(298 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or methodologies.
No.
This device is designed for monitoring (spot checking pulse oxygen saturation and pulse rate) rather than providing therapy or treatment.
Yes
Explanation: The device is described as "designed for spot checking of the pulse oxygen saturation and pulse rate" and can "display SpO2%, pulse rate value". These are measurements used to assess a patient's physiological state, which is indicative of a diagnostic function.
No
The device description explicitly states it is a "fingertip pulse oximeter" and describes physical components like displaying values and a bar graph, indicating it is a hardware device with integrated software, not a software-only 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 provide information about a person's health. These tests are performed outside of the body (in vitro).
- Pulse Oximeter Function: A pulse oximeter measures oxygen saturation and pulse rate by shining light through the skin (typically on a fingertip) and analyzing the light absorption. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Device Description: The description clearly states it's a "fingertip pulse oximeter" and describes its function as displaying SpO2% and pulse rate. There is no mention of analyzing biological samples.
- Performance Studies: The performance study involves measuring SpO2 directly from the device and comparing it to arterial blood CO-Oximetry (which is an in vitro test on a blood sample, but the device itself is not performing this test).
Therefore, based on the provided information, the YK-81C pulse oximeter is a non-invasive medical device and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;
The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
clinic environment.
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
After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-28yr, 46-74kg, 156-176cm, with light to dark pigmentation) were included in the study conducted Nov. 27-29, 2015 to evaluate the SpO2 accuracy performance of proposed devices.
Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical trial (invasive laboratory testing on healthy volunteers)
Sample Size: 12 healthy adult volunteer subjects
Key Results: The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 2.53 (YK-81C) during steady state conditions over the range of 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 70%~100%, ±3%
PR (Pulse Rate) accuracy: ±2 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.
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 stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three overlapping profiles, creating a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
Xuzhou Yongkang Electronic Science Technology Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd. Li Yuan Town, Tongzhou District, Beijing, 101121 CHINA
Re: K161938
Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 26, 2017 Received: March 30, 2017
Dear Ray Wang:
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
Page 2 - Ray Wang
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,
Tina Kiang
-s
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 Fingertip Pulse Oximeter
Indications for Use (Describe)
The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,
| 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
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K161938
-
- Date of Preparation
03/27/2017
- Date of Preparation
-
Sponsor 2.
Xuzhou Yongkang Electronic Science Technology Co., Ltd
4F Building C8, 40 Jingshan Road, Econonic and Technolgical Development Zone, Xuzhou, Jiangsu, China Establishment Registration Number: Not yet registered or the Number Contact Person: YanLi Li Position: General Manager Tel: 86-516- 87892766-631 Fax:86- 516-87892766 -606 Email: lyl@yonker.cn
- Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Fingertip Pulse Oximeter Common Name: Pulse Oximeter Model(s): YK-81C
Regulatory Information: Classification Name: Oximeter Classification: II; Product Code: DQA; Regulation Number: 21 CFR 870.2700; Review Panel: Anesthesiology;
Intended Use Statement:
The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
- Device Description 5.
The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;
The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.
5
6. Identification of Predicate Device
Predicate 1# 510(k) Number: K142687 Product Name: Pulse Oximeter Manufacturer: Shanghai Berry Electronic Tech Co., Ltd.
Predicate 2# 510(k) Number: K093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
ISO 80601-2-61:2011, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
IEC 60601-1-8:2012 Medical electrical equipment General requirements for safety - for collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
Performance Test: SpO2 and PR accuracy/SpO2 and PR accuracy under low perfusion/SpO2 and PR accuracy test after cleaning and low-level disinfection (500 times)
Performance Test: Vertical Pulse Amplitude feature.
Performance Test: Finger Off and Low Battery indicator.
8. Clinical Test Conclusion
The clinical trial was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers.
The purpose of the clinical trial was to evaluate the SpO2 accuracy performance of the YK-80C
6
Fingertip Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.
After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-28yr, 46-74kg, 156-176cm, with light to dark pigmentation) were included in the study conducted Nov. 27-29, 2015 to evaluate the SpO2 accuracy performance of proposed devices.
Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.
The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 2.53 (YK-81C) during steady state conditions over the range of 70-100%.
7
| ITEM | Proposed Device
Fingertip Pulse Oximeter
(YK-81C) | Predicate Device
Pulse Oximeter (BM1000A &
BM2000A) | Predicate Device MD300C1
Fingertip pulse oximeter | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQA | DQA | DQA | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Class | 2 | 2 | 2 | |
| Indications For
Use | The pulse oximeter (YK-81C) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | MD300C1 Finger pulse oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, anesthesia, intensive care and etc). Not for continuously monitoring. | |
| Application Site | Fingertip | Fingertip | Fingertip | |
| | ITEM | Proposed Device | Predicate Device | Predicate Device |
| | | Fingertip Pulse Oximeter
(YK-81C) | Pulse Oximeter (BM1000A &
BM2000A) | MD300C1 Fingertip pulse
oximeter |
| | Measurement
wavelength | Red: 660nm
Infrared: 940nm | Red: 660nm
Infrared: 940nm | Red: 660nm
Infrared: 940nm |
| | LED Radiant
Power | 21.8 mW/cm² | N/A | 21.8 mW/cm² |
| | SpO2 Indication
Waveform | Yes | Yes | Yes |
| | SpO2measurement
range | 0-100% | 0-100% | 0-100% |
| | SpO2accuracy | 70%~100%, ±3% | 70%-100% ±3%; Undefined for