The Level 10 NORMOFLO® Irrigation Warming Set (Disposable Set) is a disposable irrigating fluid administration set, designed for use by trained medical professionals, for warming irrigating fluids. The Disposable Set is intended for use with the Level 1 8 H-1100 series NORMOFLO® Irrigation Fluid Warmers only.

The Level 1® NORMOFLO® Irrigation Fluid Warmer (Fluid Warmer) is designed for use by trained medical personnel for in-line warming of irrigating fluids.

Device Description

The Level 1® NORMOFLO® Irrigation Fluid Warmer has been designed for safe, rapid, inline warming of irrigating fluids as they are administered to patients. This method employs single-use, disposable, irrigating sets that include a Heat Exchanger and may include a Gas Vent. The gas vent releases micro-bubbles of gas from fluids as they are warmed.

The Irrigation Fluid Warmer employs a safe re-circulating solution heating system, inherently free of any "hot spots". The primary temperature control circuit sets the recirculating solution to a temperature of approximately 41.7℃ for efficient heat exchange and maximum fluid warming.

The H-1129 provides pressurized fluid dclivery through the use of an on-board compressor and two 3-Liter (3L) pressure chambers. The pressure chambers pressurize the fluid bags for fast fluid delivery. A control panel on each pressure chamber displays the pressure in the chamber. A pressure regulator knob lets you select the desired pressure; a dial gauge displays the selected pressure.

There are 6 Irrigation Fluid Warming sets available for use on the Irrigation Fluid Warming units. Y-set adapters are available to adapt from 2 spike sets to 4.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Normoflo® Irrigation Warming Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the manner typically seen for AI/software-as-a-medical-device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this type of regulatory submission. The device is a physical fluid warming system, not an AI or software device.

Here's an attempt to address the prompts based on the provided document, highlighting what is (and isn't) present:

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

The document does not present specific quantitative acceptance criteria or reported device performance in this format. The entire submission is built around demonstrating "substantial equivalence" to predicate devices, implying that its performance is comparable and safe/effective for its intended use, rather than meeting specific numerical performance thresholds.

However, the "Non-Clinical Data" section states: "Non-clinical performance testing has been performed to ensure the device is safe and effective and meets the clinical requirement of irrigation systems." This suggests internal testing was done, but the results and criteria are not detailed in this public summary.

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

This information is not provided. The "Non-Clinical Data" refers to performance testing, but no details on sample size, data type, or provenance are given.

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)

This is not applicable and not provided. "Ground truth" as understood for AI/diagnostic devices doesn't apply to this physical fluid warming system. The "Clinical Data" section mentions "clinician surveys," which might be interpreted as a form of expert input, but details are not available.

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

This is not applicable and not provided.

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

This is not applicable. The device is a physical fluid warmer, not an AI system designed to assist human readers/diagnosticians.

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

This is not applicable. The device is a hardware product.

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

This is not applicable for this type of device. The verification and validation would likely rely on engineering tests, temperature measurements, flow rates, material compatibility, and potentially some form of user feedback or observational studies. The "Clinical Data" mentions "clinician surveys to ensure the product meets the clinical guidance of the intended uses," which is a form of user feedback rather than establishing a diagnostic "ground truth."

8. The sample size for the training set

This is not applicable. The device is a hardware product undergoing a 510(k) clearance process based on substantial equivalence, not an AI model requiring a training set.

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

This is not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a sans-serif font.

Public Health Service

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

JAN 1 0 2017

Ms. Cynthia Engelhardt Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 160 Weymouth Street Rockland, Massachusetts 02370

Re: K072080

Trade/Device Name: Normoflo® Irrigation Warming Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: May 2, 2008 Received: May 5, 2008

Dear Ms. Engelhardt:

This letter corrects our substantially equivalent letter of June 2, 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 (reporting of

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Page 2 – Ms. Cynthia Engelhardt

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 8091), 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.

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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SECTION 4, Indications for Usc Statement

Indications for Use

510(k) Number (if known): 14072080 Device Name: Normoflo® Irrigation Warming 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)

Cun

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

Page 1 of 1

51.,k) Number. k9?3w

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smiths . . . .

bringing technology to life

K072080

SECTION 5, 510(k) Summary

Company Information:

Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370 (603) 352-3812, prompt 4, ext 2923 Contact: Cynthia Engelhardt Regulatory Affairs Specialist Smiths Medical ASD Inc. Critical Care Division 160 Weymouth Street Rockland, MA 02370, USA T: +1 781 878 8011 F: +1 781 878 8201 www.smiltis-medical.com

JUN - 2 2008

Summary Prepared: July 27th, 2007

Product Name:

Trade Name: NORMOFLO® Irrigation Fluid Warmer Model H-1100; NORMOFLO® Irrigation Fluid Warmer Model H-1129; NORMOFLO® Irrigation Warming Set

Common Name: Irrigation Fluid Warmer and Irrigation Warming Set

Classification Name: Warmer, Thermal, Infusion Fluid (Unclassified, Product Code LGZ)

Predicate Device(s):

K936223 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Pressure Irrigating System.

K873435 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Level 1 IR-600 Normothermic Irrigating Set
K060939 Arizant Healthcare Inc. Ranger Irrigation Fluid Warming System

Device Description:

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There are 6 Irrigation Fluid Warming sets available for use on the Irrigation Fluid Warming units. Y-set adapters are available to adapt from 2 spike sets to 4.

Indications for Use:

NORMOFLO® Irrigation Fluid Warmer

The Level 1® NORMOFLO® Irrigation Fluid Warmer (Fluid Warmer) is designed for use by trained medical personnel for in-line warming of irrigating fluids.

NORMOFLO® Irrigation Warming Set

The Level 1 0 NORMOFLO® Irrigation Warming Set (Disposable Set) is a disposable irrigating fluid administration set, designed for use by trained medical professionals, for warming irrigating fluids. The Disposable Set is intended for use with the Level 1 9 H-1100 series NORMOFLO® Irrigation Fluid Warmers only.

Technological Characteristics:

The technological characteristics of the NORMOFLO® Irrigation Fluid Warmer and Irrigation Warming Set are substantially equivalent to the predicate devices; Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Pressure Irrigating System (K936223), Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Level 1 IR-600 Normothermic Irrigating Set (K873435) and Arizant Healthcare Inc. Ranger Irrigation Fluid Warming System (K060939) in terms of:

. Irrigation fluid warmer to warm the fluid to normothermic temperatures
Variable pressure of the output fluid to patient .

All statements and representations set forth hercin regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration, and are not made in the context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).

Non-Clinical Data:

Non-clinical performance testing has been performed to ensure the device is safe and effective and meets the clinical requirement of irrigation systems.

Clinical Data:

Clinical investigation of warming irrigation fluids for irrigation procedures was done in the form of clinician surveys to casure the product mects the clinical guidance of the intended uses.

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Conclusion:

The proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Comblee Empt.

Cynthia Engelhardi Regulatory Affairs Specialist

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).