(284 days)
K141389 Sapphire Infusion Pump
No
The document describes a standard infusion pump with various modes and a drug library. There is no mention of AI or ML capabilities for decision-making, data analysis, or adaptive control.
Yes
Explanation: The device is an infusion pump designed to deliver various fluids, including IV medication, epidural medication, and blood products, which are used for therapeutic purposes such as pain management and administration of drugs to treat conditions.
No
The device is an infusion pump designed for controlled delivery of fluids and medications, not for diagnosing medical conditions.
No
The device description clearly states it is a "single-channel, volumetric infusion pump" and lists various hardware components and accessories, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided text, the Q Core Sapphire Infusion Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes" of various fluids and medications. This involves administering substances into the body, not analyzing samples from the body.
- Device Description: The description reinforces that it's a "single-channel, volumetric infusion pump" designed to deliver fluids.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Q Core Sapphire Infusion Pump is a medical device used for drug and fluid delivery, not an IVD.
N/A
Intended Use / Indications for 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 intent use and singleuse only.
Product codes (comma separated list FDA assigned to the subject device)
FRN, MRZ
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.
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 Wi-Fi 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular, subcutaneous, intra-arterial and epidural routes
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Electrical Safety per IEC 60601-1 and IEC 60601-1-12
- 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.
Key Results:
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K141389 Sapphire Infusion Pump
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111275 CADD®-Solis VIP Ambulatory Infusion Pump
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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,
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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 Shanker
FDA 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 Pump |
| MRZ – 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 - K141389
Sapphire Infusion Pump | Subject Device - K161667
Sapphire Infusion Pump | Comparison | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--|
| Indications for use | The Q Core Sapphire infusion
pump is intended for the controlled
delivery through intravascular,
subcutaneous, intra-arterial and
epidural routes. The pump is
designed to deliver saline, Total
Parenteral Nutrition (TPN), lipids,
IV medication, epidural medication,
blood and blood products.
The Sapphire pump includes the | 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 | The subject
device includes
the addition of
use in the air
environment | |
| | following infusion modes for all
intended uses: Continuous,
Intermittent, TPN, PCA, Multi-
step, and Epidural. | includes the following infusion
modes for all intended uses:
Continuous, Intermittent, TPN, PCA,
Multi-step, and Epidural. | | |
| | The pump is intended to be used by
both licensed health care
professionals in a clinical
environment, and home users in an
ambulatory environment and in pre
hospital medical ground
transportation. | The 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
pump are intended for single-patient
use and single-use only. | The dedicated Q Core administration
sets for the Sapphire Infusion Pump
are intended for single-patient use
and 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 and
subcutaneous use | Yes | Same | - | |
| Intended for
intravascular, intra-
peritoneal and epidural
routes of infusion. | Yes | Same | - | |
| System delivery
accuracy (nominal) | $\pm2.50%$ | Same | - | |
| System Components/Features | | | | |
| WiFi function | Yes | Same | - | |
| Real-time display | Yes | Same | - | |
| Microcomputer
controlled 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 in
medication 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 Internal
Temperature | Yes | Same | - | |
| Delivery Mode | Yes | Same | - | |
| Infusion Options | Yes | Same | - | |
| Security and/or Lock
Levels | 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 Continuous
Delivery Rate | 0.1 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 | - | |
| Maximum Patient
Demand Dose | 20 mL | Same | - | |
| Clinician Bolus | Yes | Same | - | |
| Maximum Clinician
Bolus | 20 mL | 30 mL | Supported by
literature and
CADD®-Solis
VIP Ambulatory
Infusion Pump
(K111275) | |
| Maximum Epidural
Hourly Volume | 40 mL | 60 mL | Supported by
literature
references | |
| 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 | - | |
| Accessories | | | | |
| Administration sets | Yes - Q Core supplied
administration sets | Same | cleared under
(K082182,
K123049 and
K141389) | |
| 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 mounting
bracket | No | Yes | Validated
through bench
testing | |
| Battery case | No | Yes | Validated
through bench
testing | |
| Electrical Safety | | | | |
| Electrical Safety | Compliant with IEC 60601-1 | Same | - | |
| Electromagnetic
compatibility | Compliant with IEC 60601-1-2 | Same | - | |
| Mechanical and Power Specifications | | | | |
| 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 | - | |
| 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.