The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

Device Description

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/min. The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit. The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Strap device:

Important Note: The provided document (K121775) is for a modification to an already cleared device (enFlow IV Fluid Warmer, K112902). The modification is specifically the addition of a Strap as an accessory. Therefore, the core performance of the fluid warmer itself is not being re-evaluated in this submission. The focus is on the impact of the strap.

Acceptance Criteria and Reported Device Performance

The submission states: "The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm." And "[t]here have been no changes to either the intended use of the device or the fundamental scientific technology of the device."

Given this, the acceptance criteria are implicitly that the addition of the strap does not negatively impact the safety and effectiveness of the previously cleared enFlow IV Fluid Warmer.

Acceptance Criteria (Implicit for Strap Addition)	Reported Device Performance (Impact of Strap)
No degradation in the performance of the enFlow IV Fluid Warmer.	"The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence."
No new safety concerns introduced by the strap.	Risk Analysis and Biocompatibility Testing were applied to the "enFlow IV Fluid Warming system" (including the modification, as implied by the context of the submission). This suggests no new unacceptable risks were identified.
The strap effectively secures the warmer to the arm as intended.	Performance Testing was applied to the "enFlow IV Fluid Warming system." While specific results for the strap's securing function aren't detailed, the overall conclusion of substantial equivalence implies this function was met without issues.
The device remains substantially equivalent to the predicate device.	"Vital Signs, Inc. a GE Healthcare Company, considers the enFlow IV Fluid Warmer to be as safe, as effective, and the performance to be substantially equivalent to the predicate device."

Study Details

Based on the provided K121775 submission:

Sample size used for the test set and the data provenance:
- No specific test set sample size is mentioned for the strap itself.
- The document explicitly states: "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." This means there was no clinical test set in the traditional sense for the strap.
- Non-clinical studies (Risk Analysis, Biocompatibility Testing, Performance Testing) were conducted, but details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests specific to the strap are not provided in this summary. These would typically be detailed in a more comprehensive testing report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set requiring expert ground truth was performed for this specific modification.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set was performed.
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 medical fluid warmer, not an AI-powered diagnostic or assistive technology.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests (Risk Analysis, Biocompatibility, Performance Testing), the ground truth would be based on engineering specifications, regulatory standards, and established laboratory testing methodologies. No human-derived ground truth (like expert consensus or pathology) is relevant here.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of the Study for this Specific Submission (K121775):

The submission K121775 is a "Special 510(k) Premarket Notification" for a minor change (adding a strap) to an already cleared device. As such, the "study" is primarily a demonstration of substantial equivalence to the predicate device (K112902) despite the modification, based on non-clinical data.

The relevant non-clinical studies mentioned are:

Risk Analysis: To ensure the strap does not introduce new unacceptable risks.
Biocompatibility Testing: To ensure the strap material is safe for patient contact (if applicable, though its primary function is to secure the warmer to the arm, not direct patient contact, the material's interaction with the warmer itself or incidental human contact could be considered).
Performance Testing: To ensure the strap functions as intended (securing the warmer) and does not impede the warmer's performance.

The key finding is that these non-clinical tests supported substantial equivalence and that clinical testing was not required due to the nature of the modification. This implies that the strap was assessed to be safe and effective and did not alter the fundamental characteristics or performance of the fluid warmer.

Summary

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K121775

NOV 2 8 2012

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enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification

510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Name of Submitter, Contact Person and Date Summary Prepared: l.

Name:

Vital Signs, Inc., a GE Healthcare Company

Address:

Official Contact:

Phone: Fax:

Regulatory Affairs Manager 973-956-5491

Stacie Geffner-Atiya

973-956-5442

20 Campus Rd.

Totowa, NJ 07512

Alternate Contact:

Agata Smieja 410-456-0329

Date of Preparation:

June 14, 2012

1. Device Trade Name and Common Name:

Trade Name:	enFlow IV Fluid Warmer
Common/Usual Name:	Sterile Fluid Path, in-line Blood Fluid Warmer
Classification Name:	Warmer, Thermal, Infusion FluidWarmer Blood, Non Electromagnetic Radiation
Product Code:	LGZBSB - 21 CFR 864.9205
Device Class:	Class II

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enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification

Legally Marketed Predicate Device:

Substantial equivalence is claimed to: Vital Signs, Inc. enFlow Model IV Fluid Warmer (K112902) (a GE Healthcare Company)

Device and Change Description:

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/min.

The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit.

Description of Device Modification

The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.

Indications for Use:

The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

7. Technology:

The Vital Signs, Inc. enFlow* IV Fluid Warmer is substantially equivalent to the previously cleared enFlow IV Fluid Warmer (K112902). The basis for this submission is to notify the FDA of the addition of a strap to be sold as an accessory to the IV Fluid

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enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification Submission

Warmer. There have been no changes to either the intended use of the device or the fundamental scientific technology of the device.

Discussion of Non-clinical Studies: 8.

The following quality assurance and design control measures were applied to the development of the enFlow IV Fluid Warming system and, as described within the 510(k) notification, support the substantial equivalence of the device:

Risk Analysis .
. Biocompatibility Testing
Performance Testing �

Summary of Clinical Tests: 9.

The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence.

Conclusion: l 0.

Vital Signs, Inc. a GE Healthcare Company, considers the enFlow IV Fluid Warmer to be as safe, as effective, and the performance to be substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 2 8 2012

Ms. Stacie Geffner-Atiya Regulatory Affairs Manager Vital Signa. Incorporated A GE Healthcare Company 20 Campus Road Totowa, New Jersey 07512

Re: K121775

Trade/Device Name: enFlow IV Fluid Warmer Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and Plasma Warming Device Regulatory Class: II Product Code: LGZ Dated: October 26, 2012 Received: October 31, 2012

Dear Ms. Geffner-Atiya:

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 i 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.

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Page 2 - Ms. Geffner-Atiya

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); 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 Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours,

2012.11.28 Susan Runner DDS, MA -1-2:18:30 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. 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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enFlow IV Fluid Warmer Strap Special 510(k) Premarket Notification Submission

Indications for Use Statement

K121775 510(k) Number (if known):

Device Name: enFlow IV Fluid Warmer

Indications for Use:

The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

く Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2012.11.28 12:12:25 -05'00'

Page I of I

(Division Sign-Off) (Division Sign-On)
Division of Anasthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:_

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).