(458 days)
Not Found
No
The description focuses on the electro-optical function of the probe and standard performance testing, with no mention of AI or ML.
No
The device is a diagnostic tool used for monitoring purposes, not for treating or rehabilitating a condition.
Yes
The device is a pulse oximeter probe that monitors continuous, non-invasive arterial oxygen saturation and pulse rate, which are used to assess a patient's physiological state.
No
The device description clearly states it is an "electro-optical probe" containing "two light emitting diodes (LED)" and "one photodiode," which are hardware components.
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.
- Device Function: The description clearly states that the Shenzhen Med-link disposable probe is a non-invasive device that uses optical means to determine arterial oxygen saturation and pulse rate by being connected between the patient and a monitor. It does not involve the analysis of specimens taken from the body.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Shenzhen Med-link disposable probe, model S0136J-L,is indicated for single patient use when continuous,non-invasive arterial oxygen saturation and pulse ratemonitoring are required for adult patients or pediatricpatients weighing more than 30 kg. The S0136J-L iscontraindicated for use with patients during motioncondition.
Product codes
DQA
Device Description
Shenzhen Med-link Pulse Oximeter Probes are electro-optical probes which function without skin penetration, electrical contact, or heat transfer. The probes 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 silicon rubber pads. These SpO2 probes not made with natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients or pediatric patients weighing more than 30 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)
Bench testing:
The bench testing include broad band random vibration, ambient temperature testing, in vitro testing for pulse rate accuracy, shock testing, sinusoidal vibration testing , in vitro testing for SpO2 accuracy under low perfusion conditions, in vitro testing for pulse rate accuracy under low perfusion conditions and drop testing. The test results indicated that the bench testing has not produced new issue to affect the safety and effectiveness of the device of S0136J-L.
Excessive Temperature:
Shenzhen Med-link Probes 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 probes do not exceed 41°C at the probe-tissue interface at an ambient temperature of 35℃.
Test results indicated that the probes do not exceed 41°C at the probe-tissue interface at an ambient temperature of 35°C.
Clinical Testing:
Shenzhen Med-link Probes were clinically tested to validate the performance and accuracy of the probes under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approval protocol with subject informed consent. Med-link Probes clinical study 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, ISO 14155-1:2003, Clinical investigation of medical devices for human subjects -Part 1 : General requirements and ISO 14155-2, Clinical investigation of medical devices for human subjects -Part 2: Clinical investigation plans.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Range: 70% to 100% SpO2
SpO2 Accuracy (70 - 100%) Without Motion: 70-100%: ±3%, 70-80%:±3%, 80-90%:±2%, 90-100%:±2%
Pulse Rate Range: 20 to 250 bpm
Pulse Rate Accuracy: 20 to 250 bpm±3digits
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
Premarket Notification 510(K) Summary
| The assigned 510(k) number is: | K113727 (applicant leave blank) |
|---|---|
| Submission Date: | December 6, 2012 |
| Submitter: | Shenzhen Med-link Electronics Tech Co., Ltd. |
| Building 2, HuaFu Ind. Park, Hua Wang Road, | |
| LongHua, BaoAn, District 518109 Shenzhen City, | |
| P.R.China | |
| Submitter Contact: | Eric Zhan |
| Regulatory Affairs Specialist | |
| Phone Number: 011 86 (755) 61568827 | |
| Fax Number: 011 86 (755) 61120755 | |
| E-mail Address: User22@med-linket.com | |
| Device Name/Model: | Shenzhen Med-Link Pulse Oximeter Probe |
| Model S0136J-L | |
| Common Name: | Pulse Oximeter Probe |
| Classification Name: | Oximeter |
| Regulation: | 21 CFR §870.2700 |
| Product Code: | DQA |
| Intended Use: | Shenzhen Med-link disposable probe, model S0136J-L, |
| is indicated for single patient use when continuous, | |
| non-invasive arterial oxygen saturation and pulse rate | |
| monitoring are required for adult patients or pediatric | |
| patients weighing more than 30 kg. The S0136J-L is | |
| contraindicated for use with patients during motion | |
| condition. | |
| Predicate Device | Reprocessed Nellcor TM D-25 Oximetry Sensor. |
| K Number: K072194 | |
| Manufacturer: ReNu Medical, Inc. | |
| Instrument | |
| compatibility | Instrument Compatibility: Nellcor N595 |
| Shenzhen Med-link | |
| Device Description: | Shenzhen Med-link Pulse Oximeter Probes are |
| electro-optical probes which function without skin | |
| penetration, electrical contact, or heat transfer. The | |
| probes use optical means to determine the light | |
| absorption of functional arterial hemoglobin by being |
MAR 2 1 2013
1
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 silicon rubber pads. These SpO2 probes not made with natural rubber latex.
Patient contact with materials used in Med-Link Probes
were tested in accordance with ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests
cytotoxicity
and
ISO
vitro
Performance Testing: Biocompatibility Testing
for
in
Electrical Safety
Electromagnetic Compatibility Testing
Pulse Rate Accuracy
Bench testing
10993-10:2002/Amd1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment I. Test results indicated that the patient contact material were non-toxic, non-sensitizing and non-irritating. Med-Link Probes were tested in accordance with applicable clause 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 Probes comply with the applicable clauses of the Standards.
Med-Link Probes were tested in accordance with applicable clause of IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Test results indicated that the Probes comply with the applicable clauses of the Standards.
Med-Link Probes 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 probes meet pulse rate accuracy specifications.
Test results indicated that the probes meet the published specifications for pulse rate accuracy over the specified range.
Shenzhen Med-link probe have been conducted the bench testing for the subject device in accordance with FDA Guidance Document for Pulse Oximeters. The
2
bench testing include broad band random vibration, ambient temperature testing, in vitro testing for pulse rate accuracy, shock testing, sinusoidal vibration testing , in vitro testing for SpO2 accuracy under low perfusion conditions, in vitro testing for pulse rate accuracy under low perfusion conditions and drop testing. The test results indicated that the bench testing has not produced new issue to affect the safety and effectiveness of the device of S0136J-L.
Excessive Temperature
Shenzhen Med-link Probes 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 probes do not exceed 41°C at the probe-tissue interface at an ambient temperature of 35℃.
Test results indicated that the probes do not exceed 41°C at the probe-tissue interface at an ambient temperature of 35°C.
Shenzhen Med-link Probes were clinically tested to validate the performance and accuracy of the probes under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approval protocol with subject informed consent. Med-link Probes clinical study 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, ISO 14155-1:2003, Clinical investigation of medical devices for human subjects -Part 1 : General requirements and ISO 14155-2, Clinical investigation of medical devices for human subjects -Part 2: Clinical investigation plans.
Med-Link SpO2 probe 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.
The comparison of the technological characteristics between the subject device and the predicate device in following table.
Clinical
Technology Comparison:
3
Table-1 Comparison of the technological characteristics between the subject device and the predicate device
| Comparison
Item | ReNu Medical Reprocessed
NellcorTM D-25 Oximetry
Sensor (K072194) | Shenzhen Med-Link
Disposable SpO2 Probe, Model
S0136J-L |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | D-25 continuous non-invasive
arterial oxygen saturation and
pulse rate monitoring of
patients >30kg, disposable. | Shenzhen Med-link disposable
probe, model S0136J-L, is
indicated for single patient use
when continuous, non-invasive
arterial oxygen saturation and
pulse rate monitoring are required
for adult patients or pediatric
patients weighing more than 30
kg. The S0136J-L is
contraindicated for use with
patients during motion condition. |
| Measurement
Method | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption |
| Light Emitting
Diodes (LEDs)
wavelengths | RED: 660 nm, nominal;
IRED:905 nm, nominal; | RED: 660 nm, nominal;
IRED:905 nm, nominal; |
| Signal Detection
Method | Photodetector | Photodetector |
| SpO2 Range | 1% to 100% SpO2 | 70% to 100% SpO2 |
| SpO2 Accuracy
(70 - 100%)
Without Motion | 70-100%: ±2%
70-80%:±2%
80-90%:±2%
90-100%:±2% | 70-100%: ±3%
70-80%:±3%
80-90%:±2%
90-100%:±2% |
| Pulse Rate Range | 20 to 250 bpm | 20 to 250 bpm |
| Pulse Rate Accuracy | 20 to 250 bpm±3digits | 20 to 250 bpm±3digits |
| Shipped sterile | Yes | No |
| Compliance | ● IEC 60601-1:1988,
Aml:1991, Am2:1995
● IEC 60601-1-2:2001
● ISO 9919:2005
● ISO 10993-1:2003,
● ISO 10993-5:1999 and
ISO 10993-10:2006 | ● IEC 60601-1:1988,
Aml:1991, Am2:1995
● IEC 60601-1-2:2007
● ISO 9919:2005
● ISO 10993-1:2003,
● ISO 10993-5:1999 and ISO
10993-10:2006 |
| Environment
Conditions | Storage and Transport (In
shipping container)
● Temperature:
-20 °C to 70 °C
● Atmospheric Pressure:
50 kPa to 106kPa
● Operating Temperature:
5 °C to 40 °C
● Atmospheric Pressure:
50 kPa to 106kPa
Relative Humidity:
15% to 95% non-condensing | Storage and Transport(In shipping
container)
● Temperature: -10°C to 40°C
● Atmospheric Pressure:
86kPa to 106kPa
● Operating Temperature:
-10°C to 40°C
● Atmospheric Pressure:
86kPa to106kPa
Relative Humidity:
0~80% non-condensing |
| Cable Length | 0.45m | 0.9m |
Conclusion
・
:
Based upon a comparison of devices and performance testing results, Shenzhen Med-link Probes are substantially equivalent to the predicate devices.
.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circular border of the seal. The emblem is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ge Silver Spring MD 20993-0002
March 21, 2013
Shenzhen Med-Link Electronics Tech Company, Limited C/O Ms. Rhonda Alexander, M.S., M.P.A. Senior Regulatory Specialist Registrar Corporation 144 Research Drive HAMPTON VA 23666
Re: KI13727
Trade/Device Name: Shenzhen Med-Link Pulse Oximeter Probe Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: March 12, 2013 Received: March 14, 2013
Dear Ms. Alexander:
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,
ff 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
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 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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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 Small Manufacturers, International and Consumer Assistance 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.
Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. To the right of the name is the word "for" in a smaller, plain font. Behind the name is a stylized graphic, possibly a logo or design element, that adds a visual backdrop to the text.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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):
K 11 3727
Device Name:
Shenzhen Med-Link Pulse Oximeter Probe
Indications of Use:
Shenzhen Med-link disposable probe, model S0136J-L, is indicated for single patient use when continuous, non-invasive arterial oxygen saturation and pulse rate monitoring are required for adult patients or pediatric patients weighing more than 30 kg. The S0136J-L is contraindicated for use with patients during motion condition.
Prescription Use _ J AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subparts D) (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)
Page 1 of _ 1
ed by Bahram Par ninian Bahram US. Go promont northits le. co-Rahram Parvinian 0300.100.1.1=1300404336 2013.03.18 13:36:12 -04'00
for Lester Schultheis
(Division Sign-Off) (Givision of Anestheslology, General Hospital Infection Control, Dental Devices
. -
510{k) Number:
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