(159 days)
No
The description details a standard pulse oximetry technology based on light absorption and does not mention any AI/ML components or algorithms for data processing or interpretation.
No.
The device is indicated for measuring and displaying oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic ones.
Yes
Explanation: The device is indicated for "measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate," which are physiological parameters used to assess a patient's health status and can inform diagnosis.
No
The device description explicitly details hardware components including electronics, interface, sensor, LEDs, photodetector, and a rechargeable battery pack. It is a physical wrist-worn device.
Based on the provided information, the Oxitone Model 1000 Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Oxitone 1000 Function: The Oxitone 1000 measures oxygen saturation and pulse rate directly from the patient's wrist using light absorption. This is a non-invasive measurement performed on the living body (in vivo).
The device description clearly states that it "measures oxygen saturation at the wrist location" and "exploits a reflectance sensor... to align the light source properly to the Ulnar Bulge". This describes a method of measuring physiological parameters directly from the body, not from a sample taken from the body.
N/A
Intended Use / Indications for Use
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Product codes
DOA
Device Description
The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist.
This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry.
The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse.
Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW.
The device incorporates a battery state indicator and provides a visual indication of low battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospitals, clinics, long-term care, and home use.
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
Clinical Testing - Testing to insure clinical accuracy of the device in accordance with ISO 80601-2-61 was performed. This testing was performed on 10 patients with results showing compliance to the standard.
Key Metrics
Not Found
Predicate Device(s)
Nonin Model 9590 - K112843
Reference Device(s)
Nonin 8000R Forehead sensor - K050056
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2017
Oxitone Medical Ltd. % Paul Dryden Consultant Promedic, LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K163382
Trade/Device Name: Oxitone 1000 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: March 28, 2017 Received: March 29, 2017
Dear Paul Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Oxitone 1000
Indications for Use (Describe)
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
|Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary May 8, 2017 Page 1 of 6
| Official Contact: | Leon Eisen, PhD Founder and CEO
Oxitone Medical Ltd.
17 Atir Yeda Street
Kfar Saba, Israel 4464312
Tel: +972 (9) 834 6731 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Oxitone 1000 |
| Common/Usual Name: | Oximeter |
| Classification Name: | Oximeter
DQA, Class II, CFR 870.2700 |
| Predicate Device:
Reference Device: | Nonin Model 9590 - K112843
Nonin 8000R Forehead sensor - K050056 |
Device Description:
The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist.
This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry.
The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse.
Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW.
The device incorporates a battery state indicator and provides a visual indication of low battery.
Indications for Use:
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Contraindications:
None
4
Substantial Equivalence Discussion
The Oxitone 1000 Pulse Oximeter is similar to other small worn SpO2 monitors. There are pulse oximeters that use sensors that measure SpO2 at the extremities - fingers, toes, ear lobes, etc. They also have sensors which are placed on the forehead using reflectance technology for measuring SpO2
We have selected 2 devices for comparative purposes for demonstrating substantial equivalence. Table 1 outlines the rationale.
| Feature | Primary Predicate | Reference | Subject device |
|---|---|---|---|
| Nonin | |||
| Model 9590 | |||
| (K112843) | Nonin PalmSAT with | ||
| Purelight | |||
| Forehead 8000R sensor | |||
| (K050056) | Oxitone 1000 | ||
| Classification | DQA | ||
| CFR 870.2700 | |||
| Pulse oximeter | DQA | ||
| CFR 870.2700 | |||
| Pulse oximeter | DQA | ||
| CFR 870.2700 | |||
| Pulse oximeter | |||
| Intended Use | Measure functional oxygen | ||
| saturation of arterial | |||
| hemoglobin (%SpO2) and | |||
| pulse rate | Measure functional oxygen | ||
| saturation of arterial | |||
| hemoglobin (%SpO2) and | |||
| pulse rate | Measure functional oxygen | ||
| saturation of arterial | |||
| hemoglobin (%SpO2) and | |||
| pulse rate | |||
| For spot-checking | For spot-checking | For spot-checking | |
| Patients | Adult | ||
| Pediatrics | Adult | ||
| Pediatrics | Adult | ||
| Sensor location | Digits | Digits | |
| Forehead | Wrist |
Table 1 – Predicate and Reference Devices
The rationale for the selected devices is that the predicate has the indications for use and the reference shows that SpO2 measurements can be measure in other anatomical locations other than digits.
We demonstrate device pereformance by testing the subject device according to ISO 80601-2-61 and the FDA's Guidance for Pulse Oximeters (March 4, 2013).
Table of Comparison and Differences
The Oxitone 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care and home use.
The monitor features an easy-to-read display that presents patient data, status information, and alarms when appropriate.
The Oxitone 1000 permits spot checking of functional oxygen saturation (SpO2) and Pulse Rate (PR) in clinical and non-clinical settings.
5
510(k) Summary May 8, 2017 Page 3 of 6
The software monitors the signals, computes the PR and SpO2 values and displays the PR and SpO2 values.
Table 2 outlines the features of the Oxitone 1000 and compares it to the predicate and reference devices to establish substantial equivalence.
| Table 2 Device Comparison | |||||
|---|---|---|---|---|---|
| --------------------------- | -- | -- | -- | -- | -- |
| CHARACTERISTICS | Oxitone 1000 | Predicate
Nonin
Model 9590 (K112843) | Reference
Nonin PalmSAT with
Forehead 8000R sensor
(K050056) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for Use | The Oxitone Model 1000
Pulse Oximeter is a small,
wrist-worn device indicated
for use in measuring and
displaying functional
oxygen saturation of arterial
hemoglobin (% SpO2) and
pulse rate.
It is intended for spot-
checking of adult patients
with wrist between 13-22
cm circumferences in
hospitals, clinics, long-term
care, and home use. | The Nonin Onyx Vantage 9590
Finger Pulse Oximeter is a small,
lightweight, portable device indicated
for use in measuring and displaying
functional oxygen saturation of
arterial hemoglobin (%Sp02) and
pulse rate of patients who are well or
poorly perfused. It is intended for
spot-checking of adult and pediatric
patients on digits, including the
thumb and toes, that are between 0.3
-1.0 inch (0.8 - 2.5 cm) thick. The
device's intended use environments
include hospitals, clinics, long-term
care facilities, skilled nursing
facilities, emergency medical
services, and home healthcare
services. | Indicated for
non-invasive spot-checking
and/or continuous
monitoring |
| Type of use | Spot checking | Spot-checking | Spot checking
Continuous use |
| Motion | Non-motion | Not specified | Non-motion
Motion |
| Patient Population | Adults | Adult
Pediatric | Adult
Pediatric |
| Perfusion | Well | Well
Poorly | Well
Poorly |
| Environment of Use | Hospitals, clinics, long-term
care and home use | Hospitals, clinics, long-term care
facilities, skilled nursing facilities,
emergency medical services, and
home healthcare services | Hospitals, long-term
care and home use |
| Technology | Reflectance | Transmissive | Transmissive
Reflectance |
6
510(k) Summary May 8, 2017 Page 4 of 6
| CHARACTERISTICS | Oxitone 1000 | Predicate
Nonin
Model 9590 (K112843) | Reference
Nonin PalmSAT with
Forehead 8000R sensor
(K050056) |
|---------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------|
| System components / Configurations | | | |
| Batteries | Rechargeable Li-On | 2 x 1.5 AAA batteries | Batteries
Sensor has no power |
| SpO2 Display Range | 0% to 100% SpO2 | 0% to 100% SpO2 | The referenced sensor can
be placed on the forehead |
| Pulse rate declared
accuracy range | 30-250 BPM | 20-250 BPM | |
| Accuracy | | | Determined by monitor |
| SpO2 Accuracy Range | 70% to 100% $\pm$ 3% | 70% to 100% $\pm$ 3% | |
| Pulse rate | 30-250 $\pm$ 3 | 20-250 $\pm$ 2 | |
| Display | | | |
| LCD | Multi-pixel 3 digits | Multi-pixel 3 digits | |
| Pulse strength indicator | No pulse strength indicator.
LCD, readings or dashes
give pulse quality indication | Tricolor LED gives indication of
quality | |
| Application site | Wrist | Digits | Digits
Forehead |
| Data output | Front panel easy-to-read
display (LCD) | Front panel and USB | Monitor dependent |
| Operation mode | Spot checking | Spot checking | Spot checking
Continuous |
| LED wavelengths
(multiple) | 640-940 nm | 660 and 910 nm | 660-910 nm |
| Radiant Power | Red 1.05 mW IR 0.95 mW | Red 0.8 mW IR 1.2 mW | Determined by monitor |
| Type of protection | Internally powered | Internally powered | Class II |
| Degree of protection -
sensor | Type BF - applied part | Type BF - applied part | Type BF - applied part |
| Functional and safety
testing | ES 60601-1, IEC 60601-1-
11, ISO 80601-2-61 | IEC 60601-1, IEC 60601-1-11,, ISO
9919 | IEC ISO 9919 |
| Biocompatibility | Surface contact
Skin
Limited duration (