The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.

AI/ML Overview

This looks like a 510(k) premarket notification for reprocessed oximetry sensors. Unfortunately, the provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria, as one might find in a full clinical trial report.

The document states that the reprocessed sensors are "substantially equivalent" to predicate devices based on "bench testing, clinical performance data, and non-clinical performance data." However, it does not provide the specifics of these tests, including:

Acceptance Criteria: What specific metrics (e.g., accuracy against a gold standard) were targeted, and what were the thresholds for success?
Reported Device Performance: What were the numerical results of these tests for the reprocessed devices?
Study Design Details: How many subjects/samples were used, where the data came from, details about ground truth, expert qualifications, etc.

Therefore, I cannot populate the table or answer most of the specific questions based only on the provided text.

Here's what I can extract and state regarding the questions, with the understanding that much information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria	Reported Device Performance
Clinical Performance	(Not specified in text)	Functionality "Substantially Equivalent" to predicate devices. (Specific metrics not provided)
Bench Testing	(Not specified in text)	Functionality "Substantially Equivalent" to predicate devices. (Specific metrics not provided)
Non-Clinical Performance	(Not specified in text)	Functionality "Substantially Equivalent" to predicate devices. (Specific metrics not provided)
Safety Standards	Meets EN 60601-1, EN60601-1-2, Biocompatibility ISO10993-10 1995 EN 30993-1	The device "are designed to meet" these standards. (Specific test results not provided)

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not specified.
Data Provenance: The document mentions "clinical performance data" but does not specify the country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not describe the establishment of a "ground truth" using experts for performance testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified. This level of detail about study design is not present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an oximetry sensor, not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved diagnostic performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the context of an algorithm. However, the device itself (sensor) performs its measurement "stand-alone" in producing SpO2 and pulse rate data for the oximeter. The testing mentioned (bench, clinical, non-clinical) would assess its direct sensing performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. For oximetry sensors, ground truth for SpO2 would typically involve co-oximetry of arterial blood samples. The document does not detail this.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm in the context of typical training sets. The "reprocessed" aspect implies a manufacturing process, and performance is evaluated against predicate device functionality.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

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Section 13 Premarket Notification

K072194

510 (k) Summary

Submitters Name and Address: ReNu Medical, Inc. 9800 Evergreen Way Everett, WA 98024 Phone: 425-353-1110 Fax: 425-353-9116

FDA Registration Number: 3034520

Contact Person: L. Bruce Pierson Chief Operating Officer

NOV 2 9 2007

Date Summary Prepared: August 4, 2007

Trade or Proprietary Name(s): ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor, ReNu Medical Reprocessed Nellcor™ N-25 Oximetry Sensor

Common Name: Oximetry Sensor

Classification: Oximeter (21 CFR 870.2700) / NLF

Equivalent Device(s)

The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Nellcor™ N-25 Oximetry Sensor are substantially equivalent to the Nellcor™ D-25 Oximetry sensor and Nellcor™ N-25 Oximetry sensor (respectively),

Device Description:

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Intended Use

Both the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Nellcor™ Oximeter system. The Model D-25 is used for patients >30 kg. The Model N-25 is used for neonates <3 kg or adults >40 kg. Both sensors are used for noninvasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.

Technological Characteristics of the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor Compared with the Nellcor™ D-25 Oximetry Sensor and Nellcor™ N-25 Oximetry Sensor

The predicate devices and the ReNu Medical Reprocessed devices contain identical components (LED, photodiode, laminated envelope, cable, and connector.) The means of patient attachment (adhesive bandage) is identical.

Summary of Comparison Tests

Based on an assessment consisting of bench testing, clinical performance data, and non-clinical performance data the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor function in a manner that is Substantially Equivalent to that of the predicate devices.

Safety and Standards

The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are designed to meet the following safety standards:

EN 60601-1 t
. EN60601-1-2
Biocompatibility ISO10993-10 1995 EN 30993-1 .

Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed within a circle, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" surrounding it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2007

Mr. Bruce Pierson Chief Operating Officer ReNu Medical, Incorporated 9800 Evergreen Way Everett, Washington 98204

Re: K072194

Trade/Device Name: ReNu Reprocessed Nellcor Oximeter Sensor Model D-25, N-25 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: October 26, 2007 Received: October 30, 2007

Dear Mr. Pierson:

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. Pierson

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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Indications for Use

510(k) Number (if known): K072194

Device Name: ReNu Reprocessed Nellcor Oximeter Sensor Model D-25, N-25

Indications For Use:

D-25 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.

N-25: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if < 3 kg, or finger if > 40 kg.

XX Prescription Use (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)

unh Yohn

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ber: K07 2194

Page 1 of

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List of Models

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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).