(60 days)
Not Found
No
The description focuses on the hardware components and basic signal processing for calculating SpO2 and pulse rate, with no mention of AI or ML algorithms.
No.
The device is indicated for monitoring and measurement, not for treatment or therapy.
No
The device is an SpO2 sensor, an accessory for oximeters/patient monitors, used for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate), not for diagnosing a condition.
No
The device description explicitly details physical hardware components (probes, sensor housings, silicone rubber tips, rigid halves, silicone pads, sponge, velcro backing, medical tape laminate) that are attached to the patient and connected to a separate monitor. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpO2 sensor measures oxygen saturation and pulse rate by detecting light absorption through the patient's finger. This is a non-invasive measurement taken directly from the body, not from a specimen in vitro (in a test tube or other artificial environment).
- Intended Use: The intended use is for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate) on the patient's body.
Therefore, the SpO2 sensor described is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
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 than 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.
Product codes
DQA
Device Description
As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.
The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin.
The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
Four types of sensor housings are described in this submission:
- Reusable soft tip sensor comprised of an integrated silicone rubber tip.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable non- adhesive sensor with sponge and velcro backing.
- Disposable adhesive sensors constructed of a medical tape laminate.
Each SpO2 sensor has unique labeling and specifications designed for compatibility with the specific oximeters/monitors that have been legally marketed in the United States. The compatible oximeters/monitors are listed in the labeling of each SpO2 sensor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
adult patients weighing greater than 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.
Intended User / Care Setting
hospital use
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
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
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests
- 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
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
The proposed device belongs to skin contact, and the contact duration is less than 30 days. Biocompatibility tests have been conducted on the proposed device, including cytotoxicity, sensitization, and skin irritation. The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation.
Clinical test data:
The subject and predicate devices are exactly the same. Since the sensors are identical, no further clinical testing is necessary.
Key Metrics
SpO2 Measurement Range: 70-100%
SpO2 Accuracy: ± 3%
PR Measurement Range: 30-250bpm
PR Accuracy: ± 3
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 shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
JKH USA, LLC Bill Dai Manager 14271 Jeffrey Rd. #246 Irvine, California 92620
Re: K202851
Trade/Device Name: Spo2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 18, 2020 Received: September 28, 2020
Dear Bill Dai:
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 aware 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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202851
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 than 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K202851
| Submitter: | Name: JKH USA, LLC
Mailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Name: Bill Quanqin Dai
Phone Number: 909-929-9896
Email Address: Bill@jkhUSA.com |
| Date Prepared: | 09/18/2020 |
| Device Trade Name: | Spo2 Sensor |
| Device Common Name: | Spo2 Sensor |
| Model: | N543-01, U103-01, U103S-01, U403-01, U403S-01, U503-01,
U543-01, U410-03, U403-07, U410-02, U403-08, U403-125, U403-06,
U410-09, U403S-91 |
| Classification Names: | Oximeter |
| Regulation Number: | 21 CFR 870.2700 |
| Product Code: | DQA |
| Predicate Device 1: | |
| 510(k) Number: | K082546 |
| Device Name: | Unimed compatible oximeter sensors |
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC |
| Predicate Device 2: | |
| 510(k) Number: | K142832 |
| Device Name: | Unimed Reusable & Disposable Spo2 Sensor |
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC |
Description of Devices:
As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.
The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin.
. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
Four types of sensor housings are described in this submission:
4
- Reusable soft tip sensor comprised of an integrated silicone rubber tip.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable non- adhesive sensor with sponge and velcro backing.
- Disposable adhesive sensors constructed of a medical tape laminate.
Each SpO2 sensor has unique labeling and specifications designed for compatibility with the specific oximeters/monitors that have been legally marketed in the United States. The compatible oximeters/monitors are listed in the labeling of each SpO2 sensor.
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, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.
Comparison to predicate device:
The subject and predicate devices are exactly the same, and there is no difference between them.
| Description | Subject Device (K202851) | Predicate Device (K082546 and
K142832) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 40 kg, pediatric patients weighing
10-50 kg, and neonatal patients
weighing no less than 3 kg. | Unimed 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 than 40 kg, pediatric patients
weighing 10 -50 kg, and neonatal
patients weighing no less than 3 Kg. |
| Prescription /
over-the-counter
use | Prescription | Prescription |
| Energy source | Powered by compatible devices | Powered by compatible devices |
| Measurement
Method | 2-wavelength Relative Optical
Absorption | 2-wavelength Relative Optical
Absorption |
| Light Emitting | Red: 660-666nm, infrared: 880-950nm | Red: 660-666nm, infrared: 880-950nm |
| Sensor Material | ABS, PVC, TPU, Silicone, 3M medical
tape and sponge | ABS, PVC, TPU, Silicone, 3M medical
tape and sponge |
| Distal connector | finger clip , soft tip, textile adhesive
and sponge non- adhesive | finger clip , soft tip, textile adhesive
and sponge non- adhesive |
| Design | and sponge non- adhesive | and sponge non- adhesive |
| SpO2
Measurement
Range | 70-100% | 70-100% |
| Table 1 Substantial Equivalence Table | |
|---|---|
5
| SpO2 Accuracy | $\pm$ 3% | $\pm$ 3% |
|---|---|---|
| PR Measurement | ||
| Range | 30-250bpm | 30-250bpm |
| PR Accuracy | $\pm$ 3 | $\pm$ 3 |
| Usage | Reusable and disposable | Reusable and disposable |
| Sterile | Non-sterile | Non-sterile |
| Biocompatibility | ||
| contact | ||
| classification | Surface Skin contact, less than 24hrs | Surface Skin contact, less than 24hrs |
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
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests
- 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
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
The proposed device belongs to skin contact, and the contact duration is less than 30 days. Biocompatibility tests have been conducted on the proposed device, including cytotoxicity, sensitization, and skin irritation. The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation.
Clinical test data:
The subject and predicate devices are exactly the same. Since the sensors are identical, no further clinical testing is necessary.
Substantial Equivalence:
The subject and predicate devices are exactly the same. The sensors are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device.