The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intraarterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, V medication, epidural medication, blood and blood products.

The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-use only.

Device Description

The enhanced Sapphire Infusion Pump with and without the WiFi capability is the result of modifications to the FDA cleared Sapphire Infusion pump (K123049). The modifications are the addition of WiFi to allow the pump to communicate wirelessly with compatible systems and additional Software enhancements. There are no changes to the basic infusion pump technology.

The Q Core Sapphire infusion pump is a single-channel, volumetric infusion pump that is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. It is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products and includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump has alarms for occlusions, air in the line, administration set installment issues, and internal battery issues. The Pump includes software and is powered by an external power source or by an internal battery. It is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire pump is designed to follow the patient through the various care areas, and is suitable for use in the different settings.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for single- use and single-patient use only. Components from the previously cleared administration sets were used to make sets with new configurations, all within the parameters (e.g. length, diameters, materials) of the sets cleared with the Sapphire Infusion Pump. These new configurations are substantially equivalent to the administration sets that were cleared under K123049, having identical indications for use and technological characteristics.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Q Core Medical Sapphire Infusion Pump, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report with specific acceptance criteria and performance metrics for a novel AI algorithm. Therefore, the information that can be extracted will primarily relate to engineering and software validation, not necessarily a human-in-the-loop AI effectiveness study as might be expected for an AI-powered diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an infusion pump with WiFi enhancements, the "acceptance criteria" discussed are primarily related to safety, performance against established standards, and equivalence to a predicate device, rather than diagnostic accuracy metrics typically seen in AI studies.

Acceptance Criteria / Test Performed	Reported Device Performance (Summary)
Electrical Safety per IEC 60601-1	Device underwent testing to demonstrate compliance. Implies successful compliance with the standard for electrical safety in medical electrical equipment.
EMC testing per IEC 60601-1-2	Device underwent testing to demonstrate compliance. Implies successful compliance with the standard for electromagnetic compatibility in medical electrical equipment.
Software Verification and Validation (per FDA Guidance May 11, 2005)	Device underwent testing to demonstrate safety and performance as intended. Implies that the software meets the specified functional, performance, and safety requirements.
Human Factors Testing	Device underwent testing. Implies that the device's design is user-friendly and minimizes use errors.
FCC Testing	Device underwent testing. Implies compliance with Federal Communications Commission regulations for electromagnetic interference, especially relevant for the new WiFi functionality.
Administration Set Shelf Life Testing	Administration sets underwent testing. Implies that the sets maintain their integrity and functionality over their specified shelf life.
Substantial Equivalence to Predicate Sapphire Infusion Pump (K123049)	Determined to be substantially equivalent with respect to: - Indications for use - Basic infusion pump hardware/mechanism - Delivery modes - Safety features (Modifications: addition of WiFi, additional software enhancements. No changes to basic infusion pump technology.)
Substantial Equivalence to Plum A+® Infusion System with Hospira MedNet™ Software (K042081)	Determined to be substantially equivalent with respect to the WiFi function (both have WiFi function).
Substantial Equivalence of New Q Core Administration Sets to those cleared under K123049	Determined to be substantially equivalent with respect to: - Dedicated use with Q Core pumps - Indicated for intravenous infusion - Prescription use - Standard, conventional components - Same material characteristics (biocompatible, non-DEHP, latex-free) - Same free flow protection (cassette with AFFV) - Sterile, non-pyrogenic, single patient/use - Intended for hospital or home use

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

This document does not specify a "test set" in the context of an AI algorithm's performance on clinical data samples. The testing described is primarily engineering and software validation. Therefore, details like data provenance or sample size for a clinical test set are not applicable here.

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

This information is not applicable as the document describes validation for an infusion pump, not an AI diagnostic or prognostic device requiring expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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 information is not applicable as the document describes validation for an infusion pump, not an AI-powered diagnostic product that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the pump contains software and the new functionality is WiFi to communicate wirelessly, the document describes the entire device (hardware and software) as the subject of the submission. It's not a standalone AI algorithm in the typical sense. The "Software Verification and Validation" constitutes testing of the algorithm/software within the device, but it's not described as a separate "standalone" performance study on clinical data.

7. The Type of Ground Truth Used

For the software and engineering validation tests listed:

Electrical Safety, EMC, FCC Testing, Shelf Life: Ground truth is established by the specified international standards (IEC 60601-1, IEC 60601-1-2) or internal quality control specifications for the administration sets.
Software Verification and Validation: Ground truth is established by the device's functional and performance requirements specifications, as well as the FDA Guidance for medical device software.
Human Factors Testing: Ground truth relates to usability standards and the ability of users to operate the device safely and effectively, typically assessed through user studies.

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth in this submission, as it's not a diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable. The device described is an infusion pump with software, not a machine learning model that undergoes "training" on a dataset in the AI sense.

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

This information is not applicable for the reasons stated above.

Summary

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

December 11, 2014

Q Core Medical Ltd. C/O Rhona Shanker Director, Regulatory Consulting Z&B Enterprises, Inc. 12154 Darnestown Road, #236 GAITHERSBURG, MD 20878

Re: K141389

Trade/Device Name: Sapphire Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA Dated: November 12, 2014 Received: November 13, 2014

Dear Ms. Shanker:

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.

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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 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/Resourcesfor You/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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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) K141389

Device Name Sapphire Infusion Pump

Indications for Use (Describe)

The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-use only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Owner/Submitter	Q Core Medical Ltd.29 Yad Haruzim St.Netanya 4250529ISRAELPh: +972-73-2388888Fax: +972-73-2388800
Contact Person	Rhona ShankerFDA Regulatory Consultant to Q Core Medical LtdPh: 301251-9570Fax: 301-251-9571
Date Issued	15 May 2014
Trade Name	Sapphire Infusion Pump
Common Name	Infusion pump
Classification Name	Infusion Pump 21 CFR 880.5725Intravascular administration set 21 CFR 880.5440Product Codes:FRN - Infusion pumpFPA - Administration SetsClass II
Predicate DeviceInfusion Pump	(K123049) Sapphire Infusion Pump(K042081)Plum A+® Infusion System with Hospira MedNet тмSoftware
Administration Sets	Q Core Administration Sets cleared under K123049

Device Description

Image /page/3/Picture/4 description: The image shows the logo for Q-Core Medical. The logo features a blue circle with a speech bubble inside, positioned above the text "QCORE" in a larger, bolder blue font. Below "QCORE" is the word "medical" in a smaller, lighter blue font.

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Indications for Use

The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.

The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

These are the same indications for use as the predicate Sapphire infusion pump.

Technological Characteristics

The enhanced Sapphire Infusion Pump with and without the WiFi functionality is the same as the FDA cleared Sapphire Infusion pump (K123049) with the addition of the WiFi function. The

Image /page/4/Picture/10 description: The image shows the logo for Q Core Medical. The logo features a stylized letter "Q" in blue, with a lighter blue speech bubble shape inside the "Q". Below the "Q" is the text "Q CORE" in a larger, bolder blue font, and below that is the word "medical" in a smaller, lighter blue font.

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addition of the WiFi function allows the pump to communicate wirelessly with compatible systems. There are no changes to the basic infusion pump technology.

The enhanced Sapphire infusion pump with and without WiFi functionality is substantially equivalent to the predicate devices in the following respects:

All pumps are volumetric and software controlled. 1.
1. All pumps are indicated for the controlled delivery of programmed doses of saline, TPN, lipids, IV medication, epidural medication at selected rates and can be used in the hospital and out-of-hospital (home and pre-hospital) environments.
1. The Sapphire pump has six delivery modes: Continuous, Intermittent, Multi-step, PCA, TPN, and Epidural.
1. The pump is substantially equivalent to the Plum A+® Infusion System with Hospira MedNet тм Software (K042081) with respect to the WiFi function.
న. The proposed and predicate Sapphire Infusion pumps have the same safety features to prevent free flow, alarms for the detection of upstream and downstream occlusions, low battery, end of infusion, and pump failure, and authorization levels to prevent misuse.

The new Q Core Administration Sets configurations to be used with the Sapphire Infusion Pump are substantially equivalent to those cleared under K123049 in the following respects:

1. All sets are dedicated for use with Q Core infusion pumps.
1. All sets are indicated for intravenous infusion.
1. All sets can be used only by or under the order of a licensed medical practitioner.
All sets consist of standard, conventional components such as Luer locks, PVC tubing, Y-4. connector, tubing clamp.
న. All sets use materials with the same characteristics (biocompatible, non-DEHP, latex free).
All sets have the same means to protect against free flow (cassette with an Anti-Free 6. Flow Valve [AFFV]).
1. All sets are provided sterile, non-pyrogenic, intended for single patient use and single use.
All sets are intended for either hospital or home use. 8.

Pre-Clinical Testing

Preclinical testing included in the submission to demonstrate that the enhanced Sapphire Infusion Pump is safe and performs as intended involved the following:

Electrical Safety per IEC 60601-1 EMC testing per IEC 60601-1-2

Image /page/5/Picture/19 description: The image shows the logo for Q Core Medical. The logo consists of a blue circle with a smaller, lighter blue circle inside, resembling a speech bubble. Below the circle is the text "Q CORE" in a larger, bolder blue font, with the word "medical" in a smaller, lighter blue font underneath.

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Software Verification and Validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005 Human Factors testing

FCC testing

Testing of the Administration Sets involved: Shelf life

Conclusion

The enhanced Sapphire Infusion Pump with and without the WiFi functionality is substantially equivalent to the Sapphire Infusion Pump (K123049) (primary predicate) with respect to the indications for use, the basic infusion pump hardware or mechanism used to control delivery of the infusion, the delivery modes and safety features. The signification is the addition of WiFi to allow the pump to communicate wirelessly with compatible systems. The Sapphire is also substantially equivalent to the Plum A+® Infusion System with Hospira MedNet TM Software (K042081) in that they both have the WiFi function.

The new Q Core Administration Sets configurations that are to be used with the Sapphire Infusion Pump are substantially equivalent to those cleared under K123049.

In summary, the enhanced Sapphire Infusion Pump with and without WiFi functionality and its dedicated Administration Sets are substantially equivalent to its predicates with respect to indications for use, target populations, types of infusions, delivery modes, technological characteristics and safety features.

Image /page/6/Picture/7 description: The image shows the logo for QCore Medical. The logo features a stylized letter "Q" in a dark blue color, with a lighter blue speech bubble-like shape inside the "Q". Below the "Q", the word "QCORE" is written in a larger, bolder font, also in dark blue. Underneath "QCORE", the word "medical" is written in a smaller, lighter font.

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).