(309 days)
No
The description focuses on the hardware components and optical principles of operation, with no mention of AI/ML algorithms for data processing or interpretation.
No
This device is a diagnostic/monitoring device that measures SpO2 and pulse rate; it does not provide any therapeutic intervention.
Yes
The device is intended for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR)," which are measurements used by healthcare professionals to assess a patient's physiological state and aid in diagnosis.
No
The device description explicitly states it is comprised of a connector, cable, sensor housing, LEDs, and a photo detector, all of which are hardware components.
Based on the provided information, the Coreray Reusable SPO2 Sensor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Coreray Reusable SPO2 Sensor clearly states it is a non-invasive device that uses optical means to determine light absorption through the patient's finger. It does not involve the collection or analysis of any bodily fluids or tissues.
- The intended use is for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate) directly on the patient. This is characteristic of a patient monitoring device, not an IVD.
Therefore, the Coreray Reusable SPO2 Sensor falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.
Product codes
DQA
Device Description
The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing.
The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
One type of sensor housing is described in this submission:
Reusable finger clip sensor
The sensor has a labeling and specifications designed for compatibility with a specific monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingers
Indicated Patient Age Range
Adult (greater than or equal to 40Kg)
Intended User / Care Setting
Reausable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.
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
Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor.
The Reusable SpO₂ Sensor was satisfied the requirements of FDA quidance and ISO 80601-2-61:2011 in the range of 70%-100%SaO2.
Key Metrics
SPO2 Accuracy: ±3% (70-100%)
Pulse Rate Accuracy: ±3(30-250bpm)
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).
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Coreray Technology, Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayor Communication Center No. 55 Shi Zhou Zhong Road Nanshan, Shenzhen 518100 CHINA
Re: K173368
Trade/Device Name: Reusable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 24, 2018 Received: August 2, 2018
Dear Field Fu:
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 avare 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Todd D. Courtney -S" in black text. The text is positioned in front of a light blue FDA logo. The text is clear and easy to read, and the logo is a simple and recognizable design. The image is likely a nameplate or a document header.
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) K173368
Device Name Reusable SPO2 Sensor
Indications for Use (Describe)
Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Version: A/0
SECTION 05 510(k) Summary
5.1 Administrative Information
| Date of Summary
| prepared | Aug. 24, 2017 |
|---|---|
| Manufacturer | |
| information | Company title: Shenzhen Coreray Technology |
| Co., Ltd | |
| Company address: | |
| ChuangYe Technology Park, 1th Dong Huan | |
| Road, Longhua New District, Shenzhen, 510000 | |
| P.R China. P.C.:518109 | |
| Contact person: Simon Fan | |
| Phone: +86-755-28839229 | |
| Fax: +86-755-28839229 | |
| E-mail: manager@core-ray.com | |
| Submission | |
| Correspondent | |
| Image: Logo | |
| 卓远天成 | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: Room 1122, International Mayors | |
| Communication Centre, NO. 55 Shizhou middle | |
| road , Nanshan District, Shenzhen | |
| Contact person: Mr. Field Fu | |
| E-Mail: cefda13485@163.com |
5.2 Device Information
| Type of 510(k)
| submission: | Traditional |
|---|---|
| Trade Name: | Reusable SpO2 Sensor |
| Model: | CR001-3106A |
| Classification name: | Pulse Oximeter Sensor |
| Review Panel: | Cardiovascular |
| Product Code: | DQA |
| Device Class: | II |
4
Regulation Number: | 870.2700
5.3 Predicate Device Information
| Sponsor: | Shenzhen Caremed Medical Technology Co., Ltd. |
|---|---|
| Device: | Caremed Reusable & Disposable SpO2 Sensors |
| 510(K) Number: | K153184 |
| Sponsor: | Solaris Medical Technology Inc |
Medical Technology, Inc. Sponsor: Solaris Reusable & Disposable SPO2 Sensors Device: K100077 510(K) Number: |
5.4 Device Description
The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing.
The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
One type of sensor housing is described in this submission:
Reusable finger clip sensor
The sensor has a labeling and specifications designed for compatibility with a specific monitor.
5.5 Intended Use/ Indications for Use
Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg.
5
5.6 Technological characteristics of the subject device compared to the predicate device
Predicate Device Information:
| 510(K) No.: | K153184 |
|---|---|
| Common name: | Oximeter |
| Classification name: | Oximeter |
| Production regulation: | 21 CFR § 870.2700 |
| Product code: | DQA |
| Panel: | Cardiovascular |
| 510(K) No.: | K100077 |
|---|---|
| Common name: | Pulse Oximeter Sensor |
| Classification name: | Oximeter |
| Production regulation: | 21 CFR § 870.2700 |
| Product code: | DQA |
| Panel: | Cardiovascular |
Comparison to predicate device:
| Comparison
item | Subject Device
Reusable and
disposable
SPO2 sensor | Predicate Device
K153184 | Predicate Device
K100077 | Remarks | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Product Code | DQA | DQA | DQA | same | |
| Regulation
Number | 870.2700 | 870.2700 | 870.2700 | same | |
| Classification | II | II | II | | |
| Intended
use&
Indication
s for Use | Coreray
Reusable
SPO2 Sensor is
intended to be | Caremed
Reusable &
Disposable SPO2
Sensors are | When used with a
compatible
patient monitor
or a pulse | SE as
K100077 | |
| | used in hospital
settings where
patient care is
offered by
qualified
healthcare
personnel. The
Reusable SPO2
Sensor is
intended for
continuous non-
invasive | indicated for
continuous
non-invasive
monitoring of
functional oxygen
saturation of
arterial
hemoglobin
(SpO2) and
pulse rate(PR) for
adult
patients weighing | oximeter device,
Solaris Medical
Technology,
Inc. reusable &
disposable
SpO2 sensors
are intended
to be used for
continuous,
non-invasive
functional
arterial oxygen | | |
| | monitoring of
functional
oxygen
saturation of
arterial
hemoglobin
(SpO2) and
pulse rate (PR)
for adult
patients
weighing
greater than
40kg.
Prescription
device. | greater
than40kg and
pediatric
patients weighing
10 -50 kg. | 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 | | |
| | | | adult patients | | |
| | | | greater than
40kg, pediatric
patients weighing
10 - 40
kg, and infant
(non-neonatal)
patients
weighing 3 -
15kg.
Prescription
device. | | |
| Measurement
Method | 2-wavelength
Relative
Optical
Absorption | 2-wavelength
Relative
Optical
Absorption | 2-wavelength
Relative
Optical
Absorption | same | |
| Light
Emitting | Red:
660nm±10nm
Infrared:
905nm±10nm | Red:660-666nm,
Ired:880-950nm | Red:660-666nm,
Ired:880-950nm | similar
Within
the range
of the
frequency
of the
predicate
devices. | |
| Signal
Detection
Method | Photodetector | Photodetector | Photodetector | same | |
| SPO2
Accuracy | ±3% (70-100%) | ±3% (70-100%) | ±2% (70-100%) | same as
K153184,
and
compliance with
the
ISO80601
1-2-61. | |
| Pulse
Rate
Accuracy | ±3(30-250bpm) | ±3(30-250bpm) | ±3(30-250bpm) | same | |
| Applied
population | Adult (≥40Kg) | Adult(≥40Kg)
Pediatric(10-
50Kg) | Adult(≥40Kg)
Pediatric(10-
50Kg)
Neonatal ( 3- | SE as
K100077 | |
| | | | | 10Kg ) | |
| Measurement
part | Fingers | Fingers or toes | Fingers or toes | Fingers or toes | SE |
| Sterile | No | No | No | No | same |
| Material | ABS, TPU,
Silicone, | ABS, PVC, TPU,
Silicone,
sponge | ABS, PVC, TPU,
Silicone, sponge | ABS, PVC,
Silicone and 3M | similar
Passed
the
biocompa
tibility
test. |
| Biocompatibili
ty | Cytotoxicity
Irritation
Sensitization | Cytotoxicity
Irritation
Sensitization | Cytotoxicity
Irritation
Sensitization | Cytotoxicity
Irritation
Sensitization | same |
| Distal
connector
Design | clip | finger clip and
sponge
adhesive | finger clip and
sponge
adhesive | soft tip and textile
adhesive | clip
design
same as
K153184 |
| Electrical
Performance
and Safety | 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 | IEC60601-
1,IEC60601-1-2,
ISO80601-2-
61,ISO10993-
5/10 | same |
6
7
Version: A/0
8
Version: A/0
The subject device and the predicate device have the same intended use and similar technological characteristics; they both measure SpO2 values for the patients. Thus the subject device is substantially equivalent to the predicate devices.
5.7 Brief discussion of the nonclinical tests
Reusable SpO2 Sensor conforms to the following standards:
60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical IEC Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential
9
Performance.
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
ISO 80601-2-61:2011 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
5.8 Brief discussion of clinical tests
Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor.
The Reusable SpO₂ Sensor was satisfied the requirements of FDA quidance and ISO 80601-2-61:2011 in the range of 70%-100%SaO2.
5.9 Other information (such as required by FDA guidance/Test)
Animal performance testing is not required and was not performed to demonstrate substantial equivalence of the Coreray Reusable SpO2 Sensor.
5.10 Conclusions
Based on the above information, we conclude the subject device, Reusable SpO2 Sensor, is substantially equivalent to the predicate device.