SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR

K983355 · Sabratek Corp. · FLL · Mar 12, 1999 · General Hospital

Device Facts

• Record ID: K983355
• Device Name: SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
• Applicant: Sabratek Corp.
• Product Code: FLL · General Hospital
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

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.

Device Story

The Sabratek APM-2000 is an ambulatory transcutaneous temperature (TcT) monitor; it measures skin surface temperature via a probe and displays the value calibrated to an oral temperature equivalent. The device is battery-powered and intended for clinical use; it requires a 30-minute warm-up period before providing accurate readings. The monitor provides digital temperature readouts to healthcare providers to assist in patient monitoring. It does not include alarms or microprocessor-based processing. The device is designed for long-term monitoring applications.

Clinical Evidence

No clinical data. Non-clinical testing consisted of bench-top comparisons against a temperature standard to verify accuracy and performance specifications.

Technological Characteristics

Battery-powered electronic thermometer; digital display; skin surface probe; 30-minute warm-up time; accuracy 0.3°F over 95°F-105°F range; resolution ±0.1°F. No microprocessor, no alarms, no sterilization required.

Indications for Use

Indicated for patients requiring long-term body temperature monitoring. Contraindicated for use in ambient temperatures greater than patient body temperature, direct exposure to sun, or radiant heat sources.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Diatek Thermometer (K833568)
• Deep Body Thermometers Limited (pre-1976 device)

Submission Summary (Full Text)

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3/12/99

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K983355

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 Ambulatory<br>Patient Transcutaneous Temperature (TcT)<br>Monitor |
| CLASSIFICATION: | 21 CFR Part 880.2910 Clinical electronic<br>thermometer |
| PERFORMANCE STANDARDS: | No Performance Standards are in effect for this<br>device. |
| PREDICATED DEVICE | Distak Thermometer K833568 and Dean Rody |

Diatek Thermometer, K833568, and Deep Thermometers Limited, pre 1976 device.

| Parameter | Sabratek<br>Transcutaneous<br>Temperature | Deep Body<br>Thermometers<br>Limited | Diatek<br>Digital<br>Thermometer |
|------------------------------------|-------------------------------------------|-----------------------------------------|-----------------------------------------|
| Intended Use | Patient body<br>temperature | Patient body<br>temperature | Patient<br>temperature |
| Temperature Range | $90°F (31.9° C) –106°F (40.7° C)$ | $78.8° F (26° с) -107.6° F (42° C)$ | Full Range<br>Unknown |
| 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 Temperature<br>environment | Less than<br>temperature being<br>taken | Less than<br>temperature<br>being taken | Less than<br>temperature<br>being taken |
| Skin surface probe | Yes | Yes | Mouth or arm<br>pit |
| 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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)