(26 days)
Not Found
No
The device description and intended use focus solely on the physical components and function of a temperature probe, which measures temperature using a thermistor. There is no mention of any computational processing, algorithms, or learning capabilities.
No.
The device is described as being used for "monitoring temperature" and "measuring temperature," which are diagnostic or monitoring functions, not therapeutic. There is no mention of treating or alleviating any medical condition.
No.
Explanation: The device is intended for "monitoring temperature," which is a measurement function, not a diagnostic one. It provides data (temperature) to existing monitoring systems, which may then be used by qualified medical personnel for diagnostic purposes, but the device itself does not perform diagnosis.
No
The device description clearly states that the device consists of physical components (phone plug connector, thermistor) and is a reusable temperature probe, which is a hardware device.
Based on the provided text, 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 measures temperature through a thermistor in contact with the patient. It connects to a patient monitor.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly a patient monitoring device used for direct physiological measurement.
N/A
Intended Use / Indications for Use
The reusable temperature probes are intended to be used for monitoring temperature. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.
These devices are indicated for use by qualified medical personnel only ..
Product codes
FLL
Device Description
Reusable temperature probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are used during patient temperature measurement. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. These probes are to be used with 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 patient monitor either directly by using a phono plug or by an interconnect 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
Not Found
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
The reusable temperature probes (REF M1024254, M1024247 and M1024251) have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.
- EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996Part 1: General requirements for safety .
- IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient . monitoring equipment)
- 21 CFR Part 898 .
- . EN 1041:1998 Information supplied by the manufacturer with medical devices
- EN 980:2003 Graphical symbols for use in the labeling of medical devices .
- ISO 10993-5:1995, ISO 10993-10:1996Biological evaluation of medical devices .
- ISO 14971:2000 Medical devices Application of risk management to medical devices .
- EN12470-4:2000 Performance of electrical thermometers for continuous measurement .
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the reusable temperature probes (REF M1024254, M1024247 and M1024251) as compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
R 2 7 2005
Premarket Notification 510(k) Summary As required by section 807.92 Reusable Temperature Probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable)
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
NAME OF CONTACT:
Mr. Joel Kent
DATE:
March 28, 2005
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Reusable Temperature Probes M1024254, Skin Temperature Probe, reusable M1024247, GP Temperature Probe, Adult, reusable M1024251, GP Temperature Probe, Pediatric, reusable
COMMON NAME:
Temperature probe
CLASSIFICATION NAME:
The following Class II classifications appear applicable:
FLL Clinical electronic thermometer
21 CFR 880.2910
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
1
The Reusable Temperature Probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are substantially equivalent in safety and effectiveness to the predicate YSI temperature probes (K962070).
DEVICE DESCRIPTION as required by 807.92(a)(4)
Reusable temperature probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are used during patient temperature measurement. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. These probes are to be used with 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 patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.
These temperature probes are typically used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175).
Products are packed individually into a plastic bag in non-sterile condition. Package label describes product REF codes, manufacturing date, CE-mark, legal entity information and a caution "Rx Only (USA), U.S. Federal law restricts this device to sale by or on the order of a physician." ..
INTENDED USE as required by 807.92(a)(5)
Intended use/Indication for use:
The reusable temperature probes are intended to be used for monitoring temperature. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. These devices are indicated for use by qualified medical personnel only ..
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The reusable temperature probes (REF M1024254, M1024251) and M1024251) are substantially equivalent in safety and effectiveness to the predicate YSI temperature probes (K962070). The reusable temperature probes have the following similarities to the predicate device: - Surface materials, thermistor, cable and cable surface, plug interface, accuracy in 32 to 42° C range.
The proposed reusable temperature probes have the following differences compared to the predicate device:
- Labeling, plug angle, strain relief fibers inside probe
In summary, reusable temperature probes, described in this submission are substantially equivalent to the predicate YSI temperature probes (K962070).
2
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The reusable temperature probes (REF M1024254, M1024247 and M1024251) have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.
- EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996Part 1: General requirements for safety .
- IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient . monitoring equipment)
- 21 CFR Part 898 .
- . EN 1041:1998 Information supplied by the manufacturer with medical devices
- EN 980:2003 Graphical symbols for use in the labeling of medical devices .
- ISO 10993-5:1995, ISO 10993-10:1996Biological evaluation of medical devices .
- ISO 14971:2000 Medical devices Application of risk management to medical devices .
- EN12470-4:2000 Performance of electrical thermometers for continuous measurement .
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the reusable temperature probes (REF M1024254, M1024247 and M1024251) as compared to the predicate device.
3
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel C. Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492
Re: K050837
Trade/Device Name: Reusable Temperature Probes (M1024254 Skin Temperature Frade, Device Namer 100247, GP Temperature Probe, Adult, Reusable; M1024251 GP Temperature Probe, Pediatric, Reusable) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 31, 2005 Received: April 6, 2005
Dear Mr. Kent:
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 mendments, 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 the Federal 1 000; Drag, aAa You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of 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 If your device is classified (see as additional controls. Existing major regulations affecting (I MA), it may of subject to taxes and of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be found in the lee announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Kent
Please be advised that FDA's issuance of a substantial equivalence determination does not I reast be auvrsou that i Dr. I to mornitiation that your device complies with other requirements mean that I DA may Federal statutes and regulations administered by other Federal agencies. or the For of ally I outstal ethe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 01 read in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as better in product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anon your cognification of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific as a Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Quitte Michael Dms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Reusable Temperature Probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable)
Indications for Use:
The reusable temperature probes are intended to be used for monitoring temperature. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.
These devices are indicated for use by qualified medical personnel only.
Over-The-Counter Use _ Prescription Use _ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please do not write below this line-continue on another page of needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aithun V, me
Page __ of .
ann of Anesthesiology, General Hospital. Infoction Control, Dontal Devices
: 10(k) Number:_______________________________________________________________________________________________________________________________________________________________