Paladin Biomedical Corporation ThermoStat 900 Administration Set is intended to be used with the MMS Thermostat 900 Blood and Fluid Warmer. The disposable cartridge and administration set is intended to deliver high volume, rapid administration of blood and physiological fluids when connected to a large bore catheter. The set is intended to help prevent hypothermia in patients receiving large volumes of fluids.

Device Description

There are two configurations of the administration set the ASH200 (High flow - 2 spike) and ASH300 (high flow - 3 spike). Materials of construction are all known biocompatible materials. The set consists of three major sub assemblies:

tubing and administration set consisting of tubing, spikes, clamps, luers, . drip chambers
filter/vent assembly .
cartridge assembly. .

AI/ML Overview

This document is a 510(k) summary for the Paladin Biomedical Corporation ThermoStat 900 Administration Set. It identifies the device as an infusion fluid warmer and compares it to a predicate device, the Microwave Medical System ThermoStat 900 Blood & IV Fluid Adm. Set (K970045).

Here's an analysis of the provided information about acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it uses a qualitative equivalency statement.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially Equivalent (in design, materials, construction, and intended use) to predicate device.	"The Paladin Biomedical Administration Set and the MMS Administration Sets were compared with respect to various attributes (Dimensions, warming method, filter size, flow rate, and maximum pressure) and determined to be the same with respect to materials, design, specifications, construction, and performance."
Does not raise any new safety and efficacy concerns compared to the predicate device.	"Since the Paladin device is the same in intended use and technological characteristics as the predicate device, the Paladin device does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices."
Capable of safely and accurately performing the stated intended use.	"The descriptive characteristics demonstrate that the Paladin device is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use."

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

The document mentions "Bench testing was performed to determine equivalency and performance aspects of the device." However, it does not specify the sample size used for this bench testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

This document describes a premarket notification for a medical device (an administration set for a fluid warmer). The "ground truth" in this context refers to the performance of the device itself against established engineering specifications or the predicate device's performance. It is a technical evaluation, not a diagnostic one requiring expert interpretation of medical images or patient outcomes in the same way an AI diagnostic tool would.

Therefore, the concept of "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable here. The equivalency was determined through bench testing and comparison to technical characteristics.

4. Adjudication Method for the Test Set

As mentioned above, the evaluation is based on technical bench testing and comparison to a predicate device's specifications. The concept of an "adjudication method" (like 2+1 or 3+1 for expert consensus) is not applicable in this context. The determination of equivalency would likely involve engineers and regulatory affairs personnel reviewing the test results and comparing them to the predicate device's documented performance.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive technologies that directly impact human interpretation of medical data (e.g., radiology images). This device is an administration set for a fluid warmer, a purely mechanical/fluidic device.

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

This question is not applicable as the device is a mechanical administration set, not an algorithm or AI system. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for this device is technical specifications and performance data of the predicate device, as well as established engineering principles and internal test specifications for the new device. The goal was to demonstrate that the new device's performance (e.g., flow rate, warming method, filter size, maximum pressure) is equivalent to that of the legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

This question is not applicable. There is no training set for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence of a physical medical device to a predicate device through bench testing and comparison of technical specifications, rather than evaluating the performance of an AI or diagnostic algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert Bickford COO Paladin Biomedical Corporation 506 Boston Post Road Weston, Massachusetts 02493

JAN 1 0 2017

Re: K073363

Trade/Device Name: ThermoStat 900 Administration Set, Models ASH200 and ASH300 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: March 10, 2008 Received: March 13, 2008

Dear Mr. Bickford:

This letter corrects our substantially equivalent letter of March 20, 2008.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 Parts 801 and 809 ); medical device reporting of

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Page 2 - Mr. Robert Bickford

medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/1/Picture/8 description: The image shows the name "Erin I. Keith -S" in a bold, sans-serif font. The letters are black against a white background. The name appears to be a signature or label.

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Paladin Biomedical Corporation ThermoStat 900 Administration Set

Indications For Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintan

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

Page 1 of

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

000011

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MAR 2 0 2008

K073363 (A. lotz)

510K Summary of Safety and Effectiveness Paladin Biomedical Corporation ThermoStat 900 Administration Set Models ASH 200 and ASH 300 506 Boston Post Road Weston, MA 02493 March 18, 2008

1. Sponsor Name Paladin Biomedical Corporation 506 Boston Post Road Weston, MA 02493
1. Device Name Proprietary Name: ThermoStat 900 Administration Set Common/Usual Name: warmer, thermal, infusion fluid
1. Identification of Predicate or Legally Marketed Device BK970045 Microwave Medical System, 310-312 School St., Acton, MA 01720 Trade Name: ThermoStat 900 Blood & IV Fluid Adm. Set Cleared Date: 06-MAR-1998

4. Device Description

tubing and administration set consisting of tubing, spikes, clamps, luers, . drip chambers
filter/vent assembly .
cartridge assembly. .
న. Intended Use

Comparison of Technological Characteristics ર્ભ. The Paladin Biomedical Administration Set and the MMS Administration Sets were compared with respect to various attributes (Dimensions, warming method, filter size, flow rate, and maximum pressure) and determined to be the same with respect to materials, design, specifications, construction, and performance.

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K 473363 (f. 20f2)

7 Performance Testing Bench testing was performed to determine equivalency and performance aspects of the device.
1. Statement of Equivalency

The Paladin System is substantially equivalent in design, materials, construction and intended use as that of the predicate. Since the Paladin device is the same in intended use and technological characteristics as the predicate device, the Paladin device does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.

The descriptive characteristics demonstrate that the Paladin device is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).