TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT by TALLEY MEDICAL

Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.

Device Description

The TableGard Pressure Relieving Patient Warming Mattress system consists of an alternating air mattress (patient support surface) with air pump, and a connectable and thermally regulated warm air blower unit. The air mattress is enclosed in a vinyl and polyurethane cover, which is in turn fitted with air inlet and outlet ports to receive and recirculate warmed air within the air mattress cover under the patient. The patient is warmed by conduction of heat (regulated between 34° and 40° C) thru the polyurethane cover. The air pump and air blower unit operate on 110V, but there is no electrical contact between the control devices and the patient support mattress. The air pump alternately cycles pressures between sections of the mattress to relieve interface pressure against the patient's soft tissues.

AI/ML Overview

The provided text describes the TableGard Pressure Relieving Patient Warming Mattress (K080763). It focuses on the device's functional and safety testing to support its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in a human population.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, training set information, and specific effect sizes) is not applicable or not available in the provided 510(k) summary.

However, I can extract the acceptance criteria related to the device's functional performance and how it was tested.

Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on functional and safety testing, establishing that the device's performance is acceptable and does not introduce new safety or effectiveness concerns compared to predicate devices. The "acceptance criteria" here are implicitly related to the prevention of thermal injury and effective pressure relief, ensuring the device operates within safe and intended parameters.

Acceptance Criterion (Implicit)	Reported Device Performance
Prevent Thermal Injury: Surface temperatures must not cause thermal injury under normal and single-fault conditions. (Temperature regulated between 34°C and 40°C)	"Functional temperature testing shows that the warming System does not result in simulated skin temperatures that would cause thermal injury."
Provide Interface Pressure Relief: Interface pressure between the patient and the support surface must be effectively relieved cyclically and consistently.	"Functional testing shows that the interface pressure was measured as fully relieved on a cyclical and consistent basis." This implies that the alternating air mattress successfully reduces or redistributes pressure at regular intervals, which is crucial for preventing pressure ulcers.

Study Details (Based on available information):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The testing described is "functional and safety testing" and "simulated skin temperatures," implying laboratory or engineering tests, not a clinical study with a patient cohort.
- Data Provenance: Not explicitly stated, but the nature of the tests suggests they were internal laboratory tests conducted by the manufacturer, Talley Medical/Jaxports. These are not human subject data (retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the functional tests would be the physical measurements taken by instruments according to engineering specifications and safety standards, not expert consensus on clinical outcomes.
Adjudication method for the test set: Not applicable. This concept is for clinical studies involving human interpretation or outcomes, not functional device testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a patient warming mattress, not an imaging or diagnostic AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. The device's performance (temperature regulation, pressure relief) is "standalone" in the sense that it operates according to its design parameters.
The type of ground truth used: For temperature testing, the "ground truth" was established by measurements of "simulated skin temperatures" against predetermined safety limits (likely based on established thresholds for thermal injury). For pressure relief, the "ground truth" was the physical measurement of "interface pressure" by instruments, demonstrating cyclical and consistent relief according to the device's design.
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable. See point 7.

Summary of the study:

The study described is a series of functional and safety tests performed on the TableGard Pressure Relieving Patient Warming Mattress system. These were engineering/laboratory tests, not clinical studies involving human subjects.

The tests evaluated:
- Thermal Regulation: Achieved surface temperatures were measured under normal operating conditions and in conditions of possible single-fault failures. The goal was to confirm that the warming system would not cause thermal injury.
- Pressure Relief: Interface pressure between the patient support surface and the patient was measured to confirm that it was fully relieved on a cyclical and consistent basis.

The conclusion drawn from these tests was that the device met its functional and safety requirements, demonstrating substantial equivalence to predicate devices and not introducing new safety or effectiveness issues.

Summary

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K080763

510(k) Summary

MAY 3 0 2008

Talley Medical/Jaxports Submitted by: 4740 Jadestone Dr. Williamston, MI 48895
Jack Van Dyke Contact Person: Talley Medical 1070 E. Wieland Rd. Lansing, MI 48906 517-290-0089
Device Information TableGard Pressure Relieving Patient Warming Mattress Model TG700ht Product Code DWJ 21CFR 870.5900 Class II Product Code FNM 21CFR 880.5550 Class II 510k Exempt
Common name Patient Warming system Thermal Regulating System Alternating air mattress

Predicate Devices

E. KO 11859 Klinamed Thermal Mat & Controller
F. KO 01149 Bair Hugger Patient Warming System
G. KO 062794 PRN ThermalCare Patient Warming System
H. KO 501419 Inditherm Patient Warming System

Description of the Device:

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The TableGard Pressure Relieving Patient Warming Mattress Intended Use: is intended to prevent or treat hypothermia and to provide warmth and pressure relief to patients during extended periods of immobilization. The TableGard should be used in circumstances in which patients could become cold and/or require long periods of static posture.

The TableGard Pressure Relieving Patient Warming Mattress is intended for use on operating tables, surgical and diagnostic surfaces in hospitals or surgical centers to prevent and treat hypothermia and to reduce the occurrence of pressure ulcers.

Patient Population: Adult and pediatric

Comparison to Predicate Devices: See comparison Table 1 in Section 12.

The differences between the TableGard Pressure Relieving Patient Warming Mattress and the predicate devices are minimal. The predicate devices are all external, thermal requlation systems that consist of a device that is placed in contact with the patient, and connected to a control unit that provides physician determined temperature controls.

Functional and Safety Testing:

The TableGard system was evaluated in terms of achieved surface temperatures under normal operating conditions and in conditions of possible single fault failures to determine if an acceptable risk of thermal injury existed. Functional temperature testing shows that the warming System does not result in simulated skin temperatures that would cause thermal injury.

The TableGard system was also evaluated in terms of Interface pressure relief between the patient and the support surface.

Functional testing shows that the interface pressure was measured as fully relieved on a cyclical and consistent basis.

Conclusion: Based upon the testing and comparison, we believe the TableGard Pressure Relieving Patient Warming Mattress to be substantially equivalent to predicated devices and that there is no new safety or effectiveness issue.

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2008

Talley Medical c/o Mr. Jack Van Dyke 1070 E. Wieland Road Lansing, MI 48906

Re: K080763

Talley Tablegard Pressure Relieving Patient Warming Mattress Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II (two) Product Code: DWJ Dated: May 15, 2008 Received: May 18, 2008

Dear Mr. Dyke:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Jack Van Dyke

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): 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Summa R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(K) No. KO80763

TALLEY TABLEGARD PRESSURE RELIEVING PATIENT WARMING Device name: MATTRESS

Indications for Use:

Prescription Use × (21 CFR 801 Subpart D)

OR Over the Counter Use_ (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrance of CDRH, Office of Device Evaluation (ODE)

buna R. L
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_Ko8076

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).