The SPO2.COM oximetry sensors and cables are intended for the continuous nominvasive monitoring of functional oxygen saturation of arterial hermoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The SPO2.COM Oximetry Sensors are fully compatible disposable replacement sensors for use with Nellon and Nelloor compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The SPO2.COM RSI reusable sensor is essentially identical to Masimo LNOP-DCI sensor except for the end of the cable which interfaces with the Neller. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the SPO2.COM RSI and LNOP-DCI sensors. The patient contacting materials in the SPO2.COM RSI and LNOP-DCI sensors are the same. The SPO2.COM RSI sensors are supplied non-sterile.

The SPO2.COM disposable sensors are similar in construction to the predicate devices. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of stime that that tour sizes of disposable SPO2.COM sensors are available for use with adult, pediatric, infant and neonatal cuspount our sensors are cssentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the SPO2.COM disposable schsors are the same that is used in Masimo's LNOP sensor line. The SPO2.COM disposable sensors are supplied non-sterile for single patient use.

The SPO2.COM patient cables are similar in construction to the predicate device enabling the SPO2.COM Oximetry Sensors to be connected to Nellcor and Nellcor The or oz. Out oximeters. The SPO2. COM oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

AI/ML Overview

Acceptance Criteria and Study for SPO2.COM Oximetry Sensors

This response describes the acceptance criteria and the study conducted to demonstrate that the SPO2.COM Oximetry Sensors meet those criteria, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Equivalent)	Reported Device Performance (SPO2.COM)
SpO2 Accuracy (Adults, Pediatrics, Infants)	Not explicitly stated, implied to be equivalent to predicate. Predicate typically ±2% SpO2 between 70-100% SaO2	Less than 2% SpO2 accuracy between 70-100% SaO2
SpO2 Accuracy (Neonates)	Not explicitly stated, implied to be equivalent to predicate. Predicate typically ±3% SpO2 between 70-100% SaO2	Less than 3% SpO2 accuracy between 70-100% SaO2
Biocompatibility	Non-toxic, non-irritating, non-sensitizing	Materials demonstrated to be non-toxic, non-irritating, and non-sensitizing
Environmental Testing	Pass electrical, mechanical, and environmental tests per Reviewers Guidance	All tests passed (electrical, mechanical, environmental)

Note: The 510(k) summary explicitly states that "The accuracy of the SPO2.COM oximetry sensors is equivalent to those of the predicate devices." While specific numerical acceptance criteria for accuracy of the predicate devices are not provided in the summary, the reported performance of SPO2.COM sensors aligns with typical accuracy requirements for pulse oximeters.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not explicitly stated. The study involved "healthy adult volunteer[s]" but the exact number of subjects or data points is not provided.
Data Provenance: Prospective. The clinical studies were "performed using the SPO2.COM Adult and Reusable oximetry sensors on healthy adult volunteer[s]... who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This describes a prospective study design. The country of origin is not specified but implicitly implies the US, given the FDA submission.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not applicable for establishing ground truth as the ground truth was based on arterial blood samples analyzed by a CO-Oximeter.
Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. Ground truth was established by direct measurement from a CO-Oximeter from arterial blood samples. There was no expert consensus adjudication process described for the test set.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the accuracy of the device itself against a direct physiological measurement, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Standalone Study: Yes, a standalone (algorithm only) performance study was conducted. The clinical studies directly measured the performance of the SPO2.COM oximetry sensors (the device itself) against a CO-Oximeter, without human interpretation in the loop impacting the accuracy measurement.

7. Type of Ground Truth Used

Type of Ground Truth: Direct physiological measurement (reference standard). The ground truth for the clinical accuracy study was "arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This is considered a gold standard for oxygen saturation measurement.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. Pulse oximeters operate on established physical principles (spectrophotometry) and typically do not involve AI/machine learning models that require a distinct "training set" in the conventional sense. The device's calibration and performance are based on the design of the emitter, detector, and the algorithms implemented to process the optical signals, which are validated in clinical trials.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not applicable, as there isn't a traditional "training set" for AI/ML in this device. The device's underlying principles and algorithms are based on established physiological and optical physics. The extensive validation through clinical trials (as described above) serves to confirm the device's accuracy against recognized reference standards.

Summary

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DEC 1 2 2003

510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo, a company located at 2852 Kelvin Avenue in Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686. The logo features the company name in a stylized font.

Submitted by:	Masimo Corporation2852 Kelvin AveIrvine, CA 92614-5826(714) 250-9688FAX (714) 250-9686
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	October 11, 2003
Trade Name	SPO2.COM Oximetry Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700)Cable, Transducer and Electrode (74DSA) (870.2900)
Substantially Equivalent Devices:	Masimo SET ® Radical Pulse Oximeter with SatShare ™ and LNOP ® series of Sensors andCables510(k) Number - K031330Nellcor N-395 Pulse Oximeter - K991823Nellcor N-200 Pulse Oximeter - K863784

Device Description

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510(k) SUMMARY

The SPO2.COM patient cables are similar in construction to the predicate device enabling the SPO2.COM Oximetry Sensors to be connected to Nellcor and Nellcor compatible pulse oximeter monitors.

Predicate Devices

SPO2.COM Sensor Line	Masimo Predicate LNOP Sensors- in K031330	Nellcor Predicate Sensors found inK863784 and K991823
SPO2.COM RSI - Reusable Adult Sensor	LNOP-DCI	DS-100A
SPO2.COM A – Adult Disposable Sensor	LNOP-Adt	D-25
SPO2.COM P - Pediatric DisposableSensor	LNOP- Pdt	D-20
SPO2.COM I - Infant Disposable Sensor	LNOP-Neo	I-25
SPO2.COM N -- Neonatal Disposable Sensor	LNOP-Neo	N-25
SPO2.COM 200 - Patient Cable	PC Patient Cable	N/A
SPO2.COM 395 - Patient Cable	PC Patient Cable	N/A

Intended Use

Technology Comparison

The SPO2.COM oximetry sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

The SPO2.COM oximetry sensors are designed, configured, and manufactured for full compatibility with Nellcor and Nellcor The or oz. Out oximeters. The SPO2. COM oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the SPO2.COM oximetry sensors is equivalent to those of the predicate devices.

Performance Testing

Biocompatibility

All the patient contacting materials used in the SPO2.COM sensors are the same materials that are used in Masimo's LNOP series of sensors. Test results demonstrated that the materials were non-toxic, non-irritating, and non sensitizing.

Environmental Testing

Applicable environmetal testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed

Clinical Testing

Clinical studies were performed using the SPO2.COM Adult and Reusable oximetry sensors on healthy adult volunteer enhined studios nore perfective who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the SPO2.COM Adult and Reusable schsors resulted in an accuracy of less than 2% SpO2 Aranievel of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% AsMs for neonates.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is composed of three thick, curved lines, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Avenue Irvine, California 92614-5826

Re: K033298

Trade/Device Name: SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: December 5, 2003 Received: December 8, 2003

Dear Mr. Cronin:

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 J. Cronin

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 (301) 594-4646. 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,

Carls

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): K033298

SPO2.COM Sensors and Cables Device Name:

Indications For Use:

The SPO2.COM Sensors and Cables are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ANN Antoshina

510(k) Numbe

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).