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

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

It is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home. The pump is intended to be used by both licensed health care professionals and by lay users.

The Sapphire and the administration sets are indicated for use by both adult and pediatric populations.

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

Device Description

The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The SapphireInfusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products. The Sapphire Infusion 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 and lay users. The pump is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home use.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are sterile and intended for single-patient use and single-use only.

The pump software includes the following infusion modes, but any one can be disabled: Continuous, Intermittent, TPN (Total Parenteral Nutrition), PCA (Patient Controlled Analgesia), Multi-Step and Epidural.

The Sapphire Infusion Pump offers an optional preprogrammed drug library which can be programmed using an additional software program "Drug library editor". The preprogrammed range limits are associated with certain drugs and/or certain modes and/or certain care areas.

Sapphire Infusion Pump accessories include the mini cradle with IPS, PCA lock boxes (100, 250, and 500ml), PCA/PCEA bolus handle, battery charger, battery case for extra battery source, administrations sets, a backpack, multi-pump mounting bracket, and an AC adapter.

Updates included in this submission:

1. Addition of a new administration route Perineural Adding an administration route, Perineural, to the indications for use of the device. This update did not require any modification to the pump technology or design.
1. Additional updates (catchup changes) that did not change the basic functionality or technological characteristics of the pump or the administration sets
- . Software (SW) - e.g., minor enhancements, back to spec corrections, cybersecurity enhancements including implementation of digital code signing, reorganization of alarm priorities and audio and visual alarm characteristics, addition of low battery alarm at 10 minutes, addition of air-in-line alarm off option.
- Pump cradle (accessory) added ●
- Administration sets, including sets with NRFit connectors. ●

AI/ML Overview

This document is a 510(k) Summary for the Sapphire Infusion Pump and Sapphire administration sets. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the supporting study:

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

The document details various technological characteristics and their performance parameters, comparing the subject device to the predicate device. For many characteristics, the performance is stated as "Same," indicating it meets the established performance of the predicate. Where there are updates or new features, the testing confirms that safety and effectiveness are maintained.

Acceptance Criteria (Technological Characteristic)	Reported Device Performance	Comments / Supporting Information
Real-time display	Same	NA
Microcomputer controlled pump	Same	NA
Internal clock	Same	NA
Administration Set	Same	NA
Air-in-line sensor	Same	NA
Occlusion sensor	Same	NA
Temperature Sensor	Same	NA
Number of Channels	1	NA
History Log	Yes	NA
Battery/Low, Depleted	Same, with the addition of a low battery alarm at 10 minutes.	No effect on the pump safety or effectiveness. The new alarm was verified and validated as part of Software V&V and meets IEC 60601-1-8 requirements.
Pump in stop mode (unattended)	Same	(see Note #1 below, though Note 1 refers to the battery alarm. This likely refers to a previous note not fully captured, or implies it maintains parity with predicate).
High pressure (Upstream/Downstream Occlusion)	Upstream -0.4bar, Downstream 1.2 bar	NA (Same as predicate)
Pump Fault	Same	NA
Low volume in medication reservoir	Same	NA
Cassette detachment /misplaced/door open	Same	NA
Air-in-line	Same	NA
Flow Error	Same	NA
Key stuck	Same	NA
End-of-Infusion	Same	NA
Programmable End-of-Infusion alarm	Same	NA
High Internal Temperature	Same	NA
Delivery Mode	Same	NA
Infusion Options	Same	NA
Security and/or Lock Levels	Same	NA
Demand Dose Lockout	Same	NA
Delivery Limit	Yes, with option to disable by technician	No effect on the pump safety or effectiveness (see discussion # Note 2 below for details on why this doesn't raise new questions).
Air Detection	Yes, with option to disable by technician	No effect on the pump safety or effectiveness (see discussion # Note 2 below for details on why this doesn't raise new questions). This modification was implemented after risk analysis and review of similar cleared devices; verified and validated via SW V&V and Human Factors tests.
Piggy back/Secondary	Same	NA
Delayed Start	Same	NA
Flow rate accuracy	Ave: 2.5% (-3.6% at 5-15°C to +3.5% at 30-40°C)	Same as predicate.
Minimum Continuous Delivery Rate	0.1 mL/hr	Same
Maximum Continuous Delivery Rate	999 mL/hr	Same
Minimum Intermittent Delivery Rate	0.1 mL/hr	Same
Maximum Intermittent Delivery Rate	999 mL/hr	Same
Minimum PCA Delivery Rate	0 mL/hr	Same
Maximum PCA Delivery Rate	99.9 mL/hr	Same
Minimum TPN Delivery Rate	0.1 mL/hr	Same
Maximum TPN Delivery Rate	600 mL/hr	Same
Minimum Epi Delivery Rate	0.1 mL/hr	Same
Maximum Epi Delivery rate	200 mL/hr	Same
Patient Demand Dose	Yes	Same
Bolus Accuracy	Ave: 2.5% (-7.5% to 7.5% at 0.1mL/h)	Same as predicate.
Maximum Patient Demand Dose	20 mL	Same
Clinician Bolus	Yes	Same
Maximum Clinician Bolus	30 mL	Same
Maximum Epidural Hourly Volume	60 mL/hr	Same
Maximum Boluses per Hour	60 per hour / 60 per 4 hours	Same
KVO	Yes	Same
KVO Rate	0 - 20 mL/hr or the actual rate, whichever is lower	Same
Reservoir volume	0.1 to 9999 mL	Same
Dose lockout time	Yes	Same
Dose per Hour Limit	Yes	Same
Delivery Limit	Yes	Same
Programmable Maximum Delivery Rate (Continuous Rate and Bolus)	Yes	Same
Administration sets (Q Core supplied)	Same	NA
AC adapter	Same	NA
Remote Dose Cord	Same	NA
Reservoir enclosure (Lockbox)	Same (100, 250, 500)	NA
Pole mount (Mini Cradle) with embedded power supply	(New accessory)	Does not raise different questions of safety or effectiveness. Tested for performance with the pump to meet Electrical Safety (IEC 60601-1) and EMC (IEC 60601-1-2 and IEC 61000).
Pump Pouch	Same	NA
Multi-pump mounting bracket	Same	NA
Battery case	Same	NA
Electrical Safety	Compliant with IEC 60601-1	Same as predicate.
Electromagnetic compatibility	Compliant with IEC 60601-1-2	Same as predicate.
Pump Size	143 x 96 x 49 mm (5.63 x 3.78 x 1.93 inches) HxWxD	Same
Pump Weight	518 g (18.27 oz.), including battery	Same
Power Sources	Rechargeable Li-Ion Battery 7.4V/1960 mAh; AC adapter Input: 100-240 AC; 50-60 Hz	Same
Operating Environment (Temperature)	+5°C to 40°C (41°F to 104°F)	Same
Operating Environment (Relative Humidity)	15% to 95%	Same
Storage Environment (Temperature)	- 40°C to + 70°C (-40°F to 158°F).	Same
Storage Environment (Relative Humidity)	15% to 95%	Same
Administration Sets (NRFit connector)	Added NRFit connectors	Verification and validation of the connectors concluded that this modification does not alter their safety and effectiveness (ISO 80369-6:2016 compliant).
Administration Sets (Sleeve removal)	Sleeve removed	Verification and Validation of the sets performance concluded that this modification did not alter their safety and effectiveness.
Administration Sets (Length and priming update)	Length: Up to 300 cm (from 280 cm); Priming volume: Up to 30 ml (from 20 ml)	Verification and Validation of the sets performance concluded that this modification has no implication on the safety and effectiveness.

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

The document does not specify sample sizes or data provenance for the individual bench tests or performance testing. It states that "Accuracy testing under anticipated environments of use and routes" was performed, and administration sets performance testing was done per ISO 80369-6:2016, but without details on sample size. Similarly, human factors studies were conducted with the "intended user population, use environment and use scenarios," but specific numbers are not provided. The testing is bench testing and human factors testing, not clinical studies involving patient data.

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 section is Not Applicable as the document discusses testing of a medical device (infusion pump and administration sets) for performance and safety characteristics, not a diagnostic algorithm where expert ground truth is typically required for image or data interpretation. The ground truth for performance testing is established by engineering specifications, regulatory standards (e.g., IEC, ISO), and risk analysis.

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

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among experts for establishing ground truth in diagnostic studies, which is not relevant to the performance and safety testing described for an infusion pump.

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 section is Not Applicable. The document describes a medical device (infusion pump) and its administration sets, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies or human reader improvement with AI are not relevant here.

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

This section is Not Applicable. The product is a physical device (infusion pump) with embedded software, not a standalone algorithm without human interaction. Performance testing was done on the device itself and its accessories.

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

The ground truth for the performance and safety testing of the Sapphire Infusion Pump and administration sets is based on several factors:

Regulatory Standards: Compliance with established international standards such as IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (Alarms), IEC 62133-2 (Battery Safety), ISO 10993-11 (Biocompatibility), ISO 80369-6 (Administration sets performance, specifically for NRFit connectors), ASTM F2503-13 (MR Safety).
FDA Guidance Documents: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Infusion Pumps Total Product Life Cycle, Applying Human Factors and Usability Engineering to Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and Reprocessing Medical Devices in Health Care Settings.
Predicate Device Performance: The primary ground truth for many characteristics is the established safety and effectiveness of the previously cleared Sapphire Infusion Pump (K161667) and administration sets (K141389, K123049). The subject device demonstrates "Same" performance for a majority of parameters.
Risk Analysis and Verification/Validation: For any new features or modifications (e.g., perineural route, 10-minute low battery alarm, option to disable air detection, mini cradle with IPS, NRFit connectors, sleeve removal, length/priming volume changes), the ground truth is established through internal risk analyses and subsequent verification and validation testing to confirm they do not introduce new questions of safety or effectiveness and meet their design requirements.

8. The sample size for the training set

This section is Not Applicable. The Sapphire Infusion Pump is a hardware device with controlling software, not an AI/ML model that undergoes a training phase with a specific dataset.

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

This section is Not Applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Q Core Medical Ltd. % Rhona Shanker President Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, Maryland 20878

Re: K192860

Trade/Device Name: Sapphire Infusion Pump, Sapphire administration sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN, MRZ, FPA Dated: November 7, 2020 Received: November 10, 2020

Dear Rhona 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carolyn Dorgan Acting Assistant Director, Infusion Devices DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192860

Device Name

Sapphire Infusion Pump, Sapphire administration sets

Indications for Use (Describe)

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

The Sapphire and the administration sets are indicated for use by both adult and pediatric populations.

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K192860

Manufacturer's Name	Q Core Medical Ltd.29 Yad Haruzim St.Netanya 4250529ISRAELPh: +972-73-2388888Fax: +972-73-2388800
Corresponding Official:	Rhona ShankerFDA Regulatory Consultant to Q Core Medical Ltd
Telephone Number:	301-251-9570
E-mail:	rhonashanker07@verizon.net
Preparation Date:	November 19, 2020
Trade Name	Sapphire Infusion Pump, Sapphire Administration Sets
Common or Usual Name	Infusion Pump
Regulation Name	Infusion Pump
Regulation Number:	21 CFR 880.5725
Product Code:	FRN - Infusion pumpMRZ - Infusion pump accessoriesFPA - Administration Sets
Device Class:	Class II
Predicate Device Infusion pump:	(K161667) Sapphire Infusion Pump
Predicate Device Administration sets:	(K141389) Sapphire administration sets, (K123049) Sapphire Administration Sets

Device Description

Image /page/3/Picture/5 description: The image is a logo for Q-Core Medical. The logo features a large, blue letter "Q" with a speech bubble shape inside of it. Below the "Q" is the text "QCORE" in a similar blue color, with the word "medical" in a smaller font size underneath it.

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licensed health care professionals and lay users. The pump is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home use.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are sterile and intended for single-patient use and single-use only.

Updates included in this submission:

1. Addition of a new administration route Perineural Adding an administration route, Perineural, to the indications for use of the device. This update did not require any modification to the pump technology or design.
1. Additional updates (catchup changes) that did not change the basic functionality or technological characteristics of the pump or the administration sets
- . Software (SW) - e.g., minor enhancements, back to spec corrections, cybersecurity enhancements including implementation of digital code signing, reorganization of alarm priorities and audio and visual alarm characteristics, addition of low battery alarm at 10 minutes, addition of air-in-line alarm off option.
- Pump cradle (accessory) added ●
- Administration sets, including sets with NRFit connectors. ●

3. Clarification of the indications for use statement

Indications for Use

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

The Sapphire Infusion pump includes the following infusion modes for all intended uses: Continuous,

Image /page/4/Picture/16 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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Intermittent,TPN, PCA, Multi-step, and Epidural.

The Sapphire and the administration sets are indicated for use by both adult and pediations.

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

Substantial Equivalence Discussion

The table below includes a comparison of the intended use between the new device and those of the predicate device:

Characteristic	Predicate DeviceSapphire Infusion system(K161667)	Subject DeviceSapphire Infusion PumpK192860
Indications for Use	The Q Core Sapphire InfusionPump is intended for controlleddelivery through intravascular,subcutaneous, intra-arterialand epidural routes. The pump isdesigned to deliver saline, TotalParenteral Nutrition (TPN), lipids,IV medication,epidural medication, blood andblood products.The Sapphire Infusion Pumpincludes the following infusionmodes for all intended uses:Continuous, Intermittent, TPN,PCA, Multi-step, and Epidural.The pump is intended to be usedby both licensed health careprofessionals in a clinicalenvironment, and home users inan ambulatory environment and inpre-hospital medical air andground transportation.The dedicated Q Coreadministration sets for theSapphire Infusion Pump areintended for single-patient use andsingle useonly.	The Sapphire Infusion pump isintended for controlled deliverythrough intravascular,subcutaneous, intra-arterial,perineural and epidural routes.The pump is designed to deliversaline, Total Parenteral Nutrition(TPN),lipids, IV medication,perineural medication, epiduralmedication, blood and bloodproducts.The Sapphire Infusion pumpincludes the following infusionmodes for all intended uses:Continuous, Intermittent, TPN, PCA,Multi-step, and Epidural.It is intended to be used in thefollowing environments of use:clinical, ambulatory, pre-hospitalmedical air and groundtransportation and home. Thepump is intended to be used by bothlicensed health care professionalsand by lay users.The Sapphire and theadministration sets are indicatedfor use by both adult and pediatricpopulations.

Image /page/5/Picture/8 description: The image is a logo for QCore Medical. The logo features a blue circle with a speech bubble inside of it. Below the circle is the text "QCORE" in a sans-serif font, with the word "medical" in a smaller font below it. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

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		The dedicated Q Coreadministration sets for theSapphire pump are intended forsingle-patient use andsingle-useonly.
Prescription or Over the Counter	Prescription	Prescription
Intended Population	Adult and pediatric	Adult and pediatric
Environment of Use	clinical, ambulatory, pre-hospitalmedical air and groundtransportation, and home	clinical, ambulatory, pre-hospitalmedical air and groundtransportation and home

The indications for use for the subject device is the same as the predicate device, with the addition of the perineural route. The addition of the Perineural administration route did not require any design change to the pump. After analysis of (i) clinical use, (ii) risk and (iii) drug route compatibility it was concluded that the current design can support this administration route without any design modifications and does not raise different questions of safety or effectiveness. The pump has been verified and validated through performance testing to meet this additional intended use.

The intended population for the subject device (adult and pediatric) is identical to the predicate device.

The environments of use for the subject device are identical to the predicate device.

Technological Characteristics

The table below includes a comparison of the technological characteristics between the new pump and those of the predicate pump. Flow rate accuracy and bolus accuracy are unchanged with the proposed device.

TechnologicalCharacteristic	Predicate DeviceSapphire Infusion system(K161667)	Subject DeviceSapphire Infusion PumpK192860	Comments
System Components/Features
Real-time display	Yes	Same	NA
Microcomputercontrolled pump	Yes	Same	NA
Internal clock	Yes	Same	NA
Administration Set	Yes	Same	NA
Air-in-line sensor	Yes	Same	NA
Occlusion sensor	Yes	Same	NA
Temperature Sensor	Yes	Same	NA
Number of Channels	1		NA
History Log	Yes	Yes	NA
Pump Alarms and Messages
Battery/Low, Depleted	Yes	Same, with the addition of a low battery alarm at 10 minutes.	No effect on the pump safety or effectiveness
TechnologicalCharacteristic	Predicate DeviceSapphire Infusion system(K161667)	Subject DeviceSapphire Infusion PumpK192860	Comments
Pump in stop mode(unattended)	Yes	Same	(see Note #1below)
High pressure(Upstream/DownstreamOcclusion)	Upstream -0.4barDownstream 1.2 bar	Same	NA
Pump Fault	Yes	Same	NA
Low volume inmedication reservoir	Yes	Same	NA
Cassette detachment/misplaced/dooropen	Yes	Same	NA
Air-in-line	Yes	Same	NA
Flow Error	Yes	Same	NA
Key stuck	Yes	Same	NA
End-of-Infusion	Yes	Same	NA
Programmable End-of-Infusion alarm	Yes	Same	NA
Programming Functions
High InternalTemperature	Yes	Same	NA
Delivery Mode	Yes	Same	NA
Infusion Options	Yes	Same	NA
Security and/orLock Levels	Yes	Same	NA
Demand DoseLockout	Yes	Same	NA
Delivery Limit	Yes	Yes, with option to disable bytechnician	No effect onthe pumpsafety oreffectiveness(seediscussion #Note 2below)
Air Detection	Yes	Yes, with option to disable bytechnician	No effect onthe pumpsafety oreffectiveness(seediscussion #Note 2below)
Piggyback/Secondary	Yes	Same	NA
Delayed Start	Yes	Same	NA
Infusion Specifications
Flow rate accuracy	Ave: 2.5%(-3.6% at 5-15°C to +3.5% at 30-40°C)	Same	NA
MinimumContinuous DeliveryRate	0.1 mL/hr	Same	NA
MaximumContinuous DeliveryRate	999 mL/hr	Same	NA
TechnologicalCharacteristic	Predicate DeviceSapphire Infusion system(K161667)	Subject DeviceSapphire Infusion PumpK192860	Comments
MinimumIntermittentDelivery Rate	0.1 mL/hr	Same	NA
MaximumIntermittentDelivery Rate	999 mL/hr	Same	NA
Minimum PCADelivery Rate	0 mL/hr	Same	NA
Maximum PCADelivery Rate	99.9 mL/hr	Same	NA
Minimum ΤΡΝDelivery Rate	0.1 mL/hr	Same	NA
Maximum TPNDelivery Rate	600 mL/hr	Same	NA
Minimum EpiDelivery Rate	0.1 mL/hr	Same	NA
Maximum EpiDelivery rate	200 mL/hr	Same	NA
Patient DemandDose	Yes	Same	NA
Bolus Accuracy	Ave: 2.5% (-7.5% to 7.5% at 0.1mL/h)	Same	NA
Maximum PatientDemand Dose	20 mL	Same	NA
Clinician Bolus	Yes	Same	NA
Maximum ClinicianBolus	30 mL	Same	NA
Maximum EpiduralHourly Volume	60 mL/hr	Same	NA
Maximum Bolusesper Hour	60 per hour / 60 per 4 hours	Same	NA
KVO	Yes	Same	NA
KVO Rate	0 - 20 mL/hr or the actual rate,whichever is lower	Same	NA
Reservoir volume	0.1 to 9999 mL	Same	NA
Dose lockout time	Yes	Same	NA
Dose per Hour Limit	Yes	Same	NA
Delivery Limit	Yes	Same	NA
ProgrammableMaximum DeliveryRate (ContinuousRate and Bolus)	Yes	Same	NA
	Accessories
Administration sets	Yes - Q Core supplied administrationsets	Same	NA
AC adapter	Yes	Yes Same	NA
Remote Dose Cord	Same Yes	Yes Same	NA
Reservoir enclosure(Lockbox)	Yes (100, 250, 500)	Same	NA
TechnologicalCharacteristic	Predicate DeviceSapphire Infusion system(K161667)	Subject DeviceSapphire Infusion PumpK192860	Comments
(mini cradle)		supply	the pumpsafety oreffectiveness(seediscussion #3below)
Pump Pouch	Yes	Same	NA
Multi-pumpmounting bracket	Yes	Same	NA
Battery case	Yes	Same	NA
Electrical Safety
Electrical Safety	Compliant with IEC 60601-1	Same	NA
Electromagneticcompatibility	Compliant with IEC 60601-1-2	Same	NA
Mechanical and Power Specifications
Pump Size	143 x 96 x 49 mm (5.63 x 3.78 x 1.93inches) HxWxD	Same	NA
Pump Weight	518 g (18.27 oz.), including battery	Same	NA
Power Sources	Rechargeable Li-Ion Battery 7.4V/1960 SamemAh; AC adapter Input: 100-240 AC;50-60 Hz	Same	NA
Operating Environment
Temperature	+5°C to 40°C(41°F to 104°F)	Same	NA
Relative Humidity	15% to 95%	Same	NA
Storage Environment
Temperature	- 40°C to + 70°C (-40°F to 158°F).	Same	NA
Relative Humidity	15% to 95%	Same	NA

Image /page/6/Picture/8 description: The image is a logo for Q-Core Medical. The logo features a stylized letter "Q" in a dark blue color. Inside the "Q" is a speech bubble in a lighter shade of blue. Below the "Q" is the text "Q-CORE" in a larger, bold, dark blue font, and below that is the word "medical" in a smaller, lighter blue font.

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Image /page/7/Picture/2 description: The image shows the logo for Q Core Medical. The logo features a stylized letter "Q" in a dark blue color, with a lighter blue speech bubble inside the "Q". Below the "Q" is the text "QCORE" in a similar dark blue font. Underneath "QCORE" is the word "medical" in a smaller, red font.

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Image /page/8/Picture/2 description: The image shows the logo for Q-Core Medical. The logo features a stylized letter 'Q' in a dark blue color, with a lighter blue speech bubble shape inside the 'Q'. Below the 'Q' is the text 'QCORE' in a similar dark blue font, and below that is the word 'medical' in a smaller font size.

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Comments regarding differences:

1. 10-minute low battery alarm
  This high priority alarm was added as an additional "intermediate" alarm informing the user that battery is getting closer to depletion state (between the existing 30-minute low priority alarm to the high priority 3 minutes alarm before depletion). The alarm new alarm was verified and validated as part SW V & V and meet the requirements of IEC 60601-1-8.
1. Ability to turn off the air detection
  The modification was implemented after analysis of (i) risk and (ii) risk and (iii) review of the market for similar cleared devices with same feature.

This feature was verified and validated as part SW V&V and also as part of Human Factors tests, concluding that this change it does not raise different questions of safety or effectiveness.

1. Pole mount (Mini Cradle) with an embedded power supply
  Image /page/9/Picture/9 description: The image shows the logo for Q Core Medical. The logo features a blue circle with a speech bubble shape inside, also in blue but a lighter shade. Below the circle, the text "Q CORE" is written in a larger, bolder blue font. Underneath "Q CORE", the word "medical" is written in a smaller, lighter blue font.

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This configuration is made as a combination of a power supply and the Mini Cradle (for simpler integration with the pump), resulting in an accessory which reduces user interactions with the same end result, i.e. mounting the pump on a pole and charging it. The same functions were retained, and testing demonstrates that it does not raise different questions of safety or effectiveness.

This accessory was tested for performance and along with the pump to meet the requirements of Electrical Safety (IEC 60601-1) and EMC (IEC 60601-1-2 and IEC 61000).

4. Cybersecurity

Additional changes were made to authentication and authorization controls, digital code signing, and other security controls to enhance the security of the device.

The table below includes a comparison of the technological characteristics between the new administration sets and those of the predicate administration sets.

Technologicalcharacteristic	Predicate - SapphireAdministration Sets(K123049, K141389)	Subject Device -SapphireAdministration Sets	Safety and effectivenessimplication
Intended to be usedonly with the QCore InfusionPumps	Yes	Same	NA
AdministrationCassette	Yes	Same	NA
Cassette safetyfeature	Anti-Free Flow Valve	Same	NA
Differentconfigurations ofthe Sets areavailable,depending upon therequired use	Yes	Same	NA
Differentconfigurationsavailable, andconsist ofconventionalcomponents	Yes	Same, with the addition ofthe NRFit connector	No effect on the pumpsafety or effectiveness (seediscussion #5 below).
Contain sleeves toconnectcomponents	Yes	No	No effect on the pumpsafety or effectiveness (seediscussion #6 below).
Sterile, singlepatient	Yes	Same	NA
Non-DEHP, latexfree	Yes	Same	NA
Biocompatiblematerials	Yes	Same	NA
Non-pyrogenic	Yes	Same	NA
Set length	Up to 280 cm	Up to 300 cm	No effect on the pump
Priming volume	Up to 20 ml	Up to 30 ml	safety or effectiveness (see

Image /page/10/Picture/7 description: The image is the logo for QCore Medical. The logo features a blue circle with a speech bubble inside of it. Below the circle is the word "QCORE" in blue, with the word "medical" in a smaller font below it.

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Comments regarding differences between the administration sets

5. NRFit connector addition

ISO 80369-6: 2016 compliant connectors were added to administration sets for Neuraxial. Verification and validation of the connectors concluded that this modification does not alter their safety and effectiveness.

6. Sleeve removal

Removal of the sleeve component within the assembly resulted in a simpler and more cost-effective connection of set components, with reduced assembly work time. This modification did not include any change to the sets materials. Verification and Validation of the sets performance concluded that this modification does not alter their safety and effectiveness.

7. Length and priming update

The minimal length and priming volume update have no effect on the set performance or use. This modification did not include any change to the sets materials. Verification and Validation of the sets performance concluded that this modification has no implication on the safety and effectiveness.

There are no technological differences between the subject and predicate devices. All updates were evaluated for risk and fully verified and validated, confirming safety and effectiveness are maintained as in the predicate devices. The description of these changes is included in the device description and is presented in the Substantial Equivalence Discussion.

Performance Testing

The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:

Software	• Software verification and validation per the FDA Guidance for theContent of Premarket Submissions for Software Contained in MedicalDevices (May 11, 2005) for a Major Level of Concern• FDA Guidance "Guidance for Industry, FDA Reviewers andCompliance on Off-the-Shelf Software Use in Medical Devices"
Electrical safety	Electrical Safety per IEC 60601-1; 2012
EMC	EMC testing per IEC 60601-1-2; 2014
Alarms	Alarms per IEC 60601-1-8; 2012
Device Performance	• FDA Guidance "Infusion Pumps Total Product Life Cycle"• Accuracy testing under anticipated environments of use and routes• Administration sets performance testing per ISO 80369-6:2016
Battery safety	IEC 62133-2; 2017 compliance
Biocompatibility	Sub-chronic testing per ISO 10993-11:2017 (Administration sets)
Accessory compatibility	Verification that the pump is compatible with the IPS
Human Factors	Human factors studies per the FDA Guidance Applying Human Factors andUsability Engineering to Medical Devices (February 3, 2016). The human

Image /page/11/Picture/13 description: The image shows the logo for Q Core 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" is the text "QCORE" in a similar dark blue font, and below that is the word "medical" in a smaller font size.

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	factors studies were conducted with the intended user population, useenvironment and use scenarios to simulate clinical conditions. Results of thehuman factors testing demonstrate validation of the device per the intendeduse.
Cybersecurity	Cybersecurity was evaluated per the FDA Guidance Content of PremarketSubmissions for Management of Cybersecurity in Medical DevicesGuidance for Industry and Food and Drug Administration Staff, (October 2,2014). Specifically, addressing the following areas: Identify and Protect,Detect, Response and Recover
Reprocessing/Cleaning	Validation per the FDA Guidance for Reprocessing Medical Devices inHealth Care Settings: Validation Methods and Labeling (March 17, 2015)confirmed cleaning and disinfection instruction provided in instructions foruse
MR Safety	ASTM F2503-13, "Standard Practice for Marking Medical Devices andOther Items for Safety in the Magnetic Resonance Environment."

A safety assurance case is provided for the Sapphire Infusion System (pump, sets and accessories) as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle.

The stated goal of the safety assurance case is:

. Device design is adequately safe for its intended use
The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments. The supporting assurance arguments covered the following attributes:
The device is properly identified and defined .
. The device design is adequately verified and validated
. The device risks are acceptably mitigated
. The device is adequately reliable to ensure its safety over its intended use life.

The specific evidence included within the assurance case to demonstrate the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices is described in the table above.

Clinical tests

Not applicable. No clinical studies were conducted in conjunction with this application.

Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.

The Sapphire Infusion system (pump, sets and accessories) is substantially equivalent to the Sapphire Infusion Pump cleared under K161667 (infusion pump) and accessories cleared under K123049, K141389 with respect to the indications for use, target populations, thebasic infusion pump hardware and software used to control delivery of the infusion, technological characteristics, the delivery

Image /page/12/Picture/16 description: The image contains the logo for Q Core Medical. The logo features a blue circle with a speech bubble inside, positioned above the text "Q CORE" in a larger, bolder blue font. Below "Q CORE" is the word "medical" in a smaller, lighter blue font. The overall design is clean and professional, suggesting a company in the healthcare or medical technology sector.

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modes and safety features.

The modifications pertain to addition of Perineural administration route, extended administration sets portfolio, software updates and an additional accessory. There are no changes the basic infusion pump technology.

Image /page/13/Picture/3 description: The image contains the logo for Q Core Medical. The logo features a stylized letter "Q" in a dark blue color, with a lighter blue droplet shape inside the "Q". Below the "Q" is the text "QCORE" in a similar dark blue color, and below that is the word "medical" in a smaller font size and the same dark blue color.

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).