(15 days)
Not Found
No
The device description and performance studies focus on basic temperature measurement technology (thermistors) and standard electrical/biological safety testing, with no mention of AI or ML.
No
The device is used for monitoring temperature, not for treating any condition. Its function is diagnostic/monitoring, providing information to qualified medical personnel.
No
The device is intended for monitoring temperature, which is a measurement function, not a diagnostic one. It provides data (temperature) rather than interpreting it to determine a disease or condition.
No
The device description explicitly states that the probes consist of a connector and a thermistor, which are hardware components. The device also involves physical contact with the patient.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "monitoring temperature." This is a physiological measurement taken directly from the patient's body (skin or core).
- Device Description: The device is a temperature probe that makes "skin or core contact with a patient." It measures temperature through a thermistor.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not process or analyze such specimens.
The device is a medical device used for direct patient monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes.
These devices are indicated for used by qualified medical personnel only.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Unimed Skin Temperature Probe (T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS), and Unimed General Purpose Temperature Probe (T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG) are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with YSI 400 series compatible temperature measurement systems only.
Temperature probes measure temperature by a resistor that is sensitive to temperature changes.
The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin or core contact with a patient.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel only.
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 and laboratory testing to demonstrate safety and effectiveness per: IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1:1991; Amendment 2:1995
EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10:2002+A1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
K.121427
MAY 2 9 2012
Unimed Medical Supplies Inc No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Email: info@unimed.cn Website: www.unimed.cn
Image /page/0/Picture/3 description: The image shows a logo with the word "UNIMED" in bold, sans-serif font. Below "UNIMED" is smaller text, possibly in a different language. To the right of the text is a circular graphic with a complex design, possibly representing a medical symbol or emblem. The overall impression is that of a company logo for a medical or healthcare-related organization.
510(K) Summary Section 5
Date: 2012-01-15
Submitter Information:
Unimed Medical supplies Inc. No.37, Yanshan Road, Shekou, Shenzhen, China 518067
Contact Person:
Xinmei Tan, QA manager No.37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: (86) 755 26695165 Fax: (86) 755 26697984 Email: tanxinmei@unimed.cn & caijiye@unimed.cn
Proposed Device:
Trade Name: Unimed Temperature Probe (Unimed Skin Temperature Probe, Unimed General Purpose Temperature Probe) Common Name: Temperature Probe Product Classification: FLL; 880.2910; Class II Classification Panel: General Hospital
| Model | Name |
|---|---|
| T2252-AS | Unimed Skin Temperature Probe |
| THP-AS | Unimed Skin Temperature Probe |
| TMQ-AS | Unimed Skin Temperature Probe |
| TSW-AS | Unimed Skin Temperature Probe |
| TSM-15AS | Unimed Skin Temperature Probe |
| TSL-AS | Unimed Skin Temperature Probe |
| TMR-AS | Unimed Skin Temperature Probe |
| T2252-AG | Unimed General Purpose Temperature Probe |
| THP-AG | Unimed General Purpose Temperature Probe |
| TMQ-AG | Unimed General Purpose Temperature Probe |
| TSW-AG | Unimed General Purpose Temperature Probe |
1
Unimed Medical Supplies Inc
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 a www.unimed.co. Email: info@unimed co
Image /page/1/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The logo features the word "Unimed" in a bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a circular graphic with a design inside. The logo is black and white.
| webs e. w | |
|---|---|
| TSM-15AG | Unimed General Purpose Temperature Probe |
| TSL-AG | Unimed General Purpose Temperature Probe |
| TMR-AG | Unimed General Purpose Temperature Probe |
Predicate Device:
YSI 400 Series Autoclavable Temperature Probe (K962070) GE Reusable Temperature Probes (K050837)
Indications for use
Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes.
These devices are indicated for used by qualified medical personnel only.
Device description
Unimed Skin Temperature Probe (T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS), and Unimed General Purpose Temperature Probe (T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG) are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with YSI 400 series compatible temperature measurement systems only.
Temperature probes measure temperature by a resistor that is sensitive to temperature changes.
The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.
Summary of technological characteristics of device compared to the predicate device
The Unimed temperature probes are substantially equivalent in safety and effectiveness to the predicate YSI temperature probes (K962070) and GE temperature probes (K050837).
They have the same thermistor, accuracy in 25-45℃ range and they all apply to
2
Unimed Medical Supplies Inc
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Email: info@unimed.cn Website: www.unimed.cn
Image /page/2/Picture/2 description: The image shows the logo for Unimed USA medical supplies. The logo is in black and white, with the word "Unimed" in bold letters on the left. Below the word "Unimed" is the phrase "medical supplies" in smaller letters. To the right of the word "Unimed" is a circular graphic with the letters "USA" inside.
monitors compatible with YSI temperature probes and GE temperature probes. They are different in labeling, cable material, plug material, cable length.
From the biocompatibility test, safety test and other bench tests, these differences will not bring any safety and effectiveness problem.
In summary, Unimed temperature probes, described in this submission are substantially equivalent to the predicate YSI temperature probes (K962070) and GE temperature probes (K050837).
Performance data
Bench and laboratory testing to demonstrate safety and effectiveness per: IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1:1991; Amendment 2:1995
EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10:2002+A1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Conclusion:
Unimed Temperature Probes have the same intended use, the same technology as the predicate devices. They are claimed to be Substantially Equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Unimed Medical Supplies Inc. C/O Mr. Jeffrey D. Rongero Responsible Third Party Official Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, North Carolina 27709
MAY 2 9 2012
Re: K121427
Trade/Device Name: Unimed Temperature Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 14, 2012 Received: May 14, 2012
Dear Mr. Rongero:
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 Eederal Register.
4
Page 2 - Mr. Rongero
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. . Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Unimed Medical Supplies Inc
No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: info@unimed.cn
Image /page/5/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The logo features the word "Unimed" in a bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a circular graphic with the letters "LAB" inside. The logo is black and white.
Indications for Use Section 4
510(k) Number: K121427
Device Name: Unimed Temperature Probe
Skin Types: T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS; General Purpose Types: T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG
Indications for Use
Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes.
These devices are indicated for used by qualified medical personnel only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Sub part D)
Over-The-Counter Use _ (21 CFR 801 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 _
Aila C. Chay 5/29/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121427