(228 days)
Not Found
No
The description focuses on standard pulse oximetry technology using light absorption and reflection, and the components listed are typical for such devices. There is no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No
The device is indicated for measuring and monitoring physiological parameters (SpO2 and pulse rate), not for providing therapy or treatment.
Yes
The intended use explicitly states that the device is for "spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used by healthcare professionals to assess a patient's physiological state and contribute to diagnosis.
No
The device description explicitly lists hardware components such as a sensor block, analog block, controller, LCD display, and battery, indicating it is not a software-only device.
Based on the provided information, the SPO PulseOx 5500 and 7500 Pulse Oximeters are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SPO PulseOx Function: The SPO PulseOx devices measure oxygen saturation and pulse rate by shining light through or reflecting light from human tissue (specifically, a relevant body part). They do not analyze a specimen taken from the body.
- Intended Use: The intended use describes measuring physiological parameters directly from the patient, not analyzing a sample.
- Device Description: The description focuses on the optical and electronic components used to interact with the body part, not on handling or analyzing biological specimens.
Therefore, the SPO PulseOx devices are considered non-invasive medical devices that measure physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
PulseOx 5500 Finger Device
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.
PulseOx 7500 WristWatch Device
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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The SPO PulseOx pulse oximeter devices monitor the oxygen saturation levels in the blood. In pulse oximetry, changes in light intensity as the light is reflected back from human tissue (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals, medical facilities, home care, transport and sub-acute environment (PulseOx 5500)
hospitals, medical facilities, ambulatory, sub-acute and sleep study environments (PulseOx 7500)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 devices to blood sampling results in accordance with FDA Draft Guidance. The results show a sufficient correlation to the Gold Standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002100, K984570, K992340, K030668
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
Indications for Use Statement
510(k) Number (if known): K040178
Device Name:
PulseOx 5500 Finger Device
Indications For Use:
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.
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
3
Indications for Use Statement
510(k) Number (if known): K040178
Device Name:
PulseOx 7500 WristWatch Device
Indications For Use:
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.
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
4
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.
5
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
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 environments.
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.
6
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).
7
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.