The MEDLEY SpO2 Module and accessories are intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.
The MEDLEY SpO2 Module and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions, and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.

Device Description

The MEDLEY SpO2 Module, Model 8210, is essentially the same as the previously cleared device (MEDLEY SpO2 Module, Model 8220). The MEDLEY SpO2 Module (Models 8220 and 8210) and accessories is a device capable of non-invasively monitoring functional oxygen saturation of arterial hemoglobin and pulse rate. The system consists of an SpO2 Module, a Programming Module, connecting cable, and oximetry sensors.
The MEDLEY Programming Module (PM) and SpO2 Module snap together. The Nellcor board contains all of the pulse oximetry algorithms used to measure saturation and pulse rate. The patient cable and oximetry sensors, manufactured by Nellcor, work in combination with the MEDLEY SpO2 Module to utilize Nellcor's technology to measure functional oxygen saturation and pulse rate.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the MEDLEY SpO2 Module, Model 8210, meets these criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices and states that verification testing was completed.

However, based on the general nature of the submission for a pulse oximeter, we can infer some aspects and present the available information within the requested structure.

Here's an attempt to answer the questions based on the provided text, with explicit notes where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The performance information provided demonstrates that the MEDLEY SpO2 Module, Model 8210 and accessories perform as intended and within the required specifications to demonstrate the safety and effectiveness of the device." However, it does not provide a specific table of acceptance criteria (e.g., accuracy ranges for SpO2 or pulse rate) or detailed reported device performance values. These would typically be found in Section 8, which is only referenced.

Acceptance Criteria (Inferred for Pulse Oximeters)	Reported Device Performance (Not explicitly stated in the provided text)
Accuracy of functional oxygen saturation (SpO2)	"perform as intended and within the required specifications"
Accuracy of pulse rate	"perform as intended and within the required specifications"
Performance during no motion conditions	Covered by the general statement
Performance during motion conditions	Covered by the general statement
Performance for well-perfused patients	Covered by the general statement
Performance for poorly perfused patients	Covered by the general statement
Software V&V (Verification and Validation)	"complete, acceptable and design output matches design input"
Design verification testing	"complete, acceptable"

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

Sample size for test set: Not explicitly stated in the provided text.
Data provenance: Not explicitly stated in the provided text. Clinical data for pulse oximeter accuracy typically involves human subject studies, but the details (e.g., country of origin, retrospective/prospective) are absent.

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

Not explicitly stated in the provided text. For pulse oximeters, ground truth for SpO2 is usually established via co-oximetry of arterial blood samples. This does not typically involve "experts" in the sense of clinicians reviewing data, but rather laboratory analysis.

4. Adjudication method for the test set:

Not applicable as the nature of the test set (if involved human review) is not described. For objective physiological measurements like SpO2, adjudication in the sense of multiple expert reviews is not typically used for ground truth establishment.

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:

No, an MRMC comparative effectiveness study was not done. The device is a pulse oximeter, which directly measures physiological parameters. It does not involve "human readers" or "AI assistance" in the interpretation of complex images or data in a diagnostic context that would warrant an MRMC study.

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

Yes, implicitly. A pulse oximeter is a standalone device that provides direct measurements (SpO2 and pulse rate) via its internal algorithms without continuous human-in-the-loop performance influencing its primary output. The "design verification testing including software V&V" would encompass standalone algorithm performance.

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

Inferred: For SpO2 measurements, the gold standard (ground truth) is typically co-oximetry of arterial blood samples. The document does not explicitly state this, but it's the standard for pulse oximeter validation.

8. The sample size for the training set:

Not explicitly stated. The document refers to the device utilizing "Nellcor's technology" and its "pulse oximetry algorithms." The training of these algorithms would have occurred during the development of the Nellcor technology itself, rather than being a specific training set for this particular 510(k) submission, which is primarily focused on substantial equivalence.

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

Not explicitly stated. For Nellcor's existing algorithms, the ground truth would have been established through extensive physiological studies using co-oximetry of arterial blood samples across a range of subjects and conditions, typically involving induced hypoxia.

Summary

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SEP 1 1 2002

Image /page/0/Picture/2 description: The image shows the text "K022677" in a large, handwritten-style font. Below this, in a smaller, more formal font, is the text "ORIGINAL PREMARKET 510(K) NOTIFICATION MEDLEY SPO2 MODULE, MODEL 8210". The image appears to be a document header or title section, possibly from a medical device submission.

SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems, Inc. MEDLEY SpO2 Module, Model 8210

SUBMITTER'S NAME: ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, CA 92121-2772 (858) 458-7563 (858) 458-6114 FAX

Renée L. Fluet CONTACT PERSON: Principal Regulatory Affairs Specialist
August 9, 2002 DATE PREPARED:

Proprietary Name DEVICE NAME: MEDLEY SpO2 Module, Model 8210 SpO2 Sensors and Cables

Common Name Pulse Oximeter and Sensor Transducer & Electrode Cables

Classification Name Oximeter, DQA (870.2700) Cable, Transducer and Electrode, DSA (870.2900)

MEDLEY SpO2 Module, Model 8220, K010966 PREDICATE DEVICES: Nellcor OxiMax Pulse Oximetry System, K012891

DEVICE DESCRIPTION

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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 3

The MEDLEY Programming Module (PM) and SpO2 Module snap together. The Nellcor board contains all of the pulse oximetry algorithms used to measure saturation and pulse rate. The patient cable and oximetry sensors, manufactured by Nellcor, work in combination with the MEDLEY SpO2 Module to utilize Nellcor's technology to measure functional oxygen saturation and pulse rate. See Section 5 for a detailed device description and comparison.

SUBSTANTIAL EQUIVALENCE

The MEDLEY SpO2 Module, Model 8210 is similar to the predicate devices (MEDLEY SpO2 Module, Model 8220, K010966, and the Nellcor OxiMax Pulse Oximetry System, K012891) in that they have the same intended use, operating principles, technological design. incorporate similar materials and manufacturing processes. The changes as described in this Special 510(k) pose no new issues of safety or efficacy. The MEDLEY SpO2 Module, Model 8210 described in this submission. in our opinion, is substantially equivalent to the predicate devices. See Section 6 for substantial equivalence details and a comparison table.

INTENDED USE

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SUMMARY OF SAFETY AND EFFECTIVENESS Page 3 of 3

TECHNOLOGY

The MEDLEY SpO2 Module, Model 8210, as described in this Special 510(k) Premarket Notification, and the MEDLEY SpO2 Module, Model 8220 (K010966) are similar devices. The pulse oximeter systems have the same intended use, principle of operation, technology, and functionality. In addition, the MEDLEY SpO2 Module, Model 8210 (with Nellcor technology) and the MEDLEY SpO2 Module, Model 8220 (with Masimo technology) have a similar method of operation and utilize similar accessories. The minor differences as identified in this submission do not alter the fundamental technology of the predicate device.

SYSTEM AND SOFTWARE PERFORMANCE

The performance information provided demonstrates that the MEDLEY SpO2 Module, Model 8210 and accessories perform as intended and within the required specifications to demonstrate the safety and effectiveness of the device. All required verification testing for the MEDLEY SpO2 Module, Model 8210 (Nellcor) has been completed. Design verification testing including software V&V is complete, acceptable and design output matches design input. See Section 8 for detailed system and software performance information.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2002

Ms. Renee L. Fluet Principal Regulatory Affairs Specialist Alaris Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121

Re: K022677

Trade/Device Name: MEDLEY SpO2 Module and Accessories Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 9, 2002 Received: August 12, 2002

Dear Ms. Fluet:

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.

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.

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Page 2 - Ms. Fluet

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy Ulatowski 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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Attachment B

Image /page/5/Picture/3 description: The image shows the logo for Alaris Medical Systems. The logo features a stylized star to the left of the word "ALARIS" in a bold, sans-serif font. Below "ALARIS" are the words "MEDICAL SYSTEMS" in a smaller, sans-serif font. The logo is black and white.

MEDLEY SpO2 Module, Model 8210 Indications for Use

510(k) Number:

KO226 17 - - (To Be Assigned By FDA)

Device Trade Name:

MEDLEY SpO2 Module

Indications For Use: The MEDLEY SpO2 Module and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions, and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﮐﮯ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Signature

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

510(k) Number: 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).