(392 days)
No
The device description and intended use clearly define the device as a sterile medication container (reservoir) for insulin infusion. There is no mention of any computational or analytical functions that would suggest the use of AI or ML. The performance studies focus on extending the duration of use for the reservoir, not on any algorithmic capabilities.
No
The device is a reservoir for containing insulin, which is then infused by a separate pump. It is a component of a system that delivers therapy, rather than being a therapeutic device itself.
No
The device description clearly states it is a "sterile medication container" that is "indicated for the subcutaneous infusion of medication, including insulin." It is a component of a system used to deliver insulin, not to diagnose a condition.
No
The device description explicitly states it is a "sterile medication container designed for single use" and a "component of the Medtronic Insulin Pump Delivery System," indicating it is a physical hardware component, not software.
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 (specifically insulin) from an insulin pump. This is a delivery mechanism for a therapeutic substance, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as a "sterile medication container" and a "component of the Medtronic Insulin Pump Delivery System." This reinforces its role in delivering medication, not performing a diagnostic test.
- No mention of in vitro testing: The description and intended use do not involve analyzing samples (like blood, urine, etc.) outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to hold and facilitate the delivery of medication into the body.
N/A
Intended Use / Indications for Use
The Extended Reservoir is indicated for the subcutaneous infusion including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
Product codes
LZG
Device Description
Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container (Figure 1-1) designed for single use.
The Extended Reservoir (MMT-342) is a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring subcutaneous administered insulin, to maintain acceptable blood glucose levels. The Extended Reservoir (subject device) 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 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
subcutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients with diabetes mellitus
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
Medtronic performed verification testing to support extending the duration of the reservoirs use (from up to 3 days to up to 7 days). The verification testing was performed on MMT-332A (predicate device) since the MMT-342 (subject device) has the same hardware design, materials, and attributes as the predicate device (MMT-332A) except for extending the duration of the reservoirs use (from up to 3 days to up to 7 days). The test results demonstrate that MMT-342 (subject device) met all the product requirements and specifications of MMT-332A (predicate device). Additionally, Medtronic performed a risk analysis assessment to evaluate and identify potentially new hazards and failure modes related to the use of MMT-342 (subject device) for the extended duration (up to 7 days).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 6, 2022
Medtronic MiniMed, Inc. Christina Rowe Senior Regulatory Affairs Manager 18000 Devonshire Street Northridge, California 91325
Re: K210714
Trade/Device Name: Extended Reservoir Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LZG Dated: December 17, 2021 Received: December 17, 2021
Dear Christina Rowe:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210714
Device Name Extended Reservoir
Indications for Use (Describe)
The Extended Reservoir is indicated for the subcutaneous infusion including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your 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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
510(k) Summary
Extended Reservoir
| Device Trade/ Generic Name | Extended Reservoir |
|---|---|
| Predicate Device Name and | |
| Model ID | Medtronic MiniMed Paradigm Reservoir MMT-332A (3.0mL) |
| Predicate 510(K) Number | K032005 |
| 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, Inc. |
| 18000 Devonshire Street | |
| Northridge, CA 91325 USA | |
| Manufacturing Facility | 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 | Christina Rowe |
| Senior Regulatory Affairs Manager | |
| Tel: (818) 942-4875 Fax: (818) 576-6273 | |
| Email : christina.rowe@medtronic.com | |
| Secondary Contact | |
| Information | Darin S. Oppenheimer |
| Senior Regulatory Affairs Director | |
| Tel: (609) 500-9672 | |
| Email: darin.s.oppenheimer@medtronic.com |
Table 1-1: General Information
1. Device Description
Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container (Figure 1-1) designed for single use.
Figure 1-1: Extended Reservoir with Transfer Guard
Image /page/3/Picture/7 description: The image shows a Medtronic syringe with a blue cap. The syringe is clear and has black markings on it. The cap is attached to the syringe and is also clear. The syringe is lying on a white surface.
The Extended Reservoir (MMT-342) is a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring subcutaneous administered insulin, to maintain acceptable blood glucose levels. The Extended Reservoir (subject device) is indicated
4
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 a list of compatible insulins and infusion sets.
Principle of Operations
The subject device (MMT-342) has the same principle of operation as the predicate device (MMT-332A). Same as the predicate device (MMT-332A), the subject device (MMT-342) is designed to mechanically connect to compatible infusion sets (Medtronic Extended Wear Infusion Sets, i.e., EWIS). The reservoir is 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 subject device (MMT-342) shares all attributes of the predicate device (MMT-332A), including the same intended use, same technological characteristics (i.e., hardware design, material, chemical composition, energy source etc.), same 3.0mL storage reservoir, and has the same principle of operation as the marketed predicate device (MMT-332A cleared by FDA under K032005). The change is limited to extending the duration of the reservoirs use (from up to 3 days to up to 7 days).
An exploded view of the subject device (MMT-342) is presented in Figure 1-2 while its components are provided in Table 1-2.
Image /page/4/Figure/5 description: This image shows an exploded diagram of a medical syringe. The different parts of the syringe are labeled, including the barrel, plunger rod, stopper, and O-ring. The barrel is labeled as 3.0 mL. Other labeled parts include the septum, snap cap, and transfer guard.
Figure 1-2: Extended Reservoir with Transfer Guard
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| Component | 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. | |
| 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. | |
| 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 |
| Barrel | Stores the insulin. |
Table 1-2: Reservoir Components Definitions
2. Indications For Use
The Extended 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 a list of compatible insulins and infusion sets.
3. Technological Characteristics and Substantial Equivalence (SE)
The scope of the subject device (MMT-342) is limited to extending the duration of reservoir use (from up to 3 days to up to 7 days). The hardware design of the subject device MMT-342 is the same as the predicate device MMT-332A (K032005). Please note that there are no changes in the hardware design, manufacturing, packaging, sterilization processes, fluid capacity, insulin compatibility, reservoir assembly, between the predicate MMT-332A (K032005) and the subject device (MMT-342). The change is limited to extending the duration of reservoir use (from up to 3 days to up to 7 days) as shown in Table 1-3.
A Substantially Equivalent (SE) chart of the similarities and differences between the predicate device (MMT-332A) and the subject device (MMT-342) is shown in Table 1-3.
6
Table 1-3: Comparision of Predicate Device MiniMed Reservoir MMT-332A (K032005) to the Subject Device Extended Reservoir MMT-342
| Specification | MiniMed Reservoir
(Predicate Device)
MMT-332A (K032005) | Extended Reservoir
(Subject Device)
MMT-342 | Comparison |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Device | User-filled Reservoir | User-filled Reservoir | Same |
| Intended Use | 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. | The Extended 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
a list of compatible insulins and
infusion sets. | Different: the
product name and
model number for
EWR is listed. A
more specific
statement about
compatible insulins /
infusion sets is also
described. |
| Contraindication | This reservoir is contraindicated for the
infusion of blood or blood products. | This reservoir is contraindicated for the
infusion of blood or blood products. | Same |
| Duration of use | Up to 3 days | Up to 7 days | Different: The
duration of use has
increased from 3 to 7
days. |
| Principle of
Operations | Movable stopper | Movable stopper | Same |
| Nominal volume | 3.0mL (2.7mL usable) | 3.0mL (2.7mL usable) | Same |
| Filling Method | Transfer Guard with needle | Transfer Guard with needle | Same |
| Reservoir
Length (Barrel) | 4.34cm (1.707in) | 4.34cm (1.707in) | Same |
| 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 | Ethylene Oxide | Ethylene Oxide | Same |
| Sterilization
Assurance Level
(SAL) | 10-6 | 10-6 | Same |
| Specific Drug
Use | Medication labeled for subcutaneous
administration | Medication labeled for subcutaneous
administration | Same |
| Insulin
Compatibility | Humalog®/Novolog® | Humalog®/Novolog® | Same |
| Plunger Material | Polypropylene (only for filling) | Polypropylene (only for filling) | Same |
| Barrel Material
and Markings | Polypropylene
0.2mL increments | Polypropylene
0.2mL increments | Same |
| Barrel
Transparency | Translucent | Translucent | Same |
| Shelf Life | 3 years | 3 years | Same |
| Packaging | 10 each / customer box
720 each / shipper case | 10 each / customer box
720 each / shipper case | Same |
7
For the reviewer's convenience, Medtronic is providing a reservoir components comparison (Table 1-4) between the predicate device (MMT-332A) and the subject device (MMT-342). The comparison demonstrates that the subject device (MMT-342) utilizes the same hardware design elements as the predicate device (MMT-332A) and highlights the fundamental difference limited to extending the duration of reservoir use (from up to 3 days to up to 7 days).
| Reservoir
Design
Elements | Predicate Device:
MiniMed Reservoir
MMT-332A (K032005) | Subject Device:
Extended Reservoir
MMT-342 | Comparison |
|---------------------------------|--------------------------------------------------------------|--------------------------------------------------|------------|
| Model Number | MMT-332A | MMT-342 | |
| Volume | 3.0mL | 3.0mL | Same |
| Part Number | 7005317J002 | 7005317J002 | Same |
| Plunger Rod | 6014747-006 | 6014747-006 | Same |
| Ribbed Stopper | 6015400-002 | 6015400-002 | Same |
| O-Ring | D60144995-005 | D60144995-005 | Same |
| Barrel | 7005291J003 | 7005291J003 | Same |
| Lubricant | D8062007-001 | D8062007-001 | Same |
| Septum | D6014713-004 | D6014713-004 | Same |
| Transfer Guard | 7005176J-001 | 7005176J-001 | Same |
| Snap Cap | 6015129-001 | 6015129-001 | Same |
Table 1-4: Reservoir Components Comparison
4. Performance Data
Medtronic performed verification testing to support extending the duration of the reservoirs use (from up to 3 days to up to 7 days). The verification testing was performed on MMT-332A (predicate device) since the MMT-342 (subject device) has the same hardware design, materials, and attributes as the predicate device (MMT-332A) except for extending the duration of the reservoirs use (from up to 3 days to up to 7 days). The test results demonstrate that MMT-342 (subject device) met all the product requirements and specifications of MMT-332A (predicate
8
device). Additionally, Medtronic performed a risk analysis assessment to evaluate and identify potentially new hazards and failure modes related to the use of MMT-342 (subject device) for the extended duration (up to 7 days).
Based on the results. Medtronic concludes that the use of MMT-342 (subject device) for the extended duration of up to 7 days 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 MMT-342 (subject device), is substantially equivalent to MMT-332A (predicate device) in its intended use, safety, effectiveness, and underlying scientific and operating principles. Medtronic would like to reiterate the fundamental difference between the MMT-332A (predicate) and MMT-342 (subject device) is limited to extending the reservoir duration of use (from up to 3 days to up to 7 days).
6. Conclusions
In conclusion, the proposed change is limited to extending the reservoir duration of use (from up to 3 days to up to 7 days). As stated previously, MMT-342 (subject device) has the same intended use, same hardware design, same technological characteristics (i.e., hardware design, material, chemical composition, energy source), same 3.0mL storage reservoir, and same principle of operation as the MMT-332A (predicate device). Medtronic performed verification testing to support extending the reservoir duration of use (up to 7 days). The test results demonstrated that MMT-342 (subject device) met all the product requirements and intended use. Additionally, Medtronic performed risk analysis assessment to identify potential new hazards and failure modes related to the extended duration of use of MMT-342 (subject device) compared to MMT-332A (predicate device).
Based on the results, Medtronic concludes MMT-342 (subject device) can have an extended duration of use (up to 7 days) and does not raise any additional questions of safety and effectiveness when compared to the MMT-332A (predicate device). Therefore, the subject device (MMT-342) is substantially equivalent to the legally marketed predicate device (MMT-332A (K032005)).