(103 days)
Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) 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.
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, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, model C101A2, C101B1, C101A3 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.
Acceptance Criteria and Device Performance Study for Pulse Oximeter (Model C101A2, C101B1, C101A3)
The provided document, a 510(k) Summary for the Pulse Oximeter (Model C101A2, C101B1, C101A3), indicates that the device is substantially equivalent to a previously cleared predicate device (Pulse Oximeter, Model C101H1). This means that the acceptance criteria and performance data for the subject device are considered equivalent to those established for the predicate device.
Crucially, the document states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence."
Therefore, the information below refers to the performance that the predicate device (K173123) demonstrated, which the subject device (K221979) is claimed to meet by virtue of substantial equivalence. The summary does not include new testing data specifically for the subject device's performance against these criteria, except for biocompatibility due to a color change in patient-contacting materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the specifications of the predicate device, which the subject device is deemed to meet.
| Item | Acceptance Criteria (from Predicate Device K173123) | Reported Device Performance (for Subject Device K221979) |
|---|---|---|
| SpO2 Measuring Range | 0%-100% | 0%-100% |
| SpO2 Resolution | 1% | 1% |
| SpO2 Accuracy | 70-100%, ±3% | 70-100%, ±3% |
| PR Measuring Range | 30-240 BPM | 30-240 BPM |
| PR Resolution | 1 bpm | 1 bpm |
| PR Accuracy | ±1 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-1-11 | Comply with IEC 60601-1, IEC 60601-1-11 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance Standard | ISO 80601-2-61 | ISO 80601-2-61 |
| Biocompatibility | Comply with ISO 10993-1, FDA Guidance (for previous device) | Cytotoxicity per ISO 10993-5, Irritation per ISO 10993-10, Sensitization per ISO 10993-10 (for new device due to color change) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence."
Therefore, no new performance test data for SpO2 or PR accuracy is included for the subject device (K221979) in this submission. The assumption is that the previously cleared predicate device (K173123) met these criteria, and since the technology is the same, no new testing was deemed necessary for these aspects. Details regarding the sample size and data provenance for the predicate device's original performance testing are not provided in this summary.
For Biocompatibility testing (which was performed for the subject device due to a color change in patient-contacting materials):
- Sample Size: Not specified for each test (Cytotoxicity, Irritation, Sensitization), but standard procedures would involve multiple samples of the actual patient-contacting materials.
- Data Provenance: Not specified; assumed to be conducted in a laboratory setting as per international standards (ISO 10993).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary, as no new clinical or performance studies for SpO2/PR accuracy were conducted for the subject device. For the original predicate device, pulse oximeter accuracy studies typically involve comparing the device's readings to arterial blood gas analysis (co-oximetry) measurements, which serve as the ground truth. This process usually involves clinical personnel (e.g., nurses, physicians, respiratory therapists) performing the measurements and often statistical experts involved in data analysis, but not necessarily "experts establishing ground truth" in the sense of image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as no new clinical or performance studies involving adjudication were conducted for the subject device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a Pulse Oximeter, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone pulse oximeter that provides direct measurements of SpO2 and PR. Its performance evaluation would inherently be "standalone" in the sense that it directly measures physiological parameters without human interpretation in the loop (beyond reading the display). The performance criteria listed (SpO2/PR accuracy) are indicative of standalone performance against a clinical reference standard. The document states "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." This implies that the standalone performance requirements previously established for the predicate device were considered met.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For pulse oximetry, the ground truth for SpO2 accuracy is typically arterial blood gas analysis (co-oximetry), which provides a highly accurate measure of arterial oxygen saturation. For Pulse Rate (PR), the ground truth is often established by electrocardiography (ECG) or a manually measured pulse using a stopwatch. This information is not explicitly stated in this 510(k) summary for the predicate device's original testing, but these are the standard methods for validating pulse oximeter performance.
8. The sample size for the training set
This is not applicable/not provided. The device is a traditional medical device (pulse oximeter) that relies on physical principles (spectrophotometry and photoplethysmography) rather than machine learning or AI models that require training data.
9. How the ground truth for the training set was established
This is not applicable/not provided for the same reason as above; there is no "training set" in the context of this traditional device.
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October 16, 2022
Shenzhen IMDK Medical Technology CO., Ltd. % Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K221979
Trade/Device Name: Pulse Oximeter (Model C101A2, C101B1, C101A3) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 16, 2022 Received: September 16, 2022
Dear Boyle 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/cfpmn/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 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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221979
Device Name Pulse Oximeter(Model:C101A2,C101B1,C101A3)
Indications for Use (Describe)
Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) 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.
Type of Use (Select one or both, as applicable)
| Research Use (21 CFR 201.3 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201.3 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K221979
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| 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 |
| Tel: | 86-755-27155684 |
| Contact: | Yuan Xia |
| Registration Number: | 3015007456 |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Sep.27,2022
2.0 Device Information
| Trade name: | Pulse Oximeter |
|---|---|
| Common name: | Pulse Oximeter |
| Classification name: | Oximeter |
| Model(s): | C101A2, C101B1, C101A3 |
| Production code: | DQA |
| Regulation number: | 21 CFR 870.2700 |
| Classification: | Class II |
| Panel: | Cardiovascular |
3.0 Predicate Device Information
| Manufacturer: | Shenzhen IMDK Medical Technology Co., Ltd |
|---|---|
| Trade name: | Pulse Oximeter, Model: C101H1 |
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510(k) number: K173123
4.0 Indication for Use Statement
Fingertip Pulse Oximeter (Model: C101A2, C101B1, C101A3) 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.
5.0 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, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, model C101A2, C101B1, C101A3 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.
6.0 Technological Characteristics
Principle of Operation
There is no change in the principle of operation as part of this submission from the previous clearance under K173123. The module still utilizes the same principles of operation for pulse oximetry governed by the following principles:
-
Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
-
The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
Mechanism of Action for Achieving the Intended Effect
There is no change to the Mechanism of Action of the Pulse Oximeter (Model: C101A2, C101B1, C101A3) from the previous clearance K173123- Pulse Oximeter (Model: C101H1):
A mathematic formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and
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Oxyhemoglobin (Hbo2) in red and near-infrared zones. Operation principle of the instrument: Photoeletric Oxyhemoglobin Inspection Technology adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused on a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeters display through process in electronic circuits and microprocessor.
7.0 Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device
The subject device, Pulse Oximeter (Model: C101A2, C101B1, C101A3) and the predicate device Pulse Oximeter (Model: C101H1), have the following key similarities:
- · Both devices have the same intended use
- · Both devices are indicated for the same patient population
- Both devices have the same principle of operation and mechanism of action
The subject device and the primary predicate device have the following differences: The appearance of the Subject device is different with that of the Predicate device. But this difference does not affect the basic safety and essential performance, the subject and the predicate are the same and substantially equivalent.
8.0 Non-clinical Testing
In this current submission, just add four model C101A2, C101B1,C101A3 to the Legally marketed predicate device K173123.
As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence.
Performance Bench Testing
As there are no hardware or software changes as part of this submission from the previous clearance, no performance bench testing was included as part of this submission.
Biocompatibility Testing
As the color of enclosure changes to the patient contacting materials as part of this submission from the previous clearance, biocompatibility testing was included as part of this submission.
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a risk management process". The biocompatibility
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testing included the following tests:
- Cytotoxicity;
- Irritation;
- · Sensitization.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no changes to the hardware or software as part of this submission from the previous clearance, no Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning testing was included with this submission.
Software Verification and Validation Testing
As there are no software changes as part of this submission from the previous clearance, no software testing was included as part of this submission.
9.0 Clinical Test Conclusion
As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence.
10.0 Technological Characteristic Comparison Table
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Table1-General Comparison
| Item | Subject DeviceK221979 | Predicated DeviceK173123 | Remark |
|---|---|---|---|
| Product Name | Pulse Oximeter | Pulse Oximeter | -- |
| Manufacturer | Shenzhen IMDK Medical TechnologyCo., Ltd. | Shenzhen IMDK Medical TechnologyCo., Ltd. | -- |
| Product Code | DQA | DQA | Same |
| Regulation No. | 21CFR 870.2700 | 21CFR 870.2700 | Same |
| Class | Class II | Class II | Same |
| Model | C101A2, C101B1, C101A3 | C101H1 | -- |
| IntendedUse/Indicationfor Use | Fingertip Pulse Oximeter (Model:C101A2, C101B1, C101A3) is anon-invasive device intended forspot checking of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR). Thisportable device is indicated for usein adult patients in hospitals. | Fingertip Pulse Oximeter C101H1 is anon-invasive device intended for spotchecking of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR). Thisportable device is indicated for use inadult patients in hospitals. | Same |
| Principle | The device displays numericalvalues for functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate bymeasuring the absorption of red andinfrared (IR) light passing throughperfused tissue. Changes in theabsorption caused by the pulsationof blood in the vascular bed areused to determine oxygen saturationand pulse rate. | The device displays numerical valuesfor functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate by measuring the absorption of redand infrared (IR) light passing throughperfuse tissue. Changes in theabsorption caused by the pulsationof blood in the vascular bed are used todetermine oxygen saturation and pulserate. | Same |
| AppliedPopulation | Adults in a clinic environment | Adults in a clinic environment | Same |
| Application sites | Finger | Finger | Same |
| Display Type | OLED | OLED | Same |
| Display Content | Display the SPO2, PR, pulse bargraph, pulse wave and batterypower status | Display the SPO2, PR, pulse bargraph, pulse wave and battery powerstatus | Same |
| Contactingmaterial | Shell: ABSClip pad: SiliconButton: PC | Shell: ABSClip pad: SiliconButton: PC | Same |
| OverallDimension | C101A2: 603633mmC101B1: 663633mmC101A3: 583633mm | 603635mm | -- |
Table 2 Performance Comparison
| Item | Subject DeviceK221979 | Predicate DeviceK173123 | Remark |
|---|---|---|---|
| LED wavelength | Red= 660 nm; Infrared=904nm | Red= 660 nm; Infrared=904nm | Same |
| Power source | 2 AAA alkaline batteries | 2 AAA alkaline batteries | Same |
| Display data | SpO2%; PR | SpO2%; PR | Same |
| SpO2 MeasuringRange | 0%-100% | 0%-100% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70~100%, ±3%; | 70~100%, ±3%; | Same |
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510(k) Summary
| PR MeasuringRange | 30-240BPM | 30-240BPM | Same |
|---|---|---|---|
| PR Resolution | 1 bpm | 1 bpm | Same |
| PR Accuracy | ±1 bpm or ±1%, whichever isgreater | ±1 bpm or ±1%, whichever isgreater | Same |
Table 3 Safety Comparison
| Item | Subject DeviceK221979 | Predicate DeviceK173123 | Remark |
|---|---|---|---|
| Electrical Safety | Comply with IEC 60601-1IEC 60601-1-11 | Comply with IEC 60601-1IEC 60601-1-11 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | Same |
| Biocompatibility | Cytotoxicity per ISO 10993-5;Irritation per ISO 10993-10;Sensitization per ISO 10993-10 | Comply with ISO 10993-1, FDA Guidance | Same |
11.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.
§ 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).