(234 days)
General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.
Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes. The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.
Here's an analysis of the provided 510(k) summary, aiming to describe the acceptance criteria and the study proving the device meets them, based on the input text:
Acceptance Criteria and Device Performance for Dräger Temperature Probes (K121999)
Based on the provided 510(k) summary (K121999) for Dräger Temperature Probes, the document outlines verification and validation measures, but it does not explicitly state specific numerical acceptance criteria or detail the quantitative results of a study demonstrating these criteria have been met for accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general performance and safety tests.
The document indicates that the device's performance is within an acceptable range for clinicians, implying that the acceptance criteria for these tests were met, but the specific metrics are not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Accuracy | Equivalent to predicate devices (implicit) | Performance given within the range the device can be used by clinicians. The function and principle of operation, as well as the characteristic of the used NTC (YS1400), are equal to predicates. |
| Biocompatibility | Use of biocompatible materials | Devices are made from biocompatible materials. |
| Electrical Safety | Meets relevant standards (implicit) | Verified. |
| Mechanical Integrity | Withstands bending, connection cycles, pull-off forces | Verified (bending, connection cycles, pull-off forces). |
| Environmental | Withstands shock & vibration, storage, transport | Verified (Shock & Vibration, Storage and Transport). |
| Labeling | Meets regulatory requirements | Verified (Labelling review). |
| Resistance to Fluids/Disinfectants | Withstands fluids and disinfectants (implicit) | Verified (Resistance to fluids and disinfectants). |
| Shelf Life | Meets specified shelf life (implicit) | Verified (Shelf Life). |
| Compatibility | Compatible with Dräger and Siemens patient monitors | Compatible to devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the country of origin of the data. It mentions "Verification & validation measures include but are not limited to the following key tests," implying these tests were conducted, but offers no details about the testing methodology, sample sizes, or data provenance (retrospective or prospective) for each specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the use of experts to establish ground truth for a test set. This type of device (temperature probes) typically relies on metrological standards and comparisons to reference instruments rather than expert opinion for ground truth.
4. Adjudication Method for the Test Set
As there's no mention of expert ground truth establishment, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or is not mentioned in the provided document. This type of study is relevant for diagnostic imaging interpretation devices, not for basic medical instruments like temperature probes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a physical temperature probe, not an algorithm, so a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and therefore not mentioned. The probes' performance is evaluated standalone in terms of their physical and electrical properties when connected to a monitor.
7. Type of Ground Truth Used
The ground truth for the verification and validation tests would typically be established by metrological reference standards for temperature measurement, and possibly by laboratory testing against known environmental conditions, for tests like accuracy, electrical safety, mechanical tests, and environmental resistance. For biocompatibility, the ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993). The document confirms that for accuracy, the "function and principle of operation as well as the characteristic of the used NTC (YS1400) are equal" to predicate devices, implying that their inherent accuracy characteristics are comparable using established physical principles.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of this device. Temperature probes are not AI/ML devices that require training sets. Their performance is based on physical design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The two dots above the "a" in "Dräger" are prominent. Above the word "Dräger" is the number 2121999.
510(k) Summary acc. to 21 CFR 807.92
Applicants Name and Address:
FEB 2 8 2013
Dräger Medical GmbH Moislinger Allee 53-55 23542 Lübeck Germany
Manufacturer Name and Address:
Dräger Medical GmbH Moislinger Allee 53-55 23542 Lübeck Germany
Establishment Registration Number :
9611500
Contact Person:
Ulrich Schröder Director Regulatory Affairs & Clinical Affairs
Tel. No.: 011 49 (451) 882-3648 Fax No.: 011 49 (451) 882-3018
Applicants US Contact Person
Beth Zis Director Regulatory Affairs
Tel. No.: (978) 379-8265 Fax No.: (978) 379-8335
Date submission was prepared:
2012/07/06
Device Name:
Common Name: Classification Name: Regulation Number: Class:
Temperature Probes (General Purpose/ Skin) Clinical electronic thermometer, FLL 21 CFR 880.2910 ll
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Legally Marketed Devices to which Substantial Equivalence is claimed:
| 510(k) number | Trade name | Company |
|---|---|---|
| K946306 | SC 9000 Bedside Monitor, SC 9015 BedsideMonitoring System | Dräger (former Siemens) |
| K050837 | Reusable temperature probes (SkinTemperature Probe, reusable; GeneralPurpose Temperature Probe, reusable | GE HEALTHCARE |
| K051873 | Disposable temperature, Skin andOesophageal probes | GE HEALTHCARE |
| K070339 | Disposable temperature probes/ sensorsand instrument cables | CINCINNATI SUB-ZEROPRODUCTS, INC |
Device Description:
Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes.
The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.
Intended Use:
General Purpose Temperature Probes
Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum.
Skin Temperature Probes
Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.
Verification & validation measures include but are not limited to the following key tests: Shock & Vibration, Storage and Transport, Compatibility to devices, Accuracy Test, Electrical Safety, Biocompatibility, Mechanical tests (bending, connection cycles, pull-off forces) Labelling review, Resistance to fluids and disinfectants, Shelf Life.
Differences, Similarities and Conclusion:
The Dräger temperature probes are identical in fit, form and function to the predicates. The intended use and general construction as the predicate devices remain the same. The function and principle of operation as well as the characteristic of the used NTC (YS1400) are equal.
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The Dräger temperature probes are non-sterile and are intended for single patient use instead of some predicates. The Dräger temperature probes use different materials but the devices are made from biocompatible materials and all verification and validation data provided indicate product performance is given within the range the device can be used by clinicians. In summary, the disposable temperature probes described in this submission are substantially equivalent to the predicate devices.
NTC-Negative Temperature Coefficient Thermistor
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Draeger Medical GmbH C/O Ms. Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Incorporated 6 Tech Drive ANDOVER MA 01810
Re: K121999
Trade/Device Name: General Purpose Temperature Probes, Skin Temperature Probes Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 31, 2013 Received: February 4, 2013
Dear Ms. Zis:
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 Federal Register.
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Page 2 - Ms. Zis
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,
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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
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Indications for Use Statement
| 510(k) Number (if known) | K 121999 |
|---|---|
| Device Name | General Purpose Temperature Probes Skin Temperature Probes |
| Indications for Use | General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801. 109)
OR
Over-The-Counter Use
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Richard C. Chapman 2013.02.19 16:39:46 -05'00'
(Division Sign-Off) (Division of Anastheslology, General Hospital Division of Antrol, Dental Devices
510(k) Number:
§ 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.