The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

The Pak 2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.

Device Description

Each of the iv fluid warmer devices (Soft Pack, FloorMount and Pak 2) employs a heating plate or heating blanket to warm or maintain the temperature of iv fluids such as normal saline and ringers lactate. These devices use a standard temperature control method and operate reliably in the range of 36-38 degrees C. The Smithworks products are designed to use a 40 watt, 12 VDC with an optional 120 VAC adaptor, for enhanced safety and portability when used in the field.

The Thermal Sack Pressure Infuser is an accessory to the Smithworks iv fluid warmer components. This device is wrapped around the iv fluid bag and is used to apply even pressure to the iv fluid bag when it cannot be maintained in the standard hanging state, which applies normal gravity pressure. This device should only be used in conditions that require emergency personnel to move victims in conditions that prevent a normal gravity based suspension of the iv fluid bag, and when the rescue mission is conducted by a limited number of emergency medical personnel.

AI/ML Overview

This document is a 510(k) premarket notification for "The Smithworks Company IV Fluid Warmer" product line, dated November 29, 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in a robust clinical trial setting.

The document does not contain explicit acceptance criteria tables or detailed study results (like clinical trials or performance studies with statistical analysis) in the way a typical academic paper or a more recent 510(k) summary might for a novel AI device. Instead, it describes characteristics and operational parameters, and then asserts substantial equivalence based on those.

However, we can infer some "acceptance criteria" based on the described features and comparison to predicate devices. For parts of your request that cannot be directly answered from the provided text, I will state that the information is not available in the given document.

Here's an attempt to answer your questions based on the provided text:

Analysis of Acceptance Criteria and Device Performance (Inferred)

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance characteristics of the device and its substantial equivalence to predicate devices, particularly regarding temperature control and fluid compatibility. There are no explicit, quantifiable acceptance criteria presented as a table with associated performance metrics from a formal study.

However, based on the Device Descriptions and Comparison with Legally Marketed Devices sections, we can infer the following:

Acceptance Criterion (Inferred from Device Description & Predicates)	Reported Device Performance (Smithworks IV Fluid Warmer)
Fluid Temperature Maintenance:
Maintains IV fluid temperature within an established range.	"Operate reliably in the range of 36-38 degrees C"
	"Maintains 3 liters of IV fluid to a temperature of 99-101 degrees Fahrenheit (36-38 degrees C)" (Soft Sack)
	"Maintains 4 liters of IV fluid to a temperature of 99-101 degrees Fahrenheit (36-38 degrees C)" (FloorMount, Pak 2)
Fluid Compatibility:
Intended for use with crystalloid fluids.	"Intended for use with crystalloid fluids only, such as normal saline and ringers lactate."
Power Source/Safety:
Operates on safe, portable voltage; includes safety features.	"40 watt, 12 VDC operation"
	"Optional 120 VAC with 12 VDC adaptor"
	"Over-therm fuse protects silicone heater"
	"Fused circuit board controller for accurate thermal regulation and safety"
Durability/Portability:
Rugged construction for field environments; optimized for mobile use.	"Rugged anodized aluminum case"
	"Exterior bag is built of rugged Cordura fabric"
	"Packaging and components have been optimized for mobile use, such as rescue and emergency operations"
Thermal Sack Pressure Infuser:
Enhances fluid delivery and thermal maintenance in hostile environments.	"Enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing."
	"Help maintain a steady flow rate of iv fluids during rescue operations in hostile rescue environments."

Study Information:

The provided document does not describe a detailed study in the traditional sense of a clinical trial or a performance study with a test set, ground truth, experts, or statistical analysis (like sensitivity/specificity, AUC, or MRMC studies).

Rather, it is a 510(k) Premarket Notification which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is typically done through:

Comparison of technological characteristics.
Comparison of indications for use.
Risk analysis.
Verification and validation testing (which are mentioned as being part of the product development process, but no detailed results are included in this summary).

Therefore, many of your specific questions cannot be answered directly from the text because such a study design is not presented.

Here's an attempt to address your questions given this context:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available/Not applicable (N/A): The document does not describe a "test set" in the context of a clinical or performance study with a defined sample size (e.g., number of patients or cases). The submission focuses on device characteristics and substantial equivalence to predicate devices, implying engineering verification and validation rather than a clinical "test set" presented in the summary. Data provenance is therefore not specified for such a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A: There is no "test set" described that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A: There is no "test set" described that would require an adjudication method.

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

N/A: This document is for an IV fluid warmer, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not conducted.

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

N/A: This document is for an IV fluid warmer, not an AI or algorithm-based device. "Standalone performance" in this context would refer to the device's ability to warm fluids to a specific temperature, which is implicitly stated ("operates reliably in the range of 36-38 degrees C"). No formal "standalone study" results are detailed with specific methodologies or metrics, beyond the claim of reliable operation within the specified temperature range.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A (for clinical ground truth): For an IV fluid warmer, "ground truth" would typically refer to accurate temperature measurements by calibrated sensors during engineering testing. The document states, "The Smithworks products are individually tested to operate reliably in the range of 36-38 degrees C." This implies internal testing and validation against known temperature standards, rather than clinical "ground truth" from experts or pathology.

8. The sample size for the training set

N/A: This is not an AI/machine learning device that would have a "training set."

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

N/A: This is not an AI/machine learning device that would have a "training set."

Summary regarding "the study":

The provided document is a 510(k) summary, which outlines the basis for substantial equivalence to predicate devices for an IV fluid warmer. It explicitly states, "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes." However, it does not present the detailed methodology, results, or data from specific "studies" (clinical trials, performance studies with defined test sets, etc.) within this summary document itself, beyond stating the device's operational temperature range and other features. The focus is on demonstrating that the device is as safe and effective as existing, legally marketed devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

JAN 1 0 2017

The Smithworks Company C/O Ms. Patricia A. Milbank Regulatory Consultant 2615 102nd Avenue NE Bellevue, Washington 98004

Re: K060851

Trade/Device Name: The Smithworks Company IV Fluid Warmer, Product Line: Soft Sack iv Fluid Warmer, FloorMount iv Fluid Warmer, Pak 2 iv Fluid Warmer and Thermal Sack Pressure Infuser Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: November 28, 2006 Received: December 1, 2006

Dear Ms. Milbank:

This letter corrects our substantially equivalent letter of December 22. 2006.

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

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Page 2 - Ms. Patricia A. Milbank

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 (reporting of 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/ReportalProblem/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,

Erin I. Keith -S

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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K060851 1 of 4

Indication(s) for Use Statement

510(k) Number:

K060851

Device Name:

The Soft Sack iv fluid warmer

Indications for Use:

Prescription Use V (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)

Anton Brown

Jr J.C.L. Hostology, General Hospit: . Jon Contal, Unical Devices

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KCX60851
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Indication(s) for Use Statement 1

510(k) Number:

K060821

Device Name:

The FloorMount iv fluid warmer

Indications for Use:

Prescription Use (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)

Shila A. Mighdadi, M.D. for. Olen L. M.D.

... Daneral How 1 :: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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c20851
3 of 4

1

Indication(s) for Use Statement

510(k) Number:

K060851

Device Name: The PAK2 iv fluid warmer

Indications for Use:

The PAK2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

Prescription Use r (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)

Shule A. Murphy, R.N., Clin. Assoc., Ph.D.

andony, General Hoazi" ... ... Letial Davices

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Indication(s) for Use Statement

K060851 510(k) Number:

Thermal Sack Pressure Infuser Device Name:

Indications for Use:

The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in olinical and field environments. This device has not been tested for pediatric use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter, Use (21 CFR 807 Subpart C) K 060831 4 af 4

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula N. Muggahim, MD for Chin Shan, Ph.D.

gy, General H
Devices
Kolo 851

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1 of 6

1 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.

1. Identification of Submitter:

Submitter:	The Smithworks Company839 11th StreetClarkston, WA 99403
Phone:	800-576-3454
Fax:	509-758-5942
Contact:	Patricia A. Milbank, JD
Title:	Regulatory Consultant
	2615 102nd Ave NEBellevue, WA 98004
Phone:	425-894-9733
Fax:	425-822-3648
Date Prepared:	November 29, 2006

2. Identification of Products bundled within this 510(k) submission:

Trade Names:	Soft Sack iv fluid warmerFloorMount iv fluid warmerPak 2 iv fluid warmerThermal Sack Pressure Infuser
Regulatory Number:	unclassified
Common Name:	Warmer, Thermal, Infusion Fluid
Regulatory Class:	Class II
Product Code:	LGZ
Manufacturer:	The Smithworks Company839 11th StreetClarkston, WA 99403

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KOLORS ) 2 of 6

3. Indications for Use Statements

Soft Sack iv Fluid Warmer

FloorMount iv Fluid Warmer

Pak 2 iv Fluid Warmer

Thermal Sack Pressure Infuser

4. Device Descriptions:

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KCC00851

3 of 6

device should only be used in conditions that require emergency personnel to move victims in conditions that prevent a normal gravity based suspension of the iv fluid bag, and when the rescue mission is conducted by a limited number of emergency medical personnel.

Features of the Soft Sack IV Fluid Warmer:

. 40 watt, 12 volt operation for personal safety and gentle, even heating of solutions
Operates on standard 12 volt DC automotive current .
Optional 120 VAC with 12 VDC adaptor available �
Maintains 3 liters of IV fluid to a temperature of 99-101 degrees . Fahrenheit (36-38 degrees C)
. Rugged anodized aluminum case to protect the electronics
. Over-therm fuse protects silicone heater
Fused circuit board controller for accurate thermal regulation and . safety
. Exterior bag is built of rugged Cordura fabric for durability
Reflective materials meet highway safety requirements ◆
Lined with Thinsulate insulation and Mylar heat reflective material .

Features of the FloorMount IV Fluid Warmer:

. 40 watt, 12 volt operation for personal safety and gentle, even heating of solutions
Operates on standard 12 volt DC automotive current ◆
. Optional 120 VAC with 12 VDC adaptor available
. Maintains 4 liters of IV fluid to a temperature of 99-101 degrees Fahrenheit (36-38 degrees C)
Rugged anodized aluminum case to protect the electronics
Over-therm fuse protects silicone heater .
Fused circuit board controller for accurate thermal regulation and . safety

Features of the Pak 2 IV Fluid Warmer:

. 40 watt, 12 volt operation for personal safety and gentle, even heating of solutions
. Operates on standard 12 volt DC automotive current
Optional 120 VAC with 12 VDC adaptor available .
. Maintains 4 liters of IV fluid to a temperature of 99-101 degrees Fahrenheit (36-38 degrees C)
. Rugged anodized aluminum case to protect the electronics
. Over-therm fuse protects silicone heater
. Fused circuit board controller for accurate thermal regulation and safety

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Provides an alternative for non-transport ALS emergency vehicles .
. Designed for transport in a Plano 747 box

Features of the Thermal Sack Pressure Infuser:

A thermal maintenance device, designed for use with the Soft Sack � IV Fluid Warmer, the FloorMount IV Fluid Warmer or the Pak 2 IV Fluid Warmer.
. Designed for use in wilderness rescue operations or rescue operations where ambient temperature will affect the temperature of warmed fluids.

5. Comparison with Legally Marketed Devices

Several iv fluid warmers have been cleared by FDA for use in hospital, clinical and field environments. These systems have been cleared under two product codes: iv fluid warmers have been assigned the product code LGZ and remain "unclassified," whereas products intended for use as blood/fluid warmers have been classified as BSB under 21 CFR 864.9205 Both categories of these products have been cleared as Class II medical devices.

The predicate devices cited in this submission have been cleared under the 510(k) PreMarket Notification process. The predicate devices are as follows:

510(k) No.	Trade Name	Manufacturer	ProductCode	RegulationNumber
K973741	Bair Hugger	Augustine	BSB	864.9205
	Blood/Fluid Warmer	Medical, Inc.
K984640	Thermal Angel 200	Estill Medical	BSB	864.9205
	Blood/Fluid Warmer	Technologies, Inc.
K002409	MaxOne IV	Automatic	LGZ,	Unclassified
	Fluid/Blood Warmer	Medical	subsequent	and
		Technologies, Inc.	code BSB	864.9205
K921395	Hot Sack and Optional	C.F. Electronics	LGZ	Unclassified
	Insulated IV Sleeve
K012276	Listed as "Heat Stack	Medical Solutions,	LGZ	Unclassified
and	Devices": filed as	Inc.
K041839	"Temp 3" and "8None"

Similarities:

The Smithworks iv fluid warmer product line is designed to provide external warming of iv bags containing normal crystalloid iv solutions. In this application, the Smithworks iv fluid warmers incorporate features that are substantially equivalent to the features provided by the legally marketed iv fluid warmer devices cited above. All of the iv fluid warmers are designed for use in the hospital, clinical or field environment.

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Each device employs a heating element to warm iv fluids. All of the devices use a standard temperature control method and have an established range of operation for the temperature control (typically 33-41 degrees C). The Smithworks products are individually tested to operate reliably in the range of 36-38 degrees C.

As with the Hot Sack device, the Smithworks product packaging and components have been optimized for mobile use, such as rescue and emergency operations. Also, the power source for the Smithworks iv fluid warmer devices is provided by a 12V battery or 100-120 VAC. The Smithworks products are designed to use a 40 watt, 12 VDC with an optional 120 VAC adaptor, for enhanced safety and portability when used in the field.

The proposed indications for use statement for the Smithworks Company Soft Pack, FloorMount and PAK2 iv fluid warmer products is substantially equivalent to the approved indications for use statements provided in the labeling for the cited predicate devices.

Finally, Smithworks provides an optional accessory for use with its iv fluid warmer devices, the Thermal Sack Pressure Infuser, an accessory that is equivalent to the Hot Sack Optional Insulated IV Sleeve. These devices are both designed to provide thermal maintenance of previously warmed iv fluids and to help maintain a steady flow rate of iv fluids during rescue operations in hostile rescue environments, such as extreme temperature/wind chill conditions.

Differences:

The cited predicate devices that are classified under product code BSB (see Table, above) also provide "in-line" warming of blood and/or iv fluids. The Smithworks products do not provide this functionality. Smithworks iv fluid warmer products are only intended for use for the warming of iv fluid bags containing crystalloid fluids, such as Ringer's lactate or normal saline, using conduction from an external electronic component.

6. Conclusions

The Smithworks Company iv fluid warmer products, the Soft Sack, the FloorMount and the Pak2, are substantially equivalent to the identified legally marketed devices intended for use in warming iv bags containing crystalloid fluids, such as Ringer's lactate or normal saline, using conduction from an external electronic component.

The Thermal Sack Pressure Infuser is equivalent to a previously cleared device marketed as an accessory for use with iv fluid warmers to provide

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KCX.0851
6 of 6

thermal maintenance of previously warmed iv bags and steady flow rates during rescue operations in hostile environments.

The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Smithworks Company iv fluid warmer products operate in hospital, clinical and field environments in a manner comparable to the predicate devices.

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).