(261 days)
Not Found
No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities. The performance studies focus on SpO2 accuracy against a reference method, not on the performance of any AI/ML algorithm.
No
The device is designed for monitoring physiological parameters (SpO2 and pulse rate) for spot checking, not for delivering therapy.
Yes
A pulse oximeter measures physiological parameters (oxygen saturation and pulse rate) which are used by clinicians to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is a "fingertip device" and describes physical features like a low battery indicator and finger off indicator, indicating it is a hardware device with embedded software, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a pulse oximeter that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by placing it on the finger. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment." This describes a direct physiological measurement.
Therefore, the function and intended use of this pulse oximeter fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
Product codes
DQA
Device Description
The proposed device, pulse oximeter, includes two models in this application, BM1000C. The two proposed devices all are fingertip device; they are share the following same features:
- ★ Spot check and display SpO2 and PR value;
- ★ Low battery capacity indicator;
- ★ Finger off indicator;
- ★ wireless connection function
Beside the features above, the BM1000 can display Plethysmogram wave, but the BM1000C deoesn't have this function.
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of thefunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
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
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
Not Found
Summary of Performance Studies
Clinical trial 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.
Purpose: Evaluate SpO2 accuracy performance of the BM1000C 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.
Sample Size: 12 healthy adult volunteer subjects (ages 20-41yr, 42-95kg, 155-181cm, with light to dark pigmentation).
Data Collection: System evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% SaO2. Arterial blood samples drawn during simultaneous data collection from the test devices. Blood immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.
Key Results: The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 1.50 (BM1000C) during steady state conditions over the range of 70-100%. No adverse effects or complications occurred. Clinical test result of BM1000C considered applicable to BM1000 due to only difference being Plethysmogram wave display, which does not affect measurement accuracy.
Key Metrics
SpO2 accuracy: Arms of 1.50 (BM1000C) over the range of 70-100%.
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 4, 2018
Shanghai Berry Electronic Tech Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, 102401 CN
Re: K172141
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 1, 2018 Received: March 5, 2018
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.
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 device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about medical devices and radiation-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,
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
2
Indications for Use
510(k) Number (if known) K172141
Device Name Pulse Oximeter
Indications for Use (Describe)
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult 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
Tab #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: K172141
-
- Date of Preparation: 03/27/2018
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- Sponsor Identification
Shanghai Berry Electronic Tech Co., Ltd Unit C, 1st Floor, 7th Building, No.1188 Lianhang Road, Minhang District,Shanghai, China 201112 Establishment Registration Number: 3009241523
Contact Person: Xuezhi Yin Position: General Manager Tel: +86-21-5853 1958 Fax: +86-21-5853 0468 Email: berrymedical@hotmail.com
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- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Technology Service Co., Ltd.
5-402, Building #27, YangGuang YiShang, No. 56, LiangXiang East Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-80337041 Email: ray.wang@believe-med.com
4
510(k) Summary
- Identification of Proposed Device 4.
Trade Name: Pulse Oximeter Common Name: Pulse Oximeter Model(s): BM1000/BM1000C
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 (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
Device Description
The proposed device, pulse oximeter, includes two models in this application, BM1000C. The two proposed devices all are fingertip device; they are share the following same features:
- ★ Spot check and display SpO2 and PR value;
- ★ Low battery capacity indicator;
- ★ Finger off indicator;
- ★ wireless connection function
Beside the features above, the BM1000 can display Plethysmogram wave, but the BM1000C deoesn't have this function.
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of thefunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is not provided sterile and is not a reprocessed single-use device.
-
- Identification of Predicate Device(s)
Predicate Device :
- Identification of Predicate Device(s)
510(k) Number: K141362 Product Name: Pulse Oximeter CMS50EW
5
510(k) Summary
Model Name: CMS50EW Manufacturer: Contec Medical System Co., Ltd.
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Non-Clinical Test Conclusion 6.
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 60601-1:2005/A1:2012, Medical electrical equipment- Part 1: General requirements for basic safety, a. and essential performance.
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IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety b. And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
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ISO 80601-2-61:2011,Medical electrical equipment Part 2-61: Particular requirements for basic safety C. and essential performance of pulse oximeter equipment.
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d. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
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ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin e. sensitization.
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Shelf Life Testing f.
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SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test after the repeated clean & disinfection g. conditions).
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h. SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the normal conditions).
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SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the low perfusion conditions). i.
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SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the wireless Bluetooth j. conditions without outside interference).
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SpO2 Accuracy and Pulse Rate Accuracy Performance Testing (Test under the wireless Bluetooth k. conditions with outside interference).
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Wireless coexistence testing. 1.
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FCC Part 15C Testing. m.
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Software Validation and Verification Testing. n.
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- 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 BM1000C 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 20-41yr, 42-95kg, 155-181cm, with light to dark pigmentation) were included in the study conducted Nov. 9-10,
6
510(k) Summary
2013 to evaluate the SpO2 accuracy performance of proposed devices.
The system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% 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.
No adverse effects or complications occurred during the study.
The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 1.50 (BM1000C) during steady state conditions over the range of 70-100%.
Because the BM1000C and BM1000 has only difference as Plethysmogram wave display, no difference would effects the measurement accuracy, so the clinical test result of BM1000C could be consider as applicable to BM1000.
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8. Substantially Equivalent (SE) Comparison
Table 7-1 Comparison of Technology Characteristics
| ITEM | Proposed Device
Pulse Oximeter (BM1000 & BM1000C) | Predicate Device Pulse Oximeter CMS50EW (K141362) | Remark | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------|
| Product Code | DQA | DQA | SE | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | SE | |
| Class | 2 | 2 | SE | |
| Intended Use | The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery,anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use. | Analysis 1 | |
| Features | BM1000 %SpO2 and PR measurement, Plethysmogram wave, Bluetooth | %SpO2 and PR measurement, Pulse bar, Pulse wave | SE | |
| | BM1000C %SpO2 and PR measurement, Bluetooth | Alarm function, Bluetooth | SE | |
| configuration | | Fingertip | Fingertip | SE |
| SpO2 measurement range | | 0%-100% | 0%-100% | SE |
| SpO2accuracy | | $±3% (70%~100%); Undefined for