The Palmo Thermoregulation Interface Accessory for the Cincinnati Subzero Blanketrol II is designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to distal appendage.

Device Description

The Palmo consists of three main parts: 1) a vacuum chamber that contains the 2) thermal exchange surface and an 3) arm seal.

The patient inserts his/her hand through the arm seal and into the vacuum chamber. The palm is placed on the thermal exchange surface. A light vacuum is created by connecting the Palmo to the hospital's regulated vacuum source. The physician can monitor the adequacy of the vacuum and seal from the dial on the mechanical vacuum gauge attached to the top of the Palmo unit. A light vacuum is applied to increase the amount of blood available in the appendage.

The Cincinnati Subzero Blanketrol II (or equivalent) creates the temperature-controlled water that flows through the water channels of the Palmo and heats/cools the thermal exchange plate. The thermal exchange surface is warmed if the patient needs to have the body core temperature increased, and cooled if the body core temperature needs to be decreased.

This combination of light vacuum and a thermal exchange surface provides a rapid and noninvasive mechanism for changing the temperature of the blood flowing through the appendage. This, in turn, changes the temperature of the body core.

The arm seal of the Palmo is available in three different sizes (small, medium & large) to accommodate the range of possible hand and wrist sizes of patients. A variation of the device can also be applied to the foot.

AI/ML Overview

The provided text describes the Palmo Thermoregulation Interface Accessory, a medical device. However, it does not include information about specific acceptance criteria for performance metrics (like accuracy, sensitivity, or specificity), nor does it detail a study designed to prove the device meets such criteria in terms of quantitative performance outcomes.

The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices. This means the primary "study" is a comparison to existing, legally marketed devices, rather than a de novo clinical trial proving specific performance targets.

Here's an analysis based on the provided text, highlighting what is and is not present:

Missing Information:
The document does not provide:

A table of specific acceptance criteria for quantitative performance metrics.
Reported device performance data against quantitative criteria (e.g., how quickly it changes temperature, by how much, or with what accuracy).
Details about a "test set" in the context of an algorithm or diagnostic device.
Information about experts establishing ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth (pathology, outcomes), or training set details. These concepts are typically relevant for diagnostic or AI-driven devices, which this is not.

Analysis of the Provided Information:

The document outlines the basis for substantial equivalence, which is the primary "acceptance criteria" for a 510(k) submission when no new questions of safety or efficacy are raised.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from 510(k) context)	Reported Device Performance (from 510(k) context)
Intended Use Equivalence: Noninvasively lower/raise/maintain patient temperature via local negative pressure and heating/cooling to a distal appendage.	* "The Palmo Thermoregulatory Interface Accessory has the same intended use as the CSZ Hyper-Hypothermia system." * "The Palmo is also substantially equivalent in intended use... as the Aquarius Thermo-STAT System." * "Designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to a distal appendage."
Technological Equivalence: Local application of negative pressure and a thermal exchange surface to a distal appendage.	* "Uses the same CSZ Blanketrol II as a source of temperature controlled water." (in common with predicate) * "Technology uses a local application of negative pressure and a thermal exchange surface to a distal appendage." (consistent with predicate) * "As demonstrated in the bench testing, there are no significant differences in technology between the two systems."
Safety and Efficacy: No new questions of safety or efficacy raised.	* "There are no new questions of safety or efficacy raised between the two systems." * "The results of bench testing support the substantial equivalence claims..." * "Earlier human studies have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient."

2. Sample Size Used for the Test Set and Data Provenance

Test Set: Not applicable in the traditional sense of a diagnostic or AI performance study. The "test" for a 510(k) is the comparison to predicate devices and potentially bench testing.
Data Provenance:
- Bench testing: Performed to confirm technological equivalence ("As demonstrated in the bench testing, there are no significant differences in technology between the two systems."). The location or specific details of this bench testing are not provided.
- Earlier human studies: Referenced as evidence for the underlying mechanism ("Earlier human studies have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient."). No details about these studies (sample size, country of origin, retrospective/prospective) are provided beyond their existence and conclusion.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is not a diagnostic device or an AI algorithm requiring expert-established ground truth for its performance assessment in a 510(k) context.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of expert review for ground truth.

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 device is a therapeutic interface, not a diagnostic imaging or AI-assisted diagnostic tool involving human readers.

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

Not applicable. This device is a hardware interface for thermoregulation, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) is the established performance and safety profile of the predicate devices (Cincinnati Subzero Blanketrol II and Aquarius Thermo-STAT System) and the general scientific understanding that negative pressure and thermal exchange can affect core body temperature. The bench testing serves to show that the Palmo system operates within this established technological equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" like an AI algorithm would.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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AVAcore Technologies, Inc.

AUG 1 6 2002

K014210

Palmo Thermoregulation Interface Premarket Notification 510(k)

SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Contact Person Craig Coombs Vice President, Regulatory/Clinical Affairs & Quality Assurance 415.531.1932 650.321.3908 fax cjcoombs@aol.com

Device Name Trade Name: Palmo Thermoregulation Interface Accessory Common Name: System, Thermal Regulating Classification Name: Thermal Regulation System Accessory (21 CFR 870.5900)

Predicate Devices Cincinnati Subzero Blanketrol II Hyper-Hyopthermia System Preamendment K970376 Aquarius Thermo-STAT System

Device Description

The Palmo consists of three main parts: 1) a vacuum chamber that contains the 2) thermal exchange surface and an 3) arm seal.

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Indications for Use

Testing in Support of Substantial Equivalence Determination

The results of bench testing support the substantial equivalence claims of the Palmo Thermoregulatory Interface Accessory in the above claims. Earlier human studies have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient.

Substantial Equivalence Conclusion

Substantial equivalence is based on the fact that the Palmo Thermoregulatory Interface Accessory has the same intended use as the CSZ Hyper-Hypothermia system. Both use the same CSZ Blanketrol II as a source of temperature controlled water.

The Palmo is also substantially equivalent in intended use and technology as the Aquarius Thermo-STAT System. The technology uses a local application of negative pressure and a thermal exchange surface to a distal appendage. As demonstrated in the bench testing, there are no significant differences in technology between the two systems. There are no new questions of safety or efficacy raised between the two systems

Therefore, it can be concluded that the Palmo Thermoregulatory Interface Accessory is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2002

AVAcore Technologies, Inc. c/o Mr. Craig J. Coombs Vice President Regulatory/Clinical Affairs & Quality Assurance 251 High Street, Suite B Palo Alto, CA 94301

Re: K014210

Trade Name: Palmo Thermoregulation Interface Accessory Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Accessory Regulatory Class: Class II (two) Product Code: DWJ Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Coombs:

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. Craig J. Coombs

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.

Elisa Ortiz for

Bram D. Zuckerman. M Director Division of Cardiovascular 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):

KC014210

Device Name: Palmo Thermoregulation Interface Accessory

Indications for Use

The Palmo Thermoregulation Interface Accessory is designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to a distal appendage.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-the-Counter Use	_________________
(Optional Format 1-2-96)

(Division Sign-Off

Division of Cardiovascur

and Respiratory Device)

510(k) Number	CONFIDENTIAL < 01-4710 -
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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).