(57 days)
No
The summary describes a standard pulse oximetry device using established technology and does not mention any AI/ML components or capabilities.
No.
The device is indicated for measuring, displaying, and storing %SpO2 and pulse rate. It does not provide any therapy or treatment.
Yes
The device is indicated for noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR), which are diagnostic measurements used to assess a patient's physiological state.
No
The device description explicitly states it is a "wrist-worn device" with a "reflectance pulse oximetry sensor" including LEDs and a photodiode, a display, battery, memory, and other hardware components. It is described as a "standalone device" and testing included electrical, mechanical, and biocompatibility testing, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
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 detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Device Function: The oCare Wrist Pulse Oximeter, Model Pro 100, measures functional oxygen saturation and pulse rate non-invasively by shining light through the skin on the wrist. It does not require taking any samples from the body.
- Intended Use: The intended use is for noninvasive measuring, displaying, and storing of physiological parameters (% SpO2 and PR) directly from the patient's body.
Therefore, based on the provided information, the oCare Wrist Pulse Oximeter is a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospital-type facilities, and home environments.
Product codes
DQA
Device Description
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a wrist-worn device for noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. The intended measuring site of this device is the lateral side of wrist and slightly above the wrist bone (ulnar styloid processus).
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a watch-like device with a reflectance pulse oximetry sensor located at the bottom of the watch case and on top of the wrist. The reflectance pulse oximetry sensor includes three light emitting diodes (LEDs) of red, infrared and green wavelength and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW.
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist.
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, a memory, an analog and digital unit, a microprocessor and an operating software.
The functions of oCare™ Wrist Pulse Oximeter, Model Pro 100 include the following:
- (1) Measurement, display and storage of the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate,
- (2) Spot-checking or continuous monitoring of specific physiological parameters,
- (3) Built-in memory for up to 72 hours of data storage,
- (4) Interface to other health data collection system through the embedded Bluetooth module,
- (5) Easy to read 128 x 128 (RGB) color OLED graphic display.
- (6) Peripheral micro-USB connector used as the battery charging port,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflectance Optical Sensor
Anatomical Site
Wrist, wrist skin surface, lateral side of wrist and slightly above the wrist bone (ulnar styloid processus).
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found, but indicated for use in hospital-type facilities, and home environments.
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
The SpO2 accuracy testing of the subject device, oCare™ Wrist Pulse Oximeter, Model Pro 100 has been conducted at an independent research university hospital. The human subjects screened for this testing are health, male, female, no-smoking and light to dark-skinned adult subjects of 20-40 years of age. The non-invasive functional oxygen saturation of arterial hemoglobin (% SpO2) measured by the subject device were compared to the invasive functional oxygen saturation of arterial hemoglobin (% SaO2) analyzed by the co-oximetry method with arterial blood samples taken simultaneously. The accuracy of SpO2 measured by the subject device is evaluated over the SaO2 range of 70-100% under non-motion condition. Accuracy data was calculated using the root-mean-squared (ARMS value) for all human subjects, per ISO 80601-2-61, Standard Specification for Pulse Oximeters for Accuracy in a non-motion environment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study (SpO2 accuracy testing) and Non-clinical Testing (electrical, mechanical, electromagnetic compatibility, software, biocompatibility).
Sample Size: Human subjects (number not specified, but stated "all human subjects") for clinical study.
Key Results:
Clinical Study: Demonstrated that the SpO2 accuracy of the subject device is within ± 3% over the SaO2 range of 70-100% under non-motion condition on the wrist. There were no reported adverse effects during these investigations. The Accuracy Root Mean Square (Arms) performance was expected to meet a specification of ± 3% for the range of 70-100% SaO2, and the study confirmed this.
Non-clinical Testing: The device complies with electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, alarm system, usability engineering, battery safety, particulate and water ingress testing, home used medical devices safety and photobiological safety standards. Test results show that the subject device meets the product specifications including: SpO2 accuracy without motion of ±3% from 70-100%, and pulse rate of ±3% from 40-240 bpm. The software was considered a "moderate" level of concern, and verification/validation testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: ±3% SpO2 (from 70-100%)
Pulse rate accuracy: ±3 bpm (from 40-240 bpm)
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.
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.
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Taiwan Biophotonic Corporation JC Chen President 4F-1, No. 6-1, Sec.2, Shengyi Rd. Zhubei, 30261 Tw
Re: K183556
Trade/Device Name: oCare Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 18, 2018 Received: December 20, 2018
Dear JC Chen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd D. Courtney -S
for 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
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Indications for Use
510(k) Number (if known) K183556
Device Name
oCare Wrist Pulse Oximeter, Model Pro 100
Indications for Use (Describe)
The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospital-type facilities, and home environments.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
K183556
This 510(k) summary is being submitted in accordance with the requirements of 21CFR 807.92.
| Submitter: | Taiwan Biophotonic Corporation |
|---|---|
| Submitter's Address and | |
| Telephone Number | 4F-1, No. 6-1, Section 2, Shengyi Road, Zhubei City, |
| Hsinchu County 30261, Taiwan, R.O.C. | |
| Phone: +886-3-667-0888; Fax: +886-3-667-0222 | |
| Contact Person: | JC Chen, President |
| Phone: +886-3-667-0888 ext.201 | |
| e-mail: jc.chen@tbpchc.com | |
| Date Prepared: | November 9, 2018 |
1. Submitter Information
2. Device Information
| Trade Name: | oCare™ Wrist Pulse Oximeter, Model Pro 100 |
|---|---|
| Common Name: | Oximeter |
| Classification Name | Oximeter |
| Regulation Number: | 21 CFR 870.2700 |
| Regulatory Class: | Class II |
| Product Code: | DQA |
3. Legally Marketed Predicate Devices
The predicates (legally marketed devices) for the subject device (oCare™ Wrist Pulse Oximeter, Model Pro 100) are identified as below:
Primary Predicate: Oxitone 1000, Wrist Pulse Oximeter (K163382)
Reference Device: Nellcor Bedside SpO2 Patient Monitoring System (K142865).
Device Description 4.
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The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a wrist-worn device for noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. The intended measuring site of this device is the lateral side of wrist and slightly above the wrist bone (ulnar styloid processus).
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a watch-like device with a reflectance pulse oximetry sensor located at the bottom of the watch case and on top of the wrist. The reflectance pulse oximetry sensor includes three light emitting diodes (LEDs) of red, infrared and green wavelength and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW.
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist.
The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, a memory, an analog and digital unit, a microprocessor and an operating software.
The functions of oCare™ Wrist Pulse Oximeter, Model Pro 100 include the following:
- (1) Measurement, display and storage of the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate,
- (2) Spot-checking or continuous monitoring of specific physiological parameters,
- (3) Built-in memory for up to 72 hours of data storage,
- (4) Interface to other health data collection system through the embedded Bluetooth module,
- (5) Easy to read 128 x 128 (RGB) color OLED graphic display.
- (6) Peripheral micro-USB connector used as the battery charging port,
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(7) Built-in rechargeable lithium ion polymer battery,
(8) Pulsing quality indicator and battery power indicator in OLED graphic display,
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device does not contain drug or biological products.
5. Indications for Use
The oCare™ Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospitals, hospital-type facilities, and home environments.
The subject device has the same intended uses as the predicate Oxitone 1000, Wrist Pulse Oximeter. However, the indications for use of the subject device include additional features as storing and continuous monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. Although these features are not present in the predicate Oxitone 1000, Wrist Pulse Oximeter, they are present in the reference predicate Nellcor Bedside SpO2 Patient Monitoring System. Thus, it does not constitute a new intended use for the wrist pulse oximeter nor do they different questions of safety and effectiveness for the subject device relative to the predicates.
6. Comparison of Technological Characteristics with the Predicate Devices
The subject device and predicates all use the well-established non-invasive pulse oximetry method to measure the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. It is based on two basic principles: (1) oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different absorption characteristic to red and infrared light; (2) the light absorption by the blood (Hb and HbO2) is cyclic changing by the periodic pulsations of the arterial blood volume during each heartbeat. This periodic changing of light absorption signal is commonly known as the photoplethysmography (PPG).
At a high level, the subject device and predicates are based on the following similar technological elements:
- (1) Use of a reflectance pulse oximetry sensor which includes LEDs for emitting light beams through the skin to the arteriolar bed of the tissue, and the photodiode for detecting the PPG signals reflected back from the pulsating arteriolar bed. It has
Image /page/5/Picture/12 description: The image contains the logo for Taiwan Biophotonic Co. The logo consists of a colorful graphic to the left of the company name. The graphic is made up of three interlocking shapes in yellow, pink, and teal. The company name is written in a simple, sans-serif font.
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identical radiant output wavelength of red and infrared and radiant output power of less than 15 mW.
- (2) Use of patient contact materials which have been tested to compile with the same standard of ISO 10993 for the category of surface device, intact skin contact and limited contact duration (