← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K121697 # FINGERTIP PULSE OXIMETER (K121697) _Andon Health Co, Ltd. · DQA · Oct 15, 2012 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K121697 ## Device Facts - **Applicant:** Andon Health Co, Ltd. - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** Oct 15, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring. ## Device Story APO-8284 Fingertip Pulse Oximeter; portable, non-invasive device for spot-checking SpO2 and pulse rate. Input: light absorption through fingertip via red (660 nm) and infrared (880 nm) LEDs and photodiode. Operation: MCU calculates SpO2 ratio; isolates varying absorption spectrum to detect pulse rate; ignores non-arterial tissue. Output: digital display of SpO2 and pulse rate. Used in home and clinical environments (internist, surgery, anesthesia, ICU) by clinicians or patients. Features low battery alarm and auto-power off. Powered by 2x AAA batteries. Benefits: provides rapid, non-invasive physiological status assessment. ## Clinical Evidence Bench testing only. Device performance evaluated against ISO 9919:2005, IEC 60601-1, and EN 60601-1-2. Biocompatibility testing performed per ISO 10993 (cytotoxicity, irritation, skin sensitization). No clinical data provided. ## Technological Characteristics Fingertip pulse oximeter; 660nm/880nm LED/photodiode sensing; silica gel patient contact material; 2x AAA battery power; non-sterile; MCU-based processing. Standards: IEC 60601-1, EN 60601-1-2, ISO 9919:2005, ISO 10993. ## Regulatory 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 - MD300C1 Fingertip Pulse Oximeter ([K093757](/device/K093757.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) Summary 1 5 2012 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92. ### 1.0 submitter's information | Name: | Andon Health Co., Ltd. | |----------------------|--------------------------------------------------------------------------| | Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin,
P.R. China | | Phone number: | 86-22-6052 6161 | | Fax number: | 86-22-6052 6162 | | Contact: | Liu Yi | | Date of Application: | 05/25/2012 | ### 2.0 Device name Device name: APO-8284 Fingertip Pulse Oximeter ### 3.0 Classification DQA - Oximeter Production code: Regulation number: 870.2700 Classification: II Panel: Cardiovascular ### 4.0 Predicate device information Manufacturer: Beijing Choice Electronic Technology Co., Ltd. MD300C1 Fingertip Pulse Oximeter Device: 510(k) number: K093757 5- I {1}------------------------------------------------ ### 5.0 Intended use The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring. ### 6.0 Device description Our device APO-8284 Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user. It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate. More over, the APO-8284 also has the function of low battery voltage alarm and automatically power off. The power source is 2 × AAA batteries. The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile. The intended use and the indication for use of APO-8284 Fingertip Pulse Oximeter, as described in the labeling are the same as their predicated device MD300C1 Fingertip Pulse Oximeter (K093757) {2}------------------------------------------------ # 7.0 Summary comparing technological characteristics with predicate | device | | |-------------------------------|-------------------| | Technological Characteristics | Comparison result | | Design principle | Identical | | Appearance | Similar | | Patients contact Materials | Identical | | Performance | Similar | | Biocompatibility | Identical | | Mechanical safety | Identical | | Energy source | Identical | | Standards met | Identical | | Electrical safety | Identical | | EMC | Identical | | Function | Similar | ### 8.0 Performance summary APO-8284 Fingertip Pulse Oximeter conforms to the following standards: - · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. - · EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007. - · ISO 9919:2005: Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. - · ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. - · ISO 10993: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity. - · ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization. {3}------------------------------------------------ ### 9.0 Comparison to the predicate device and the conclusion The applicant device APO-8284 Fingertip Pulse Oximeter is substantially equivalent to MD300C1 Fingertip Pulse Oximeter whose 510(k) number is K093757. | Similarities and differences comparision | | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Characteristics | Subject device APO-8284 | Predicate device
(K093757) | | Intended use | blood oxygen aturation
(SpO2), and pulse
rate(bpm) measurement | blood oxygen
aturation(SpO2), and pulse
rate(bpm) measurement | | Design priciple | | | | Presentation or OTC | Presentation | Presentation | | Contact material | Silica gel | Silica gel | | SpO2 measuring
range | 70%-99% | 70%--99% | | SpO2 Accuracy | ±2% | 80-99%: ±2%
70-79%: ±3% | | Pulse Rate
Measuring Range | 30-250bpm | 30-235bpm | | Pulse Rate Accuracy | ± 2 bpm during the pulse
rate range of 30-99 bpm
and 2% during the pulse
rate range of 100-235 bpm | ± 2 bpm during the pulse
rate range of 30-99 bpm
and 2% during the pulse
rate range of 100-235 bpm | | Operation
Temperature | 5°C-40°C | 5°C-40°C | | Power Source | 2*AAA batteries | 2*AAA or rechargeable
batteries | | Operation Humidity | <80% | 15%~80% | | Other function | low battery voltage alarm:
automatically power off | low battery voltage alarm:
automatically power off | As a result, APO-8284 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the power source, the pulse rate range and the operation humidity range are a little bit different. However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Andon Health Company, Limited Mr. Liu Yi President Number 3, Jin Ping Street, Ya An Road Nankai District Tianjin, China 300190 Re: K121697 Trade/Device Name: APO-8284 Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 13, 2012 Received: September 13, 2012 Dear Mr. Yi: 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. 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. {5}------------------------------------------------ #### Page 2- Mr. Yi Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Antmon D. N. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Statement of Indications for Use 510(k) Number : Device name: APO-8284 Fingertip Pulse Oximeter ### Indications for use: The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring. Prescription use Over-The-Counter Use ア AND/OR Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) y. Adultho esthesiology, General Hospital ) Number: 1421697 Page 1 of ા --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K121697](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K121697) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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