Who is the manufacturer of Checkme O2 Pulse Oximeter?

Shenzhen Viatom Technology Co., Ltd. filed the 510(k) submission for Checkme O2 Pulse Oximeter (K191088).

What is the FDA product code for Checkme O2 Pulse Oximeter?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Checkme O2 Pulse Oximeter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Checkme O2 Pulse Oximeter?

Wrist Pulse Oximeter MD300W314B4 (K172366).

Who can help prepare an FDA 510(k) submission like Checkme O2 Pulse Oximeter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Checkme O2 Pulse Oximeter

K191088 · Shenzhen Viatom Technology Co., Ltd. · DQA · Dec 2, 2019 · Cardiovascular

Device Facts

Record ID	K191088
Device Name	Checkme O2 Pulse Oximeter
Applicant	Shenzhen Viatom Technology Co., Ltd.
Product Code	DQA · Cardiovascular
Decision Date	Dec 2, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

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.

Device Story

Wrist-worn pulse oximeter; measures SpO2 and pulse rate via external detachable sensor; utilizes dual light source (red/infrared) and photodetector to detect cyclic light absorption changes in arteriolar vascular bed; processes signals via MCU and SpO2 measurement circuit; displays results on OLED screen; stores and transmits data via Bluetooth; used in sleep labs, hospitals, long-term care, and home settings; operated by clinicians or patients; provides spot-check or continuous data collection; data used for pre-check screening; not for diagnostic or treatment decisions; not for continuous monitoring; not life-supporting/sustaining.

Clinical Evidence

No new clinical studies performed. Substantial equivalence supported by clinical data from reference predicate (K150869), which demonstrated SpO2 accuracy (ARMS 1.88) in steady-state conditions (70-100% range) per ISO 80601-2-61 and ISO 14155:2011. Subject device shares identical algorithm and sensor design with reference predicate.

Technological Characteristics

Wrist-worn pulse oximeter; OLED display; Bluetooth connectivity; internal rechargeable lithium-ion polymer battery; Type BF applied parts; external detachable SpO2 sensor; materials compliant with ISO 10993-1; non-sterile; dimensions 44mm x 25mm x 15mm; software level of concern: moderate.

Indications for Use

Indicated for adult patients for measuring, displaying, storing, and transmitting functional oxygen saturation (SpO2) and pulse rate. Intended for spot-check and continuous data collection; not for continuous monitoring. Use in sleep labs, long-term care, hospitals, and home settings.

Regulatory Classification

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.

Predicate Devices

Wrist Pulse Oximeter MD300W314B4 (K172366)

Reference Devices

Checkme Pro Health Monitor (K150869)

Related Devices

K183556 — oCare Wrist Pulse Oximeter · Taiwan Biophotonic Corporation · Feb 15, 2019
K172366 — Wrist Pulse Oximeter · Beijing Choice Electronic Technology Co., Ltd. · Mar 16, 2018
K200414 — Pulse Oximeter · Shenzhen Aeon Technology Co., Ltd. · Sep 23, 2020
K122046 — WRIST PULSE OXIMETER · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 4, 2013
K152089 — Wrist Pulse Oximeter · Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. · Aug 17, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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/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 {2}------------------------------------------------ ## 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) | <div>☒ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY #### 1. Submitter's Identification: | Applicant: | Establishment Registration Number: 3011200896 Shenzhen Viatom Technology Co., Ltd 4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67 Xin'an Street, Baoan District, Shenzhen Guangdong, CHINA 518101 www.viatomtech.com | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Zhou Saixin General Manager Shenzhen Viatom Technology Co., Ltd. 4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67 Xin'an Street, Baoan District, Shenzhen Guangdong, CHINA 518101 Phone: +86 755 86638929 Fax: +86 755 22649904 Email: zhousaixin@viatomtech.com | | Prepared by: | Mr. Vaibhav Arvind Rajal Regulatory Consultant mdi Consultants, Inc. Direct Tel. 201-887-3180 Phone- 516-482-9001 Fax- 516-482-0186 Email: 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 {4}------------------------------------------------ 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. {5}------------------------------------------------ | Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device | Substantial Equivalence or Difference | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name of the device | Oxiband (Checkme) O2 Pulse Oximeter | Wrist Pulse Oximeter MD300W314B4 | Health Monitor Checkme Pro | Substantially Equivalent. | | Manufacturer | Shenzhen Viatom Technology Co., Ltd | Beijing Choice Electronic Technology Co., Ltd. | Shenzhen Viatom Technology Co., Ltd | Substantially Equivalent. | | 510(K) Number | K191088 | K172366 | K150869 | Substantially Equivalent. | | Product code | 21 CFR 870.2700, DQA | 21 CFR 870.2700, DQA | 21 CFR 870.2300, MWI Secondary product codes: 21 CFR 870.2700, DQA 21 CFR 870.2340, DPS 21 CFR 880.2910, FLL 21 CFR 870.2300, DRT | Substantially Equivalent. | | Classification | II | II | II | Substantially Equivalent. | | Indication for 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 | The Wrist 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, adolescent, child and infant patients. It is | The Checkme Pro Health Monitor is intended to be used for measuring, displaying, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and | Compared with Primary Predicate Device: Both the subject device and the primary predicate device have same IFU including measuring, displaying, storing and transmitting of pulse oxygen saturation | | is intended for | intended for spot- | pediatrics for | (SpO2) and Pulse Rate. | | | 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. | check and/ or data collection, recording and transmitting. It can be used in sleep labs, long- term care, hospitals and home use. | spot-checking) and temperature in the home or in healthcare facilities. This device is not intended to substitute for a hospital diagnostic ECG device and not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio- defibrillators (ICDs). | Both the devices are wrist pulse oximeter. The subject device is used for adult patients whereas the predicate device is used in a wider range of patient population like adult, adolescent, child and infant patients The subject device is used for spot-check or continuous data collection, and not continuous monitoring whereas the primary predicate device is intended for spot-check and/ or data collection. The primary predicate device is also not used for continuous monitoring, so they are substantially | | # 6.Comparison to the 510(k) Cleared Devices (Predicate Devices): {6}------------------------------------------------ {7}------------------------------------------------ | | | different expression. | |--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Compared with Reference Predicate Device: Both the subject device and the reference predicate device have similar function including measuring, displaying, storing and transmitting of pulse oxygen saturation (SpO2) and Pulse Rate. The reference predicate device is a Cardiac Monitor and has more function (such as ECG and Temperature). The ECG, Temperature and SpO2 are separate function in reference predicate device, so the ECG and Temperature functions do not affect the SpO2 and | {8}------------------------------------------------ | | | | | Pulse Rate accuracy, the differences will not raise new questions of safety and effectiveness. The subject device is used for spot-check or continuous data collection, and not continuous monitoring in adults whereas the reference predicate device is used in adults only for continuous data collection and recording, adults and pediatrics for spot-checking . The reference predicate device is also not used for continuous monitoring, the subject device is based ob the reference predicate device, so they are substantially equivalent, just different expression. | | | Predicate Device: | |--------------|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Rx or OTC | Rx | Rx | Rx | Substantially Equivalent. | | | The subject device is used for adult patients whereas the predicate device is used in a wider range of patient population like adult, adolescent, child and infant patients. The differences does not affect the safety and effectiveness of the subject device. | | Patient type | Adult | Adult, Adolescent, Child and Infant | Adult and pediatric | Compared with Primary | | | Compared with Reference Predicate Device: | | | | The subject device is used for adult patients whereas the reference predicate device is used in a wider range of patient types like adults and pediatric patients. tTe differences does not affect the safety and effectiveness | | | | | | {9}------------------------------------------------ {10}------------------------------------------------ | | | | | of the subject device. | SpO2 display range | 0%-100% | 70%-100% | 0%-100% | Compared with Primary Predicate Device: The subject device has a wider SpO2 display range of 0% to 100% whereas the predicate device SpO2 range is 70% to 100%. The SpO2 display range of subject device meets the requirements of the ISO 80601-2-61 and the FDA Guidance of pulse oximeter- premarket notification issued on March 4, 2013, so the difference does not affect the safety and effectiveness of the Subject device. | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------|----------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design principle | The subject device design is based on the reference predicate device (Checkme Pro Health Monitor), so they use the same design principle. | The device uses pulse oximetry technology to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed, such as a finger. The sensor contains a dual light source and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable mounts of light during the pulsations. The ratio of light absorbed is translated into a measurement of functional oxygen saturation (SpO2). | The device uses pulse oximetry technology to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed, such as a finger. The sensor contains a dual light source and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable mounts of light during the pulsations. The ratio of light absorbed is translated into a measurement of functional oxygen saturation (SpO2). | Substantially Equivalent. | SpO2 measurement accuracy | 70%-100%: ±2% (Arms:1.88) 70%-80%: ±3% | 70%-100%: ±2%; <70%: unspecified | External sensor 70%-100%: ±2% (Arms:1.88) | Compared with Reference Predicate Device: Substantially Equivalent. Compared with Primary Predicate Device: | | Intended application site | Finger | Finger | Finger | Substantially Equivalent. | | | | | | | Work mode | Spot-check and Continuous data collection. The device is not used for continuous monitoring. | Spot-check | Adults for Spot- check and Continuous Pediatrics for Spot-check | Compared with Primary Predicate Device: The subject device has spot-check and continuous data collection work mode whereas the primary predicate device just has spot check mode. The subject device continuous work mode is based on the reference predicate device. The subject device meets the requirements of the ISO 80601-2-61 and the FDA Guidance of pulse oximeter- premarket notification issued on March 4, 2013 so the difference doesn't affect the safety and effectiveness of the Subject device. | | | | | | | | | | | Predicate Device: Both the subject device and the predicate device are used in adults for Continuous and Spot-check. The subject device and the reference predicate devices are Substantially Equivalent. | | | | | | | Sensor type | External detachable SpO2 sensor | External detachable SpO2 sensor | Integrated and External detachable SpO2 sensor | Compared with Primary Predicate Device: Substantially Equivalent. Compared with Reference Predicate Device: The reference predicate device uses both integrated and external detachable SpO2 sensors. The subject device external detachable SpO2 sensor are substantially equivalent to the external detachable SpO2 sensor of the reference predicate device. | | | | | | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ | | 80%-90%: ±2% 90%-100%: ±2% 0%-69%: not defined | | 70%-80%: ±3% 80%-90%: ±2% 90%-100%: ±2% 0%-69%: not defined | The SpO2 measurement accuracy of the subject device is similar to the SpO2 measurement accuracy for the primary predicate device. The SpO2 measurement accuracy of subject device meets the requirements of the ISO 80601-2-61, so the difference does not affect the safety and effectiveness of the subject device. Compared with Reference Predicate Device: Substantially Equivalent. | |------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SpO2 resolution | 1% | 1% | 1% | Substantially Equivalent. | | Pulse rate measurement range | 30 bpm~250 bpm | 30 bpm~250 bpm | 30 bpm~250 bpm | Substantially Equivalent. | | Pulse rate accuracy | ±2bpm or ±2% (whichever is greater) | 30-99bpm, ±2bpm; 100-250bpm, ±2% | ±2bpm or ±2% (whichever is greater) | Compared with Primary Predicate Device: The Pulse rate accuracy of subject device is similar to the pulse rate | | | | | | the predicate device. The pulse rate accuracy of subject device meets the requirements of the ISO 80601-2-61, so the difference does not affect the safety and effectiveness of the subject device. | | | | | | Compared with Reference Predicate Device: | | | | | | Substantially Equivalent. | | Pulse rate resolution | 1bpm | 1bpm | 1bpm | Substantially Equivalent. | | Type, Degree of protection against electric shock | Internal electric power supply; Type BF applied parts. | Internal electric power supply; Type BF applied parts. | Internal electric power supply; Type BF applied parts. | Substantially Equivalent. | | Power supply | Lithium rechargeable battery | Lithium rechargeable battery | Lithium rechargeable battery | Substantially Equivalent. | | Display screen | OLED | OLED | LCD | Compared with Primary Predicate Device: Substantially Equivalent. Compared with Reference Predicate Device: The subject | | | | | | OLED screen whereas the reference predicate device has an LCD screen. The subject device together with the OLED meets the requirements of the IEC 60601-1, IEC 60601-1-11, ISO 80601-2- 61 and IEC 60601-1-2. The difference does not affect the safety and effectiveness of the subject device. | | Wireless | Bluetooth | Bluetooth | Bluetooth | Substantially Equivalent. | | Storage data | Yes | Yes | Yes | Substantially Equivalent. | | Physical dimension(mm) | 44 mm (L) × 25 mm (W) × 15 mm (H) | 67 mm (L) × 66 mm (W) × 28 mm (H) | 88mm (L) x56mm (W) x13mm (H) | Compared with Primary Predicate Device and Reference Predicate Device: The physical dimension of subject device is smaller than both, the predicate device and the reference predicate device. The subject device meets the requirements of mechanical | | | | | | test in IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-61. The difference does not affect the safety and effectiveness of the Subject device. | | Operating temperature | 5°C~40°C | 5°C~40°C | 5°C~45°C | Compared with Primary Predicate Device: Substantially Equivalent. Compared with Reference Predicate Device: The operating temperature of the subject device is same as the primary predicate device. The reference predicate device has a wider range of operating temperature, which includes the operating temperature range of the subject device. The subject device meets the requirements of the IEC 60601-1, IEC 60601-1-11 | | | | | | | | Storage and transportation temperature | -25°C~70°C | -25°C~70°C | -25°C~70°C | and ISO 80601-2-61. The difference does not affect the safety and effectiveness of the subject | | Relative humidity | 10%~95% | <93%, no condensation | 10%~95% | Compared with Primary Predicate Device: The relative humidity of the subject device is similar to the predicate device and is same as the reference predicate device. The subject meets the requirements of the IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-61, so the difference does not affect the safety and effectiveness of the subject device. Compared with Reference Predicate Device: Substantially Equivalent | {15}------------------------------------------------ {16}------------------------------------------------ {17}------------------------------------------------ {18}------------------------------------------------ {19}------------------------------------------------ | Atmospheric pressure | 70kPa~106kPa | 70kPa~106kPa | 70kPa~106kPa | Substantially Equivalent. | |-------------------------------------------------|-----------------------------|-----------------------------|-----------------------------|------------------------------| | Contacting duration | Less than 24h | Less than 24h | Less than 24h | Substantially Equivalent. | | Contacting type | Skin surface- contacting | Skin surface- contacting | Skin surface- contacting | Substantially Equivalent. | | Biocompatibility of patient contact parts | Comply with ISO10993-1 | Comply with ISO10993-1 | Comply with ISO10993-1 | Substantially Equivalent. | #### 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: - 1. 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. - 2. The subject device and both the predicate device are not used for continuous monitoring. - 3. 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. - 4. 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. - 5. 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. - 6. 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 {20}------------------------------------------------ sensor for measurement. - 7. The operating and storage environment of the Subject device and the Predicate devices are substantially equivalent. - 8. 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: - 1. 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. - 2. 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. - 3. The Pulse rate accuracy of the subject device is slightly different compared with primary predicate device but is identical to reference predicate device. - 4. 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. - 5. The relative humidity of the subject device is slightly different compared with primary predicate device but is identical to reference predicate device - 6. 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…

Checkme O2 Pulse Oximeter

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Checkme O2 Pulse Oximeter

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