 51st Street Phoenix, Arizona 85044

Re: K081238

Trade/Device Name: Reprocessed Masimo Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: April 29, 2008 Received: May 1, 2008

Dear Ms. Bray:

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 - Ms. Bray

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

K. Kommelts-Lending for II

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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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed Masimo Pulse Oximeter Sensors

Indications For Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

14081238 510(k) Number: ___

Ascent Healthcare Solutions Reprocessed Pulse Oximeter Sensors Traditional 510(k)

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).