(428 days)
Not Found
No
The device description and performance studies focus on standard optical sensing technology and clinical validation against co-oximetry, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), which is a diagnostic or monitoring function, not a therapeutic one.
Yes
Explanation: The device is indicated for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR)". Monitoring vital signs like SpO2 is a diagnostic activity, as it provides information about the patient's physiological state that can be used to diagnose conditions or track progress.
No
The device description explicitly states that the device contains hardware components: two light emitting diodes (LED) and one photodiode, contained in sensor housing.
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. They are used to examine specimens outside of the body.
- Device Function: The Caremed Reusable & Disposable SPO2 Sensors work by using optical means to measure oxygen saturation and pulse rate directly on the patient's body (fingers or toes). This is a non-invasive, in vivo measurement.
- Intended Use: The intended use is for continuous non-invasive monitoring of physiological parameters on the patient.
Therefore, because the device operates by measuring parameters directly on the patient's body rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingers or toes
Indicated Patient Age Range
adult patients weighing greater than 40 kg and pediatric patients weighing 10 -50 kg
Intended User / Care Setting
hospital facilities
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
☑ Prescription Use (Part 21 CFR 801 Subpart D) |
---|
☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
xinling.xiao@gmail.com |
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. | |
Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. | |
K111888 | Masimo LNOP/M-LNCS/LNCS | |
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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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
Monitor |
|----------|----------------------------------------------------|-------------------------|
| C403-01 | Nellcor Adult Reusable Finger Clip SpO2 Sensor | N395 |
| C403S-15 | Masimo Adult Reusable Soft tip SpO2 Sensor | Masimo Radical
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
on item | Subject Device
Caremed Reusable and
disposable SPO2 sensor
compatibility with Nellcor
(Model:C403-01,C403S-15
&N543-01) | Predicate Device
Reusable and disposable
SPO2 sensor compatibility
with Nellcor
(model:T100A-090103 and
DP100A-090103)
K100077 | Predicate Device
Adult and pediatric/slender
digit spo2 sensor (model:
LNOP DCI series)
K111888 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Intended
use&
Indications for Use | Caremed Disposable and
Reusable 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 | When used with a
compatible patient monitor
or a pulse oximeter device,
Solaris Medical Technology,
Inc. reusable & disposable
SpO2 sensors are intended
to be used for continuous,
non-invasive functional
arterial oxygen saturation
(SpO2)
and pulse rate monitoring.
Solaris Medical Technology,
Inc. reusable multi-patient
use SpO2 Soft Sensors,
reusable multi-patient use
SpO2 Finger Sensors, and
disposable single patient
use SpO2 Soft-finger
Sensors are for use with
adult/pediatric patients
weighing greater than 40kg.
Solaris Medical Technology,
Inc. disposable single
patient use SpO2 Adhesive
Sensors are for use with
adult patients weighing
greater than 40kg, pediatric
patients weighing 10 - 40
kg, and infant
(non-neonatal) patients
weighing 3 - 15kg.
Prescription device. | The Masimo
LNOP/M-LNCS/LNCS
Multisite-L Oximetry
Sensors are indicated for
the continuous noninvasive
monitoring of functional
oxygen saturation of
arterial
hemoglobin (SPO2) and
pulse rate (measured by an
SPO2 sensor) for use with
adult, pediatric, infant, and
neonatal patients during
both no motion and motion
conditions, and for patients
who are well or poorly
perfused in hospitals,
hospital-type facilities,
mobile, and home
environments. |
| | Measurement
Method | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption |
| | Light
Emitting | Red:660-666nm,
Ired:880-950nm | Red:660-666nm,
Ired:880-950nm |
| | Signal
Detection
Method | Photodetector | Photodetector |
| | SPO2
Accuracy | $\pm$ 3%(70-100%) | $\pm$ 2%(70-100%) |
| Pulse
Rate
Accuracy | ±3(30-250bpm) | ±2(30-250bpm) | ±3(30-250bpm) |
| Applied
population | C403-01 & C403S-15:
Adult(≥40Kg)
N543-01: Adult(≥40Kg) &
Pediatric(10-50Kg) | Adult(≥40Kg) | Adult(≥30Kg) |
| Measurement part | Fingers or toes | Fingers or toes | Fingers or toes |
| compatible monitor | Nellcor Non oximax
(N395)& Masimo set | Nellcor Non oximax (N395) | Masimo set |
| Sterility | No | No | No |
| Usage | Reusable&disposable | Reusable&disposable | Reusable |
| Material | ABS,PVC,TPU,Silicone,
sponge | ABS,PVC,Silicone and 3M | ABS,PVC,TPU,Silicone |
| Cable
Length | 1.1 | 0.9 | 0.9 |
| Proximal
connector
Design | DB9 9pin&1269 LNOP DC | DB9 7pin | 1269 LNOP DC |
| Distal
connector
Design | finger clip and sponge
adhesive | soft tip and textile adhesive | finger clip |
| Conformance
standard | IEC60601-1,IEC60601-1-2,
ISO80601-2-61,ISO10993-
5/10 | IEC60601-1,IEC60601-1-2,
ISO80601-2-61,ISO10993-
5/10 | IEC60601-1,IEC60601-1-2,
ISO80601-2-61,ISO10993-
5/10 |
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Caremed Reusable & Disposable SPO2 Sensors -510(k) Submission
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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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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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11. Conclusions
Based on the comparison, analysis, and the submitted performance data, Caremed Reusable & Disposable SPO2 Sensors are substantially equivalent to the predicate devices.