Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required.

Device Description

The reprocessed pulse oximeter sensor is an electro-optical sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Please note that this submission only pertains to the sensor. It does not pertain to the pulse oximeter or connecting cable.

AI/ML Overview

The provided document is a 510(k) summary for SterilMed's reprocessed pulse oximeter sensors. It outlines the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide a complete answer with the requested details from the text. The document states that "Representative samples of reprocessed sensors underwent bench testing and a clinical study to verify functional characteristics," but it does not elaborate on these studies' methodologies, results, or specific acceptance criteria met.

Here's a breakdown of what can be extracted and what is missing:

What can be inferred from the document:

Device Name: SterilMed Reprocessed Nellcor Pulse Oximeter Oxisensor II Sensor N-25 and N-25LF
Intended Use: "Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required."
Predicate Device: Nellcor Oxisensors™ (compatible with Nellcor N-200 pulse oximeter, K863784).
Study Types Mentioned: Bench testing and a clinical study were performed to verify functional characteristics. Process validation testing was done for cleaning, sterilization, and packaging. Manufacturing includes visual and functional testing.
Conclusion: The reprocessed sensors are "substantially equivalent" to predicate devices based on functional design, materials, indications for use, and construction methods.

What is missing from the document and therefore cannot be provided:

A table of acceptance criteria and the reported device performance: The document states that testing was done to "verify functional characteristics which are substantially equivalent to the predicate devices'," but it provides no specific performance metrics or thresholds for acceptance.
Sample size used for the test set and the data provenance: No details about the number of devices or subjects in the clinical study or bench testing are given, nor is the origin of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given the nature of pulse oximetry, the "ground truth" for oxygen saturation would typically come from arterial blood gas analysis, not expert consensus on images.
Adjudication method for the test set: Not mentioned.
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: This is not applicable to a reprocessed pulse oximeter sensor, which is a hardware device for direct measurement, not an AI interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm. Its performance is inherent to the device itself.
The type of ground truth used: While not explicitly stated, for a pulse oximeter, the ground truth for oxygen saturation would typically be obtained through methods like arterial blood gas analysis.
The sample size for the training set: Not applicable and not mentioned, as this is a device reprocessing submission rather than an AI/machine learning model.
How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided text confirms that studies were conducted to demonstrate substantial equivalence, but it lacks the granular details requested regarding acceptance criteria, specific performance results, and study methodologies.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

Dr. Bruce Lester Vice President of Research and Development SterilMed, Incorporated 11400 73Rd. Avenue North Minneapolis, Minnesota 55369

Re: K012677 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: August 13, 2001 Received: August 14, 2001

Dear Dr. Lester:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 28, 2003. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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Page 2 - Dr. Bruce Lester

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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/dsma/dsmamain.html.

Sincerely yours,

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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Page 3 - Dr. Bruce Lester

Trade/Device Names

SterilMed Reprocessed Nellcor Pulse Oximeter Oxisensor II Sensor N-25 SterilMed Reprocessed Nellcor Pulse Oximeter Oxisensor II Sensor N-25LF

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Indications for use Page

510(K) Number Kolze 77

Device Name: Reprocessed Pulse Oximeter Sensors

Indications for Use:

Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required.

Concurrence of CDRH, Office of Device Evaluation (ODE)

$\underset{-}{\checkmark}$ PRESCRIPTION

SAWesterman

on of Anesthesiology, General Hospital Infection Control, Dental Devi

510(k) Number: K012677

SterilMed, Inc. Pulse Oximeter Probes Confidential

Premarket Notification

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SECTION 2. SUMMARY AND CERTIFICATION

510(k) Summary A.

Submitter:	SterilMed, Inc.
Contact Person:	Patrick FleischhackerSubmitted by SterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 888-856-4870Fax: 763-488-3350
Date Prepared:	August 13, 2001
Trade Name:	SterilMed Reprocessed Pulse Oximeter Sensors
Classification Name:and Number:	Class II, 21 CFR 870.2700
Product Code:	DQA
Predicate Device(s):	The reprocessed pulse oximeter sensors are substantiallyequivalent to the Nellcor Oxisensors™, which arecompatible with the Nellcor N-200 pulse oximeter(K863784).
Device Description:	The reprocessed pulse oximeter sensor is an electro-opticalsensor that uses an optical means to determine the lightabsorption of functional arterial hemoglobin. The sensorcontains three optical components: two light emittingdiodes (LED's) that serve as light sources, and onephotodiode, that acts as a light receiver. The oximetersensor is positioned so that the LED's and photodiodeoppose one another across the tissue. The sensor isconnected via cable to a pulse oximeter, which providescontinuous non-invasive, self-calibrated measurements ofboth oxygen saturation of functional hemoglobin and pulserate. Please note that this submission only pertains to thesensor. It does not pertain to the pulse oximeter orconnecting cable.
Intended Use:	Reprocessed pulse oximeter sensors are used whencontinuous external monitoring of arterial oxygensaturation and pulse rate is required.
Functional andSafety Testing:	Representative samples of reprocessed sensors underwentbench testing and a clinical study to verify functionalcharacteristics which are substantially equivalent to thepredicate devices'. Process validation testing was done tovalidate the cleaning and sterilization procedures as well asthe device's packaging. In addition, the manufacturingprocess includes visual and functional testing of allproducts produced.
Conclusion:	The pulse oximeter sensors reprocessed by SterilMed aresubstantially equivalent the Nellcor Oxisensors™ whichare compatible with the Nellcor N-200 pulse oximeter.This conclusion is based upon the fact that the reprocessedsensors are substantially equivalent to their predicatedevices in terms of functional design, materials, indicationsfor use, and methods of construction.

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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).