(250 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 for monitoring vital signs (SpO2 and pulse rate), not for treating a disease or condition.
Yes
The device is indicated for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR)," which involves assessing a physiological state (oxygen saturation and pulse rate) to inform medical decisions.
No
The device description explicitly states that the sensors are made up of hardware components including a connector, cable, LEDs, a photo detector, and 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 medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The SpO2 Sensors described here are used for continuous non-invasive monitoring of oxygen saturation and pulse rate on the patient's body (specifically, on the fingers). They use optical means to measure light absorption in vivo.
- No Specimen Testing: The device does not involve collecting or analyzing specimens taken from the body.
Therefore, the SpO2 Sensors fall under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / 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 than40kg at hospital facilities.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
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 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.
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 patients weighing greater than 40kg
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SPO2 Accuracy: ±3%(70-100%)
Pulse Rate Accuracy: ±3(30-250bpm)
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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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 , |
| ShangHengLang, HuaHui Road , DaLang Street , LongHua new | |
| 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 , |
| ShangHengLang, HuaHui Road , DaLang Street , | |
| LongHua new district , Shenzhen City , GuangDong | |
| Province ,China | |
| Tel | 0086-755-23463462 |
| Fax | 0086-755-29553084 |
| Mei_FDA@foxmail.com |
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 | |
| 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
item | Subject Device | Predicate Device
K142832 | Note |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended
use&
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 | Unimed Disposable and
Reusable SPO2 Sensors
are indicated for continuous
non-invasive monitoring of
functional oxygen saturation
of arterial hemoglobin | Similar |
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K173045
| Comparison
item | Subject Device | Predicate Device
K142832 | Note |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------|
| patients weighing greater
than 40kg. | (SpO2) and pulse rate(PR)
for adult patients weighing
greater than40kg, pediatric
patients weighing 10 -50 kg,
and neonatal patients
weighing no less than 3 Kg. | | |
| Measuremen
t Method | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Light
Emitting | Red: 660-666nm,
Ired: 880-950nm | Red: 660-666nm,
Ired: 880-950nm | same |
| Signal
Detection
Method | Photodetector | Photodetector | Same |
| SPO2
Accuracy | ±3%(70-100%) | ±3%(70-100%) | Same |
| Pulse Rate
Accuracy | ±3(30-250bpm) | ±3(30-250bpm) | Same |
| Applied
population | Adult(≥40Kg) | Adult(≥30Kg)&Pediatric(10-
50Kg) | Similar |
| Measuremen
t part | Fingers | Fingers or toes | Similar |
| compatible
monitor | Nellcor(N395)
Ohmeda3800 | Nellcor(N395)
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
connector
Design | DB9 9pin&Round-head
7pin/8p | DB9 9pin&Round-head
7pin/8p | Same |
| Distal
connector
Design | finger clip , soft tip, textile
adhesive | finger clip , soft tip, textile
adhesive and sponge
adhesive | Similar |
| Conformance
standard | IEC 60601-1 ,IEC
60601-1-2, ISO
80601-2-61, ISO
10993-5/10 | IEC 60601-1 ,IEC
60601-1-2, ISO
80601-2-61, ISO
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& | |
| Indications for Use | |
| & Applied | |
| population | The subject device is intended use for adult |
| patients weighing greater than 40Kg. The | |
| predicate device, which includes 12 models, is | |
| intended for adult, pediatric and neonate patients. | |
| but both devices are compatible with the same | |
| monitor. This difference does not raise different | |
| questions of safety and effectiveness. | |
| Measurement part | The subject devices are intended to be used on |
| fingers not toes; the predicate devices will be | |
| applied for fingers and toes. But the spo2 and PR | |
| accuracy of subject device applied for fingers | |
| meets the requirements of ISO 80601-2-61. This | |
| difference does not raise different questions of | |
| safety and effectiveness. | |
| compatible monitor | The subject devices is compatible with |
| Nellcor(N395) and Ohmeda3800 monitors. The | |
| predicate devices is compatible with Nellcor(N395) | |
| and Ohmeda3700 monitors. This difference does | |
| not raise different questions of safety and | |
| effectiveness. | |
| Cable Length | According to the clinical requirements, the subject |
| device's cable length were designed to be 1.0m & | |
| 3.0m. The predicate device's cable lengths are | |
| 1.1m & 3.0m. This difference does not raise | |
| different questions of safety and effectiveness. | |
| Meanwhile the subject device has passed the | |
| IEC60601-1, IEC 60601-1-2 and ISO 80601-2-61. | |
| Distal connector | |
| Design | The spo2 sensor in this submission have 3 types |
| (finger clip , soft tip &3M). The predicate device | |
| has an additional connector of sponge adhesive. | |
| This difference does not raise different questions | |
| of safety and effectiveness. This subject devices | |
| have passed the IEC 60601-1, IEC 60601-1-2and | |
| 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.