The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environment.

The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.

Device Description

The SPO PulseOx pulse oximeter devices monitor the oxygen saturation levels in the blood using pulse oximetry, i.e., changes in light intensity as the light is reflected back from human tissue. Two different wavelengths (in the visible and infrared wavelength) are used. Comparisons between the standard signal and the variances can be used to calculate the oxygen saturation of arterial blood. The SPO PulseOx pulse oximeter devices are based on the reflective method whereby the sensor is located on one side of the relevant body part so as to measure the necessary parameters.

The main components of the SPO pulse oximeter devices are a sensor block, analog block, controller, LCD display and battery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the PulseOx 5500 Finger Device and PulseOx 7500 WristWatch Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list quantitative acceptance criteria in a table format for performance. Instead, it states that:

Bench Studies: "Tests results showed that the devices perform within their specification and according to the requirements of FDA Draft Guidance Document of the Non-Invasive Pulse Oximeter."
Software Validation: "Software Validation according to the IEC60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices."
Electrical Safety & EMC: "Test results showed that the PulseOx device meet the requirements of these standards [IEC 60601-1 and IEC 60601-1-2]."
Environmental Testing: "The PulseOx device will undergo environmental and mechanical testing in accordance With FDA Reviewer Guidance for Premarket Notification Submissions; November 1993; With I DA Reviewer Gallanov Tor Free Branch; Division of Cardiovascular, Respiratory and Neurological Devices."
Clinical Studies: "results show a sufficient correlation to the Gold Standard."

While it doesn't provide specific numerical criteria or results, the general acceptance criterion implied for all tests is "meets specifications/requirements of relevant standards and FDA guidance."

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

The document provides limited detail on the clinical study sample sizes and provenance.

Clinical Studies: "The performance of the PulseOx devices was validated by three clinical studies."
- A comparison of PulseOx, Masimo/Radical and Arterial Blood Sampling.
- A comparison of PulseOx 5500/7500 models to Masimo/Radical.
- A comparison of accuracy of a reflectance pulse oximeter in comparison to a standard pulse oximeter in adult patients.
Meta-analysis: A meta-analysis was performed comparing PulseOx devices to blood sampling results (Gold Standard).

Sample Size: Not explicitly stated for any of the clinical studies or the meta-analysis.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The applicant's address is in Kfar Saba, ISRAEL, but this doesn't confirm the study location.

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

This information is not provided in the document. The ground truth for pulse oximetry accuracy is typically established by arterial blood gas (ABG) analysis, not by human expert interpretation of oximeter readings.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device performance study. Adjudication is typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree. Pulse oximetry accuracy is compared against a quantitative "gold standard" (arterial blood gas analysis).

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. This type of study assesses how AI assistance impacts human performance (e.g., radiologists reading images). The PulseOx device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers.

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

Yes, a standalone performance assessment was conducted. The clinical studies and meta-analysis described compare the PulseOx devices' readings (algorithm-only output) directly against established standards (e.g., arterial blood sampling, other predicate oximeters).

7. The Type of Ground Truth Used

Arterial Blood Sampling (ABG) for Oxygen Saturation: The document explicitly mentions "Arterial Blood Sampling" and refers to "Gold Standard" in relation to blood sampling results for the meta-analysis. This is the accepted gold standard for determining actual arterial oxygen saturation.
Predicate Oximeters: Comparisons were also made against other legally marketed pulse oximeters (Masimo/Radical, a "standard pulse oximeter"). While not a "ground truth" in the strict sense of direct physiological measurement, these serve as a comparative standard for substantial equivalence demonstrations.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes premarket notification for a medical device and typically focuses on performance validation rather than the internal development or training of algorithms that might have occurred during the device's design phase.

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

This information is not provided in the document, as it pertains to the device's internal development process, which is often proprietary and not detailed in 510(k) summaries unless explicitly called out by FDA guidance for specific types of algorithmic devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SPO Medical Equipment Limited C/O Ms. Ahava M. Stein Consulting 20 Hata'as Street, Suite 213 44425 Kfar Saba ISRAEL

Re: K040178

Trade/Device Name: PulseOx 7500 WristWatch Device, PulseOx 5500 Finger Device Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 17, 2004 Received: August 23, 2004

Dear Ms. Stein:

This letter corrects our substantially equivalent letter of September 10, 2004.

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 (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 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.

SEP 2 8 2004

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o 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/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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Indications for Use Statement

510(k) Number (if known): K040178

Device Name:

PulseOx 5500 Finger Device

Indications For Use:

Com Suom

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K040178

AND/OR

Prescription Use _ V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (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)

Page 1 of 1

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Indications for Use Statement

510(k) Number (if known): K040178

Device Name:

PulseOx 7500 WristWatch Device

Indications For Use:

Cune Suliom

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

K 040 178 510(k) Number:

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

Over-The-Counter Use (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)

Page 1 of 1

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K040178

SEP 1 0 2004

SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant: 1.

SPO Medical Equipment Ltd. Kfir Barkan Bldg. 3 Hagavish Str. P.O.B. 2454 Kfar Saba 44425 ISRAEL Tel: +972-8-6842332 Fax: +972-8-6842374

Corresponding Official: 2.

Ahava M. Stein, Consultant A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as Str., Suite 213 44425 Kfar Saba, ISRAEL Tel: +972-9-7670002 Fax: +972-9-7668534

Device Name and Classification 3.

Pulse Oximeter, CFR classification section 870.2700

Device trade or proprietary name: 4.

PulseOx 5500 Finger Device PulseOx 7500 WristWatch Device

Common Name: 5.

Pulse Oximeter

Classification Name: 6.

CFR classification section 870.2700 and product code DQA, Class II.

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Description of the Device 7.

The SPO PulseOx pulse oximeter devices monitor the oxygen saturation levels in the blood I no or oximetry, i.e., changes in light intensity as the light is reflected back from human of purse onlinery, now different wavelengths (in the visible and infrared wavelength) are used. Comparisons between the standard signal and the variances can be used to calculate the oxygen saturation of arterial blood. The SPO PulseOx pulse oximeter devices are based the onygon battlizes the reflective method whereby the sensor is located on one side of the relevant body part so as to measure the necessary parameters.

The main components of the SPO pulse oximeter devices are a sensor block, analog block, controller, LCD display and battery.

Intended Use: 8.

PulseOx 5500

PulseOx 7500

The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use is measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute and sleep study environments.

Performance Data: 9.

The following performance tests have been performed on the SPO pulse oximeter devices:

Bench Studies

Bench studies were performed to verify that the PulseOx devices meet their specifications. Tests results showed that the devices perform within their specification and according to the requirements of FDA Draft Guidance Document of the Non-Invasive Pulse Oximeter.

Software Validation

Software Validation according to the IEC60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.

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Electrical Safety and Electromagnetic Compliance

The device was tested according to the following recognized standards:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety;

IEC 60601-1-2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

Test results showed that the PulseOx device meet the requirements of these standards.

Environmental Testing

The PulseOx device will undergo environmental and mechanical testing in accordance With FDA Reviewer Guidance for Premarket Notification Submissions; November 1993; With I DA Reviewer Gallanov Tor Free Branch; Division of Cardiovascular, Respiratory and Neurological Devices.

Clinical Studies

The performance of the PulseOx devices was validated by three clinical studies:

A comparison of PulseOx, Masimo/Radical and Arterial Blood Sampling. .
- A comparison of PulseOx 5500/7500 models to Masimo/Radical. .
- A comparison of Palse and accuracy of a reflectance pulse oximeter in comparison to . a standard pulse oximeter in adult patients.

In addition, a meta-analysis was performed to compare the performance of the PulseOx m uddition, a mone anding testing results in accordance with FDA Draft Guidance de rices to orood sampling results results show a sufficient correlation to the Gold Standard.

Predicate Devices 10.

The PulseOx pulse oximeter devices are substantially equivalent to the combination of the The I dise Oximetry device (manufactured by Nonin Medical Inc., and subject of Onlyx 9700 I also Oximely at 1100 (the PulSox-3 (manufactured by Minolta and the subject of 510(k) document no. K984570), the Masimo Radical Pulse Oximeter (manufactured by Masimo Corp. and the subject of 510(k) document no. K992340) and to the 3100 WristOx Wrist Pulse Oximeter (manufactured by Nonin Medical Inc. and subject of 510(k) document no. K030668).

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Technological Characteristics Compared to Predicate Device 11.

The technological characteristics, e.g., overall design, materials, mechanism of action, The toolmological enaracteristics, etc., and the intended use of the PulseOx mode of operation, performance entiraly equivalent to the predicate devices cited above as demonstrated in Section 3 of the 510(k) submission.

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).