(27 days)
Not Found
No
The device description and intended use clearly define the device as a sterile medication container (reservoir) for insulin pumps. There is no mention of any computational or analytical functions, let alone AI/ML. The performance studies focus on sterilization and material properties, not algorithmic performance.
Yes
Explanation: The device is a reservoir indicated for the subcutaneous infusion of medication, including insulin, from compatible insulin pumps, used by patients with diabetes mellitus to maintain acceptable blood glucose levels. This function directly contributes to treating a medical condition, qualifying it as a therapeutic device.
No
The device is described as a "sterile medication container designed for single use" for the "subcutaneous infusion of medication" (insulin). Its purpose is to deliver medication, not to diagnose a condition.
No
The device description clearly states that the devices are "sterile medication containers" and "a component of the Medtronic Insulin Pump Delivery System." It also describes their mechanical connection to infusion sets and fluid path, indicating a physical, hardware-based device. The testing described focuses on sterilization and material performance, further supporting that this is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous infusion of medication, including insulin." This describes a device used to deliver a substance into the body, not to perform a diagnostic test on a sample taken from the body.
- Device Description: The description clearly states the reservoirs are "sterile medication containers designed for single use" and are a "component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring the subcutaneous administration of insulin." This reinforces its role in drug delivery.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is a component of a system for delivering medication, which is a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZG
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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.
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.
Not Found
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).
0
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).
1
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
2
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
MiniMed Reservoir
Extended Reservoir
| Device Trade/ Generic Name | MiniMed Reservoir
Extended 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 | K001828
K032005
K210714 |
| Classification Name | Class II
Infusion Pump Accessory |
| Pro Code | LZG |
| Cite | 21 CFR 880.5725 |
| Applicant Registration Number | 2032227 |
| Manufacturer and Design Facility | Medtronic MiniMed
18000 Devonshire Street
Northridge, CA 91325 USA |
| Manufacturing Facility | (Contract Manufacturer)
Medtronic Puerto Rico Operations Co. (MPROC)
Road 31, KM 24, HM 4
Ceiba Norte Industrial Park
Juncos, Puerto Rico 00777 |
| Establishment Number | 3004209178 |
| Primary Contact Information | Shruti Prakash
Senior Regulatory Affairs Specialist
Tel: (213) 372-9753
Email: shruti.prakash2@medtronic.com |
| Secondary Contact Information | Christina Rowe
Senior Regulatory Affairs Manager
Tel: (818) 942-4875
Email : 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.
4
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"
5
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 the |
| reservoir with medication. | |
| Ribbed Stopper | Movable sealing member within the reservoir which is driven by the pump mechanism |
| to deliver medication. | |
| O-Ring | Provides support between the stopper-to-barrel assemblies as it serves as an interface to |
| prevent leaks. | |
| Barrel | A cylindrical plastic container for storing medication. |
| Septum | Elastomeric, static closure mounted on the Barrel end. The septum is to be penetrated |
| with a needle, and seals around it for filling and infusion. |
6
| Component/Material | Definition |
|---|---|
| Transfer Guard | A plastic component encapsulating a hypodermic needle, designed to facilitate filling of |
| the 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.
7
| Specification | Predicate Devices
MiniMed Reservoir 1.8mL
(MMT-326A, K001828)
MiniMed Reservoir 3.0mL
(MMT-332A, K032005)
Extended Reservoir (MMT-
342, MMT-342G, K210714) | Subject Devices
MiniMed 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 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 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. | Same |
| Contraindication | The reservoir is contraindicated for
the infusion of blood and blood
products. | The reservoir is contraindicated for the
infusion of blood and blood products. | Same |
| Duration of Use | MiniMed Reservoir 1.8mL (MMT-
326A) = Up to 3 days
MiniMed Reservoir 3.0mL (MMT-
332A) = Up to 3 days
Extended Reservoir (MMT-342,
MMT-342G) = Up to 7 days | MiniMed Reservoir 1.8mL (MMT-
326A) = Up to 3 days
MiniMed Reservoir 3.0mL (MMT-
332A) = Up to 3 days
Extended Reservoir (MMT-342, MMT-
342G) = Up to 7 days | Same |
| Principle of
Operation | Movable stopper | Movable stopper | Same |
| Nominal
Volume | 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 (1.5
usable)
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 |
| Reservoir
Length (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 Devices
MiniMed Reservoir 1.8mL
(MMT-326A, K001828)
MiniMed Reservoir 3.0mL
(MMT-332A, K032005)
Extended Reservoir (MMT-
342, MMT-342G, K210714) | Subject Devices
MiniMed 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 Needle
Material | 304 stainless steel | 304 stainless steel | Same |
| Filling Needle
Length | 0.74in | 0.74in | Same |
| Filling Needle
Gauge | 26 gauge | 26 gauge | Same |
| Needle Tip
Configuration | Beveled | Beveled | Same |
| Biocompatibility | Non-toxic, non-pyrogenic; meets
ISO 10993 | Non-toxic, non-pyrogenic; meets ISO
10993 | Same |
| Sterilization
Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Sterilization
Cycle | Cycle 415 | Cycle 415
Cycle 86 | Different: The
Cycle
parameters have
been changed to
optimize EO
sterilization. |
| Sterilization
Location | Steri-Tech, Inc., Puerto Rico | Steri-Tech, Inc., Puerto Rico
Sterigenics US, LLC, Atlanta, GA | Different: The
Sterigenics site
has been added
as an alternate
sterilization
facility. |
| Sterilization
Release | Biological Indicators (BI) | Biological Indicators (BI)
Parametric Release | Different: The
parametric
release process
has been
qualified as an
additional
release process |
| Sterilization
Assurance Level
(SAL) | 10-6 | 10-6 | Same |
| Specific Drug
Use | Medication labeled for
subcutaneous administration | Medication labeled for subcutaneous
administration | Same |
| Specification | Predicate Devices
MiniMed Reservoir 1.8mL
(MMT-326A, K001828)
MiniMed Reservoir 3.0mL
(MMT-332A, K032005)
Extended Reservoir (MMT-342, MMT-342G, K210714) | Subject Devices
MiniMed Reservoir 1.8mL
(MMT-326A, K001828)
MiniMed Reservoir 3.0mL
(MMT-332A, K032005)
Extended Reservoir (MMT-342, MMT-342G, K210714) | Comparison |
| Insulin
Compatibility | Humalog®/Novolog® | Humalog®/Novolog® | Same |
Table 3-1: Comparison of Predicate Device to Subject Device
8
9
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.
10
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.