(318 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description relies on standard optical and signal processing techniques for pulse oximetry.
No
The device is described as a non-invasive device intended for spot checking of physiological parameters (SpO2 and pulse rate), not for treatment or therapy.
Yes
The device is intended for "spot checking of function of arterial hemoglobin (SpO2) and pulse rate (PR)", which involves measuring physiological parameters to assess a patient's condition, thus serving a diagnostic purpose.
No
The device description explicitly states that the electrical signal from the finger sensor is "processed by hardware and software of the unit," indicating the presence of dedicated hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The Fingertip Pulse Oximeter C101H1 is a non-invasive device that measures SpO2 and pulse rate by shining light through the finger and analyzing the absorption of that light by the blood. It does not involve the collection or analysis of specimens taken from the body.
The device is a medical device, but it falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Fingertip Pulse Oximeter C101H1 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
Product codes
DOA
Device Description
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.
The pulse oximeter, C101H1, 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 device is not for life-supporting or life-sustaining, not for implant.
The device is not provided sterile and is NOT a reprocessed single-use device.
The device is a spot-check pulse oximeter and does not include alarms.
The device does not support the measurement in the condition of low perfusion.
The device is not intended for life-supporting or life-sustaining.
The device is reusable and does not need sterilization.
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 patients
Intended User / Care Setting
Hospitals
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 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. 12 healthy adult volunteer subjects (ages 22-27yr, with light to dark pigmentation) were included in the study conducted 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 SpO2 accuracy comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility evaluation: The biocompatibility evaluation for the Pulse Oximeter C101H1 were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included: Cytotoxicity, Sensitization, Irritation.
Electrical safety and electromagnetic compatibility (EMC): Testing was conducted on the Pulse Oximeter C101H1. The system complies with the IEC 60601-1:2005/A1: 2012, IEC 60601-1-11: 2015 and ISO 80601-2-61: 2011 standards for electrical safety and the IEC 60601-1-2:2014 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Performance Testing: Pulse rate accuracy test and Cleaning and disinfection cycle test were performed.
Clinical data: 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 was to evaluate the SpO2 accuracy performance of the C101H1 Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. 12 healthy adult volunteer subjects (ages 22-27yr, with light to dark pigmentation) were included. The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 2.12 during steady state conditions over the range of 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70~100%, ±3%; 0-69%, unspecified.
PR Measuring Range: 30-240BPM.
PR Accuracy: ±1 bpm or ±1%, whichever is greater.
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
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Shenzhen IMDK Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square No. 18, Taizi Road Nanshan District, Shenzhen, 518067 Cn
Re: K173123
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 12, 2018 Received: July 12, 2018
Dear Kevin 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. 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/cfpmp/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
1
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) 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 (QS) 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Pulse Oximeter
Indications for Use (Describe)
Fingertip Pulse Oximeter C101H1 is a non-invasive device intended for spot checking of function of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
| 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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2017/09/20
1. Submission sponsor
Name: Shenzhen IMDK Medical Technology Co., Ltd.
Address: C Zone, 10F, Building 16, Yuanshan Industrial B Area, Gongming Street, Guangming
District, Shenzhen, Guangdong, P.R. China
Contact person: Xia Yuan
Title: Administration Director
E-mail: vicky@estne.org
Tel: +86 755 33637905
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: 22A, Haijing Square, No. 18, Taizi Road, Nanshan District, Shenzhen, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Pulse Oximeter |
|---|---|
| Model | C101H1 |
| Common Name | Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
AMEMO Inc. Fingertip Pulse Oximeter A310/ K153021.
The subject device has same intended use, same target patient population, and same performance effectiveness as the predicate device and there are no different questions of effectiveness and safety. So, the conclusion is that the subject device is substantial equivalent to the predicate.
5. Device Description
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.
The pulse oximeter, C101H1, is designed for spot checking of the pulse oxygen saturation and pulse rate
4
for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring. The device is not for life-supporting or life-sustaining, not for implant.
The device is not provided sterile and is NOT a reprocessed single-use device.
The device is a spot-check pulse oximeter and does not include alarms.
The device does not support the measurement in the condition of low perfusion.
The device is not intended for life-supporting or life-sustaining.
The device is reusable and does not need sterilization.
6. Intended use & Indication for use
Fingertip Pulse Oximeter C101H1 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
7. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters improvement, detailed substantial equivalence discussion is included in the following tables.
| Comparison Items | Proposed device: C101H1 | Predicate device: A310
(K153021) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/ Indications
for use | Fingertip Pulse Oximeter C101H1
is a non-invasive device intended
for spot checking of functional
oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate
(PR). This portable device is
indicated for use in adult patients
in hospitals. | Fingertip Pulse Oximeter A310 is
a non-invasive device intended for
spot checking of functional
oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate
(PR). This portable device is
indicated for use in adult patients
in hospitals |
| Principle | The device displays numerical
values for functional oxygen
saturation of arterial hemoglobin
(SpO2) and pulse rate by
measuring the absorption of red
and infrared (IR) light passing
through perfused tissue. Changes
in the absorption caused by the
pulsation of blood in the vascular | The device displays numerical
values for functional oxygen
saturation of arterial hemoglobin
(SpO2) and pulse rate by
measuring the absorption of red
and infrared (IR) light passing
through perfused tissue. Changes
in the absorption caused by the
pulsation of blood in the vascular |
5
| | Comparison Items | Proposed device: C101H1 | Predicate device: A310
(K153021) |
|-----------|----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| | | bed are used to determine oxygen
saturation and pulse rate. | bed are used to determine oxygen
saturation and pulse rate. |
| ecificati | LED wavelength | Red= 660 nm; Infrared=904nm | Red= 660 nm; Infrared=905nm |
| | Power source | 2 AAA alkaline batteries. | 2 AAA alkaline batteries. |
| | Display data | SpO2%; PR | SpO2%; PR |
| | SpO2 Measuring
Range | 0%-100% | 0%-100% |
| | SpO2 Resolution | 1% | 1% |
| | SpO2 Accuracy | 70100%, ±3%; | 70100%, ±3%; |
| | | | 0-69%, unspecified; |
| | PR Measuring
Range | 30-240BPM. | 30-235BPM. |
| | PR Resolution | 1 bpm | 1 bpm |
| | PR Accuracy | ±1 bpm or ±1%, whichever is | ±2 bpm (30-99bmp) |
| | | greater | ±1% (100-235bmp) |
| | Biocompatibility | ISO 10993-5 and ISO 10993-10 | ISO 10993-5 and ISO 10993-10 |
| 'esting | Electrical Safety | IEC 60601-1 | IEC 60601-1 |
| | | IEC 60601-1-11 | IEC 60601-1-11 |
| | Electromagnetic
Compatibility | IEC 60601-1-2 | IEC 60601-1-2 |
| | Performance | ISO 80601-2-61 | ISO 80601-2-61 |
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination. Biocompatibility evaluation:
The biocompatibility evaluation for the Pulse Oximeter C101H1 were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject devices are made up of enclosure, button and finger clip. The finger clip will contact with patient skin. According to ISO 10993-1, the contacting classification is surface contacting and the
6
duration is intact skin contact less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the Pulse Oximeter C101H1, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012, IEC 60601-1-11: 2015 and ISO 80601-2-61: 2011 standards for electrical safety and the IEC 60601-1-2:2014 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Performance Testing
- Pulse rate accuracy test
- Cleaning and disinfection cycle test
Clinical data:
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 C101H1 Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. 12 healthy adult volunteer subjects (ages 22-27yr, with light to dark pigmentation) were included in the study conducted 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 SpO2 accuracy comparison. The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 2.12 during steady state conditions over the range of 70-100%.
Summary:
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to substantially equivalent to the predicate device.
9. Conclusion
The non-clinical data support the substantial equivalence of the device and the hardware and software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. The clinical data demonstrate that the subject device performs comparably to the predicate
7
device that is currently marketed for the same intended use.