(222 days)
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment. The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
I am unable to answer this question. The provided text does not contain detailed information about the acceptance criteria for the Oxiband (Checkme) O2 Pulse Oximeter, nor does it describe a specific study proving the device meets these criteria in the structured format requested (e.g., test set sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).
While the document mentions non-clinical and clinical tests were performed and standards were met (e.g., ISO 80601-2-61 for SpO2 accuracy), it does not provide the granular details necessary to fill out all the requested fields. For example, it states "The SpO2 accuracy performance results showed the Checkme Pro Health Monitor with external SpO2 sensor to have an ARMS of 1.88 during steady state conditions over the range of 70%-100%", but it does not specify the sample size of subjects in this study, the provenance of the data, the methodology for establishing ground truth, or details about any human-in-the-loop studies.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Viatom Technology Co., Ltd. % Vaibhav Rajal Official Correspondent for Shenzhen Viatom Technology Co., Ltd mdi Consultants, Inc. 55 Northern Blvd.. Suite 200 Great Neck, New York 11021
Re: K191088
Trade/Device Name: Oxiband (Checkme) O2 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: October 31, 2019 Received: November 1, 2019
Dear Vaibhav Rajal:
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
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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/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,
Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K191088
Device Name Oxiband (Checkme) O2 Pulse Oximeter
Indications for Use (Describe)
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
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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510(k) SUMMARY
1. Submitter's Identification:
| Applicant: | Establishment Registration Number: 3011200896Shenzhen Viatom Technology Co., Ltd4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67Xin'an Street, Baoan District, Shenzhen Guangdong, CHINA 518101www.viatomtech.com |
|---|---|
| Contact: | Zhou SaixinGeneral ManagerShenzhen Viatom Technology Co., Ltd.4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67Xin'an Street, Baoan District, Shenzhen Guangdong, CHINA 518101Phone: +86 755 86638929Fax: +86 755 22649904Email: zhousaixin@viatomtech.com |
| Prepared by: | Mr. Vaibhav Arvind RajalRegulatory Consultantmdi Consultants, Inc.Direct Tel. 201-887-3180Phone- 516-482-9001Fax- 516-482-0186Email: vaibhav@mdiconsultants.com |
| Date Prepared: | November 25, 2019 |
2. Name of the Device:
Device Common Name: Pulse Oximeter Device Trade Name: Oxiband (Checkme) O2 Pulse Oximeter Model: Oxiband Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA
3. Predicate Device information:
3.1 Primary Predicate Device
510(k) Number: K172366 Trade/ Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter
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Regulatory Class: II Product Code: DOA Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
3.2 Reference Predicate Device
510(k) Number: K150869 Trade/ Device Name: Checkme Pro Health Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: II Product Code: MWI Manufacturer: Shenzhen Viatom Technology Co., Ltd.
4. Device Description:
The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring.
The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment.
The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc.
The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
5. Indications for Use/ Intended Use:
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing, and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
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| Characteristics | Subject Device | PrimaryPredicate Device | ReferencePredicateDevice | SubstantialEquivalenceor Difference |
|---|---|---|---|---|
| Name of thedevice | Oxiband(Checkme) O2Pulse Oximeter | Wrist PulseOximeterMD300W314B4 | Health MonitorCheckme Pro | SubstantiallyEquivalent. |
| Manufacturer | ShenzhenViatomTechnologyCo., Ltd | Beijing ChoiceElectronicTechnology Co.,Ltd. | ShenzhenViatomTechnologyCo., Ltd | SubstantiallyEquivalent. |
| 510(K) Number | K191088 | K172366 | K150869 | SubstantiallyEquivalent. |
| Product code | 21 CFR870.2700, DQA | 21 CFR870.2700, DQA | 21 CFR870.2300, MWISecondaryproduct codes:21 CFR870.2700, DQA21 CFR870.2340, DPS21 CFR880.2910, FLL21 CFR870.2300, DRT | SubstantiallyEquivalent. |
| Classification | II | II | II | SubstantiallyEquivalent. |
| Indication forUse | The OxibandPulse Oximeteris a wrist pulseoximeterindicated foruse inmeasuring,displaying,storing andtransmittingfunctionaloxygensaturation ofarterialhemoglobin(SpO2) andpulse rate foradult patients. It | The Wrist PulseOximeter is awrist pulseoximeterindicated for usein measuring,displaying,storing andtransmittingfunctionaloxygen saturationof arterialhemoglobin(SpO2) and pulserate for adult,adolescent, childand infantpatients. It is | The CheckmePro HealthMonitor isintended to beused formeasuring,displaying,reviewing andstoring of ECG(adults only),oxygensaturation andpulse rate(adults only forcontinuous datacollection andrecording,adults and | Comparedwith PrimaryPredicateDevice:Both thesubject deviceand theprimarypredicatedevice havesame IFUincludingmeasuring,displaying,storing andtransmitting ofpulse oxygensaturation |
| is intended for | intended for spot- | pediatrics for | (SpO2) and Pulse Rate. | |
| spot-check and/or continuousdata collection,and notcontinuousmonitoring. Itcan be used insleep labs, long-term care,hospitals andhome use. | check and/ ordata collection,recording andtransmitting. Itcan be used insleep labs, long-term care,hospitals andhome use. | spot-checking)and temperaturein the home orin healthcarefacilities.This device isnot intended tosubstitute for ahospitaldiagnostic ECGdevice and notto be used onpatients withimplantedcardiac devices,such aspacemakersand/orimplantedcardio-defibrillators(ICDs). | Both thedevices arewrist pulseoximeter.The subjectdevice is usedfor adultpatientswhereas thepredicatedevice is usedin a widerrange ofpatientpopulation likeadult,adolescent,child andinfant patientsThe subjectdevice is usedfor spot-checkor continuousdata collection,and notcontinuousmonitoringwhereas theprimarypredicatedevice isintended forspot-checkand/ or datacollection. Theprimarypredicatedevice is alsonot used forcontinuousmonitoring, sothey aresubstantially |
6.Comparison to the 510(k) Cleared Devices (Predicate Devices):
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| differentexpression. | ||
|---|---|---|
| ComparedwithReferencePredicateDevice:Both thesubject deviceand thereferencepredicatedevice havesimilarfunctionincludingmeasuring,displaying,storing andtransmitting ofpulse oxygensaturation(SpO2) andPulse Rate.The referencepredicatedevice is aCardiacMonitor andhas morefunction (suchas ECG andTemperature).The ECG,Temperatureand SpO2 areseparatefunction inreferencepredicatedevice, so theECG andTemperaturefunctions donot affect theSpO2 and |
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| Pulse Rateaccuracy, thedifferenceswill not raisenew questionsof safety andeffectiveness.The subjectdevice is usedfor spot-checkor continuousdata collection,and notcontinuousmonitoring inadults whereasthe referencepredicatedevice is usedin adults onlyfor continuousdata collectionand recording,adults andpediatrics forspot-checking .The referencepredicatedevice is alsonot used forcontinuousmonitoring, thesubject deviceis based ob thereferencepredicatedevice, so theyaresubstantiallyequivalent, justdifferentexpression. | PredicateDevice: | ||||||
|---|---|---|---|---|---|---|---|
| Rx or OTC | Rx | Rx | Rx | SubstantiallyEquivalent. | The subjectdevice is usedfor adultpatientswhereas thepredicatedevice is usedin a widerrange ofpatientpopulation likeadult,adolescent,child andinfant patients.Thedifferencesdoes not affectthe safety andeffectivenessof the subjectdevice. | ||
| Patient type | Adult | Adult,Adolescent, Childand Infant | Adult andpediatric | Comparedwith Primary | ComparedwithReferencePredicateDevice: | ||
| The subjectdevice is usedfor adultpatientswhereas thereferencepredicatedevice is usedin a widerrange ofpatient typeslike adults andpediatricpatients. tTedifferencesdoes not affectthe safety andeffectiveness |
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| of the subjectdevice. | SpO2 displayrange | 0%-100% | 70%-100% | 0%-100% | Comparedwith PrimaryPredicateDevice:The subjectdevice has awider SpO2display rangeof 0% to 100%whereas thepredicatedevice SpO2range is 70%to 100%. TheSpO2 displayrange ofsubject devicemeets therequirementsof the ISO80601-2-61and the FDAGuidance ofpulseoximeter-premarketnotificationissued onMarch 4, 2013,so thedifference doesnot affect thesafety andeffectivenessof the Subjectdevice. | ||||
|---|---|---|---|---|---|---|---|---|---|
| Design principle | The subjectdevice design isbased on thereferencepredicate device(Checkme ProHealthMonitor), sothey use thesame designprinciple. | The device usespulse oximetrytechnology tomeasurefunctionaloxygen saturationin the blood.Pulse oximetryworks byapplying a sensorto a pulsatingarteriolar vascularbed, such as afinger. The sensorcontains a duallight source and aphoto detector.Bone, tissue,pigmentation, andvenous vesselsnormally absorb aconstant amountof light over time.The arteriolar bednormally pulsatesand absorbsvariable mountsof light duringthe pulsations.The ratio of lightabsorbed istranslated into ameasurement offunctionaloxygen saturation(SpO2). | The device usespulse oximetrytechnology tomeasurefunctionaloxygensaturation in theblood. Pulseoximetry worksby applying asensor to apulsatingarteriolarvascular bed,such as a finger.The sensorcontains a duallight source anda photodetector. Bone,tissue,pigmentation,and venousvesselsnormally absorba constantamount of lightover time. Thearteriolar bednormallypulsates andabsorbs variablemounts of lightduring thepulsations. Theratio of lightabsorbed istranslated into ameasurement offunctionaloxygensaturation(SpO2). | SubstantiallyEquivalent. | SpO2measurementaccuracy | 70%-100%:±2%(Arms:1.88)70%-80%: ±3% | 70%-100%: ±2%;<70%:unspecified | External sensor70%-100%:±2%(Arms:1.88) | ComparedwithReferencePredicateDevice:SubstantiallyEquivalent.Comparedwith PrimaryPredicateDevice: |
| Intendedapplication site | Finger | Finger | Finger | SubstantiallyEquivalent. | |||||
| Work mode | Spot-check andContinuous datacollection. Thedevice is notused forcontinuousmonitoring. | Spot-check | Adults for Spot-check andContinuousPediatrics forSpot-check | Comparedwith PrimaryPredicateDevice:The subjectdevice hasspot-check andcontinuousdata collectionwork modewhereas theprimarypredicatedevice just hasspot checkmode. Thesubject devicecontinuouswork mode isbased on thereferencepredicatedevice. Thesubject devicemeets therequirementsof the ISO80601-2-61and the FDAGuidance ofpulseoximeter-premarketnotificationissued onMarch 4, 2013so thedifferencedoesn't affectthe safety andeffectivenessof the Subjectdevice. | |||||
| PredicateDevice:Both thesubject deviceand thepredicatedevice are usedin adults forContinuousand Spot-check.The subjectdevice and thereferencepredicatedevices areSubstantiallyEquivalent. | |||||||||
| Sensor type | Externaldetachable SpO2sensor | Externaldetachable SpO2sensor | Integrated andExternaldetachable SpO2sensor | Comparedwith PrimaryPredicateDevice:SubstantiallyEquivalent.ComparedwithReferencePredicateDevice:The referencepredicatedevice usesboth integratedand externaldetachableSpO2 sensors.The subjectdevice externaldetachableSpO2 sensor aresubstantiallyequivalent tothe externaldetachableSpO2 sensor ofthe referencepredicatedevice. |
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| 80%-90%: ±2%90%-100%:±2%0%-69%: notdefined | 70%-80%: ±3%80%-90%: ±2%90%-100%:±2%0%-69%: notdefined | The SpO2measurementaccuracy of thesubject deviceis similar to theSpO2measurementaccuracy forthe primarypredicatedevice. TheSpO2measurementaccuracy ofsubject devicemeets therequirementsof the ISO80601-2-61, sothe differencedoes not affectthe safety andeffectivenessof the subjectdevice.ComparedwithReferencePredicateDevice:SubstantiallyEquivalent. | ||
|---|---|---|---|---|
| SpO2 resolution | 1% | 1% | 1% | SubstantiallyEquivalent. |
| Pulse ratemeasurementrange | 30 bpm~250bpm | 30 bpm~250 bpm | 30 bpm~250 bpm | SubstantiallyEquivalent. |
| Pulse rateaccuracy | ±2bpm or ±2%(whichever isgreater) | 30-99bpm,±2bpm;100-250bpm,±2% | ±2bpm or ±2%(whichever isgreater) | Comparedwith PrimaryPredicateDevice:The Pulse rateaccuracy ofsubject deviceis similar to thepulse rate |
| the predicatedevice. Thepulse rateaccuracy ofsubject devicemeets therequirementsof the ISO80601-2-61, sothe differencedoes not affectthe safety andeffectivenessof the subjectdevice. | ||||
| ComparedwithReferencePredicateDevice: | ||||
| SubstantiallyEquivalent. | ||||
| Pulse rateresolution | 1bpm | 1bpm | 1bpm | SubstantiallyEquivalent. |
| Type, Degree ofprotectionagainst electricshock | Internal electricpower supply;Type BFapplied parts. | Internal electricpower supply;Type BF appliedparts. | Internal electricpower supply;Type BFapplied parts. | SubstantiallyEquivalent. |
| Power supply | Lithiumrechargeablebattery | Lithiumrechargeablebattery | Lithiumrechargeablebattery | SubstantiallyEquivalent. |
| Display screen | OLED | OLED | LCD | Comparedwith PrimaryPredicateDevice:SubstantiallyEquivalent.ComparedwithReferencePredicateDevice:The subject |
| OLED screenwhereas thereferencepredicatedevice has anLCD screen.The subjectdevice togetherwith the OLEDmeets therequirementsof the IEC60601-1, IEC60601-1-11,ISO 80601-2-61 and IEC60601-1-2.The differencedoes not affectthe safety andeffectivenessof the subjectdevice. | ||||
| Wireless | Bluetooth | Bluetooth | Bluetooth | SubstantiallyEquivalent. |
| Storage data | Yes | Yes | Yes | SubstantiallyEquivalent. |
| Physicaldimension(mm) | 44 mm (L) × 25mm (W) × 15mm (H) | 67 mm (L) × 66mm (W) × 28mm (H) | 88mm (L)x56mm (W)x13mm (H) | Comparedwith PrimaryPredicateDevice andReferencePredicateDevice:The physicaldimension ofsubject deviceis smaller thanboth, thepredicatedevice and thereferencepredicatedevice. Thesubject devicemeets therequirementsof mechanical |
| test in IEC60601-1, IEC60601-1-11and ISO80601-2-61.The differencedoes not affectthe safety andeffectivenessof the Subjectdevice. | ||||
| Operatingtemperature | 5°C~40°C | 5°C~40°C | 5°C~45°C | Comparedwith PrimaryPredicateDevice:SubstantiallyEquivalent.ComparedwithReferencePredicateDevice:The operatingtemperature ofthe subjectdevice is sameas the primarypredicatedevice. Thereferencepredicatedevice has awider range ofoperatingtemperature,which includesthe operatingtemperaturerange of thesubject device.The subjectdevice meetstherequirementsof the IEC60601-1, IEC60601-1-11 |
| Storage andtransportationtemperature | -25°C~70°C | -25°C~70°C | -25°C~70°C | and ISO80601-2-61.The differencedoes not affectthe safety andeffectivenessof the subject |
| Relativehumidity | 10%~95% | <93%, nocondensation | 10%~95% | Comparedwith PrimaryPredicateDevice:The relativehumidity of thesubject deviceis similar to thepredicatedevice and issame as thereferencepredicatedevice. Thesubject meetstherequirementsof the IEC60601-1, IEC60601-1-11and ISO80601-2-61, sothe differencedoes not affectthe safety andeffectivenessof the subjectdevice.ComparedwithReferencePredicateDevice:SubstantiallyEquivalent |
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| Atmosphericpressure | 70kPa~106kPa | 70kPa~106kPa | 70kPa~106kPa | SubstantiallyEquivalent. |
|---|---|---|---|---|
| Contactingduration | Less than 24h | Less than 24h | Less than 24h | SubstantiallyEquivalent. |
| Contacting type | Skin surface-contacting | Skin surface-contacting | Skin surface-contacting | SubstantiallyEquivalent. |
| Biocompatibilityof patientcontact parts | Comply withISO10993-1 | Comply withISO10993-1 | Comply withISO10993-1 | SubstantiallyEquivalent. |
Discussion of Similarities and Differences between Subject and Predicate Devices:
The aforementioned table provides a more detailed comparison of all the characteristic and parameters of the subject device and both the predicate devices. The subject device and the predicate devices all use the same design principle to measure the SpO2 and Pulse Rate. It is based on the below two basic principles:
- Oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different . absorption characteristic to red and infrared light;
- The light absorption by the blood (Hb and HbO2) is cyclic changing by the periodic . pulsations of the arterial blood volume during each heartbeat.
The subject device and both the predicate devices are Substantially Equivalent based on the following similar technological elements:
-
- The Subject device is designed based on our own 510k cleared reference Predicate device. The subject device and both the predicate device and reference predicate device are substantially equivalent with respect to theory, critical component, algorithm and technical specification.
-
- The subject device and both the predicate device are not used for continuous monitoring.
-
- The SpO2 display range for the subject device is broader than the primary predicate device but is identical to the reference predicate device. In addition, SpO2 measurement accuracy over a range of 70% - 100% is identical to subject device and both the predicate device and the reference predicate device.
-
- The subject device and both the predicate device and reference predicate device are identical for features like SpO2 resolution, Pulse rate measurement range and the Pulse rate resolution.
-
- The subject device and both the predicate device have an internal rechargeable lithium ion polymer battery as the power sources for the devices. The Degree of protection against electric shocks is substantially equivalent too.
-
- The subject device and both the predicate device have a Bluetooth feature for transmission and storage of data. All the devices use an external detachable SpO2
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sensor for measurement.
-
- The operating and storage environment of the Subject device and the Predicate devices are substantially equivalent.
-
- Use of patient contact materials which have been tested to compile with the same standard of ISO 10993 for the category of surface device, intact skin contact and limited contact duration (< 24 hours).
The subject device and both the predicate devices are Substantially Equivalent based on the similar technological elements except:
-
- The subject device is used for spot-check in adult patients. The measuring mode for the predicate device is spot check in adult, adolescent, child and infant population whereas the reference predicate device has both continuous and spot checking mode. For the reference, predicate device the continuous mode is for adults only and spotchecking mode is for adult and pediatrics.
-
- The subject device is used in adult population only, which is within the patient type range of both the predicate devices. The primary predicate device is used in adult, adolescent, child and infant whereas the reference predicate device is used in adult and pediatric population.
-
- The Pulse rate accuracy of the subject device is slightly different compared with primary predicate device but is identical to reference predicate device.
-
- The subject device has an external detachable sensor, which is substantially equivalent to the primary predicate device external detachable sensor. The reference predicate device uses both the integrated and external detachable SpO2 sensors. The reference predicate device external SpO2 sensor is substantially equivalent to the subject device.
-
- The relative humidity of the subject device is slightly different compared with primary predicate device but is identical to reference predicate device
-
- The physical dimension of the subject device is different from the physical dimension of the predicate devices.
Based on the aforementioned substantial equivalence discussion between the subject device and the predicate device, these different technological characteristics of Subject device does not raise new risk for the safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating the substantial equivalence of the Oxiband Pulse Oximeter in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements. Accuracy of pulse oximeter, electrical,
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mechanical, electromagnetic compatibility, software and biocompatibility testing have been performed on the subject device Pulse Oximeter. The results of the testing demonstrate that the subject device is as safe and as effective, as the legally marketed predicate devices. The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Testing
Non-clinical tests were conducted on the subject pulse oximeter device to verify that the subject device met design specifications was substantially equivalent to the predicates. The test results demonstrated that the subject device complies with electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, battery safety, home used medical devices safety.
The subject device is considered as skin contacting for duration less than 24 hours. The patient contact materials used by the subject device have been tested to compile with the ISO 10993, and is substantially equivalent to the predicates.
The software for this subject device was considered as a "moderate" level of concern, which is the same as the predicates. Software verification and validation testing were conducted and documentation was provided.
The following testing was conducted to demonstrate substantial equivalence to the predicate device:
| Test Standard | Description | Result |
|---|---|---|
| ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 | (Consolidated Text) Medical electricalequipment - Part 1: General requirements forbasic safety and essential performance (IEC60601-1:2005, MOD) | Passed |
| IEC 60601-1-2 Edition 4.02014-02 | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests | Passed |
| IEC 60601-1-11 Edition 2.02015-01 | Medical electrical equipment - Part 1-11:Generalrequirements for basic safety and essentialperformance - Collateral Standard:Requirements for medical electrical equipmentand medical electrical systems used inthe home healthcare environment | Passed |
| ISO 80601-2-61 First edition2011-04-01 | Medical electrical equipment - Part 2-61:Particular requirements for basic safety andessential performance of pulse oximeterequipment | Passed |
| IEC 62133 Edition 2.0 2012-12 | Secondary cells and batteries containingalkaline orother non-acid electrolytes - Safetyrequirements for portable sealed secondary | Passed |
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| cells, and for batteries made from them, foruse in portable applications [Including:Corrigendum 1 (2013)] | ||
|---|---|---|
| ISO 10993-1 Fourth edition2009-10-15 | Biological evaluation of medical devices - Part1: Evaluation and testing within a riskmanagement process [Including: TechnicalCorrigendum 1 (2010)] | Passed |
| ISO 10993-5 Third edition2009-06-01 | Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity | Passed |
| ISO 10993-10 Third Edition2010-08-01 | Biological evaluation of medical devices - Part10: Tests for irritation and skin sensitization | Passed |
| ISO 14971 Second Edition2007-03-01 | Medical Devices - Application of RiskManagement to medical devices | Passed |
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It is concluded that the subject Oxiband Pulse Oximeter device is in compliance with the requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
The predicate device, our own previously 510(k) cleared Checkme Pro Health Monitor (K150869) is in compliance with clinical testing according to ISO14155: 2011 and ISO 80601-2-61: 2011. In addition, the SpO2 accuracy performance results showed the Checkme Pro Health Monitor with external SpO2 sensor to have an ARMS of 1.88 during steady state conditions over the range of 70%-100%. The results showed that the SpO2 accuracy of Checkme Pro Health Monitor claimed under the range of 70%-100% by the manufacturer is in compliance.
At the same time, the Oxiband Pulse Oximeter and Checkme Pro Health Monitor with external SpO2 sensor shows the equivalence in intended use, sensor design, hardware design, algorithm design and technical specification. The subject and predicate devices are substantially equivalent. The aforementioned information justifies the use of the predicate device Checkme Pro Health Monitor clinical study results for the subject device, Oxiband pulse oximeter. The SpO2 accuracy of the Oxiband pulse oximeter claimed in the range of 70%-100% by the manufacturer is also in compliance.
9. Software information:
Similar to the predicate device, the software level of concern for the Oxiband pulse oximeter is MODERATE. According to FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff", the software validation documentation summarizes the required information for a MODERATE Level of Concern device.
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10. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Viatom Technology Co., Ltd. concludes that the subject device Oxiband Pulse Oximeter is as safe and as effective, and thus substantially equivalent, to the predicate device, Checkme Pro Health Monitor.
§ 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).