The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System® - Modification. The Model 630 Cardiac Blanket is constructed of the same materials as the Model 525 Blanket and other blankets currently on the market.

AI/ML Overview

This document describes the safety and effectiveness of the Bair Hugger® Total Temperature Management System® - Modification (Model 630 Cardiac Blanket) for warming adult patients during cardiac surgery. The submission is a 510(k) premarket notification, comparing the device to a predicate device, the Bair Hugger Patient Warming System, Model 525 Blanket (K903360).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Safety/Effectiveness Issue)	Reported Device Performance (Prevention/Action)
Safety:
Cutaneous burns/Thermal injury	"Maximum Heat Output (setting III at 43°C) do not provide temperatures high enough to cause burns to tissue. Performance testing demonstrated that by the time the air leaves the Bair Hugger Temperature Management Units, flows through the hose and is circulated through the inflatable Blanket placed over the patient, temperatures have dropped from 43°C to 41°C. These temperatures are well within the range of safety."
Overtemperature condition	"Bair Hugger Temperature Management Units temperature-out-of-range detection system is mechanical, using thermostats to detect over/under temperature conditions. The system triggers audible and visual alarms and shuts the blower's heating elements off when overtemperature conditions are detected."
Hyperthermia	"Instructions packaged with each Bair Hugger Blanket instruct the user to 'Monitor the patient's temperature at least every 10 to 20 minutes'."
Systemic Complications	"Patient core temperature is continually monitored by clinicians during anesthesia with a device of their choice. The 'Instructions for Use' packaged with each Bair Hugger Blanker states that patient temperature should be continually monitored with an appropriate device."
Contamination (Airborne)	"All Bair Hugger® Blankets designed for use in the operating room feature a tape barrier which prevent air from migrating toward the surgical site. Additionally, air is filtered through a 0.2 micron filter. Two studies have concluded that the Bair Hugger 500 Series Units (that have the same air output specifications and the same filter density as the Model 600) do not increase the incidence of microbial or wound contamination."
Effectiveness:
Effective hypothermia treatment (warming mode)	"Performance data show that the Model 630 Cardiac Blanket delivers air temperatures in the warming mode within the same specifications as the Bair Hugger Model 525 Blankets, using the same Bair Hugger Temperature Management Units."

2. Sample size used for the test set and the data provenance

The document does not explicitly state a separate "test set" in the context of a typical AI/algorithm evaluation. The evidence provided is primarily based on performance testing of the device's heating capabilities and existing studies on the predicate device's contamination prevention.

For Thermal Safety: "Performance testing demonstrated that by the time the air leaves the Bair Hugger Temperature Management Units, flows through the hose and is circulated through the inflatable Blanket placed over the patient, temperatures have dropped from 43°C to 41°C." The sample size for this performance testing is not specified, nor is the specific provenance, though it would be internal company testing.
For Contamination Prevention: Two studies are cited as evidence: Hall, A. (1991) and Zink, RS. (1992 & 1993). The document states these studies "concluded that the Bair Hugger 500 Series Units... do not increase the incidence of microbial or wound contamination." The sample sizes and specific provenance (e.g., country of origin, retrospective/prospective) for these studies are not detailed within this 510(k) summary, referring to bibliography entries for full details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document does not describe the use of experts to establish a "ground truth" for a test set in the way this question implies (e.g., for image analysis or diagnostic accuracy). The safety and effectiveness claims are based on direct physical measurements and references to medical literature and prior studies. The "ground truth" for thermal safety is based on established scientific principles regarding burn thresholds and temperature measurements.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication process as would be typical for expert-reviewed data in AI studies.

5. 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 document pertains to a physical medical device (patient warming system), not an AI algorithm, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that its heating and safety mechanisms operate independently of human "intervention" in their core function, but it is always used with human-in-the-loop clinical monitoring and application.

7. The type of ground truth used

The "ground truth" for safety is based on:

Established scientific understanding of thermal injury (per citations 1 & 2: Moritz AR, Henriques FC, and Stoll AM, Green LC).
Direct temperature measurement through performance testing.
Engineering design (thermostats for overtemperature detection).
Clinical protocols for patient monitoring (instructions for use to prevent hyperthermia and systemic complications).

The "ground truth" for effectiveness is based on:

Direct temperature measurement comparing the new model (630 Cardiac Blanket) to the predicate model (525 Blanket).
Biological studies on microbial contamination (per citations 4 & 5: Hall, A. and Zink, RS).

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm described here.

Summary

{0}------------------------------------------------

Safety

JUN 26 1997

K964673

This 510(k) Summary of Safectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System® - Modification. The predicate device is the Bair Hugger Patient Warming System, Model 525 Blanket (K903360). The following summarizes safety issues related to skin surface warming devices and the measures to prevent these problems.

1. Summary of Safety:

Injuries to tissue: Cutaneous burns. Thermal injury is determined by a combination of temperature A. and time. Patients with ischemic limbs or extremely poor perfusion are especially susceptible to thermal injuries.
Prevention: The Bair Hugger Series 500 and 600's Maximum Hear Outpur (setting III at 43°C) do not provide temperatures high enough to cause burns to tissue. Performance testing demonstrated that by the time the air leaves the Bair Hugger Temperature Management Units, flows through the hose and is circulated through the inflatable Blanket placed over the patient, temperatures have dropped from 43°C to 41°C. These temperatures are well within the range of safety.12

Overtemperature condition: Bair Hugger Temperature Management Units temperature-out-ofrange detection system is mechanical, using thermostats to detect over/under temperature conditions. The system triggers audible and visual alarms and shuts the blower's heating elements off when overtemperature conditions are detected.

Labeling: Labels affixed to each Bair Hugger Blanket next to the inlet port and packaged with each Bair Hugger Blanket read as follows:

"Contraindications: 1. Do not apply heat to lower extremities during aortic cross-clamping. Thermal injury to ischemic limbs may occur.

Do not leave patients with poor perfusion unmonitored during prolonged warming therapy sessions."

B. Hyperthermia:
Warming treatment continued past the point of the patient reaching normothermia may eventually produce hyperthermia.3

Prevention: Instructions packaged with each Bair Hugger Blanket instruct the user to "Monitor the patient's temperature at least every 10 to 20 minutes."

C. Systemic Complications:
Prevention: Patient core temperature is continually monitored by clinicians during anesthesia with a 1. device of their choice. The "Instructions for Use" packaged with each Bair Hugger Blanker states that patient temperature should be continually monitored with an appropriate device.

{1}------------------------------------------------

D. Other Safety Concerns:
Contamination. Airborne contamination from air blown intraoperatively across the surgical wound 1. may result in airborne contamination.

Prevention of airborne conramination: All Bair Hugger® Blankets designed for use in the operating room feature a tape barrier which prevent air from migrating toward the surgical sire. Additionally, air is filtered through a 0.2 micron filter. Two studies have concluded that the Bair Hugger 500 Series Units (that have the same air output specifications and the same filter density as the Model 600) do not increase the incidence of microbial or wound contamination.45

Summary of Effectiveness 2.

The Bair Hugger Model 630 Cardiac Blanket effectively provides hypothermia treatment when used as part of a system with Bair Hugger Temperature Management Units.

Performance data show that the Model 630 Cardiac Blanket delivers air temperatures in the warming mode within the same specifications as the Bair Hugger Model 525 Blankets, using the same Bair Hugger Temperature Management Units.

Conclusion

The Model 630 Cardiac Blanker is constructed of the same materials as the Model 525 Blanket and other blankets currently on the market. The intended use of the Model 630 Cardiac Blanket is identical to that of the Model 525 Blanket. Therefore, because of the similarities to the predicate device, Augustine Medical believes this Modification does not raise any new safety or effectiveness issues.

Bibliography

1. Moritz AR, Henriques FC. The Relative Importance of the Time and Surface Temperature in the Causation of Cutaneous Burns. Am J Path 23:695-720, 1947.
Stoll AM, Green LC. Relationship Between Pain and Tissue Damage Due to Thermal Radiation. J Apply Phys 14:373-2. 382, 1959.
Genauer, MB. Postoperative Heat Stroke. Anesthesiology 7:302-309, 1946. 3.
1. Hall, A. Bair Hugger® Warmer Does Not Increase Microbial Contamination in the Operating Room. Abstract presented at the Post Graduate Assembly, New York Society of Anesthesiologists, New York, NY, December 1991.
న. Zink, RS. Convective Warming Therapy Does Not Increase the Risk of Wound Contamination in the Operating Room. Anesthesiology 77:A1093, 1992 & Anesth Analg, 1993:76;50-3.

Contact: Scott D. Augustine, M.D., CEO Augustine Medical, Inc.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an association with public health services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scott Augustine, M.D. CEO, Augustine Medical, Inc. 10393 West 70th Street Eden Prairie, Minnesota – 55344 –

JUN 26 1997

Re: K964673 Augustine Medical Bair Huqqer® Model 630 Cardiac Blanket Regulatory Class: II (Two) Product Code: 74 DWJ Dated: April 8, 1997 Received: April 9, 1997

Dear Dr. Auqustine:

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 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 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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.

{3}------------------------------------------------

Page 2 - Scott Augustine, M.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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, "Misbranding by reference to premarket notification" (21 CFR 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"dsmo@fdadr.cdrh.fda.gov."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

870 . STOO - Thermal Kequil Sting Hatient ﺎ Wa DWJ-II ket

Indications for Use

510(k) number: K964673

Device name: The Bair Hugger® Patient Temperature Managcment® System - Modification: Model 630 Cardiac Blanket

Indications for use:

The Bair Hugger® Model 630 Cardiac Blanket is intended to be used to warm adult patients during cardiac surgery.

PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEET TID

Concurrence of CDRH, Office of Device Evaluation (ODE)

Betre R. Espensle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K964673

Prescription Usc (Per 21 CFR 801-109)

()[

Over the Counter Use

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).