(244 days)
Not Found
No
The device description and performance studies focus on standard electro-optical sensing technology and do not mention any AI or ML components or algorithms.
Yes
The device is indicated for "continuous, non-invasive arterial oxygen saturation and pulse rate monitoring," which are functions consistent with a therapeutic device.
Yes
The device is indicated for use in "continuous, non-invasive arterial oxygen saturation and pulse rate monitoring," which involves measuring physiological parameters to assess a patient's condition, a key function of diagnostic devices.
No
The device description explicitly states that the device is an "electro-optical sensor" containing "two light emitting diodes (LED)" and "one photodiode," which are hardware components. The summary also details performance studies related to hardware aspects like biocompatibility, electrical safety, and temperature.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is a non-invasive sensor that measures arterial oxygen saturation and pulse rate directly from the patient's finger using optical means. It does not analyze a specimen taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical device used for patient monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are indicated for use in continuous, non-invasive arterial oxygen saturation and pulse rate monitoring.
Model S0044D-S is reusable and for patients weighing more than 40 kg.
Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are contraindicated for use on active patients, or during conditions of motion or low perfusion.
Product codes
DQA
Device Description
Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Med-Linket Sensors) are compatible sensors for use with major brands of patient monitors and oximeter devices.
Med-Linket Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The 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 sensor 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 silicon rubber pads.
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 (more than 40 kg)
Intended User / Care Setting
Not Found
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)
Biocompatibility Testing: Patient contact materials used in Med-Linket Sensors were tested in accordance with ISO 10993-1: 2003, Biological evaluation of medical devices – Part 1: Evaluation and testing for skin surface-contact. limited-duration devices. Test results indicated that the patient contact materials were non-toxic, non-sensitizing and non-irritating.
Electrical Safety: Med-Linket Sensors were tested in accordance with the applicable clauses of IEC 60601-1:1988; Am1: 1991; A2: 1995, Medical electrical equipment - Part 1: General requirements for safety, and ISO 9919: 2005. Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. Test results indicated that the sensors comply with the applicable clauses of the Standards.
Electromagnetic Compatibility Testing: Med-Linket Sensors were tested in accordance with the applicable clauses of IEC 60601-1-2:2001, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. Test results indicated that the sensors comply with the applicable clauses of the Standard.
Pulse Rate Accuracy: Med-Linket Sensors were tested in accordance with ISO 9919: 2005, Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use to ensure that the sensors meet pulse rate accuracy specifications. Test results indicated that the sensors meet the published specifications for pulse rate accuracy over the specified range.
Cleaning: Med-Linket Sensors were tested in accordance with internal protocols to ensure that the cleaning instructions do not damage sensor labeling, degrade materials, and that the sensors remain functional after cleaning. Test results indicated that the cleaning instructions do not damage sensor labeling, degrade materials, and that the sensors remain functional after cleaning.
Excessive Temperature: Med-Linket Sensors were tested in accordance with ISO 9919: 2005, Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use to ensure that the sensors do not exceed 41° C at the sensor-tissue interface at an ambient temperature of 35° C. Test results indicated that the sensors do not exceed 41° C at the sensor-tissue interface at an ambient temperature of 35° С.
Environmental: Med-Linket Sensors were tested in accordance with internal protocols to ensure that the operative and storage temperatures, and random vibration do not damage sensor functionality. Test results indicated that the operative and storage temperatures, and random vibration do not damage sensor functionality.
Clinical: Med-Linket Sensors were clinically tested to validate the performance and accuracy of the sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approved protocol with subject informed consent. Test results indicated that the sensors meet the published specifications for accuracy over the specified range.
Conclusion: Based upon a comparison of devices and performance testing results, Med-Linket Sensors are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
1083010
JUN 1 0 2009
510(k) Summary
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Submission Date: | 15 September 2008 |
---|---|
Submitter: | Shenzhen Med-Link Electronics Tech Co., Ltd. |
2F, Building A, Liangheng Ind. Zone, | |
LongHua Town, Baoan District | |
Shenzhen, Guangdong 518109 China | |
Submitter Contact: | Shaorong Lin |
Marketing Manager | |
011 86 (755) 61120085 | |
011 86 (755) 61120055 | |
link03@med-linket.com | |
Manufacturing Site: | Shenzhen Med-Link Electronics Tech Co., Ltd. |
2F, Building A, Liangheng Ind. Zone, | |
LongHua Town, Baoan District | |
Shenzhen, Guangdong 518109 China | |
Official Contact: | Thomas Kroenke |
Principal Consultant | |
Speed To Market, Inc. | |
PO Box 3018 | |
Nederland, CO 80466 USA | |
tkroenke@speedtomarket.net | |
303 956 4232 | |
Trade Name: | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors including |
• Model S0044D-S. | |
Common Name: | Pulse Oximeter Sensor |
Classification Name: | Oximeter |
Classification | |
Regulation: | 21 CFR §870.2700 |
Product Code: | DQA |
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なる
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| Substantially
Equivalent Devices: | Shenzhen Med-Linket™
Model | Predicate
510(k) Number | Predicate
Manufacturer / Model |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------|
| | Adult Silicone Soft Tip
SpO2 Sensor, Model
S0044D-S (S0012A) | K910852* | CSI 975AD-3 Adult
Reusable Pita SpO2
Sensor, 3 foot |
| | * Please note these 510(k) numbers represent monitors containing a pulse oximetry module in which the predicate sensors were included as accessories. | | |
| Device Description: | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Med-Linket
Sensors) are compatible sensors for use with major brands of patient
monitors and oximeter devices. | | |
| | Med-Linket Sensors are electro-optical sensors which function without
skin penetration, electrical contact, or heat transfer. The 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 sensor 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 silicon rubber pads. | | |
| Intended Use: | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are indicated for
use in continuous, non-invasive arterial oxygen saturation and pulse
rate monitoring. | | |
| | Model S0044D-S is reusable and for patients weighing more than 40
kg. | | |
| | Shenzhen Med-Linket™ Adult SpO2 Finger Sensors are
contraindicated for use on active patients, or during conditions of
motion or low perfusion. | | |
| Technology
Comparison: | Med-Linket Sensors employ 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. | | |
Substantially - - - - - - - Shonghon Mad Linkat™
and the comments of the comments of
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Pradicate
and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the county of the country of the
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Page 2 of 4
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Performance Testing:
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and the control control of the control of the control of
:
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| Biocompatibility
Testing | Patient contact materials used in Med-Linket Sensors were tested in
accordance with ISO 10993-1: 2003, Biological evaluation of medical
devices – Part 1: Evaluation and testing for skin surface-contact.
limited-duration devices.
Test results indicated that the patient contact materials were non-toxic,
non-sensitizing and non-irritating. |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | Med-Linket Sensors were tested in accordance with the applicable
clauses of IEC 60601-1:1988; Am1: 1991; A2: 1995, Medical electrical
equipment - Part 1: General requirements for safety, and ISO 9919:
2005. Medical electrical equipment - Particular requirements for the
basic safety and essential performance of pulse oximeter equipment for
medical use.
Test results indicated that the sensors comply with the applicable
clauses of the Standards. |
| Electromagnetic
Compatibility
Testing | Med-Linket Sensors were tested in accordance with the applicable
clauses of IEC 60601-1-2:2001, Medical electrical equipment - Part 1-
2: General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
Test results indicated that the sensors comply with the applicable
clauses of the Standard. |
| Pulse Rate Accuracy | Med-Linket Sensors were tested in accordance with ISO 9919: 2005,
Medical electrical equipment — Particular requirements for the basic
safety and essential performance of pulse oximeter equipment for
medical use to ensure that the sensors meet pulse rate accuracy
specifications.
Test results indicated that the sensors meet the published specifications
for pulse rate accuracy over the specified range. |
| Cleaning | Med-Linket Sensors were tested in accordance with internal protocols
to ensure that the cleaning instructions do not damage sensor labeling,
degrade materials, and that the sensors remain functional after cleaning.
Test results indicated that the cleaning instructions do not damage
sensor labeling, degrade materials, and that the sensors remain
functional after cleaning. |
| | |
| Excessive
Temperature | Med-Linket Sensors were tested in accordance with ISO 9919: 2005,
Medical electrical equipment — Particular requirements for the basic
safety and essential performance of pulse oximeter equipment for
medical use to ensure that the sensors do not exceed 41° C at the
sensor-tissue interface at an ambient temperature of 35° C. |
| | Test results indicated that the sensors do not exceed 41° C at the sensor-
tissue interface at an ambient temperature of 35° С. |
| Environmental | Med-Linket Sensors were tested in accordance with internal protocols
to ensure that the operative and storage temperatures, and random
vibration do not damage sensor functionality. |
| | Test results indicated that the operative and storage temperatures, and
random vibration do not damage sensor functionality. |
| Clinical | Med-Linket Sensors were clinically tested to validate the performance
and accuracy of the sensors under controlled hypoxia versus arterial
oxygen saturation as determined by co-oximetry. All testing was
performed under an institutionally approved protocol with subject
informed consent. |
| | Test results indicated that the sensors meet the published specifications
for accuracy over the specified range. |
| Conclusion | Based upon a comparison of devices and performance testing results,
Med-Linket Sensors are substantially equivalent to the predicate
devices. |
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and the comments of the comments of the comments of
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shenzhen Med-Link Electronics Tech Company, Limited C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Incorporated PO Box 3018 Nederland, Colorado 80466
JUN 1 0 2009
Re: K083010
Trade/Device Name: Shenzhen Med-Linket™ Adult SpO2 Finger Sensor, Model S0044D-S Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 12, 2009 Received: May 13, 2009
Dear Mr. Kroenke:
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.
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.
5
Page 2 - Mr. Kroenke
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Runner
Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
K 083DIO
Shenzhen Med-Linket™ Adult SpO2 Finger Sensor, Model S0044D-S.
The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is indicated for use in continuous, non-invasive arterial oxygen saturation and pulse rate monitoring.
Model S0044D-S (S0012A) is reusable and for patients weighing more than 40 kg.
The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is contraindicated for use on active patients, or during conditions of motion or low perfusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
y. Schutte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k-083010
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