AS-3XX Series Fingertip Pulse Oximeter

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Xiamen Acurio Instruments Co., Ltd Angel Liu General Manager Assistant 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen, 361026 Cn Re: K180685 Trade/Device Name: AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L, AS-311) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: October 19, 2018 Received: October 25, 2018 Dear Angel Liu: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Todd D. Courtney -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180685 #### Device Name The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) #### Indications for Use (Describe) The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301-L, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospital-type facilities, and home environments. Type of Use (Select one or both, as applicable) | <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------| | <div> <span></span>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 AS-3XX Series Fingertip Pulse Oximeter 510(k) Number: K180685 This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.87(h) and 21 CFR 807.92. #### Submitter: Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, Biomedical Industry Park, No.2028, Wengjiao West Road, Haicang District, Xiamen, Fujian, 361026, CHINA #### ● Contact Person: Angel Liu General Manager Assistant Tel: 86-592-6312776 Fax: 86-592-6312776 Email: liushuzhen@acurio.cn - Date Prepared: ● November 28, 2018 ## Name of the Devices: - Device Common Name: Oximeter - Device Proprietary Name: AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L, AS-311) - Classification Name: Oximeter - Classification: Class II - Regulation Number: 21CFR 870.2700 - Product Code: DQA {4}------------------------------------------------ - Review Panel: Anesthesiology #### Legally Marketed Predicate Device(s): K140582 Fingertip Pulse Oximeter, Model JPD-500 #### Indications for Use: The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospital-type facilities, and home environments. ## Device Description: The AS-301/AS-302/AS-301-L/AS-302-L/AS-303/AS-304/AS-304-L/AS-311 Fingertip Pulse Oximeter manufactured by ACURIO provides noninvasive blood oxygen measurement by the dual-wavelength spectrophotometric technique, and shows the results by the OLED. The oximeter is easy to operate, small in volume, light in weight, convenient in carrying, low consumption in design and with strong resistance to ambient light interference. 2pcs of AAA batteries can be continuously used for 20 hours, and the battery voltage can be indicated. The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adults in hospitals, hospital-type facilities, and home environments. The components of the oximeter include the body part and a hanging rope. Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger), to a receiver on the other side. Two beams of different wavelength of lights (660nm red and 895nm near infrared light) can be focused onto a human nail tip through c clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor. #### Comparison to Predicate Devices: The Substantial Equivalence Comparison Chat is provided as follows: Table 1: Substantial Equivalence Comparison Chart {5}------------------------------------------------ | Comparison items | Manufacturer (aCurio) | Manufacturer (Jumper) | Comparison results | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------| | Name | Fingertip pulse oximeter | Fingertip pulse oximeter | Identical | | | Model | AS-301/AS-302/AS-301-L/AS-<br>302-L/AS-303/AS-304/AS-304-<br>L/AS-311 | JPD-500A | | | | 510(K) number | K180685 | K140582 | | | | Regulatory Class | Class II | Class II | Identical | | | Intended use | This product is used for spot-<br>checking of oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate for adults. | This product is used for spot-<br>checking of oxygen saturation<br>of arterial hemoglobin (SpO2)<br>and pulse rate for adult and<br>pediatric users. | Identical | | | Indications for use | The AS-3XX Series Fingertip<br>Pulse Oximeter (with models AS-<br>301, AS-302, AS-301-L, AS-302-<br>L, AS-303, AS-304, AS-304-L and<br>AS-311) is a portable non-<br>invasive device intended for spot-<br>checking of oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate of adult in hospitals,<br>hospital-type facilities, and home<br>environments. | The JPD-500A Fingertip Pulse<br>Oximeter is non-invasive<br>device intended for spot-<br>checking of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate. The portable fingertip<br>device is indicated for adult<br>and pediatric patients in home<br>and hospital environments<br>(including clinical use in<br>internist/surgery, anesthesia,<br>intensive care, etc) | Similar | | | Target population | Adults only | Adult and pediatric users | Similar | | | Anatomical sites | Fingertip | Fingertip | Identical | | | Where used | hospitals, hospital-type facilities,<br>and home environments. | Home and hospital (including<br>clinical use in<br>internist/surgery, Anesthesia,<br>intensive care etc. | similar | | | Energy used and/or<br>delivered | D.C.3.0V (2xAAA alkaline<br>batteries) | D.C. 3.0V (2×AAA alkaline<br>batteries) | Identical | | | Human factors | | | | | | Design | Body part and a lanyard | Body part and a lanyard | Identical | | | Performance | Measuring<br>principle | Dual-wavelength<br>spectrophotometr<br>y | Dual-wavelength<br>spectrophotometry | Identical | | | | | | | | | AS-<br>301/AS302/AS30<br>3 AS-304/AS-<br>311:<br>SpO2: 36% ~<br>99%<br>Pulse rate:<br>30bpm ~ 250bpm<br>AS-301-<br>L/AS302-L:<br>SpO2: 36% ~<br>100%<br>Pulse rate:<br>30bpm ~ 250bpm | SpO2: 35%~100%<br>Pulse Rate: 25bpm ~ 250bpm | | | | Measurement<br>range | | | | | | | | | | | | Measurement<br>accuracy | AS-301/AS-<br>302/AS-303/AS-<br>304/AS-311:<br>SpO2: ±3% (70%<br>- 99%), ±3%<br>(70% - 80%),<br>±2% (80% -<br>90%), ±2%<br>(90% - 99%)<br>less than 70% no<br>definition<br>Pulse rate<br>accuracy: ±2bpm<br>AS-301-L/AS-<br>302-L/AS-304-L:<br>SpO2: ±3% (70%<br>- 100%) ±3%<br>(70% - 80%),<br>±2% (80% -<br>90%), ±2%<br>(90%-99%)<br>less than 70% no<br>definition<br>Pulse rate<br>accuracy: ±2bpm | SpO2: ±2% (70% ~100%), no<br>definition (35%~69%)<br>Pulse rate: ±2bpm | Similar | | | | | | | | | Low<br>perfusion | SpO2 and pulse<br>rate can be | Measurement performance in<br>low perfusion condition is | Similar | | | | | | | | | | error | shown correctly when pulse-filling ratio is 0.2% | 0.3%. | | | | Light sensor | RED wavelength 660nm<br>IR wavelength 940nm | RED wavelength 660nm<br>IR wavelength 940nm | Identical | | | | | | | | | Protection against electric shock | Internal power supply;<br>Type BF | Internal power supply;<br>Type BF | Identical | | | Operating environment | Operation temperature: 5-40°C<br>Relative humidity: 15% - 95% (Non condensing) | Operation temperature: 5-40°C<br>Relative humidity: 15% - 80 %( Non condensing) | Similar | | | | | | | | | Storage environment | Storage temperature: - 20~55°C<br>Relative humidity: 15% - 95% (Non condensing) | Storage temperature: - 10°C~50°C<br>Relative humidity: 10% - 95 %( Non condensing) | Similar | | | | | | | | | Weight | 50g (including batteries) | 57g (including batteries) | Similar | | | Size | AS-301, AS-301-L:<br>56(L)×34(W)×32(H)mm<br>AS-302, AS-302-L:<br>58(L)×35(W)×32(H)mm<br>AS-303:<br>57(L)×35(W)×37(H)mm | 64(L)×35(W)×34(H) mm | Similar | | | | | | | | | | | | | | | | | | | | Standards met | ISO 80601-2-61: 2011<br>IEC 60601-1: 2005<br>IEC 60601-1-2: 2007/AC | | ISO 80601-2-61: 2011<br>IEC 60601-1: 2005<br>IEC 60601-1-2: 2007/AC | Identical | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | | 510(K) Summary | |--|----------------| |--|----------------| | Materials | ISO 10993-5: 2009<br>ISO 10993-10: 2010<br>ISO 13485: 2003<br>ISO 15223-1: 2012<br>IEC 62304: 2006<br>IEC 62366: 2007<br>ISO 10993-1: 2009/AC: 2010<br>IEC 60601-1-11: 2010<br>IEC 60601-1-6: 2010<br>ABS+TPR | ISO 10993-5: 2009<br>ISO 10993-10: 2010<br>ISO 13485: 2003<br>ISO 15223-1: 2012<br>IEC 62304: 2006<br>IEC 62366: 2007<br>ISO 10993-1: 2009/AC: 2010<br>IEC 60601-1-11: 2010<br>IEC 60601-1-6: 2010<br>ABS+TPR | Conform to the<br>bio-compatibility<br>requirements. | |------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Biocompatibility | Passed the detection of ISO10993-<br>5 and ISO10993-10. | Passed the detection of<br>ISO10993-5 and ISO10993-<br>10. | Conform to the<br>bio-compatibility<br>requirements. | | Compatibility with<br>the environment and<br>other devices | The pulse oximeter can't be used<br>in an MRI or CT environment, in<br>situations where alarms are<br>required, or in an explosive<br>atmosphere. | The pulse oximeter can't be<br>used in an MRI or CT<br>environment, in situations<br>where alarms are required, or<br>in an explosive atmosphere. | Identical | | Sterility | Non-sterile | Non-sterile | Identical | | Electrical safety | Same | Same | Identical | ## Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence: The Sponsor performed a risk assessment based on the changes made to their predicate device and determined that the following non-clinical testing was necessary to demonstrate that the changes did not introduce any new risks to the subject device. Laboratory testing was conducted to validate and verify that the Pulse Oximeters continued to meet all requirements of related international standards, including electrical safety, EMC, software, bio-compatibility. Results of these tests demonstrated compliance to the requirements of the below consensus standards and FDA Guidance documents. #### Electrical Safety and Performance: 1. IEC 60601-1:2005+A1:2012; 2. ISO 80601-2-61:2011. Medical Electrical Equipment and medical Electrical Systems Used in the Home {9}------------------------------------------------ #### Healthcare Environment: 1. IEC 60601-1-11:2010+CORR.1:2011. Electromagnetic Compatibility: 1. IEC 60601-1-2:2007. #### Biocompatibility: - 1. ISO 10993-5:2009 - 2. ISO 10993-10:2010 #### Software: - 1. IEC 62304: 2006 - 2. General Principles of Software Validation Final Guidance for Industry and FDA Staff. ## Pulse Oimeters Guidance: Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff Therefore, we conclude that the AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L, AS-311) is both safe and effective for its intended use. ## Discussion of Clinical Tests Performed: Clinical hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on 10 healthy, nonsmoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range of 70-100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the STANDARD ; and the Agreement between Methods of Measurement with Multiple Observations per each subject was analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement, the data points beyond or below this scope were regarded as outliers. By analyzing, these few outliers are occasional, which does not raise safety and performance concerns regarding the accuracy of the device. #### Conclusions: The AS-3XX Series Fingertip Pulse Oximeter(with models AS-301. AS-302. AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L, AS-311) has the same intended use and {10}------------------------------------------------ similar characteristics as the predicate device. Moreover, bench testing contained in this submission demonstrates that any difference in their technological characteristics do not raise any different questions of safety or effectiveness. Thus, the AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L, AS-311) is substantially equivalent to the predicate devices.