Oximeter

K173045 · Shenzhen Greatmade Tech Limited · DQA · Jun 5, 2018 · Cardiovascular

Device Facts

• Record ID: K173045
• Device Name: Oximeter
• Applicant: Shenzhen Greatmade Tech Limited
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg at hospital facilities.

Device Story

SpO2 sensors connect to compatible pulse oximeters to monitor arterial hemoglobin oxygen saturation and pulse rate. Device consists of a connector, cable, two LEDs (red 660-666nm, infrared 880-950nm), and a photodetector housed in finger clip, soft tip, or textile adhesive formats. Operation involves transmitting red and infrared light through patient tissue; photodetector captures modulated light, converting it into electrical signals. External oximeter unit processes signals to calculate SpO2 and pulse rate, displaying plethysmographic curves and numerical values. Used in hospital facilities by clinicians. Provides real-time physiological data to assist in patient monitoring and clinical decision-making.

Clinical Evidence

Clinical hypoxia testing performed on 13 adult human volunteers. Accuracy of SpO2 sensors validated against arterial oxygen saturation (SaO2) measured via co-oximetry. Results support accuracy claims of ±3% for SpO2 (70-100%) and ±3 bpm for pulse rate (30-250 bpm).

Technological Characteristics

Materials: ABS, PVC, TPU, Silicone, 3M. Sensing: 2-wavelength optical absorption (Red 660-666nm, IR 880-950nm). Photodetector: 20V breakdown, 50ns response time. Connectivity: Wired (DB9/Round-head connectors) to compatible monitors. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-5/10.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate (PR) in adult patients weighing >40kg in hospital 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

• Unimed Disposable And Reusable Spo2 Sensors (K142832)

Submission Summary (Full Text)

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June 5, 2018

Shenzhen Greatmade Tech limited Mei Mei QA Manager 3th floor, B building, BaiFuli Industrial Zone ShangHengLang, HuaHui Road Shenzhen, CN

Re: K173045

Trade/Device Name: SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: April 26, 2018 Received: April 30, 2018

Dear Mei Mei:

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.

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 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);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -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

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#### Indications for Use

510(k) Number (if known) K173045

Device Name SpO2 Sensor

Indications for Use (Describe)

SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than40kg at hospital facilities.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## Section 6

# 510(K) Summary

#### 1. Prepared Date: 2018/2/24

### 2. Submitter Information

| Name | Shenzhen Greatmade Tech limited |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 3th floor , B building , BaiFuli Industrial Zone ,<br>ShangHengLang, HuaHui Road , DaLang Street , LongHua new<br>district , Shenzhen City , GuangDong Province ,China |
| Tel | 86-755-28144774 |

### 3. Contact Person

| Contact person | Mei |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Title | QA manager |
| Address | 3th floor , B building , BaiFuli Industrial Zone ,<br>ShangHengLang, HuaHui Road , DaLang Street ,<br>LongHua new district , Shenzhen City , GuangDong<br>Province ,China |
| Tel | 0086-755-23463462 |
| Fax | 0086-755-29553084 |
| E-mail | [e-mail] |

#### 4. Proposed Device Information

| Trade Name | SpO2 Sensor |
|------------------|--------------------------------------------------------|
| Model | AF009, AS009, AF063, AS063, AF024-1, AS024-1, DS024-NB |
| Common name | Oximeter |
| Regulatory class | 디 |
| Production | |
| requlation | 21 CFR §870.2700 |
| Product code | DQA |
| Panel | Cardiovascular |

### 5. Predicate Device Information

| 510(K)No. | Trade Name/model | Submitter |
|-----------|------------------------------------------------|------------------------------|
| K142832 | Unimed Disposable And Reusable<br>Spo2 Sensors | Unimed Medical Supplies Inc. |

### 6. Device description

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The SpO2 Sensors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors. The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Sensors contain finger clip type, soft tip and textile adhesive type. All the sensors will be labeled for compatibility for a specific monitor.

## 7. Operation principle& Mechanism of action

The SpO2 Sensors will connect with a compatible patient monitor or a pulse oximeter to continuously, non-invasively monitor the functional arterial oxygen saturation (SpO2) of the patient under stationary state. The SpO2 measurement is based on the absorption of pulse blood oxygen to red and infrared light by means of sensor and SpO2 measuring unit(Pulse Oximeter). The light-electronic transducer in sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of SpO2 measuring unit(Pulse Oximeter). The pleth curve or(and) numeral value of Sp02 will be obtained.

### 8. Key electrical components description

Spo2 sensor is made up of connector, cable, two specific wavelength LEDs & a photo detector. LED & photo detector are the key electrical components to the subject device. The LED is with wavelength Red: 660-666/Infrared: 880-950m. The minimum breakdown voltage photo detector is 20V and its response time is 50ns.

### 9. Indications for use

SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg at hospital facilities.

#### Comparison to predicate device 10.

A comparison of key similarities and differences between the subject devices and the predicate devices (K142832) is provided below

| Comparison<br>item | Subject Device | Predicate Device<br>K142832 | Note |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended<br>use&<br>Indications<br>for Use | Spo2 sensors are indicated<br>for continuous non-invasive<br>monitoring of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate(PR) for adult | Unimed Disposable and<br>Reusable SPO2 Sensors<br>are indicated for continuous<br>non-invasive monitoring of<br>functional oxygen saturation<br>of arterial hemoglobin | Similar |

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#### K173045

| Comparison<br>item | Subject Device | Predicate Device<br>K142832 | Note |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------|
| patients weighing greater<br>than 40kg. | (SpO2) and pulse rate(PR)<br>for adult patients weighing<br>greater than40kg, pediatric<br>patients weighing 10 -50 kg,<br>and neonatal patients<br>weighing no less than 3 Kg. | | |
| Measuremen<br>t Method | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative<br>Optical Absorption | Same |
| Light<br>Emitting | Red: 660-666nm,<br>Ired: 880-950nm | Red: 660-666nm,<br>Ired: 880-950nm | same |
| Signal<br>Detection<br>Method | Photodetector | Photodetector | Same |
| SPO2<br>Accuracy | ±3%(70-100%) | ±3%(70-100%) | Same |
| Pulse Rate<br>Accuracy | ±3(30-250bpm) | ±3(30-250bpm) | Same |
| Applied<br>population | Adult(≥40Kg) | Adult(≥30Kg)&Pediatric(10-<br>50Kg) | Similar |
| Measuremen<br>t part | Fingers | Fingers or toes | Similar |
| compatible<br>monitor | Nellcor(N395)<br>Ohmeda3800 | Nellcor(N395)<br>Ohmeda3700 | Similar |
| Sterility | No | No | Same |
| Usage | Reusable&disposable | Reusable&disposable | Same |
| Material | ABS,PVC,TPU,Silicone,3M | ABS,PVC,TPU,Silicone,3M | Same |
| Cable Length | 3.0/1.0 m | 3.0/1.1m | Similar |
| Proximal<br>connector<br>Design | DB9 9pin&Round-head<br>7pin/8p | DB9 9pin&Round-head<br>7pin/8p | Same |
| Distal<br>connector<br>Design | finger clip , soft tip, textile<br>adhesive | finger clip , soft tip, textile<br>adhesive and sponge<br>adhesive | Similar |
| Conformance<br>standard | IEC 60601-1 ,IEC<br>60601-1-2, ISO<br>80601-2-61, ISO<br>10993-5/10 | IEC 60601-1 ,IEC<br>60601-1-2, ISO<br>80601-2-61, ISO<br>10993-5/10 | Same |

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From the comparison form above, both devices have the same Measurement Method, Light Emitting, Signal Detection Method, Sterility, Usage & Conformance standard. There are slightly differences between the subject devices and predicate devices as follows.

| Difference clause | Discussion |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use&<br>Indications for Use<br>& Applied<br>population | The subject device is intended use for adult<br>patients weighing greater than 40Kg. The<br>predicate device, which includes 12 models, is<br>intended for adult, pediatric and neonate patients.<br>but both devices are compatible with the same<br>monitor. This difference does not raise different<br>questions of safety and effectiveness. |
| Measurement part | The subject devices are intended to be used on<br>fingers not toes; the predicate devices will be<br>applied for fingers and toes. But the spo2 and PR<br>accuracy of subject device applied for fingers<br>meets the requirements of ISO 80601-2-61. This<br>difference does not raise different questions of<br>safety and effectiveness. |
| compatible monitor | The subject devices is compatible with<br>Nellcor(N395) and Ohmeda3800 monitors. The<br>predicate devices is compatible with Nellcor(N395)<br>and Ohmeda3700 monitors. This difference does<br>not raise different questions of safety and<br>effectiveness. |
| Cable Length | According to the clinical requirements, the subject<br>device's cable length were designed to be 1.0m &<br>3.0m. The predicate device's cable lengths are<br>1.1m & 3.0m. This difference does not raise<br>different questions of safety and effectiveness.<br>Meanwhile the subject device has passed the<br>IEC60601-1, IEC 60601-1-2 and ISO 80601-2-61. |
| Distal connector<br>Design | The spo2 sensor in this submission have 3 types<br>(finger clip , soft tip &3M). The predicate device<br>has an additional connector of sponge adhesive.<br>This difference does not raise different questions<br>of safety and effectiveness. This subject devices<br>have passed the IEC 60601-1, IEC 60601-1-2and<br>ISO 80601-2-61. |

#### Summary of Biocompatibility test 11.

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According to IFU, the sensor end will contact with patient finger skin. This submission have three types of sensor housings (soft tip, finger clip & Non-woven) and its duration contact time is less than 2 hours.

The Nature of body contact is skin surface. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable tests are:

- Cytotoxicity ●
- Sensitization
- Irritation / Intracutaneous ●

#### 12. Summary of Non-clinical test data

Non clinical tests as follows were conducted to verify that the proposed device met all design specifications to demonstrate Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with requirements of the recognized standards and IFU.

- a) Biocompatibility test
- b) Testing/ANSI/AAMI/IEC60601-1
- c) Testing /ANSI/AAMI/IEC60601-1-2
- d) Testing /ISO80601-2-61
- e) Cleaning and Disinfection Validation test
- Shelf life test f)
- q) Performance test for sensors connecting with compatible monitors
- h) Pulse rate accuracy test

#### 13. Clinical test data

Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in 13 human adult volunteers to validate the accuracy of Spo2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

#### Substantial Equivalence Statement 14.

Based on the comparison, analysis, and the submitted performance data, Spo2 Sensors are as safe, as effective and performs as well as or better

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than the predicate device and thus can be considered substantially equivalent to the predicate devices.