(170 days)
Measures and displays long-term "body temperature" as calibrated to the equivalent oral temperature standard.
Will not provide valid data in ambient temperatures greater than patient body temperature.
Requires 30 minute warm-up before achieving accurate readings.
Will not operate while exposed directly to sun or other forms of radiant heat.
Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.
The document describes the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor, which is an electronic thermometer that measures and displays patient transcutaneous temperature. It has a digital display with a resolution of ± 0.1 F, a warm-up time of 30 minutes, and an accuracy of 0.3° F over a range of 95° F-105° F. It uses a skin surface probe and is powered by a battery.
The document provided is a 510(k) summary for the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor. It outlines substantial equivalence to predicate devices but does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail metrics. Instead, it compares the Sabratek APM-2000's parameters to those of predicate devices. The implication is that meeting or being comparable to the predicate's performance makes the device acceptable for market.
| Parameter | Acceptance Criteria (Implied from Predicate/Sabratek) | Reported Device Performance (Sabratek APM-2000) |
|---|---|---|
| Intended Use | Patient body temperature | Patient body temperature |
| Temperature Range | Comparable to predicate (e.g., 78.8°F-107.6°F) | 90°F (31.9°C) – 106°F (40.7°C) |
| Display Type | Digital | Digital |
| Display Resolution | ± 0.1°C or ± 0.1°F | ± 0.1°F |
| Warm-up Time | 30 Minutes | 30 Minutes |
| Accuracy | 0.3°C or 0.3°F | 0.3°F over range of 95°F-105°F |
| Counts Up and Down | Yes (preferred, or Up only) | Yes |
| Ambient Temperature environment | Less than temperature being taken | Less than temperature being taken |
| Skin surface probe | Yes | Yes |
| Power Supply | Battery or Mains | Battery |
| Battery Charger | Yes or No | No |
| Single Patient Probe | Yes | Yes |
| Shipped Sterile | No | No |
| Microprocessor | No or Unknown | No |
| Alarms | No | No |
2. Sample Size Used for the Test Set and Data Provenance:
The document briefly mentions "Non-clinical tests included comparison with temperature standard." However, it does not provide any specific information regarding:
- The exact sample size used for any test set.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document states that non-clinical tests compared the device with a "temperature standard." It does not mention the involvement of human experts in establishing ground truth for any test set. The ground truth appears to be based on an objective measurement standard.
4. Adjudication Method:
Since no human experts are mentioned in establishing ground truth for a test set, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe an MRMC comparative effectiveness study. This device is a transcutaneous temperature monitor, not an AI diagnostic tool that would typically involve human readers to interpret outputs. Therefore, there's no discussion of human readers improving with or without AI assistance.
6. Standalone Performance Study:
The "Non-clinical tests included comparison with temperature standard" can be interpreted as a standalone performance evaluation of the device. However, the details are extremely limited. It does not provide metrics like sensitivity, specificity, or any specific numerical outcomes beyond the accuracy claim.
7. Type of Ground Truth Used:
The ground truth used for the device's evaluation was a "temperature standard." This implies a reference thermometer or a calibrated temperature source.
8. Sample Size for the Training Set:
The document does not mention a training set or any machine learning/AI components that would require one. The APM-2000 appears to be a traditional electronic measurement device.
9. How Ground Truth for the Training Set Was Established:
Since there is no mention of a training set, there is no information on how ground truth for a training set was established.
Conclusion:
The K983355 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on device specifications and a general statement about non-clinical testing against a "temperature standard." It does not provide the detailed study information typically associated with proving a device meets specific acceptance criteria through a rigorous clinical or performance study, especially not for AI/ML-enabled devices that require such extensive validation. The lack of information on sample sizes, expert involvement, and specific study designs is characteristic of 510(k) summaries for less complex devices where performance is primarily demonstrated through comparison with well-established predicate technology.
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3/12/99
510(k) Submission, Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor Sabratek, Skokie, IL 60067
Section 2 Summary
The following is a Summary of the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor substantial equivalence and safety and efficacy.
| CLASSIFICATION NAME: | Clinical electronic thermometer |
|---|---|
| COMMON/USUAL NAME: | Electronic thermometer |
| PROPRIETARY NAME: | Sabratek Corporation, APM-2000 AmbulatoryPatient Transcutaneous Temperature (TcT)Monitor |
| CLASSIFICATION: | 21 CFR Part 880.2910 Clinical electronicthermometer |
| PERFORMANCE STANDARDS: | No Performance Standards are in effect for thisdevice. |
| PREDICATED DEVICE | Distak Thermometer K833568 and Dean Rody |
Diatek Thermometer, K833568, and Deep Thermometers Limited, pre 1976 device.
| Parameter | SabratekTranscutaneousTemperature | Deep BodyThermometersLimited | DiatekDigitalThermometer |
|---|---|---|---|
| Intended Use | Patient bodytemperature | Patient bodytemperature | Patienttemperature |
| Temperature Range | $90°F (31.9° C) –106°F (40.7° C)$ | $78.8° F (26° с) -107.6° F (42° C)$ | Full RangeUnknown |
| Display Type | Digital | Digital | Digital |
| Display Resolution | ± 0.1 F | ± 0.1 C | ± 0.1 C |
| Warm-up Time | 30 Minutes | 30 Minutes | 30 Minutes |
| Accuracy | $0.3° F over rangeof 95° F-105° F$ | $0.3° C$ | $0.3° C$ |
| Counts Up and Down | Yes | Yes | Up only |
| Ambient Temperatureenvironment | Less thantemperature beingtaken | Less thantemperaturebeing taken | Less thantemperaturebeing taken |
| Skin surface probe | Yes | Yes | Mouth or armpit |
| Power Supply | Battery | Battery or Mains | Battery |
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510(k) Submission, Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor Sabratek, Skokie, IL 60067
| Battery Charger | No | Yes | Yes |
|---|---|---|---|
| Single Patient Probe | Yes | Yes | Yes |
| Shipped Sterile | No | No | No |
| Microprocessor | No | No | Unknown |
| Alarms | No | No | No |
| FDA "K" Number | Pre 1976 device | K833568 |
INDICATIONS
Measures and displays long-term "body temperature" as calibrated to the equivalent oral temperature standard.
Will not provide valid data in ambient temperatures greater than patient body temperature.
Requires 30 minute warm-up before achieving accurate readings.
Will not operate while exposed directly to sun or other forms of radiant heat.
NON-CLINICAL TEST
CONTRAINDICATIONS
CONCLUSIONS
Non-clinical tests included comparison with temperature standard.
The Sabratek Corporation, APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is equivalent in safety and efficacy to its predicate devices.
Sabratek Corporation 8111 N. St. Louis Skokie, Illinois 60067 847-720-2400 847-647-2382 Facsimile
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1999
Mr. Edward F. Waddell Director of Regulatory Affairs and Quality Assurance Sabratek Corporation 5601 West Howard Niles, IL 60714
K983355 Re: Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor (TcT) for the Sabratek APM-2000 Requlatory Class: II (two) Product Code: FLL Dated: January 21, 1999 Received: January 22, 1999
Dear Mr. Waddell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. Edward F. Waddell
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan, Ph.D.
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K983355
Device Name: Sabratek, Corporation. APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor
Indications for use: Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.
Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Bartell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K983355 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.