(284 days)
The Q Core Sapphire Infusion Pump is intended for 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 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 in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.
The dedicated Q Core administration sets for the Sapphire Infusion Pump are intent use and singleuse only.
The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV 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 in the clinical environment, and home users in an ambulatory environment. The Sapphire Infusion 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 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.
The Q Core Sapphire Infusion Pump includes Wiff functionality that is compatible with MedNet. The WiFi feature can be turned on or off, via an authorized Technician. As such, the Sapphire Infusion Pump is available with and without the WiFi functionality.
Sapphire Infusion Pump accessories include the mini cradle, 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.
The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.
The provided text describes a 510(k) premarket notification for the Sapphire Infusion Pump (K161667). This submission is for modifications to a previously cleared device (K141389). Therefore, the study focuses on demonstrating substantial equivalence rather than a new device meeting specific acceptance criteria in a comparative effectiveness study.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical trial or performance study for a novel device. Instead, it details that the modified device maintains substantial equivalence to its predicate device. The acceptance criteria are implicitly that the modified device's performance, especially for the new features/environments, should be comparable to or meet the safety and effectiveness standards of the predicate device and relevant industry standards.
The table in the document (pages 5-6) is a comparison between the Predicate Device (K141389) and the Subject Device (K161667), highlighting similarities and differences. The "Reported Device Performance" for the subject device is implied to be "Same" as the predicate for most attributes, or "Supported by literature and/or bench testing/validation" for differences.
Here's a restructured table based on the information provided, focusing on changes and how they meet criteria (implicitly, the criteria are "equivalent to predicate" or "validated"):
| Acceptance Criteria (Implied) | Reported Device Performance (K161667) |
|---|---|
| Indications for Use: Expanded to include medical air transport. | Validated through testing for the additional environment. Does not alter original indications or intended use. |
| Max Clinician Bolus: New maximum of 30 mL. | Supported by literature and reference device (K111275 CADD®-Solis VIP). |
| Max Epidural Hourly Volume: New maximum of 60 mL. | Supported by literature references. |
| Additional Lockbox Size (250mL): Introduction of new size. | No new risks introduced. |
| Multi-pump mounting bracket: New accessory. | Validated through bench testing. |
| Battery case: New accessory. | Validated through bench testing. |
| New Cleaning and Disinfection Agent: Compatibility and effectiveness. | Validated through a cleaning and disinfection validation protocol. |
| Software Enhancements: Functionality remains robust. | Validated through software validation and verification testing; changes to user interface validated through human factors testing. No basic functionality changes. |
| Electrical Safety: Compliance with standards. | Compliant with IEC 60601-1 and IEC 60601-1-12 (Same as predicate). |
| Electromagnetic Compatibility: Compliance with standards. | Compliant with IEC 60601-1-2 (Same as predicate). |
| Basic Functionality/Performance (e.g., accuracy, modes, alarms, mechanical specs): Remain equivalent to predicate. | "Same" as predicate device for all listed attributes (System delivery accuracy, Delivery Modes, Patient population, WiFi function, alarms, programming functions, infusion specifications, physical dimensions, power, and operating/storage environments). |
2. Sample sizes used for the test set and the data provenance
The document does not specify discrete "sample sizes" in terms of number of patients or cases for the various validation tests. The testing described is primarily non-clinical bench testing, software verification/validation, and human factors evaluations. For these types of tests, sample size generally refers to the number of test units (pumps, accessories) or test runs. These details are not provided in the summary.
Data provenance: The testing was carried out by the manufacturer, Q Core Medical Ltd., in Netanya, ISRAEL. The studies are prospective as they are conducted to validate modifications to an existing device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document details that some changes (e.g., maximum clinician bolus, maximum epidural hourly volume) are "supported by literature and a reference device." This implies reliance on established medical knowledge and previously cleared device specifications rather than new expert consensus for ground truth on these specific parameters for the current submission. For human factors testing, experts (e.g., clinicians) would typically be involved, but their number and qualifications are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided, as the studies described are primarily technical performance validations and verifications, not clinical trials requiring independent expert adjudication of diagnostic outcomes.
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
No MRMC comparative effectiveness study was done. This is an infusion pump, not an AI-powered diagnostic imaging device. The concept of "human readers improving with AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable to an infusion pump. The device itself is a "standalone" algorithmic system in the sense that it performs its infusion functions based on its programming. The software verification and validation activities essentially cover the "standalone" performance of the algorithm without human intervention in the infusion process itself. Human factors testing focuses on the human-device interface and user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is primarily based on:
- Engineering specifications and design requirements: For pump accuracy, delivery modes, alarm thresholds, physical characteristics, and material compatibility.
- Industry standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-12 (Electrical Safety in medical environment), IEC 60601-1-2 (EMC testing).
- Regulatory guidance: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Literature references: For increased bolus volumes and hourly epidural volumes.
- Predicate device's established performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness profile of the K141389 Sapphire Infusion Pump.
8. The sample size for the training set
Not Applicable. As described, this is a modification to an existing infusion pump, and the studies mentioned are verification and validation activities for hardware, software, and changes in use environment. There is no mention of "training sets" in the context of machine learning or AI algorithm development, which is typically where such terminology applies.
9. How the ground truth for the training set was established
Not Applicable, as there is no training set for a machine learning model mentioned in the document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2017
Q Core Medical Ltd. % Rhona Shanker President Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, Maryland 20878
Re: K161667
Trade/Device Name: Sapphire Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ Dated: February 24, 2017 Received: February 24, 2017
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. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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,
Image /page/1/Picture/8 description: The image contains a signature of Tina Kiang. The signature is written in black ink and is located in the center of the image. The signature is followed by the letters '-s'.
Tina Kiang, Ph.D. Acting 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) K161667
Device Name
Sapphire Infusion Pump
Indications for Use (Describe)
The Q Core Sapphire Infusion Pump is intended for 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 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 in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.
The dedicated Q Core administration sets for the Sapphire Infusion Pump are intent use and singleuse 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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K161667 510(K) SUMMARY
Manufacturer's Name:
O Core Medical Ltd. 29 Yad Haruzim St. Netanya 4250529 ISRAEL Ph: +972-73-2388888 Fax: +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:
Trade Name:
Common or Usual Name:
Infusion Pump
March 23, 2017
Sapphire Infusion Pump
| Regulation Name: | Infusion Pump |
|---|---|
| Regulation Number: | 21 CFR 880.5725 |
| Product Code: | FRN - Infusion PumpMRZ – Infusion Pump Accessories |
| Device Class: | Class II |
| Primary Predicate Device: | K141389 Sapphire Infusion Pump |
| Reference Device: | K111275 CADD®-Solis VIP Ambulatory Infusion Pump |
Device Description
The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV 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 in the clinical environment, and home users in an ambulatory environment. The Sapphire Infusion 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 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.
{4}------------------------------------------------
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.
The Q Core Sapphire Infusion Pump includes Wiff functionality that is compatible with MedNet. The WiFi feature can be turned on or off, via an authorized Technician. As such, the Sapphire Infusion Pump is available with and without the WiFi functionality.
Sapphire Infusion Pump accessories include the mini cradle, 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.
The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.
Intended Use
The Q Core Sapphire Infusion Pump is intended for 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 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 in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.
The dedicated Q Core administration sets for the Sapphire Infusion Pump are intended for singleuse only.
Substantial Equivalence Discussion
The Sapphire Infusion Pump (pump and accessories) covered by this submission is the result of modifications to the FDA cleared Sapphire Infusion Pump (K141389). The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
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| Attribute | Predicate Device - K141389Sapphire Infusion Pump | Subject Device - K161667Sapphire Infusion Pump | Comparison | |
|---|---|---|---|---|
| Indications for use | The Q Core Sapphire infusionpump is intended for the controlleddelivery through intravascular,subcutaneous, intra-arterial andepidural routes. The pump isdesigned to deliver saline, TotalParenteral Nutrition (TPN), lipids,IV medication, epidural medication,blood and blood products.The Sapphire pump includes the | The Q Core Sapphire Infusion Pumpis intended for controlled deliverythrough intravascular, subcutaneous,intra-arterial and epidural routes. Thepump is designed to deliver saline,Total Parenteral Nutrition (TPN),lipids, IV medication, epiduralmedication, blood and bloodproducts.The Sapphire Infusion Pump | The subjectdevice includesthe addition ofuse in the airenvironment | |
| following infusion modes for allintended uses: Continuous,Intermittent, TPN, PCA, Multi-step, and Epidural. | includes the following infusionmodes for all intended uses:Continuous, Intermittent, TPN, PCA,Multi-step, and Epidural. | |||
| The pump is intended to be used byboth licensed health careprofessionals in a clinicalenvironment, and home users in anambulatory environment and in prehospital medical groundtransportation. | The pump is intended to be used byboth licensed health careprofessionals in a clinicalenvironment, and home users in anambulatory environment and in pre-hospital medical air and groundtransportation. | |||
| The dedicated Q Coreadministration sets for the Sapphirepump are intended for single-patientuse and single-use only. | The dedicated Q Core administrationsets for the Sapphire Infusion Pumpare intended for single-patient useand single-use only. | |||
| Type of Pump | Volumetric | Same | - | |
| Operating Principle | Linear Peristaltic | Same | - | |
| Patient population | Adult and pediatric | Same | - | |
| Delivery Modes | Continuous, Intermittent, Multi-step, PCA, TPN, and Epidural | Same | - | |
| Intended for intravenous,intra-arterial andsubcutaneous use | Yes | Same | - | |
| Intended forintravascular, intra-peritoneal and epiduralroutes of infusion. | Yes | Same | - | |
| System deliveryaccuracy (nominal) | $\pm2.50%$ | Same | - | |
| System Components/Features | ||||
| WiFi function | Yes | Same | - | |
| Real-time display | Yes | Same | - | |
| Microcomputercontrolled pump | Yes | Same | - | |
| Internal clock | Yes | Same | - | |
| Administration Set | Yes | Same | - | |
| Air-in-line sensor | Yes | Same | - | |
| Occlusion sensor | Yes | Same | - | |
| Temperature Sensor | Yes | Same | - | |
| Number of Channels | 1 | Same | - | |
| History Log | Yes | Same | - | |
| Pump Alarms and Messages | ||||
| Battery/Low, Depleted | Yes | Same | - | |
| Pump in stop mode(unattended) | Yes | Same | - | |
| High pressure(Upstream/Downstream Occlusion) | Yes | Same | - | |
| Pump Fault | Yes | Same | - | |
| Low volume inmedication reservoir | Yes | Same | - | |
| Cassette detachment/misplaced/door open | Yes | Same | - | |
| Air-in-line | Yes | Same | - | |
| Flow Error | Yes | Same | - | |
| Key stuck | Yes | Same | - | |
| End-of-Infusion | Yes | Same | - | |
| Programmable End-of-Infusion alarm | Yes | Same | - | |
| Programming Functions | ||||
| High InternalTemperature | Yes | Same | - | |
| Delivery Mode | Yes | Same | - | |
| Infusion Options | Yes | Same | - | |
| Security and/or LockLevels | Yes | Same | - | |
| Demand Dose Lockout | Yes | Same | - | |
| Delivery Limit | Yes | Same | - | |
| Maximum Rate | Yes | Same | - | |
| Minimum Rate | Yes | Same | - | |
| Occlusion pressure | Yes | Same | - | |
| Air Detection | Yes | Same | - | |
| Piggy back/Secondary | Yes | Same | - | |
| Bolus | Yes | Same | - | |
| Delayed Start | Yes | Same | - | |
| Infusion Specifications | ||||
| Minimum ContinuousDelivery Rate | 0.1 mL/hr | Same | - | |
| Minimum IntermittentDelivery Rate | 0.1 mL/hr | Same | - | |
| Maximum IntermittentDelivery Rate | 999 mL/hr | Same | - | |
| Minimum PCA DeliveryRate | 0 mL/hr | Same | - | |
| Maximum PCA DeliveryRate | 99.9 mL/hr | Same | - | |
| Minimum TPN DeliveryRate | 0.1 mL/hr | Same | - | |
| Maximum TPN DeliveryRate | 600 mL/hr | Same | - | |
| Minimum Epi DeliveryRate | 0.1 mL/hr | Same | - | |
| Maximum Epi Deliveryrate | 200 mL/hr | Same | - | |
| Patient Demand Dose | Yes | Same | - | |
| Maximum PatientDemand Dose | 20 mL | Same | - | |
| Clinician Bolus | Yes | Same | - | |
| Maximum ClinicianBolus | 20 mL | 30 mL | Supported byliterature andCADD®-SolisVIP AmbulatoryInfusion Pump(K111275) | |
| Maximum EpiduralHourly Volume | 40 mL | 60 mL | Supported byliteraturereferences | |
| Maximum Boluses perHour | 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 | - | |
| ProgrammableMaximum Delivery Rate(Continuous Rate andBolus) | Yes | Same | - | |
| Accessories | ||||
| Administration sets | Yes - Q Core suppliedadministration sets | Same | cleared under(K082182,K123049 andK141389) | |
| AC adapter | Yes | Same | - | |
| Remote Dose Cord | Yes | Same | - | |
| Reservoir enclosure(Lockbox) | Yes (100, 500) | Yes (100, 250, 500) | Similar | |
| Pole mount bracket(mini cradle) | Yes | Same | - | |
| Pump Pouch | Yes | Same | - | |
| Multi-pump mountingbracket | No | Yes | Validatedthrough benchtesting | |
| Battery case | No | Yes | Validatedthrough benchtesting | |
| Electrical Safety | ||||
| Electrical Safety | Compliant with IEC 60601-1 | Same | - | |
| Electromagneticcompatibility | Compliant with IEC 60601-1-2 | Same | - | |
| Mechanical and Power Specifications | ||||
| Pump Size | 143 x 96 x 49 mm (5.63 x 3.78 x1.93 inches) HxWxD | Same | - | |
| Pump Weight | 518 g (18.27 oz.), including battery | Same | - | |
| Power Sources | Rechargeable Li-Ion Battery7.4V/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 | - | |
| Relative Humidity | 15% to 95% | Same | - | |
| Storage Environment | ||||
| Temperature | - 40°C to + 70°C (-40°F to 158°F) | Same | - | |
| Relative Humidity | 15% to 95% | Same | - |
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The indication for use statement is identical to the predicate device, K141389, with the exception of the additional use environment - ar transport. The addition of pre-hospital medical air transport does not alter the original indications for use or the intended use described above. The change indicates an additional environment where the device can be used and the testing performed supports this additional environment.
The increases in the maximum clinical bolus and maximum epidural hourly volume are supported through a reference device, CADD®-Solis VIP Ambulatory Infusion Pump (K111275) and extensive literature references. The additional size lockbox (250) does not introduce any new risks. The additional accessories, multi-pump mountain bracket and battery case, are supported through validation and verification testing.
Other modifications to the Sapphire Infusion Pump include an additional cleaning and disinfection agent and minor software changes. The additional cleaning and disinfection agent was validated through a cleaning and disinfection validation protocol. The software modifications do not influence the basic functionality of the device and were validated through software validation and verification testing. Changes to the software which impacted the user interface were validated through human factors testing.
{9}------------------------------------------------
Performance Testing
A safety assurance case was provided for the Sapphire Infusion Pump 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 following evidence was included in the assurance case:
- Performance Test Summary System verification and validation activities for Sapphire Infusion Pump confirmed ● that the system modifications meets user needs and design inputs. All the testing met the acceptance criteria.
- . Human factors evaluations have been conducted to validate the effectiveness of use error related mitigations
- . Electrical and Electromagnetic Compatibility testing were conducted. The Infusion System complies with following standards:
- O Electrical Safety per IEC 60601-1 and IEC 60601-1-12
- o EMC testing per IEC 60601-1-2
- Software Verification and Validation per the FDA Guidance for the Content of Premarket Submissions for . Software Contained in Medical Devices dated May 11, 2005
- Cleaning and Disinfection Validation for the Sapphire Infusion Pump confirmed that the new agent meets the cleaning and disinfection requirements.
The testing conducted demonstrates that the Sapphire Infusion Pump system with changes described meet the design requirements of the cleared Sapphire Infusion Pump system. Therefore, the Sapphire Infusion Pump system that is the subject of this submission is substantially equivalent to its predicate.
Clinical Tests
Not Applicable
Conclusions
The modifications pertain to the expansion of pre-hospital medical transport environment to include another means (air) of medical transport, an additional cleaning and disinfection agent, software enhancements and additional accessories. There are no changes the basic infusion pump technology. The modifications do not raise new questions of safety and effectiveness and are supported by non-clinical testing.
The Sapphire Infusion Pump is substantially equivalent to the Sapphire Infusion Pump cleared under K141389 with respect to the indications for use, target populations, the basic infusion pump hardware and software used to control delivery of the infusion, technological characteristics, the delivery modes and safety features.
§ 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).