Medtronic Extended infusion set

K210544 · Unomedical A/S · FPA · Jul 16, 2021 · General Hospital

Device Facts

• Record ID: K210544
• Device Name: Medtronic Extended infusion set
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Jul 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

Device Story

Sterile, single-use subcutaneous infusion set; includes 90-degree soft cannula and preloaded insertion device with automatic needle retraction. Connects to external insulin pump via tubing connector. Insertion needle and cannula remain hidden from user before, during, and after insertion to prevent needle stick injuries. Designed for up to 7-day wear. Used by patients or caregivers in home or clinical settings. Healthcare providers select insertion sites based on adipose tissue availability and patient mobility. Output is continuous subcutaneous medication delivery; device performance affects glycemic control in patients using insulin pumps.

Clinical Evidence

Clinical study conducted in the US with 291 subjects across 15 investigational centers. Results demonstrated the device is safe and effective for the full 7-day wear period. No device-related serious adverse events reported.

Technological Characteristics

Materials: Polypropylene, polyoxymethylene, stainless steel (AISI 304), PTFE, nonwoven polyester/polyacrylate, polyethylene, silicone, MABS, Terlux 2802 HD, polycarbonate, polyvinylalcohol. 90-degree soft cannula; 27-gauge introducer needle. Three-layer tubing (polypropylene/polyethylene/polyurethane). Sterilization: Ethylene Oxide (SAL 10^-6). Complies with ISO 10993-1, ISO 11135, ISO 11607, and ISO 8536-8/9.

Indications for Use

Indicated for subcutaneous infusion of medication via external pump in patients requiring such therapy. Single use only.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• MiniMed™ Mio™ Advance Infusion Set (K173879)

Submission Summary (Full Text)

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July 16, 2021

Unomedical A/S Lone Vestergaard Jepsen Regulatory Affairs Specialist Aaholmvei 1-3 Osted, Lejre 4320 Denmark

Re: K210544

Trade/Device Name: Medtronic Extended infusion set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 5, 2021 Received: May 10, 2021

Dear Lone Vestergaard Jepsen:

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 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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Marianela Perez-torres -S

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

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#### Indications for Use

510(k) Number (if known) K210544

Device Name Medtronic Extended infusion set

Indications for Use (Describe)

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 5. 510(k) Summary

Device Name:

Medtronic Extended infusion set

### 5.1 Submission Sponsor

Unomedical a/s Aaholmvej 1-3, Osted DK-4320 Lejre, Denmark Primary contact: Lone Sylvest Vestergaard Jepsen Title: Regulatory Affairs Specialist

Secondary contact: Mette Busk Henningsen Title: Regulatory Affairs Specialist

#### 5.2 Date Prepared

July 13, 2021

#### 5.3 Device Identification

| Trade/Proprietary Name: | Medtronic Extended infusion set |
|-------------------------|---------------------------------------|
| Common/Usual Name: | Set, Administration, Intravascular |
| Classification Name: | Intravascular administration set |
| Regulation Number: | 880.5440 |
| Product Code: | FPA, Intravascular administration set |
| Device Class: | Class II |
| Classification Panel: | General Hospital |

### 5.4 Legally Marketed Predicate Device(s)

#### Table 5.1: Legally Marketed Predicate Device.

| Device Name | 510(k)<br>No. | Product<br>Code | Classification<br>Regulation | Sponsor |
|------------------------------------|---------------|-----------------|------------------------------|------------|
| MiniMed™ Mio™ Advance Infusion Set | K173879 | FPA | 880.5440 | Unomedical |

#### 5.5 Indication for Use Statement

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

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### 5.6 Device Description

The Medtronic Extended infusion set manufactured by Unomedical a/s is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump.

The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use.

The Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

## 5.7 Substantial Equivalence

The following table compares the Medtronic Extended infusion set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The proposed device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

| Manufacturer | Unomedical a/s | Unomedical a/s | Device Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | MiniMed™ Mio™ Advance<br>Infusion Sets<br>(predicate device) | Medtronic Extended infusion<br>set<br>(proposed device) | N/A |
| 510(k)<br>Number | K173879 | K210544 | N/A |
| Product Code | FPA | FPA | Same |
| Regulation<br>Number | 880.5440 | 880.5440 | Same |
| Regulation<br>Name | Intravascular Administration<br>Set | Intravascular Administration<br>Set | Same |
| Indications<br>for Use | The MiniMed™ Mio™<br>Advance Infusion Set is<br>indicated for subcutaneous<br>infusion of medication<br>administered by an external<br>pump. | The Medtronic Extended<br>infusion set is indicated for the<br>subcutaneous infusion of<br>medication from an external<br>pump.<br>The infusion set is indicated for<br>single use | Same<br>"The infusion set is<br>indicated for single<br>use" has been<br>moved from<br>"Warnings" section<br>for clarification. |
| Mechanism of<br>Action | The MiniMed™ Mio™<br>Advance Infusion Set is an<br>infusion administration set,<br>connecting to a<br>reservoir/infusion pump and<br>inserted in the subcutaneous<br>tissue of a user. | The Medtronic Extended<br>infusion set is an infusion<br>administration set, connecting<br>to a reservoir/infusion pump<br>and inserted in the<br>subcutaneous tissue of a user. | Same |
| Manufacturer | Unomedical a/s | Unomedical a/s | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance<br>Infusion Sets<br>(predicate device) | Medtronic Extended infusion<br>set<br>(proposed device) | N/A |
| Technology<br>Overview | Serter:<br>• Subcutaneous insertion of<br>soft cannula by introducer<br>needle situated inside soft<br>cannula at a 90° insertion<br>angle.<br>• insertion of soft cannula: 2<br>user steps for insertion:<br>remove protective cap for<br>base and press release button<br>• The Base Set in MiniMed™ Mio™<br>Advance infusion set is<br>made of two components, the<br>Fluid Part and the Base Part<br>• The MiniMed™ Mio™<br>Advance infusion set is<br>delivered ready to use in a<br>pre-loaded insertion device<br>with automatic needle<br>retraction. This mechanism<br>allows the needle to be hidden<br>from the user and/or caregiver<br>before and after insertion. | Serter:<br>• Subcutaneous insertion of<br>soft cannula by introducer<br>needle situated inside soft<br>cannula at a 90° insertion<br>angle.<br>• insertion of soft cannula: 2<br>user steps for insertion:<br>remove protective cap for base<br>and press release button<br>• The Base Set in Medtronic<br>Extended infusion set is made<br>of two components, the Fluid<br>Part and the Base Part<br>• The Medtronic Extended<br>infusion set is delivered ready<br>to use in a pre-loaded<br>insertion device with automatic<br>needle retraction. This<br>mechanism allows the needle<br>to be hidden from the user<br>and/or caregiver before and<br>after insertion. | Serter:<br>Visually identical,<br>with identical mode<br>of operation.<br><br>The design of the<br>Medtronic Extended<br>infusion set is<br>detailed in section 11<br>of this 510K. |
| | Administration Set:<br>The administration set<br>attaches to the reservoir by<br>means of a "tubing connector",<br>and subcutaneously into the<br>user through an indwelling<br>cannula made of<br>polytetrafluoroethylene<br>(PTFE).<br>The tubing is made of two<br>layers: the inner layer is<br>polyethylene; the outer is<br>polyurethane.<br>The indwelling cannula is<br>introduced into the<br>subcutaneous tissue by a<br>removable 27-gauge<br>introducer needle (catheter)<br>made of AISI 304 stainless<br>steel. | Administration Set:<br>The administration set<br>attaches to the reservoir by<br>means of a "tubing connector",<br>and subcutaneously into the<br>user through an indwelling<br>cannula made of<br>polytetrafluoroethylene<br>(PTFE).<br>The tubing connector and the<br>adhesive patch are updated to<br>facilitate an extended wear<br>time. The tubing is made of<br>three layers: the inner layer is<br>polypropylene; the middle layer<br>is polyethylene and the outer is<br>polyurethane.<br>The indwelling cannula is<br>introduced into the<br>subcutaneous tissue by a<br>removable 27-gauge<br>introducer needle (catheter)<br>made of AISI 304 stainless<br>steel. | Administration Set:<br>Same technology |
| Manufacturer | Unomedical a/s | Unomedical a/s | Device Comparison |
| Trade Name | MiniMed ™™ Mio™™ Advance<br>Infusion Sets<br>(predicate device) | Medtronic Extended infusion<br>set<br>(proposed device) | N/A |
| Anatomical<br>Location | Standard recommended sites<br>for subcutaneous infusion of<br>medication i.e. subcutaneous<br>sites are selected based on<br>the presence of adequate<br>adipose tissue. The choice of<br>insertion site depends on<br>treatment and patient specific<br>factors as recommended by<br>HCP. Preference is given to<br>sites that do not affect the<br>patient's mobility, the insertion<br>site has to be free of skin<br>irritation and inflammation<br>such as redness, scar tissue<br>and bleeding.<br>Site selection: the abdomen, in<br>a roughly semicircular area<br>around and below the<br>umbilicus is preferred as an<br>application site. Other<br>insertion sites include the<br>upper leg, upper buttocks,<br>hips, upper arms and lower<br>back and occasionally the<br>chest when other sites have<br>edema.<br>The area to place the infusion<br>set is particularly important in<br>patients with many years of<br>use, since the overuse of skin<br>sites has an influence on<br>absorption variability. | Standard recommended sites<br>for subcutaneous infusion of<br>medication i.e. subcutaneous<br>sites are selected based on the<br>presence of adequate adipose<br>tissue. The choice of insertion<br>site depends on treatment and<br>patient specific factors as<br>recommended by HCP.<br>Preference is given to sites<br>that do not affect the patient's<br>mobility, the insertion site has<br>to be free of skin irritation and<br>inflammation such as redness,<br>scar tissue and bleeding.<br>Site selection: the abdomen, in<br>a roughly semicircular area<br>around and below the<br>umbilicus is preferred as an<br>application site. Other insertion<br>sites include the upper leg,<br>upper buttocks, hips, upper<br>arms and lower back and<br>occasionally the chest when<br>other sites have edema.<br>The area to place the infusion<br>set is particularly important in<br>patients with many years of<br>use, since the overuse of skin<br>sites has an influence on<br>absorption variability. | Same |
| Material | Materials include:<br>Polypropylene,<br>polyoxymethylene, stainless<br>steel, polytetraflouroethylene,<br>nonwoven<br>polyester/polyacrylate,<br>polyethylene, silicone, Methyl<br>Methacrylate Acrylonitrile<br>Butadiene<br>Styrene (MABS), Terlux 2802<br>HD, transp., medical grade<br>paper, polycarbonate | Materials include:<br>Polypropylene,<br>polyoxymethylene, stainless<br>steel, polytetraflouroethylene,<br>nonwoven<br>polyester/polyacrylate,<br>polyethylene, silicone, Methyl<br>Methacrylate Acrylonitrile<br>Butadiene<br>Styrene (MABS), Terlux 2802<br>HD, transp., medical grade<br>paper, polycarbonate,<br>polyvinylalcohol | Essentially identical,<br>with the notable<br>addition of<br>polyvinylalcohol.<br>Appropriate<br>biocompatibility<br>testing has been<br>conducted on the<br>proposed device. |
| Sterile | Yes - EO – SAL 10-6 | Yes - EO - SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 2 years | Shelf life reduced |
| Complies<br>with ISO<br>10993-1 | Yes | Yes | Same |
| Manufacturer | Unomedical a/s | Unomedical a/s | Device Comparison |
| Trade Name | MiniMed™ Mio™ Advance<br>Infusion Sets | Medtronic Extended infusion<br>set | N/A |
| | (predicate device) | (proposed device) | |
| Soft Cannula<br>Length | 6 and 9 mm | 6 and 9 mm | Same |
| Tubing:<br>ID<br>OD | 0.385 mm,<br>1.50 mm | 0.406 mm,<br>1.52 mm | Change due to<br>added middle layer in<br>tubing. Substantially<br>equivalent based on<br>bench testing. |
| Soft Cannula<br>OD | 0.68 mm | 0.68 mm | Same |
| Needle Gauge | 27 gauge | 27 gauge | Same |
| Tubing<br>Length | 46, 60 and 110 cm | 46, 60, 80 and 110 cm | Same tubing length<br>range. Added<br>intermediate size. |
| Angle of<br>Insertion | 90 degrees, perpendicular | 90 degrees, perpendicular | Same |
| Insertion<br>Method | Pre-loaded insertion device<br>with automatic needle<br>retraction. The<br>insertion needle and soft<br>cannula are hidden from the<br>user before, during and after<br>insertion of the soft cannula. | Pre-loaded insertion device<br>with automatic needle<br>retraction. The<br>insertion needle and soft<br>cannula are hidden from the<br>user before, during and after<br>insertion of the soft cannula. | Same |
| Time of Use | Up to 72 hours (3 days) | Up to 168 hours (7 days) | Recommended<br>maximum wear time<br>extended. The claim<br>is supported by the<br>clinical performance<br>testing (see section<br>20). |

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