(366 days)
The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60ml syringe (model no. 309653)
To pump fluids from a reservoir into an adult or pediatric patients (2 years and older) in a controlled manner in a home or hospital environment.
The EMED SCIg60 Infusion System consists of: SCIg60 Infuser, fixed-rate Infuset flow control extension set, VersaRate variable-rate flow regulator, SUB-O patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset flow control extension sets, VersaRate flow regulator, and SUB-Q patient administration sets are also manufactured by EMED Technologies. The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of indicated human plasma-derived immunoglobulin solutions. The Infuset flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stoping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates. The change proposed in this 510(k) includes the addition of the VersaRate flow regulator. The VersaRate flow regulator consists of a barrel-type regulator component, medium-density PVC standard luer lock connectors. Snap-fit design elements of the regulator halves hold the gasket in place and allow the VersaRate to withstand fluid pressures up to 18 psi. The rotation of the flow regulator component alters internal fluid path dimensions.
This document is a 510(k) Summary for the EMED SCIg60 Infusion System, intended for the subcutaneous infusion of specific immunoglobulin solutions. It describes the device, its intended use, and argues for substantial equivalence to a predicate device (K161906, SCIg60 Infuser). As such, it focuses on bench testing and a safety assurance case rather than clinical studies with human participants. Therefore, several aspects of your request (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, ground truth for training set) are not applicable or not explicitly detailed in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison of technological characteristics and performance specifications between the subject device (SCIg60 Infusion System, K173783) and its predicate (SCIg60 Infuser, K161906). The acceptance criteria are generally implied by the predicate device's performance, with deviations justified through safety and effectiveness arguments.
| Technological Characteristic | Predicate Device (K161906) Performance | Subject Device (K173783) Performance | Acceptance Criteria (Implied) | Comment/Justification for Differences |
|---|---|---|---|---|
| Infuser Material(s) | PPE Resin, Delrin, Stainless Steel | PPE Resin, Delrin, Stainless Steel | Same as predicate | Same |
| Infuser Weight | 1 lb | 1 lb | Same as predicate | Same |
| Infuser Dimensions (L x H x D) | 10.2" x 2.6" x 2.6" | 10.2" x 2.6" x 2.6" | Same as predicate | Same |
| Syringe/Fluid Container | BD 60ml Syringe (model no. 309653) | BD 60ml Syringe (model no. 309653) | Same as predicate | Same |
| Principle of Action | Spring force, no batteries | Spring force, no batteries | Same as predicate | Same |
| Pressure Source | Spring | Spring | Same as predicate | Same |
| Principle of Flow Control | Internal dimensions of flow control set | Internal dimensions of flow control set | Same as predicate | Same |
| Materials (Flow Controller) | PVC (Infuset) | PVC (Infuset), PVC, Polycarbonate, Styrene-ethylene-butylene (VersaRate) | Biocompatibility equivalent to predicate and previous cleared device (K123729) | Subject device includes VersaRate with additional materials. Biocompatibility deemed equivalent. |
| Flow Controller Residual Volume | 0.10 - 0.20 ml (Infuset) | 0.10 – 0.20 ml (Infuset), 0.20 ml (VersaRate) | No clinically significant difference from predicate | VersaRate has up to 0.10mL higher residual volume, not clinically significant. |
| Flow Controller Sterilization | Ethylene Oxide | Ethylene Oxide | Same as predicate | Same |
| Maximum Operating Pressure (psi) | 16.8 | 16.8 | Same as predicate | Same |
| Average Operating Pressure (psi) | 14.4 | 14.4 | Same as predicate | Same |
| Total Flow Rate Range (ml/hr) | 11 - 145 | 9 – 145 | Ranges are within comparable limits. | Achieved flow rates with subject device are substantially equivalent to predicate when used as recommended. |
| Flow Rate Accuracy (%) | +/- 15 (Infuset only) | +/- 15 (Infuset only), Up to +/- 37 (VersaRate, Positions ½ - 1), Up to +/- 26 (VersaRate, Positions 2-3), Up to +/- 15 (VersaRate, Positions 4-6) | Performance within immunoglobulin manufacturer recommendations when used as per instructions. | Increased variability at low flow rates with VersaRate, explained by small absolute differences resulting in larger % differences. Labeling ensures compliance with manufacturer recommendations. |
| Vertical Sensitivity at +12" | Up to +6% from target flow rate | Up to +6% from target flow rate | Same as predicate | Same |
| Vertical Sensitivity at -12" | Up to -4% from target flow rate | Up to -4% from target flow rate | Same as predicate | Same |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a bench testing summary, not a clinical trial. Performance testing typically involves a sufficient number of samples to ensure statistical validity for the specific test (e.g., flow rate, pressure).
- Data Provenance: Bench testing data, conducted by the manufacturer (EMED Technologies Corporation). The document does not specify country of origin for the data (beyond the manufacturer's location in California), and it is inherently prospective for the device under review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the evaluation primarily involved objective bench testing on the device's physical and functional performance against technical specifications and predicate device performance. Expert consensus would typically be for subjective assessments in clinical settings (e.g., image interpretation).
4. Adjudication Method for the Test Set
- Not applicable for bench testing. Go/no-go criteria based on engineering specifications and comparison to the predicate device's performance.
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 study was done. This device is an infusion system, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No AI component is indicated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a mechanical infusion system, not an algorithm. Bench testing evaluated the standalone functional performance of the device components.
7. The Type of Ground Truth Used
- For performance testing, the "ground truth" was established by engineering specifications, direct measurements, and comparison to the performance characteristics of the legally marketed predicate device (K161906). Additionally, adherence to relevant international standards (e.g., ISO 85368:2015, ANSI/AAMI HE75:2009) and FDA guidance documents played a role in defining acceptable performance. For biocompatibility, the ground truth was based on previous clearances for similar materials and intended uses (e.g., K123729 for VersaRate Controller).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the traditional sense. The design and manufacturing processes are refined through engineering development, not machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" for an AI/ML model for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2018
EMED Technologies Corporation Peter Kollings Director Regulatory Affairs and Quality Assurance 1264 Hawks Flight Ct, Suite 200 El Dorado Hills, California 95762
Re: K173783
Trade/Device Name: SCIg60 Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PKP Dated: December 12, 2017 Received: December 13, 2017
Dear Peter Kollings:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Carolvn C.
Dorgan -S
Digitally signed by Carolyn C. Dorgan -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=2001800814
cn=Carolyn C. Dorgan -S
Date: 2018.12.14 15:18:30 -05'00'
For 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) K173783
Device Name SCIg60 Infusion System
Indications for Use (Describe)
The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60ml syringe (model no. 309653)
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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K173783 510(K) SUMMARY
| Preparation Date: | December 14, 2018 |
|---|---|
| Manufacturer's Name: | EMED Technologies Corporation1264 Hawks Flight Ct, El Dorado Hills, CA 95762 |
| Corresponding Official: | Peter KollingsDirector Regulatory Affairs and Quality Assurance |
| Telephone Number: | 916-932-0071 |
| Fax Number: | 916-932-0074 |
| E-mail Address: | pkollings@emedtc.vom |
| Trade Name: | SCIg60 Infusion System |
| Common or Usual Name: | Immunoglobulin G(Igg) Infusion System |
| Regulation Name: | Infusion pump |
| Regulation Number: | 21 CFR 880.5725 |
| Product Code: | PKP |
| Device Class: | Class II |
| Primary Predicate Device: | K161906, SCIg60 Infuser |
Device Description
The EMED SCIg60 Infusion System consists of :
- . SCIg60 Infuser
- fixed-rate Infuset flow control extension set ●
- VersaRate variable-rate flow regulator
- SUB-O patient administration set ●
The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset flow control extension sets, VersaRate flow regulator, and SUB-Q patient administration sets are also manufactured by EMED Technologies.
The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of indicated human plasma-derived immunoglobulin solutions.
The Infuset flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stoping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates.
The change proposed in this 510(k) includes the addition of the VersaRate flow regulator. The VersaRate flow regulator consists of a barrel-type regulator component, medium-density PVC standard luer lock connectors. Snap-fit design elements of the regulator halves hold the gasket in place and allow the VersaRate to withstand fluid pressures up to 18 psi. The rotation of the flow regulator component alters internal fluid path dimensions.
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thereby changing the resulting flow rate. This capability allows one VersaRate to provide the flow control of multiple individual Infuset flow control sets. SCIg60 Infusion System should be used in accordance with its directions for use.
Indications for Use
The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60ml syringe (model no. 309653)
The device is prescription only.
Intended Use
To pump fluids from a reservoir into an adult or pediatric patients (2 years and older) in a controlled manner in a home or hospital environment.
Substantial Equivalence Discussion
Intended Use Comparison
The table below includes a comparison of the intended use between the new device and those of the predicate device:
| Characteristic | Predicate DeviceSCIg60 InfuserK161906 | Subject DeviceSCIg60 Infusion SystemK173783 |
|---|---|---|
| Indications for Use | The SCIg60 Infusion System is intended foruse in the home or hospital environment for thesubcutaneous infusion of Hizentra, ImmuneGlobulin Subcutaneous (Human), 20% Liquid(manufactured by CSL Behring), GammagardLiquid, Immune Globulin Infusion (Human)10% (manufactured by Baxalta), and CuvitruImmune Globulin Infusion (Human) 20%(manufactured by Baxalta) with the BD 60 mlsyringe (model no. 309653). | The SCIg60 Infusion System is intended for usein the home or hospital environment for thesubcutaneous infusion of Hizentra, ImmuneGlobulin Subcutaneous (Human), 20% Liquid(manufactured by CSL Behring), GammagardLiquid, Immune Globulin Infusion (Human)10% (manufactured by Baxalta), and CuvitruImmune Globulin Infusion (Human) 20%(manufactured by Baxalta) with the BD 60mlsyringe (model no. 309653) |
| Prescription Only orOver the Counter | Prescription Only | Prescription Only |
| Intended Population | adult or pediatric patients (2 years and older) | adult or pediatric patients (2 years and older) |
| Environment of Use | Home or hospital | Home or hospital |
Discussions of differences in Indications for Use statement
The indications for use statement for the subject device is identical to the predicate device.
Discussions of differences in intended population
The intended population for the subject device is identical to the predicate device.
Discussions of differences in environment of use
The environment of use for the subject device is identical to the predicate device.
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Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| TechnologicalCharacteristic | Predicate DeviceSCIg60 InfuserK161906 | Subject DeviceSCIg60 Infusion SystemK173783 | Comments |
|---|---|---|---|
| InfuserMaterial(s) | PPE ResinDelrinStainless Steel | PPE ResinDelrinStainless Steel | Same |
| Infuser Weight | 1 lb | 1 lb | Same |
| InfuserDimensions (L x H x D) | 10.2" x 2.6" x 2.6" | 10.2" x 2.6" x 2.6" | Same |
| Syringe/FluidContainer | BD 60ml Syringe (model no. 309653) | BD 60ml Syringe (model no. 309653) | Same |
| Principle ofAction | Spring force generated by user infusesliquid through flow regulatingaccessories; no batteries/electrical power. | Spring force generated by user infusesliquid through flow regulatingaccessories; no batteries/electrical power. | Same |
| Pressure Source | Spring | Spring | Same |
| Principle of FlowControl | Flow rate result of internaldimensions of flow control set. | Flow rate result of internal dimensions offlow control set. | Same |
| Materials | PVC | PVC (Infuset)PVC, Polycarbonate, Styrene-ethylene-butylene (VersaRate) | Same/SeeComment #1 |
| Flow ControllerResidual Volume | 0.10 - 0.20 ml (Infuset) | 0.10 – 0.20 ml (Infuset)0.20 ml (VersaRate) | SeeComment #2 |
| Flow ControllerSterilization | Ethylene Oxide | Ethylene Oxide | Same |
| MaximumOperatingPressure (psi) | 16.8 | 16.8 | Same |
| AverageOperatingPressure (psi) | 14.4 | 14.4 | Same |
| Total Flow RateRange (ml/hr) | 11 - 145 | 9 – 145 | SeeComment #3 |
| Flow RateAccuracy (%) | +/- 15 (Infuset only) | +/- 15 (Infuset only)Up to +/- 37 (VersaRate, Positions ½ - 1)Up to +/- 26 (VersaRate, Positions 2-3)Up to +/- 15 (VersaRate, Positions 4-6) | SeeComment #4 |
| VerticleSensitivty at +12"At -12" | Up to +6% from target flow rateUp to -4% from target flow rate | Up to +6% from target flow rateUp to -4% from target flow rate | Same |
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Comment 1
The patient-contacting and fluid path materials of the subject SCIg60 Infuser flow control accessory are identical to that of the predicate, K161906. The manufacturing, and packaging processes of the subject SCIg60 Infuser and Infuset flow control accessory are identical to that of the predicate, K161906.
The patient contacting and fluid path materials of the subject VersaRate flow control accessory are identical to the currently marketed VersaRate Controller (K123729). The contact type and duration is similar from a biocompatibility perspective. The subject device is indicated for subcutaneous administration whereas the VersaRate controller (K123729) is indicated for intravenous. However, there are no additional biocompatibility endpoints that need to be evaluation for this change of intended use. The previous determination that the biocompatibility endpoints have been verified to meet the intravenous route of administration per K123729 can be leveraged to determine that the addition of this component to the subject device does not raise different questions of safety and effectiveness.
Comment 2
VersaRate controller has up to 0.10mL higher residual volume that the predicate device. However, the difference is not clinically significant. This does not raise different questions of safety or effectiveness.
Comment 3
The total flow rates of the subject device are within the range of the predicate device. In addition, the total flow rates that are achieved with the subject device when used as indicaturer recommended flow rate limits) are substantially equivalent to those of the predicate.
Comment 4
Flow rate accuracy of the SCIg60 Infusion System employing the VersaRate variable rate flow control accessory is more variable at low flow rates than that of the predicate. This increased variation, expressed as a % of target, at low VersaRate positions (that equate to lower flow rates) is expected in that a small difference between measured flow rate and target flow rate results in a large % difference. Given that the VersaRate provides a similar variability in terms of ml/hr across its positions, flow rate variation in terms of % of target would be expected to be much smaller for higher VersaRate positions and the resulting higher target flow rates.
As with the predicate, instructions for use and labeling for the subject SCIg60 Infusion System employing the VersaRate variable flow control accessory include only those combinations of VersaRate position and SUB-Q sets that provide flow rate performance in line with indicated immunoglobulin manufacturer recommendations. Combinations that allow for flow rates that exceed manufacturer recommendations taking into account system accuracy and vertical sensitivity are excluded.
Because only those VersaRate position and SUB-Q combinations that meet label requirements for administration of each of the indicated immunoglobulin solutions are presented in user instructions, any differences in flow rate accuracy provided by the VersaRate or Infuset flow control devices are well controlled, do not adversely impact users, and do not raise different questions of safety or effectiveness of the system when it is used as intended
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
- Validation of simulated test fluids
- Infusion flow rate testing with SCIg60 Infusion System and indicated human plasma-derived immunoglobulin . solutions*
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- Influence of elevation on flow rate for indicated human plasma-derived immunoglobulin solutions
- Infusion flow rate testing with combinations of SCIg60 Infuser, VersaRate flow regulator positions and SUB-Q ● patient administration sets, and Infuset flow control sets and SUB-Q patient administration sets was performed with simulated test fluid for the indicated human plasma-derived immunoglobulin solutions. Additional performance and flow rate testing was conducted per:
- ISO 85368:2015 Infusion equipment for medical use Part 8: Infusion sets for single use with pressure O infusion apparatus
- Human factors validation of the SCIg60 Infusion System, including additional evaluation of critical tasks ● associated with introduction of the VersaRate Flow rate controller as well as with the currently indicated immunoglobulin solutions. The testing was conducted per:
- Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability O Engineering to Medical Devices, 2016 (https://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf)
- ANSI/AAMI HE75:2009 Human Factors engineering Design of medical devices O
- . Compatibility of human plasma-based immunoglobulin solutions with the SCIg60 Infusion System, including the VersaRate flow control accessory, related to adverse impact to either the SCIg60 Infusion System or the indicated fluids.
- . Particulate testing per USP <788>
- The SCIg60 Infusion System includes directions for the selection of Infuset flow control extension sets and SUB-Q set combinations, or VersaRate flow controller positions and SUB-Q set combinations, in order to achieve desired infusion rates for each of the indicated human plasmaderived immunoglobulin solutions.
Only those combinations that provide flow rate performance in line with indicated immunoglobulin manufacturer recommendations after taking into account total system accuracy and vertical sensitivity are included. This strategy is identical to that employed in K161906 for presenting only Infuset and SUB-Q set combinations that meet label requirements for administration of each of the indicated immunoglobulin solutions.
A safety assurance case was provided for the SCIg60 Infusion System, as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle
(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidanceDocuments/UCM209337.pdf)
The stated goal of the safety assurance case is:
-
. The SCIg60 Infusion System 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: -
(1) Device is adequatelt defined (as a contet for the assurance case)
-
(2) Device design is adequately verified and validated
-
(3) Device associated risks are completely identified and adequately mitigated
-
(4) Device is adequately reliable to ensure safety over device use life
The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices:
- SCIg60 Infuser Product Requirements Matrix ●
- SCIg60 Infusion Pump Design Verification Report ●
- . SCIg60 Infusion Pump Design Validation Report
In addition, the safety assurance case has been updated to include unique hazards associated with use of the VersaRate flow control accessory as part of the SCIg60 Infusion System, such as those related to selection of flow control positions to achieve target flow rates, and acceptable use and performance of the VersaRate "Off" function.
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Clinical Tests
Not Applicable
Conclusions
The differences between the predicate and the subject device do not raise any different questions of safety or effectiveness. The SCIg60 Infusion System is substantially equivalent to the SCIg60 Infuser cleared under K161906 with respect to the indications for use, target populations, treatment method, and technological characteristics.
§ 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).