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.

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 infuscate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the enFlow IV Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/medical device might.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes for test and training sets, and expert involvement for ground truth establishment cannot be fully provided from this document.

Here's an explanation based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it states that the device is substantially equivalent to a predicate device and lists a series of non-clinical studies for verification and validation.

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

Not applicable. The document states that clinical testing was not required to support substantial equivalence due to the nature of the modifications (minor labeling, shelf life, design, and software modifications). Therefore, there is no clinical test set for which to determine sample size or data provenance.

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)

Not applicable, as no clinical test set was used for this 510(k) submission.

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

Not applicable, as no clinical test set was used for this 510(k) submission.

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. The enFlow IV Fluid Warmer is a physical medical device (an IV fluid warmer), not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

Not applicable, as no clinical ground truth was established for this submission. The "ground truth" for this device's performance would be its ability to warm fluids to a specific temperature range, which is verified through engineering specifications and performance testing, not clinical outcomes in a study. The document mentions "Performance/Functional Verification and Validation" in the non-clinical studies section, implying engineering and bench testing.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

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

Not applicable, as no training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (based on the document):

The document states that "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." (Page 2, Section 9).

Instead, the substantiation for this 510(k) submission relies on a series of non-clinical studies and design control measures applied to the development of the enFlow IV Fluid Warming system. These studies confirm that the device, even with the minor modifications, continues to be substantially equivalent to its predicate device (eFlow Model 100 IV Fluid Warmer, K060537).

The "acceptance criteria" in this context are not clinical performance metrics but rather the demonstration through these non-clinical studies that the modified device functions safely and effectively within its intended use and is equivalent to the predicate. The "study" proving this consists of:

Risk Analysis
Requirements Development and Reviews
Software Verification and Validation (for the device's inherent software, not an AI algorithm)
Performance/Functional Verification and Validation (bench testing to confirm the device performs as intended, e.g., heats fluids to the specified temperature and flow rates)
Biocompatibility Testing
Sterilization and Shelf-Life Testing
Electrical Safety and EMC Testing

The document specifically highlights that "There have been no changes to the fundamental scientific technology of the device" (Page 1, Section 7), further supporting the reliance on non-clinical data for substantial equivalence. The FDA ultimately found the device substantially equivalent based on this information (Pages 3-5).

Summary

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1296 Vital Signs, a GE Healthcare Company 510(k) Premarket Notification

MAR 1 4 2012

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.

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

Name:	Vital Signs, Inc., a GE Healthcare Company
Address:	20 Campus Rd.Totowa, NJ 07512
Official Contact:	Stacie Geffner-AtiyaRegulatory Affairs Manager
Phone:	973-956-5491
Fax:	973-956-5442
Alternate Contact:	Agata Smieja410-456-0329
Date of Preparation:	September 30, 2011

1. Device Trade Name and Common Name:

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

Legally Marketed Predicate Device: 4.

Substantial equivalence is claimed to: eFlow Model 100 IV Fluid Warmer (K060537) Enginivity / Vital Signs

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5. Description of the Device:

ર. Intended Use of the Device:

7. Technology:

The Vital Signs, Inc. enFlow Fluid Warmer is substantially equivalent to the previously cleared eFlow IV Fluid Warmer (K060537). The basis for this submission is to notify the FDA of the accumulation of various modifications to the enFlow IV Fluid Warmer since the previous clearance, including minor labeling, shelf life, design and software modifications. There have been no changes to the fundamental scientific technology of the device.

8. Discussion of Non-clinical Studies:

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
� Requirements Development and Reviews
. Software Verification and Validation
. Performance/Functional Verification and Validation
. Biocompatibility Testing
Sterilization and Shelf Life Testing .
Electrical Safety and EMC Testing .

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is in black and white.

. .

9. Summary of Clinical Tests:

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

1. Conclusion:
  Vital Signs, 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Stacie Geffner-Atiya Regulatory Affairs Manager Vital Signs, Incorporated 20 Campus Road Totowa, New Jersey 07512

MAR 1 4 2012

Re: K112902 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: February 16, 2012 Received: February 17, 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 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 Eederal 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/ucm 115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental 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): ____________________________________________________________________________________________________________________________________________________

Device Name: enFlow IV Fluid Warmer

Indications for Use:

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)

M. Chapman 3/8/12

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

Page 1 of 1

510(k) Number: K112902

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).