(388 days)
The Fingertip Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatic patients in hospitals, hospital facilities and home healthcare environments.
This device is a small, lightweight, portable device intended for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senor and displays on the OLED after certain futher processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.
The provided text describes a 510(k) premarket notification for a Fingertip Pulse Oximeter and includes information about its acceptance criteria and the study conducted to prove it meets these criteria.
Here's the breakdown of the information requested based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Target) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | 70% to 100% saturation range, Root-Mean-Square (Arms) value of ±2% | Root-Mean-Square (Arms) value of ±2% (for 70% to 100% saturation) |
| Pulse Rate Accuracy | 25bpm~250bpm, ±3bpm (for predicate device) | ±3bpm (for 25bpm~250bpm) |
| Biocompatibility | No toxicity to cells, no delayed contact sensitization, no irritation to skin, compliance with ISO10993-1 | No toxicity to cells, no delayed contact sensitization, no irritation to skin, compliant with ISO10993-1 |
| Electrical Safety | Compliance with IEC60601-1 | Compliant with IEC60601-1 |
| EMC | Compliance with IEC60601-1-2 | Compliant with IEC60601-1-2 |
| Home Healthcare Env. Safety | Compliance with IEC 60601-1-11 | Compliant with IEC 60601-1-11 |
| General Pulse Oximeter Requirements | Compliance with ISO 80601-2-61 | Compliant with ISO 80601-2-61 |
| Software Validation | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Compliant with FDA Guidance |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 24 healthy adult male and female volunteers.
- Data Provenance: The document does not explicitly state the country of origin for the volunteers or whether the data was retrospective or prospective. However, given that it's a clinical evaluation for a regulatory submission, it is almost certainly a prospective study. The racial distribution of the volunteers is mentioned: 2 white people, 7 black people, and 15 yellow-skin people.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document implies that the ground truth for SpO2 measurements was established using a reference method as per ISO 80601-2-61:2011 and FDA guidance - "Pulse Oximeter Premarket Notification Submissions." It does not explicitly state that human experts were involved in establishing the ground truth for the test set, but rather that functional oxygen saturation measurement itself (presumably measured by co-oximetry, the reference standard for pulse oximeters) was the ground truth. Therefore, no specific number of experts or their qualifications for establishing ground truth are provided.
-
Adjudication Method for the Test Set:
- Not applicable/Not mentioned. The ground truth method for SpO2 measurements in pulse oximetry studies typically involves a reference co-oximeter (a laboratory instrument that directly measures arterial oxygen saturation from blood samples), not human adjudication of images or signals.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study (MRMC) is typically performed for AI/CAD systems where human readers interpret medical images. For a pulse oximeter, the study focuses on the device's accuracy against a physiological gold standard.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data presented (SpO2 accuracy Arms value) is the direct performance of the device itself, without human intervention in its measurement process. The study validates the device's ability to measure SpO2 alone.
-
The Type of Ground Truth Used:
- The document states that the clinical evaluation "is in compliance with the criteria of ISO 80601-2-61:2011 standard and FDA guidance - 'Pulse Oximeter Premarket Notification Submissions'." These standards and guidance documents for pulse oximeter testing mandate the use of reference co-oximetry measurements from simultaneously drawn arterial blood samples (often during induced hypoxia in healthy volunteers) as the ground truth for SpO2. This is a form of physiological/biometric ground truth.
-
The Sample Size for the Training Set:
- Not applicable/Not mentioned. The device described appears to be a hardware-based medical device with integrated software, not an AI/Machine Learning algorithm that requires a separate "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering validation, not AI model training.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a traditional "training set" for an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 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: K152091
Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA 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
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Page 2 - Mr. Defeng
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 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, Michael J. Ryan -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) K152091
Device Name Fingertip Pulse Oximeter
Indications for Use (Describe)
The Fingertip Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatic patients in hospitals, 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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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: Yu Dengfeng Telephone No.:+86-511-86378639 Fax No.: +86-511-86381308
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | Fingertip Pulse Oximeter |
|---|---|
| Model Name: | SONOSAT-F01T,SONOSAT-F02T |
| 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:
K142888 Fingertip Pulse Oximeter
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 functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senor and displays on the OLED after certain futher processing.
The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.
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The power supply is 3.7V Li-battery and also the subject device can be powered by adapter.
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 Fingertip Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The Finger 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 finger 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.
| Predicate device | Subject device | |
|---|---|---|
| Items | MD300C318T2 | SONOSAT-F01TSONOSAT-F02T |
| Indications foruse | The MD300C318T2 is intendedfor spot checking in measuringand displaying functionalarterial hemoglobin (SpO2) andpulse rate. It is intended for adult,adolescent, child andinfant users in hospitals, hospitalfacilities and home healthcareenvironments. | The Fingertip Pulse Oximeter isintended for spot checking inmeasuring and displayingfunctional arterial hemoglobin(SpO2) and pulse rate of adult andpediatric patients in hospitals,hospital facilities and homehealthcare environments. |
| Intendedpatient | adult, adolescent, child and infant | Adult, pediatric |
| population | ||
| Intendapplication site | Finger | Finger |
| Intendedapplicationenvironment | hospitals, hospital facilities andhome healthcare environments. | hospitals, hospital facilities andhome healthcare environments. |
| SpO2 | SpO2 | |
| Measurement | 70%-100% | 0%-100% |
| Range | Pulse Rate | Pulse Rate |
| 30 to 235 bpm | 18 to 250 bpm | |
| Saturation | Saturation | |
| 70 to 100% ±2% | 70 to 100% ±2% | |
| AccuracyTolerance | Less than 70%, unspecified | Less than 70%, unspecified |
| Pulse Rate | Pulse Rate | |
| ±2bpm | 25bpm~250bpm, ±3bpm | |
| Resolution | SpO21% | SpO21% |
| Pulse Rate1 bpm | Pulse Rate1 bpm | |
| Generalrequirement | Compliance with IEC60601-1 | Compliance with IEC60601-1 |
| Special | Compliance with ISO 80601-2-61 | Compliance with ISO 80601-2-61 |
| reqiurement | Compliance with IEC 60601-1-11 | 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 |
| Classficaiton | II | II |
| Type ofprotection | Internally powered | Internally powered |
| Power Type | battery | battery |
| Degree ofprotection | Type BF - Applied part | Type BF - Applied part |
| Principles ofSensor | pulse oximetry sensors adoptsnon-invasive double wavelengthto measure SpO2 and PR | pulse oximetry sensors adoptsnon-invasive double wavelength tomeasure SpO2 and PR |
| Testsconducted | Cytotoxicity,Delayed Contact Sensitization,Skin Irritation | Cytotoxicity,Delayed Contact Sensitization,Skin Irritation |
| Result of tests | No toxicity to cells.No delayed contact sensitization,No irritation to skin | No toxicity to cells,No delayed contact sensitization,No irritation to skin |
| Description | OLED | OLED |
| Pleth waveform | YES | YES |
| Large Numeric | YES | YES |
| SpO2 | YES | YES |
| PR | YES | YES |
| Level of | YES | YES |
The following is comparison table between subject device and predicate device.
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The Indications for Use is a little different in intended patient population, the clinical study data shows that the proposed device could be used effectively in the patient population we claimed. Therefore, this difference is not critical to the intended use of the proposed device and the difference doesn't affect the safety and effectiveness of the device when used as labeled.
Based on the comparison mentioned above, Test data and report information included in this submission, we demonstrate that the subjected device is substantially equivalent to the predicate device.
9. Functional and safety testing
Non-Clinical Test
The Fingertip Pulse Oximeter models SONOSAT-F02T is tested in accordance with both mandatory and voluntary standards, including:
60601-1:2005+Corr.1 (2006)+Corr.2(2007) Medical electrical equipment-Part 1: General IEC 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 Finger Type 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 with 2 white people, 7 black people, and 15 yellow-skin people in the range of 70% to 100%.
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The SpO2 accuracy result showed that the root-mean-square (Arms) value of the SONOSAT-F01T and SONOSAT-F02T Fingertip 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 Fingertip Pulse Oximeter models SONOSAT-F01T and SONOSAT-F02T is substantially equivalent to predicate devices.
§ 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).