(147 days)
Not Found
No
The 510(k) summary describes a standard pulse oximeter that measures light absorption to determine SpO2 and pulse rate. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies listed are standard for this type of device and do not suggest the use of AI/ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is indicated for noninvasive spot checking of oxygen saturation and pulse rate, which are diagnostic indicators, not treatments.
Yes
The device measures and displays physiological parameters (SpO2, PR, PI) to assess a patient's health status, which falls under the definition of a diagnostic device. The stated "Intended Use" clearly mentions "spot checking of functional oxygen saturation... and pulse rate" for patients.
No
The device description explicitly states it consists of hardware components including a probe, electronic circuits, display, plastic housing, and batteries.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the pulse oximeter is a "noninvasive spot checking" device that measures "absorption of red and infrared light passing through perfused tissue." This means it measures physiological parameters directly from the patient's body without taking a sample.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (>=10Kg) patients during both no motion and for patients who are well or poorly perfused.
Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.
Product codes
DQA
Device Description
The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (>=10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric (>=10Kg) patients
Intended User / Care Setting
hospitals, hospital-type facilities, home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The devices and the predicate are identical devices. The predicate devices have been conducted functional and system level test. The functional and system level testing showed that the devices continue to meet specifications and meets relevant consensus standards.
Biocompatibility Testing
The devices and the predicate are identical devices. Testing of the predicate devices have been completed per FDA's "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" guidance document and the requirements of ISO 10993-1:2018.
Software Verification and Validation Testing
The predicate devices were tested for Software verification and validation, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the pulse oximeter was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Electromagnetic Compatibility and Electrical Safety
The pulse oximeter was assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and . A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
- . IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 62471: 2006 Photobiological Safety of Lamps and Lamp Systems.
Bench Testing
The device and the predicate are identical devices. The predicate devices have been conducted functional and system level testing. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
Cleaning Validation
Cleaning and disinfection validation testing of the predicate devices were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The test results meet relevant standards. The device and the predicate are identical devices.
Clinical Data
Clinical testing of the predicate devices have shown that pulse oximeters meet relevant consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2022
Unimed Medical Supplies, Inc. Hui Zhang General Manager Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan Shenzhen, Guangdong 518108 China
Re: K222213
Trade/Device Name: Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 10, 2022 Received: November 10, 2022
Dear Hui Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222213
Device Name Pulse Oximeter
Indications for Use (Describe)
The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused.
Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" above the word "Unimed" in gray letters. To the right of the word "Unimed" is a red oval with a white design inside.
510(k) Summary
In accordance with 21 CFR 807.92 the 510(k) Summary for the Unimed pulse oximeters are provided below.
1. SUBMITTER
| Applicant: | Unimed Medical Supplies, Inc.
Bld #8,Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan
Shenzhen Guangdong, CHINA 518108
Tel: +86 755 2669 5165 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: HuiZhang
Title: General Manager
Phone: +86 15013808983
Tel: +86 755 2669 5165
E-mail: FrankZhang@unimed.cn |
Date Prepared: June 24, 2022
2. DEVICE
510(k) Number: K222213
- Device Trade Name: Oximeter (including UC-200, UC-201, Pulse UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
- Classification Name: 21 CFR 870.2700, Oximeter
- Regulatory Class: Class II
- Product Code, Panel: DQA, Anesthesiology
- Reason for Submission: New Application. No prior submission associated with the current submission.
- Predicate Device: Nariq Bio-Medical Pulse Oximeter, K211632
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Image /page/4/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "UNIMED" in a larger, gray font. Below "UNIMED" is the text "medical supplies" also in gray. To the right of the text is a red circle containing a white stylized "UM".
DEVICE DESCRIPTION 3.
The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.
The function difference of models is listed as follows:
Function Difference of Models
Abbreviation description:
- A sup: support function
- A opt: optional function
-
n/a: disable/not support function
| Function | UC-200 | UC-201 | UC-202 | UC-203 | UC-204 | UC-100 | UC-101 | UC-102 | UC-103 | UC-104 |
|---|---|---|---|---|---|---|---|---|---|---|
| Display Type | OLED | OLED | OLED | OLED | OLED | LED | LED | LED | LED | LED |
| Key Function | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Automatic Shut-Down | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Low Power Tip | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Low Power Shut-Down | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Display Light Intensity | opt | opt | opt | opt | opt | opt | opt | opt | opt | opt |
| Direction Rotation | opt | opt | opt | opt | opt | n/a | n/a | n/a | n/a | n/a |
| SpO2 Parameter | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Pulse Parameter | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Perfusion Parameter | opt | opt | opt | opt | opt | opt | opt | opt | opt | opt |
| Bargraph | sup | sup | sup | sup | sup | sup | sup | sup | sup | sup |
| Plethysmogram | sup | sup | sup | sup | sup | n/a | n/a | n/a | n/a | n/a |
| Battery Display | sup | sup | sup | sup | sup | n/a | n/a | n/a | n/a | n/a |
| User Menu Setup | opt | opt | opt | opt | opt | n/a | n/a | n/a | n/a | n/a |
| Trend Graph | opt | opt | opt | opt | opt | n/a | n/a | n/a | n/a | n/a |
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Image /page/5/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "UNIMED" in a larger, gray font. Below "UNIMED" is the text "medical supplies" in a smaller, gray font. To the right of the text is a red circle with a white, stylized "UM" inside.
INTENDED USE/INDICATIONS FOR USE 4.
The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
Pulse Oximeter is intended for hospital-type facilities, home environments.
SUBSTANTIAL EQUIVALENCE 5.
Device Specification
| Feature | Specification | Models |
|---|---|---|
| Display | ||
| Display Range | Oxygen Saturation (SpO2): 0-100% | All models |
| Pulse Rate (PR): 25-250 beats per minute (BPM) | All models | |
| Perfusion Index (PI): 0.02-20% | All models | |
| Display Waveform | Plethysmogram | UC-200/ UC-201/ UC-202/ |
| UC-203/UC-204 | ||
| Bargraph | All models | |
| Display Resolution | SpO2: 1% | All models |
| PR: 1 BPM | ||
| Measurement Accuracy in Accordance with ISO80601-2-61 | ||
| SpO2, No Motion | 70 – 100%, 2%, ARMS, adults/pediatrics | All models |
| SpO2, Motion | 70 – 100%, 3% ARMS, adults/pediatrics | All models |
| SpO2, Low Perfusion | 70 – 100%, 2%, ARMS, adults/pediatrics | UC-200/ UC-100 |
| Pulse Rate, No Motion | 25 – 250 BPM, 2 BPM ARMS, adults/pediatrics | All models |
| Pulse Rate, Motion | 25 – 250 BPM, 4 BPM ARMS, adults/pediatrics | All models |
| Pulse Rate, Low Perfusion | 25 – 250 BPM, 2 BPM ARMS, adults/pediatrics | UC-200/ UC-100 |
| Power | ||
| Internal battery | Alkaline “AAA” batteries | All models |
The pulse oximeter specifications are as follows:
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Image /page/6/Picture/0 description: The image is a logo for Unimed medical supplies, a brand of Xinwell. The word "Unimed" is in large, gray, sans-serif font. Below it, the words "medical supplies" are in a smaller, lighter font. To the right of the word "Unimed" is a red oval with a white, stylized "um" inside.
| Mechanical | ||
|---|---|---|
| Enclosure Material | Plastic | All models |
| Dimensions/Weight | 62mm × 35mm × 31mm | All models |
| Weight | Less than 75g (contain battery) | All models |
| Environmental | ||
| Operating Temperature | 0°C to +40°C, ambient humidity | All models |
| Storage Temperature | -20°C to +60°C, ambient humidity | All models |
| Operating/Storage Humidity | 15% to 95%, non-condensing | All models |
| Atmospheric Pressure | 79.5kPa~107.4kPa | All models |
| Mode of Operation | ||
| Mode of Operation | Spot Check | All models |
In conclusion, the minor differences of the models do not change the fundamental intended use of the pulse oximeter.
Technological Comparison
The table below compares the key technological feature of the subject devices to the predicate device (the Narig Bio-Medical's Pulse Oximeter, K211632).
| Item | Predicate Devices(K211632) | Subject Devices | Comparison |
|---|---|---|---|
| Display | |||
| Display Type | OLED display (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204) | ||
| LED display (FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) | OLED display (UC-200, UC-201, UC-202, UC-203, UC-204) | ||
| LED display (UC-100, UC-101, UC-102, UC-103, UC-104) | Different | ||
| Display Range | Oxygen Saturation (SpO2): 0-100% | ||
| Pulse Rate (PR): 25-250 beats per minute (BPM) | |||
| Perfusion Index (PI): 0.02-20% | Oxygen Saturation (SpO2): 0-100% | ||
| Pulse Rate (PR): 25-250 beats per minute (BPM) | |||
| Perfusion Index (PI): 0.02-20% | Same | ||
| Display Waveform | Plethysmogram (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204) | ||
| Bargraph | Plethysmogram (UC-200/ UC-201/ UC-202/UC-203/UC-204) | ||
| Bargraph | Same | ||
| Display Resolution | SpO2: 1% | ||
| PR: 1 BPM | SpO2: 1% | ||
| PR: 1 BPM | Same | ||
| Measurement Accuracy in Accordance with ISO80601-2-61 | |||
| SpO2, No Motion | 70 - 100%, 2%, ARMS, adults/pediatrics | 70 - 100%, 2%, ARMS, adults/pediatrics | Same |
| SpO2, Motion | 70 - 100%, 3% ARMS, adults/pediatrics | 70 - 100%, 3% ARMS, adults/pediatrics | Same |
| SpO2, Low Perfusion | Only for FRO-200 / FRO-100 | Only for UC-200 / UC-100 | Different |
| 70 - 100%, 2%, ARMS, adults/pediatrics | 70 - 100%, 2%, ARMS, adults/pediatrics | ||
| Pulse Rate, No Motion | 25 - 250 BPM, 2 BPM ARMS, adults / | 25 - 250 BPM, 2 BPM ARMS, adults / | Same |
| pediatrics | pediatrics | ||
| Pulse Rate, Motion | 25 - 250 BPM, 4 BPM ARMS, adults / | 25 - 250 BPM, 4 BPM ARMS, adults / | Same |
| pediatrics | pediatrics | ||
| Pulse Rate, Low Perfusion | Only for FRO-200/ FRO-100 | Only for UC-200/ UC-100 | Different |
| 25 - 250 BPM, 2 BPM ARMS, adults / | 25 - 250 BPM, 2 BPM ARMS, adults / | ||
| pediatrics | pediatrics | ||
| Power | |||
| Internal battery | Alkaline "AAA" batteries | Alkaline "AAA" batteries | Same |
| Mechanical | |||
| Enclosure Material | Plastic | Plastic | Same |
| Dimensions/Weight | 62mm × 35mm × 31mm | 62mm × 35mm × 31mm | Same |
| Weight | Less than 75g (contain battery) | Less than 75g (contain battery) | Same |
| Environmental | |||
| Operating Temperature | 0°C to +40°C, ambient humidity | 0°C to +40°C, ambient humidity | Same |
| Storage Temperature | -20°C to +60°C, ambient humidity | -20°C to +60°C, ambient humidity | Same |
| Operating/Storage Humidity | 15% to 95%, non-condensing | 15% to 95%, non-condensing | Same |
| Atmospheric Pressure | 79.5kPa-107.4kPa | 79.5kPa-107.4kPa | Same |
| Mode of Operation | |||
| Mode of Operation | Spot Check | Spot Check | Same |
| Compliance Standards | |||
| Bio-compatibility | ISO 10993-1 | ISO 10993-1 | Same |
| ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-10 | ||
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| IEC 60601-1-11 | IEC 60601-1-11 | ||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
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Image /page/7/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "Unimed" in a larger, bold font. To the right of "Unimed" is a red oval shape with a white "U" inside. Below "Unimed" is the text "medical supplies" in a smaller font.
Image /page/7/Picture/1 description: The image shows a red oval with white letters inside. The letters appear to be 'u' and 'm' intertwined. The logo is simple and modern, with a focus on the color red.
As seen in the comparison tables, the subject and predicate devices have same design principle, same design features and performance specifications. In conclusion, the different technological characteristics between the subject and predicate devices will not impact the substantial equivalence.
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Image /page/8/Picture/0 description: The image shows the logo for Unimed medical supplies, a brand of Xinwell. The word "Unimed" is written in a gray sans-serif font, with the words "medical supplies" written in a smaller font below. To the right of the word "Unimed" is a red oval with a white design inside.
PERFORMANCE DATA 6.
The devices and the predicate are identical devices. The predicate devices have been conducted functional and system level test. The functional and system level testing showed that the devices continue to meet specifications and meets relevant consensus standards.
Biocompatibility Testing
The devices and the predicate are identical devices. Testing of the predicate devices have been completed per FDA's "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" guidance document and the requirements of ISO 10993-1:2018.
Software Verification and Validation Testing
The predicate devices were tested for Software verification and validation, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the pulse oximeter was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Electromagnetic Compatibility and Electrical Safety
The pulse oximeter was assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and . A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
- . IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 62471: 2006 Photobiological Safety of Lamps and Lamp Systems.
Bench Testing
The device and the predicate are identical devices. The predicate devices have been conducted functional and system level testing. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
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Image /page/9/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in smaller font above the word "Unimed" in a larger, bolder font. To the right of the text is a red oval containing a white stylized design.
- IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment-part 1-6: general . requirements for basic safety and essential performance- collateral standard: usability.
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to ● medical devices.
- . ISO 80601-2-61:2011 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment.
- EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, . labelling and information to be supplied. General requirements.
Cleaning Validation
Cleaning and disinfection validation testing of the predicate devices were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The test results meet relevant standards. The device and the predicate are identical devices.
Clinical Data
Clinical testing of the predicate devices have shown that pulse oximeters meet relevant consensus standards.
- . ISO 80601-2-61:2017 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
SUBSTANTIAL EQUIVALENCE CONCLUSION 7.
The subject and predicate devices are exactly the same. The pulse oximeter is identical to the cleared version and is not modified. Therefore, the subject device is substantially equivalent to the predicate device.