Sapphire Infusion Pump, Sapphire administration sets

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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. | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K192860 | Manufacturer's Name | Q Core Medical Ltd.<br>29 Yad Haruzim St.<br>Netanya 4250529<br>ISRAEL<br>Ph: +972-73-2388888<br>Fax: +972-73-2388800 | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Corresponding Official: | Rhona Shanker<br>FDA 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 pump<br>MRZ - Infusion pump accessories<br>FPA - 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 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 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. {4}------------------------------------------------ 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. - 2. 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. {5}------------------------------------------------ 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 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 Device<br>Sapphire Infusion system<br>(K161667) | Subject Device<br>Sapphire Infusion Pump<br>K192860 | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Q Core Sapphire Infusion<br>Pump is intended for controlled<br>delivery through intravascular,<br>subcutaneous, intra-arterial<br>and epidural routes. The pump is<br>designed to deliver saline, Total<br>Parenteral Nutrition (TPN), lipids,<br>IV medication,<br>epidural medication, blood and<br>blood products.<br>The Sapphire Infusion Pump<br>includes the following infusion<br>modes for all intended uses:<br>Continuous, Intermittent, TPN,<br>PCA, Multi-step, and Epidural.<br>The pump is intended to be used<br>by both licensed health care<br>professionals in a clinical<br>environment, and home users in<br>an ambulatory environment and in<br>pre-hospital medical air and<br>ground transportation.<br>The dedicated Q Core<br>administration sets for the<br>Sapphire Infusion Pump are<br>intended for single-patient use and<br>single use<br>only. | The Sapphire Infusion pump is<br>intended for controlled delivery<br>through intravascular,<br>subcutaneous, intra-arterial,<br>perineural and epidural routes.<br>The pump is designed to deliver<br>saline, Total Parenteral Nutrition<br>(TPN),lipids, IV medication,<br>perineural medication, epidural<br>medication, blood and blood<br>products.<br>The Sapphire Infusion pump<br>includes the following infusion<br>modes for all intended uses:<br>Continuous, Intermittent, TPN, PCA,<br>Multi-step, and Epidural.<br>It is intended to be used in the<br>following environments of use:<br>clinical, ambulatory, pre-hospital<br>medical air and ground<br>transportation and home. The<br>pump is intended to be used by both<br>licensed health care professionals<br>and by lay users.<br>The Sapphire and the<br>administration sets are indicated<br>for use by both adult and pediatric<br>populations. | 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. {6}------------------------------------------------ | | | The dedicated Q Core<br>administration sets for the<br>Sapphire pump are intended for<br>single-patient use andsingle-use<br>only. | |----------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Prescription or Over the Counter | Prescription | Prescription | | Intended Population | Adult and pediatric | Adult and pediatric | | Environment of Use | clinical, ambulatory, pre-hospital<br>medical air and ground<br>transportation, and home | clinical, ambulatory, pre-hospital<br>medical air and ground<br>transportation 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. | Technological<br>Characteristic | Predicate Device<br>Sapphire Infusion system<br>(K161667) | Subject Device<br>Sapphire Infusion Pump<br>K192860 | Comments | |-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | System Components/Features | | | | | Real-time display | Yes | Same | NA | | Microcomputer<br>controlled 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 | | Technological<br>Characteristic | Predicate Device<br>Sapphire Infusion system<br>(K161667) | Subject Device<br>Sapphire Infusion Pump<br>K192860 | Comments | | Pump in stop mode<br>(unattended) | Yes | Same | (see Note #1<br>below) | | High pressure<br>(Upstream/<br>Downstream<br>Occlusion) | Upstream -0.4bar<br>Downstream 1.2 bar | Same | NA | | Pump Fault | Yes | Same | NA | | Low volume in<br>medication reservoir | Yes | Same | NA | | Cassette detachment<br>/misplaced/door<br>open | 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-<br>of-Infusion alarm | Yes | Same | NA | | Programming Functions | | | | | High Internal<br>Temperature | Yes | Same | NA | | Delivery Mode | Yes | Same | NA | | Infusion Options | Yes | Same | NA | | Security and/or<br>Lock Levels | Yes | Same | NA | | Demand Dose<br>Lockout | Yes | Same | NA | | Delivery Limit | Yes | Yes, with option to disable by<br>technician | No effect on<br>the pump<br>safety or<br>effectiveness<br>(see<br>discussion #<br>Note 2<br>below) | | Air Detection | Yes | Yes, with option to disable by<br>technician | No effect on<br>the pump<br>safety or<br>effectiveness<br>(see<br>discussion #<br>Note 2<br>below) | | Piggy<br>back/Secondary | Yes | Same | NA | | Delayed Start | Yes | Same | NA | | Infusion Specifications | | | | | Flow rate accuracy | Ave: 2.5%<br>(-3.6% at 5-15°C to +3.5% at 30-40°C) | Same | NA | | Minimum<br>Continuous Delivery<br>Rate | 0.1 mL/hr | Same | NA | | Maximum<br>Continuous Delivery<br>Rate | 999 mL/hr | Same | NA | | Technological<br>Characteristic | Predicate Device<br>Sapphire Infusion system<br>(K161667) | Subject Device<br>Sapphire Infusion Pump<br>K192860 | Comments | | Minimum<br>Intermittent<br>Delivery Rate | 0.1 mL/hr | Same | NA | | Maximum<br>Intermittent<br>Delivery Rate | 999 mL/hr | Same | NA | | Minimum PCA<br>Delivery Rate | 0 mL/hr | Same | NA | | Maximum PCA<br>Delivery Rate | 99.9 mL/hr | Same | NA | | Minimum ΤΡΝ<br>Delivery Rate | 0.1 mL/hr | Same | NA | | Maximum TPN<br>Delivery Rate | 600 mL/hr | Same | NA | | Minimum Epi<br>Delivery Rate | 0.1 mL/hr | Same | NA | | Maximum Epi<br>Delivery rate | 200 mL/hr | Same | NA | | Patient Demand<br>Dose | Yes | Same | NA | | Bolus Accuracy | Ave: 2.5% (-7.5% to 7.5% at 0.1mL/h) | Same | NA | | Maximum Patient<br>Demand Dose | 20 mL | Same | NA | | Clinician Bolus | Yes | Same | NA | | Maximum Clinician<br>Bolus | 30 mL | Same | NA | | Maximum Epidural<br>Hourly Volume | 60 mL/hr | Same | NA | | Maximum Boluses<br>per Hour | 60 per hour / 60 per 4 hours | Same | NA | | KVO | Yes | Same | NA | | KVO Rate | 0 - 20 mL/hr or the actual rate,<br>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 | | Programmable<br>Maximum Delivery<br>Rate (Continuous<br>Rate and Bolus) | Yes | Same | NA | | | Accessories | | | | Administration sets | Yes - Q Core supplied administration<br>sets | Same | NA | | AC adapter | Yes | Yes Same | NA | | Remote Dose Cord | Same Yes | Yes Same | NA | | Reservoir enclosure<br>(Lockbox) | Yes (100, 250, 500) | Same | NA | | Technological<br>Characteristic | Predicate Device<br>Sapphire Infusion system<br>(K161667) | Subject Device<br>Sapphire Infusion Pump<br>K192860 | Comments | | (mini cradle) | | supply | the pump<br>safety or<br>effectiveness<br>(see<br>discussion #3<br>below) | | Pump Pouch | Yes | Same | NA | | Multi-pump<br>mounting bracket | Yes | Same | NA | | Battery case | Yes | Same | NA | | Electrical Safety | | | | | Electrical Safety | Compliant with IEC 60601-1 | Same | NA | | Electromagnetic<br>compatibility | 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 1.93<br>inches) HxWxD | Same | NA | | Pump Weight | 518 g (18.27 oz.), including battery | Same | NA | | Power Sources | Rechargeable Li-Ion Battery 7.4V/1960 Same<br>mAh; AC adapter Input: 100-240 AC;<br>50-60 Hz | Same | NA | | Operating Environment | | | | | Temperature | +5°C to 40°C<br>(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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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. {9}------------------------------------------------ # 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. - 2. 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. - 3. 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. {10}------------------------------------------------ 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. | Technological<br>characteristic | Predicate - Sapphire<br>Administration Sets<br>(K123049, K141389) | Subject Device -<br>Sapphire<br>Administration Sets | Safety and effectiveness<br>implication | |----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------| | Intended to be used<br>only with the Q<br>Core Infusion<br>Pumps | Yes | Same | NA | | Administration<br>Cassette | Yes | Same | NA | | Cassette safety<br>feature | Anti-Free Flow Valve | Same | NA | | Different<br>configurations of<br>the Sets are<br>available,<br>depending upon the<br>required use | Yes | Same | NA | | Different<br>configurations<br>available, and<br>consist of<br>conventional<br>components | Yes | Same, with the addition of<br>the NRFit connector | No effect on the pump<br>safety or effectiveness (see<br>discussion #5 below). | | Contain sleeves to<br>connect<br>components | Yes | <b>No</b> | No effect on the pump<br>safety or effectiveness (see<br>discussion #6 below). | | Sterile, single<br>patient | Yes | Same | NA | | Non-DEHP, latex<br>free | Yes | Same | NA | | Biocompatible<br>materials | 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. {11}------------------------------------------------ # 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 the<br>Content of Premarket Submissions for Software Contained in Medical<br>Devices (May 11, 2005) for a Major Level of Concern<br>• FDA Guidance "Guidance for Industry, FDA Reviewers and<br>Compliance 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"<br>• Accuracy testing under anticipated environments of use and routes<br>• 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 and<br>Usability 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. {12}------------------------------------------------ | | factors studies were conducted with the intended user population, use<br>environment and use scenarios to simulate clinical conditions. Results of the<br>human factors testing demonstrate validation of the device per the intended<br>use. | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cybersecurity | Cybersecurity was evaluated per the FDA Guidance Content of Premarket<br>Submissions for Management of Cybersecurity in Medical Devices<br>Guidance for Industry and Food and Drug Administration Staff, (October 2,<br>2014). Specifically, addressing the following areas: Identify and Protect,<br>Detect, Response and Recover | | Reprocessing/Cleaning | Validation per the FDA Guidance for Reprocessing Medical Devices in<br>Health Care Settings: Validation Methods and Labeling (March 17, 2015)<br>confirmed cleaning and disinfection instruction provided in instructions for<br>use | | MR Safety | ASTM F2503-13, "Standard Practice for Marking Medical Devices and<br>Other 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. {13}------------------------------------------------ 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.