(387 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its processing is basic signal processing.
No.
The device is for measuring and displaying physiological parameters (SpO2 and pulse rate) for spot checking, not for treating or preventing a disease or condition.
Yes
The device measures and displays oxygen saturation (SpO2) and pulse rate, which serve as physiological indicators used in the assessment and monitoring of a patient's health status.
No
The device description explicitly states it is composed of hardware components including a motherboard, SpO2 transducer, and built-in battery, and has a detachable sensor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Wrist Pulse Oximeter measures oxygen saturation and pulse rate by placing a sensor on the finger. This is a non-invasive measurement taken directly from the body, not from a specimen in vitro (in glass or outside the body).
- Intended Use: The intended use is for "spot checking in measuring and displaying oxygen saturation... and pulse rate," which is a physiological measurement, not an analysis of a biological sample.
Therefore, based on the provided information, the Wrist Pulse Oximeter is a medical device, but it falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing.
The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.
The power supply is 4.2V Li-battery and also the subject device can be powered by adapter.
The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device.
The subject device owns software which has been validated by the manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
hospital facilities and home healthcare 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 clinical evaluation was conducted and the result of SONOSAT-W01T Wrist Pulse Oximeter is in compliance with the criteria of ISO 80601-2-61:2011 standard and FDA guidance - "Pulse Oximeter Premarket Notification Submissions". The functional oxygen saturation (SpO2) measurement has been validated on a total of 24 healthy adult male and female volunteers with2 white people, and 15 yellow-skin people in the range of 70% to 100%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test: The functional oxygen saturation (SpO2) measurement has been validated on a total of 24 healthy adult male and female volunteers with2 white people, and 15 yellow-skin people in the range of 70% to 100%. The SpO2 accuracy result showed that the root-mean-square (Arms) value of SONOSAT-W01T Wrist Pulse Oximeter is ±2% with the saturations from 70% to 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: The root-mean-square (Arms) value of SONOSAT-W01T Wrist Pulse Oximeter is ±2% with the saturations from 70% to 100%.
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.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
Jiangsu Konsung Bio-Medical Science and Technology Co. Ltd Mr. Yu Defeng No. 8, Shengchang West Road Danyang Economy Development Zone Jiang Su. China
Re: K152089
Trade/Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 12, 2016 Received: July 19, 2016
Dear Mr. Defeng:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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
2
Indications for Use
510(k) Number (if known) K152089
Device Name Wrist Pulse Oximeter
Indications for Use (Describe)
The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.
| 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
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 5th, 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd Address: NO.8,Shengchang West Road,Danyang Economy Development Zone China Contact Name: Li xu Telephone No.:+86-511-86378639 Fax No.: +86-511-86381308
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | Wrist Pulse Oximeter |
|---|---|
| Model Name: | SONOSAT-W01T |
| Common Name: | Pulse Oximeter |
| Regulatory Classification: | 21 CFR 870.2700 |
| Product Code: | DQA |
| Classification Panel: | Anesthesiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicates within this submission are as follows:
K122046 Wrist Pulse Oximeter model MD300W4
5. Description of the Device [21 CFR 807.92(a)(4)]
This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing.
The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.
4
The power supply is 4.2V Li-battery and also the subject device can be powered by adapter.
The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device.
The subject device owns software which has been validated by the manufacturer.
6. Indications for Use [21 CFR 807.92(a)(5)]
The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, hospital facilities and home healthcare environments.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The Wrist Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 662±3 nm, which is red light; the other is 890±5 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.This equipment mainly composed of the motherboard, SpO2 transducer and built-in battery.
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
The subject device wrist pulse oximeter has taken the Electricity safety, EMC, performance and biocompatibility testing into concern in accordance with Food and Drug Administration related guidance and recognized international standards.
| Items | Predicate device | Subject device |
|---|---|---|
| MD300W4 | SONOSAT-W01T | |
| Indications for | ||
| use | The MD300W4 wrist pulse | |
| oximeter is a portable non- | ||
| invasive device intended for spot | ||
| checking, data collection and | ||
| recording of arterial oxygen | ||
| saturation (SpO2) and pulse rate | ||
| of adult and pediatric patient at | ||
| home and hospital( including | ||
| clinical use in internist/ surgery, | ||
| Anesthesia, intensive care and | ||
| etc). | The Wrist Pulse Oximeter is | |
| intended for spot checking in | ||
| measuring and displaying oxygen | ||
| saturation of functional arterial | ||
| hemoglobin (SpO2) and pulse rate | ||
| of adult and pediatric patients in | ||
| hospitals, hospital facilities and | ||
| home healthcare environments. | ||
| Intended | ||
| patient | ||
| population | Adult, pediatric | Adult, pediatric |
| Intend | ||
| application site | Finger | Finger |
| Measurement | ||
| Range | SpO2 | |
| 70%-100% | SpO2 | |
| 0%-100% | ||
| Accuracy | ||
| Tolerance | Saturation | |
| 70 to 100% ±3% | ||
| Less than 70%, unspecified | Saturation | |
| 70 to 100% ±2% | ||
| Less than 70%, unspecified | ||
| Pulse Rate | ||
| 25bpm~250bpm,±3bpm | Pulse Rate | |
| 25bpm~250bpm,±3bpm | ||
| Resolution | SpO2 1% | |
| Pulse Rate 1 bpm | SpO2 1% | |
| Pulse Rate 1 bpm | ||
| General | ||
| requirement | Compliance with IEC60601-1 | |
| Special | ||
| requirement | Compliance with ISO 80601-2-61 | |
| Compliance with IEC 60601-1-11 | Compliance with ISO 80601-2-61 | |
| Compliance with IEC 60601-1-11 | ||
| EMC | Compliance with IEC60601-1-2 | Compliance with IEC60601-1-2 |
| Biocompatibility | Compliance with ISO10993-1 | Compliance with ISO10993-1 |
| Regulation No. | CFR 870.2700 | CFR 870.2700 |
| Product code | DQA | DQA |
| Classification | II | II |
| Type of | ||
| protection | Internally powered | Internally powered |
| Power Type | battery | battery |
| Degree of | ||
| protection | Type BF - Applied part | Type BF - Applied part |
| Principles of | ||
| Sensor | pulse oximetry sensors adopts | pulse oximetry sensors adopts |
| non-invasive double wavelength | ||
| to measure SpO2 and PR | non-invasive double wavelength to | |
| measure SpO2 and PR | ||
| Tests | ||
| conducted | Cytotoxicity, | Cytotoxicity, |
| Delayed Contact Sensitization, | Delayed Contact Sensitization, | |
| Skin Irritation | Skin Irritation | |
| Result of tests | No toxicity to cells, | No toxicity to cells, |
| No delayed contact sensitization, | No delayed contact sensitization, | |
| No irritation to skin | No irritation to skin | |
| Description | OLED | OLED |
| Pleth waveform | YES | YES |
| Lagre Numeric | YES | YES |
| SpO2 | YES | YES |
| PR | YES | YES |
| Level of | ||
| concern | Moderate | Moderate |
The following is comparison table between subject device and predicate device.
5
Based on the comparison mentioned above, Test data and report information included in this submission, we demonstrate that the subject device is substantially equivalent to the predicate device.
6
9. Functional and safety testing
Non-Clinical Test
The SONOSAT-W01T Wrist Pulse Oximeter is tested in accordance with both mandatory and voluntary standards, including:
IEC 60601-1:2005+Corr.1 (2006)+Corr.2(2007) Medical equipment-Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007/AC:2010 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility
IEC 60601-1-11:2010 medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO 80601-2-61:2011 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO10993. "Biological Evaluation of Medical Devices".
Clinical Test
The clinical evaluation was conducted and the result of SONOSAT-W01T Wrist Pulse Oximeter is in compliance with the criteria of ISO 80601-2-61:2011 standard and FDA guidance - "Pulse Oximeter Premarket Notification Submissions". The functional oxygen saturation (SpO2) measurement has been validated on a total of 24 healthy adult male and female volunteers with2 white people, and 15 yellow-skin people in the range of 70% to 100%.
The SpO2 accuracy result showed that the root-mean-square (Arms) value of SONOSAT-W01T Wrist Pulse Oximeter is ±2% with the saturations from 70% to 100%.
10. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd concludes that SONOSAT-W01T Wrist Pulse Oximeter is substantially equivalent to predicate devices.