Caremed Reusable & Disposable SPO2 Sensors

K153184 · Shenzhen Caremed Medical Technology Co., Ltd. · DQA · Jan 4, 2017 · Cardiovascular

Device Facts

• Record ID: K153184
• Device Name: Caremed Reusable & Disposable SPO2 Sensors
• Applicant: Shenzhen Caremed Medical Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Caremed Reusable & Disposable 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 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities.

Device Story

Device consists of reusable and disposable SpO2 sensors; utilizes optical plethysmography to measure arterial hemoglobin oxygen saturation. Sensor contains two LEDs (red and infrared) and one photodiode; illuminates arterially perfused tissue (fingers or toes) to detect light absorption. Output is transmitted to compatible patient monitors (e.g., Nellcor, Masimo) for display of SpO2 and pulse rate. Used in hospital environments by clinicians to monitor patient oxygenation status; provides real-time data for clinical decision-making regarding respiratory or cardiovascular status. Benefits include non-invasive, continuous monitoring of patient oxygen levels.

Clinical Evidence

Clinical hypoxia testing performed on human adult volunteers. Accuracy validated against arterial oxygen saturation (SaO2) measured by co-oximetry. Results support accuracy claims within the specified saturation range.

Technological Characteristics

Optical sensor with two LEDs (Red: 660-666nm, IR: 880-950nm) and photodetector. Materials include ABS, PVC, TPU, silicone, and sponge. Compatible with Nellcor and Masimo monitors. Conforms to IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, and ISO 10993-5/10.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate (PR) in hospital facilities for adult patients >40 kg and pediatric patients 10-50 kg.

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

• Solaris Medical Technology, Inc. Reusable & Disposable SPO2 Sensors (K100077)
• Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors (K111888)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 04, 2017

Shenzhen Caremed Medical Technology Co., Ltd. Xinlin Xiao OA Manager Zone B, 3/F, 11 Building, Hebei Industrial Area Longhua Office, Longhua New District Shenzhen, Guangdong 518021 China

Re: K153184

Trade/Device Name: Caremed Reusable & Disposable SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 13, 2016 Received: December 5, 2016

Dear Xinlin Xiao:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH 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) K153184

Device Name

Caremed Reusable & Disposable SPO2 Sensors

#### Indications for Use (Describe)

Caremed Reusable & Disposable 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 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities

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

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☐</span> 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 Caremed. The logo consists of the letters "CM" in red and black, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray.

# Section 5

510(K) Summary

## 1. Prepared Date: 2017/1/3

#### 2. Submitter Information

| Name | Shenzhen Caremed Medical Technology Co., Ltd. |
|---------|-------------------------------------------------------------------------------------------------------|
| Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen,China |
| Tel | 0086-755-27184369 |
| Fax | 0086-755-27186486 |

#### 3. Contact Person

| Contact person | Xinling Xiao |
|----------------|--------------------------------------------------------------------------------------------------------|
| Title | QA manager |
| Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen, China |
| Tel | 0086-755-27184369 |
| Fax | 0086-755-27186486 |
| E-mail | [e-mail] |

#### 4. Proposed Device Information

| Trade Name | Caremed Reusable & Disposable SPO2 Sensors |
|-----------------------|--------------------------------------------|
| Model | C403-01,C403S-15&N543-01 |
| Common name | Oximeter |
| Regulatory class | II |
| Production regulation | 21 CFR §870.2700 |
| Product code | DQA |
| Panel | Cardiovascular |

#### 5. Predicate Device Information

| 510(K)No. | Trade Name/model | Submitter |
|-----------|------------------------------------------------------------------------|----------------------------------|
| K100077 | Solaris Medical Technology, Inc.<br>Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. |
| K111888 | Masimo LNOP/M-LNCS/LNCS<br>Multisite-L Oximetry Sensors | Masimo Corporation |

#### 6. Device description

Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission Page 1 of 6

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Image /page/4/Picture/0 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in a stylized font, with the "C" in red and the "M" in black. To the right of the letters is the word "caremed" in red, with the first letter in lowercase and the rest in uppercase. Below the word "caremed" are two Chinese characters in gray.

patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.

| Model | Description | Compatible<br>Monitor |
|----------|----------------------------------------------------|-------------------------|
| C403-01 | Nellcor Adult Reusable Finger Clip SpO2 Sensor | N395 |
| C403S-15 | Masimo Adult Reusable Soft tip SpO2 Sensor | Masimo Radical<br>Rad-8 |
| N543-01 | Nellcor Adult Disposable Non- Adhesive SpO2 Sensor | N395 |

Three models of sensors are described as follows:

# 7. Intended use

Caremed Reusable & Disposable 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 and pediatric patients weighing 10 -50 kg at hospital facilities.

# 8. Comparison to predicate device

Caremed Reusable & Disposable SPO2 Sensors use the same technological characteristics as the predicate devices to determine arterial oxygen saturation: arterially perfused tissue is illuminated sequentially by two wavelengths of LEDs, and the time varying absorbance of the tissue is measured by a photodetector.

Based on the following comparison, both device have same intended use,working principle ,measurement part,compatibility ,only in technical parameters and cable length have slightly difference. But the subject devices have passed IEC60601-1,IEC60601-1-2,ISO80601-2-61&performance testing, so these difference does not raise different questions of safety or effectiveness. Please see the following comparison table:

Table 1

| Comparis<br>on item | Subject Device<br>Caremed Reusable and<br>disposable SPO2 sensor<br>compatibility with Nellcor<br>(Model:C403-01,C403S-15<br>&N543-01) | Predicate Device<br>Reusable and disposable<br>SPO2 sensor compatibility<br>with Nellcor<br>(model:T100A-090103 and<br>DP100A-090103)<br>K100077 | Predicate Device<br>Adult and pediatric/slender<br>digit spo2 sensor (model:<br>LNOP DCI series)<br>K111888 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Intended<br>use&<br>Indications for Use | Caremed Disposable and<br>Reusable SPO2 Sensors are<br>indicated for continuous<br>non-invasive monitoring of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate(PR) for adult<br>patients weighing greater<br>than40kg and pediatric<br>patients weighing 10 -50 kg | When used with a<br>compatible patient monitor<br>or a pulse oximeter device,<br>Solaris Medical Technology,<br>Inc. reusable & disposable<br>SpO2 sensors are intended<br>to be used for continuous,<br>non-invasive functional<br>arterial oxygen saturation<br>(SpO2)<br>and pulse rate monitoring.<br>Solaris Medical Technology,<br>Inc. reusable multi-patient<br>use SpO2 Soft Sensors,<br>reusable multi-patient use<br>SpO2 Finger Sensors, and<br>disposable single patient<br>use SpO2 Soft-finger<br>Sensors are for use with<br>adult/pediatric patients<br>weighing greater than 40kg.<br>Solaris Medical Technology,<br>Inc. disposable single<br>patient use SpO2 Adhesive<br>Sensors are for use with<br>adult patients weighing<br>greater than 40kg, pediatric<br>patients weighing 10 - 40<br>kg, and infant<br>(non-neonatal) patients<br>weighing 3 - 15kg.<br>Prescription device. | The Masimo<br>LNOP/M-LNCS/LNCS<br>Multisite-L Oximetry<br>Sensors are indicated for<br>the continuous noninvasive<br>monitoring of functional<br>oxygen saturation of<br>arterial<br>hemoglobin (SPO2) and<br>pulse rate (measured by an<br>SPO2 sensor) for use with<br>adult, pediatric, infant, and<br>neonatal patients during<br>both no motion and motion<br>conditions, and for patients<br>who are well or poorly<br>perfused in hospitals,<br>hospital-type facilities,<br>mobile, and home<br>environments. |
| | Measurement<br>Method | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative<br>Optical Absorption |
| | Light<br>Emitting | Red:660-666nm,<br>Ired:880-950nm | Red:660-666nm,<br>Ired:880-950nm |
| | Signal<br>Detection<br>Method | Photodetector | Photodetector |
| | SPO2<br>Accuracy | $\pm$ 3%(70-100%) | $\pm$ 2%(70-100%) |
| Pulse<br>Rate<br>Accuracy | ±3(30-250bpm) | ±2(30-250bpm) | ±3(30-250bpm) |
| Applied<br>population | C403-01 & C403S-15:<br>Adult(≥40Kg)<br>N543-01: Adult(≥40Kg) &<br>Pediatric(10-50Kg) | Adult(≥40Kg) | Adult(≥30Kg) |
| Measurement part | Fingers or toes | Fingers or toes | Fingers or toes |
| compatible monitor | Nellcor Non oximax<br>(N395)& Masimo set | Nellcor Non oximax (N395) | Masimo set |
| Sterility | No | No | No |
| Usage | Reusable&disposable | Reusable&disposable | Reusable |
| Material | ABS,PVC,TPU,Silicone,<br>sponge | ABS,PVC,Silicone and 3M | ABS,PVC,TPU,Silicone |
| Cable<br>Length | 1.1 | 0.9 | 0.9 |
| Proximal<br>connector<br>Design | DB9 9pin&1269 LNOP DC | DB9 7pin | 1269 LNOP DC |
| Distal<br>connector<br>Design | finger clip and sponge<br>adhesive | soft tip and textile adhesive | finger clip |
| Conformance<br>standard | IEC60601-1,IEC60601-1-2,<br>ISO80601-2-61,ISO10993-<br>5/10 | IEC60601-1,IEC60601-1-2,<br>ISO80601-2-61,ISO10993-<br>5/10 | IEC60601-1,IEC60601-1-2,<br>ISO80601-2-61,ISO10993-<br>5/10 |

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Image /page/5/Picture/0 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in red and black, followed by the word "caremed" in black. Below the word "caremed" are two Chinese characters in black.

Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission

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Image /page/6/Picture/0 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and black, followed by the word "caremed" in gray. Below the word "caremed" are two Chinese characters in gray.

From the comparison form above, both devices have the same Measurement Method, Light Emitting, Signal Detection Method, Measurement part, compatible monitor, Sterility, Usage & Conformance standard.

In Intended use& Indications for Use, SPO2 & Pulse Rate Accuracy, Applied population, Material item, both devices have some differences; please see the following analyses.

# Note1 Intended use, Indications for Use& Applied population

The C403-01 is intended use for adult keeping still in in hospital environment which is same as predicate device T100A-090103. And the applied population of C403S-15 is adult with no motion which is slightly difference from the predicate device LNOP DCI series sensor. The N543-01 will be intended use for adult and Pediatric patients weighting 10-50Kg, which are same as the Nellcor(OEM) spo2 sensor. The subject Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission Page 4 of 6

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Image /page/7/Picture/0 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and black, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in black.

device has passed the IEC60601-1, IEC60601-1-2and ISO80601-2-61, so this difference does not raise different questions of safety and effectiveness.

## Note2 SPO2 Accuracy & Pulse Rate Accuracy

The SPO2&Pulse rate Accuracy of subject device has slightly difference from the predicate device. But, the subject device's SPO2&Pulse rate Accuracy meets the requirement of ISO80601-2-61,so this difference also does not raise different questions of safety and effectiveness.

## Note3 Material

The reusable spo2 sensor of both device have the same material of patient end, only the cable connecting with skin material is different, the subject device's is TPU, and the predicate device's is PVC. The patient end of Caremed disposable sensors is sponge adhesive, but the subject device meets the requirements of ISO10993-5/10, so this difference also does not raise different questions of safety and effectiveness.

# According to contrast and analysis, the differences between subject device and predicate device does not raise different questions of safety and effectiveness.

#### 9. Non-clinical test data

The subject device meets the following the recognized standards:

- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 2005
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010

# 10. Clinical test data

Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Reusable & Disposable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

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Image /page/8/Picture/0 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below "caremed" is some text in a different language, possibly Chinese.

# 11. Conclusions

Based on the comparison, analysis, and the submitted performance data, Caremed Reusable & Disposable SPO2 Sensors are substantially equivalent to the predicate devices.