(27 days)
MiniMed Reservoir- This Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for compatibility.
Extended Reservoir- The Extended Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
The MiniMed family of reservoirs (MMT-326A, MMT-342, MMT-342, MMT-342G) (herein referred to as "reservoirs" or "subject devices") are sterile medication containers designed for single use. The reservoirs are a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring the subcutaneous administration of insulin to maintain acceptable blood glucose levels. The reservoirs are indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps (i.e., Paradigm pumps and NGP pumps) and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets. The reservoirs have the same principle of operation as the predicate devices (MMT-326A, MMT-332A, MMT-342, MMT-342G) and are designed to mechanically connect to compatible infusion sets. Reservoirs are connected to the infusion set via the tubing connector (H-Cap), which enables insulin infusion from the reservoir through a fluid path into the subcutaneous tissue.
This document describes a 510(k) premarket notification for Medtronic MiniMed's Extended Reservoir and MiniMed Reservoir. The purpose of the submission is to qualify an additional sterilization site and an optimized ethylene oxide (EO) sterilization cycle for these devices.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "The test results demonstrate the subject devices met all the product requirements and specifications of the predicate devices." and "Medtronic concludes the reservoirs can be sterilized at the additional facility using the optimized parameters for EO sterilization cycle."
The acceptance criteria are implicitly defined by the product requirements and specifications of the predicate devices. The performance reported is that the subject devices met these predicate device requirements/specifications.
The relevant performance data from the text is summarized as follows:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties and function (as per predicate device) | Met all product requirements and specifications of the predicate devices following the new sterilization cycle and at the new site. The new sterilization process does not impact the product's material, performance, and shelf-life. |
| Material integrity and compatibility (as per predicate device) | Met all product requirements and specifications of the predicate devices following the new sterilization cycle and at the new site. The new sterilization process does not impact the product's material, performance, and shelf-life. |
| Shelf-life stability (as per predicate device) | Met all product requirements and specifications of the predicate devices following the new sterilization cycle and at the new site. The new sterilization process does not impact the product's material, performance, and shelf-life. |
| Sterility Assurance Level (SAL) | Maintained at 10^-6 (Same as predicate). |
| Biocompatibility | Non-toxic, non-pyrogenic; meets ISO 10993 (Same as predicate). |
| Risk Analysis | A risk analysis assessment was performed to evaluate and identify potential new hazards and failure modes related to the use of the reservoirs following sterilization at the new site under the new cycle parameters. Medtronic concludes that the use of the reservoirs sterilized at the new site under the optimized EO cycle does not raise any additional questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "The testing was performed on MMT-332A since the subject devices have the same hardware design, materials, and attributes as the predicate device."
- Sample Size: The document does not specify the exact sample size (number of units) used for the verification testing. It only mentions that the testing was performed on "MMT-332A" (a 3.0mL MiniMed Reservoir).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's "verification testing," it would typically be prospective data generated by Medtronic as part of the submission process. Medtronic MiniMed is located in Northridge, CA, USA, and the contract manufacturer and one sterilization site are in Puerto Rico, so the data likely originated from these locations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this submission. The device is an infusion pump accessory, and the testing focuses on the impact of a sterilization process change on the device's physical, chemical, and functional attributes, as well as its sterility. It does not involve human interpretation or diagnostic performance where experts establish a "ground truth" in the diagnostic sense. The "ground truth" here is the established product requirements and specifications of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results, where multiple experts provide opinions that may need to be reconciled to establish a ground truth. The testing described here is engineering and sterilization validation, which does not involve such an adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. An MRMC study is relevant for AI-powered diagnostic or screening devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Medtronic reservoirs are physical medical devices, and the submission is about a sterilization process change, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm or software. It is a physical medical device (reservoir) for insulin delivery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is the established product requirements and specifications of the predicate devices (MiniMed Reservoir 1.8mL (MMT-326A), MiniMed Reservoir 3.0mL (MMT-332A), and Extended Reservoir (MMT-342, MMT-342G)). The verification testing aimed to demonstrate that the subject devices, after the sterilization change, still meet these existing, validated performance standards.
8. The sample size for the training set
This is not applicable. This is not a machine learning or AI device that requires a training set. The submission concerns changes to a manufacturing process (sterilization) for an existing medical device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
July 2, 2024
Medtronic MiniMed Shruti Prakash Sr. Regulatory Affairs Specialist 18000 Devonshire St Northridge, California 91325
Re: K241622
Trade/Device Name: Extended Reservoir; MiniMed Reservoir Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: June 5, 2024 Received: June 5, 2024
Dear Shruti Prakash:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
MiniMed Reservoir Extended Reservoir
Indications for Use (Describe)
MiniMed Reservoir- This Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for compatibility.
Extended Reservoir- The Extended Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
MiniMed Reservoir
Extended Reservoir
| Device Trade/ Generic Name | MiniMed ReservoirExtended Reservoir |
|---|---|
| Predicate Device Name and Model ID | MiniMed Reservoir 1.8mL (MMT-326A)MiniMed Reservoir 3.0mL (MMT-332A)Extended Reservoir (MMT-342, MMT-342G) |
| Predicate 510(k) Number | K001828K032005K210714 |
| Classification Name | Class IIInfusion Pump Accessory |
| Pro Code | LZG |
| Cite | 21 CFR 880.5725 |
| Applicant Registration Number | 2032227 |
| Manufacturer and Design Facility | Medtronic MiniMed18000 Devonshire StreetNorthridge, CA 91325 USA |
| Manufacturing Facility | (Contract Manufacturer)Medtronic Puerto Rico Operations Co. (MPROC)Road 31, KM 24, HM 4Ceiba Norte Industrial ParkJuncos, Puerto Rico 00777 |
| Establishment Number | 3004209178 |
| Primary Contact Information | Shruti PrakashSenior Regulatory Affairs SpecialistTel: (213) 372-9753Email: shruti.prakash2@medtronic.com |
| Secondary Contact Information | Christina RoweSenior Regulatory Affairs ManagerTel: (818) 942-4875Email : christina.rowe@medtronic.com |
Table 1-1: General Information
1. Device Description
The MiniMed family of reservoirs (MMT-326A, MMT-342, MMT-342, MMT-342G) (herein referred to as "reservoirs" or "subject devices") are sterile medication containers (Figure 1-1 and Figure 1-2) designed for single use.
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Figure 1-1: MMT-326A Reservoir, 1.8 mL, with Transfer Guard
Image /page/4/Picture/3 description: The image shows a Medtronic syringe. The syringe is clear with black markings and the word "Medtronic" printed on the side. The syringe has a blue cap on the end.
Figure 1-2: MMT-332A and MMT-342 Reservoir, 3.0 mL, with Transfer Guard
Image /page/4/Picture/5 description: The image shows a Medtronic syringe with a blue cap. The syringe is clear with black markings indicating volume measurements. The Medtronic logo is printed on the side of the syringe. The blue cap is partially detached from the syringe.
The reservoirs are a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring the subcutaneous administration of insulin to maintain acceptable blood glucose levels. The reservoirs are indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps (i.e., Paradigm pumps and NGP pumps) and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
Principles of Operation 1.1.
The reservoirs have the same principle of operation as the predicate devices (MMT-326A, MMT-332A, MMT-342, MMT-342G) and are designed to mechanically connect to compatible infusion sets. Reservoirs are connected to the infusion set via the tubing connector (H-Cap), which enables insulin infusion from the reservoir through a fluid path into the subcutaneous tissue.
The reservoirs share all attributes of the predicate devices, including the same intended use, same technological characteristics (i.e., hardware design, material, chemical composition, energy source, etc.), same storage capacity (1.8mL or 3.0mL), and have the same principle of operation as the marketed predicate devices (MMT-326A cleared by FDA under K001828; MMT-332A cleared by FDA under K032005; and MMT-342 and MMT-342G cleared by FDA under K210714). The change is limited to the qualification of an alternate sterilization site and optimized sterilization cycle for the reservoirs. The cycle is considered "optimized"
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because it reduces sterilization complexity by consolidating the Medtronic EO sterilization cycles and modifying EO concentration and processing time to improve the overall efficiency of the sterilization process.
An exploded view of the reservoirs is shown in Figure 1-3. The associated components are provided in Table 1-2.
Image /page/5/Figure/4 description: This image shows an exploded view of a medical device. The device consists of several components, including a barrel, septum, snap cap, transfer guard, ribbed stopper, plunger rod, and o-ring. The barrel has the word "Medtronic" printed on it. The image also includes some numbers and letters, such as "005 & 009".
Figure 1-3: Reservoir Overview
| Table 1-2: Reservoir Component/Material Definitions | ||
|---|---|---|
| ----------------------------------------------------- | -- | -- |
| Component/Material | Definition |
|---|---|
| Plunger Rod | Rigid handle which can be used to move the stopper for the purposes of filling thereservoir with medication. |
| Ribbed Stopper | Movable sealing member within the reservoir which is driven by the pump mechanismto deliver medication. |
| O-Ring | Provides support between the stopper-to-barrel assemblies as it serves as an interface toprevent leaks. |
| Barrel | A cylindrical plastic container for storing medication. |
| Septum | Elastomeric, static closure mounted on the Barrel end. The septum is to be penetratedwith a needle, and seals around it for filling and infusion. |
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| Component/Material | Definition |
|---|---|
| Transfer Guard | A plastic component encapsulating a hypodermic needle, designed to facilitate filling ofthe Reservoir from a vial and to reduce needle-stick probability. |
| Snap Cap | Connects to the infusion set |
2. Indications For Use
2.1. MiniMed Reservoir, 1.8mL (K001828) and 3.0mL (K032005)
This Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for compatibility.
MiniMed Extended Reservoir (K210714) 2.2.
The Extended Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
3. Technological Characteristics and Substantial Equivalence (SE)
The scope of the change is limited to qualifying an additional sterilization site and implementing an optimized sterilization cycle for the reservoirs. The hardware design of the reservoirs is the same as the predicate device. Additionally, there are no changes in the manufacturing, packaging, fluid capacity, insulin compatibility, or reservoir assembly between the predicate and the subject devices.
A substantial equivalence (SE) chart detailing the similarities and differences between the predicate devices and the subject devices is shown in Table 3-1.
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| Specification | Predicate DevicesMiniMed Reservoir 1.8mL(MMT-326A, K001828)MiniMed Reservoir 3.0mL(MMT-332A, K032005)Extended Reservoir (MMT-342, MMT-342G, K210714) | Subject DevicesMiniMed Reservoir 1.8mL(MMT-326A, K001828)MiniMed Reservoir 3.0mL(MMT-332A, K032005)Extended Reservoir (MMT-342,MMT-342G, K210714) | Comparison |
|---|---|---|---|
| Type of Device | User-filled reservoir | User-filled reservoir | Same |
| Intended Use | The MiniMed Reservoir isindicated for the subcutaneousinfusion of medication, includinginsulin, from compatibleMedtronic insulin pumps andinfusion sets. Refer to theMedtronic insulin pump user guidefor a list of compatible insulins andinfusion sets. | The MiniMed Reservoir is indicated forthe subcutaneous infusion ofmedication, including insulin, fromcompatible Medtronic insulin pumpsand infusion sets. Refer to theMedtronic insulin pump user guide fora list of compatible insulins andinfusion sets. | Same |
| Contraindication | The reservoir is contraindicated forthe infusion of blood and bloodproducts. | The reservoir is contraindicated for theinfusion of blood and blood products. | Same |
| Duration of Use | MiniMed Reservoir 1.8mL (MMT-326A) = Up to 3 daysMiniMed Reservoir 3.0mL (MMT-332A) = Up to 3 daysExtended Reservoir (MMT-342,MMT-342G) = Up to 7 days | MiniMed Reservoir 1.8mL (MMT-326A) = Up to 3 daysMiniMed Reservoir 3.0mL (MMT-332A) = Up to 3 daysExtended Reservoir (MMT-342, MMT-342G) = Up to 7 days | Same |
| Principle ofOperation | Movable stopper | Movable stopper | Same |
| NominalVolume | MiniMed Reservoir 1.8mL (MMT-326A) = 1.8mL (1.5 usable)MiniMed Reservoir 3.0mL (MMT-332A) = 3.0mL (2.7 usable)Extended Reservoir (MMT-342,MMT-342G) = 3.0mL (2.7 usable) | MiniMed Reservoir 1.8mL (MMT-326A, MMT-326AT) = 1.8mL (1.5usable)MiniMed Reservoir 3.0mL (MMT-332A) = 3.0mL (2.7 usable)Extended Reservoir (MMT-342, MMT-342G) = 3.0mL (2.7 usable) | Same |
| Filling Method | Transfer guard with needle | Transfer guard with needle | Same |
| ReservoirLength (barrel) | MiniMed Reservoir 1.8mL (MMT-326A) = 3.19cm (1.255 in)MiniMed Reservoir 3.0mL (MMT-332A) = 4.34cm (1.707in) | MiniMed Reservoir 1.8mL (MMT-326A) = 3.19cm (1.255 in)MiniMed Reservoir 3.0mL (MMT-332A) = 4.34cm (1.707in) | Same |
| Specification | Predicate DevicesMiniMed Reservoir 1.8mL(MMT-326A, K001828)MiniMed Reservoir 3.0mL(MMT-332A, K032005)Extended Reservoir (MMT-342, MMT-342G, K210714) | Subject DevicesMiniMed Reservoir 1.8mL(MMT-326A, K001828)MiniMed Reservoir 3.0mL(MMT-332A, K032005)Extended Reservoir (MMT-342,MMT-342G, K210714) | Comparison |
| Extended Reservoir (MMT-342,MMT-342G) = 4.34cm (1.707in) | Extended Reservoir (MMT-342, MMT-342G) = 4.34cm (1.707in) | ||
| Filling NeedleMaterial | 304 stainless steel | 304 stainless steel | Same |
| Filling NeedleLength | 0.74in | 0.74in | Same |
| Filling NeedleGauge | 26 gauge | 26 gauge | Same |
| Needle TipConfiguration | Beveled | Beveled | Same |
| Biocompatibility | Non-toxic, non-pyrogenic; meetsISO 10993 | Non-toxic, non-pyrogenic; meets ISO10993 | Same |
| SterilizationMethod | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| SterilizationCycle | Cycle 415 | Cycle 415Cycle 86 | Different: TheCycleparameters havebeen changed tooptimize EOsterilization. |
| SterilizationLocation | Steri-Tech, Inc., Puerto Rico | Steri-Tech, Inc., Puerto RicoSterigenics US, LLC, Atlanta, GA | Different: TheSterigenics sitehas been addedas an alternatesterilizationfacility. |
| SterilizationRelease | Biological Indicators (BI) | Biological Indicators (BI)Parametric Release | Different: Theparametricrelease processhas beenqualified as anadditionalrelease process |
| SterilizationAssurance Level(SAL) | 10-6 | 10-6 | Same |
| Specific DrugUse | Medication labeled forsubcutaneous administration | Medication labeled for subcutaneousadministration | Same |
| Specification | Predicate DevicesMiniMed Reservoir 1.8mL(MMT-326A, K001828)MiniMed Reservoir 3.0mL(MMT-332A, K032005)Extended Reservoir (MMT-342, MMT-342G, K210714) | Subject DevicesMiniMed Reservoir 1.8mL(MMT-326A, K001828)MiniMed Reservoir 3.0mL(MMT-332A, K032005)Extended Reservoir (MMT-342, MMT-342G, K210714) | Comparison |
| InsulinCompatibility | Humalog®/Novolog® | Humalog®/Novolog® | Same |
Table 3-1: Comparison of Predicate Device to Subject Device
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Medtronic MiniMed Special 510K Additional Sterilizer for Reservoirs 510(k) Summary K241622
4. Performance Data
Medtronic performed verification testing to support the addition of a new sterilization facility and the implementation of an optimized EO sterilization cycle. As part of the verification testing, the impact of the sterilization change on the product's material, performance and shelf-life was evaluated. The testing was performed on MMT-332A since the subject devices have the same hardware design, materials, and attributes as the predicate device. The test results demonstrate the subject devices met all the product requirements and specifications of the predicate devices.
Additionally, Medtronic performed a risk analysis assessment to evaluate and identify potential new hazards and failure modes related to the use of the reservoirs following sterilization at the new site under the new cycle parameters. Based on the results, Medtronic concludes that the use of the reservoirs sterilized at the new site under the optimized EO cycle does not raise any additional questions of safety and effectiveness.
5. Substantial Equivalence
Based on the 510(k) summary information provided herein, Medtronic concludes that the subject devices are substantially equivalent to the predicate devices in intended use, safety, effectiveness, and underlying scientific and operating principles. The fundamental difference between the subject devices and the predicate devices is limited to an additional sterilization site and optimized EO sterilization cycle.
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6. Conclusions
The proposed change is limited to qualifying an additional sterilization site and optimized EO sterilization cycle for the reservoirs have the same intended use, hardware design, technological characteristics (i.e., material, chemical composition, energy source), storage reservoir capacity (1.8mL or 3.0mL), and principle of operation as the predicate devices. Medtronic evaluated and performed required verification testing to support the additional sterilization site and optimized EO sterilization cycle. The test results demonstrated that the reservoirs met all the product requirements and intended use.
Additionally, Medtronic performed a risk analysis assessment to evaluate and identify potential new hazards and failure modes related to the use of the reservoirs following sterilization at the new site under the new sterilization cycle parameters. Based on the results, Medtronic concludes the reservoirs can be sterilized at the additional facility using the optimized parameters for EO sterilization cycle. This change does not raise additional questions of safety and effectiveness when compared to Medtronic's currently marketed predicate devices. Therefore, the subject devices are substantially equivalent to the legally marketed predicate devices.
§ 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).