neria guard Infusion Set

K192647 · Unomedical A/S · FPA · Dec 13, 2019 · General Hospital

Device Facts

• Record ID: K192647
• Device Name: neria guard Infusion Set
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

Device Story

The neria™ guard Infusion Set is a sterile, single-use subcutaneous infusion set featuring a 90-degree soft cannula and a preloaded insertion device with automatic needle retraction. The device connects to an external infusion pump via tubing. The insertion needle and soft cannula remain hidden from the user before, during, and after insertion to prevent needle stick injuries. The device is used in clinical or home settings by patients or caregivers. The healthcare provider selects the insertion site based on adipose tissue availability. The device facilitates medication delivery by maintaining a subcutaneous fluid path. The automatic retraction mechanism simplifies the insertion process and enhances safety compared to manual insertion methods.

Clinical Evidence

Bench testing only. Performance testing included sterilization validation (ISO 11135:2014), biocompatibility (ISO 10993-1), shelf-life (ASTM F1980:2011), and functional testing (tensile strength, leak testing, flow testing, and serter activation force).

Technological Characteristics

Materials: Polypropylene, polyoxymethylene, stainless steel (AISI 304), PTFE, polyethylene, polyurethane, silicone, MABS (Terlux 2802 HD), polycarbonate. 90-degree soft cannula (6mm or 9mm). 27-gauge introducer needle. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 11135:2014, ISO 10993-1:2009, ISO 14971:2012, ASTM F1980:2011, ASTM D4169-16.

Indications for Use

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

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

• Unomedical Inset™ Subcutaneous Infusion Set (K032854)

Submission Summary (Full Text)

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December 13, 2019

Unomedical a/s % Deirdre Barrow Senior Consultant. Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K192647

Trade/Device Name: neria™ guard Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 23, 2019 Received: September 24, 2019

Dear Deirdre Barrow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices 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) K192647

Device Name neria™ guard infusion set

Indications for Use (Describe)

The neria™ guard infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k)Summary

## K192647

### 1. Submission Sponsor

Unomedical a/s

Aaholmvej 1-3, Osted

DK-4320 Lejre,

Denmark

Contact: Mette Henningsen

Title: Regulatory Affairs Specialist

### 2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: [phone]

Contact: Deirdre Barrow

Title: Senior Consultant, RA

### 3. Date Prepared

Dec-11-2019

### 4. Device Identification

Trade/Proprietary Name: neria™ guard Infusion Set

Common/Usual Name: Set, Administration, Intravascular

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| Classification Name: | Intravascular administration set |
|-----------------------|---------------------------------------|
| Regulation Number: | 880.5440 |
| Product Code: | FPA, Intravascular administration set |
| Device Class: | Class II |
| Classification Panel: | General Hospital |

### 5. Legally Marketed Predicate Device(s)

#### Table 5A: Legally Marketed Predicate Device

| Device<br>Name | 510(k) No. | Product Code | Classification<br>Regulation | Classification<br>Name | Sponsor |
|---------------------------------------------------------------------------------------------------------------------------|------------|--------------|------------------------------|----------------------------------------|------------|
| Unomedical<br>Inset™<br>Subcutaneous<br>Infusion Set<br>(formerly<br>known asthe<br>Unomedical<br>Monica<br>Infusion Set) | K032854 | FPA | 880.5440 | Intravascular<br>administration<br>set | Unomedical |

### 6. Indication for Use Statement

The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

### 7. Device Description

The neria™ guard Infusion Set manufactured by Unomedical 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.

The insertion needle and soft cannula of the neria™ guard Infusion Set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle is then automatically retracted after use.

### 8. Substantial Equivalence Discussion

The following table compares the neria™ guard Infusion Set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.

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It should be noted that the cannula from the subject device and the predicate are identical (same materials from the same suppliers, same manufacturing process, same intended use). Differences between the subject device and predicate device include difference in the insertion method, needle retraction mechanism, additional available lengths, and material differences.

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| Manufacturer | Unomedical | Unomedical | Device Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | neriaTM guard Infusion Set | Unomedical InsetTM Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | |
| 510(k) Number | K192647 | K032854 | N/A |
| Product Code | FPA | FPA | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Regulation Name | Intravascular Administration Set | Intravascular Administration Set | Same |
| Indications for Use | The neriaTM guard Infusion Set is<br>indicated for subcutaneous infusion of<br>medication administered by an<br>external pump. | The Unomedical InsetTM Subcutaneous<br>Infusion Sets are indicated for the<br>subcutaneous infusion of medication<br>from an external pump. | Similar- Difference in the name of the<br>subject device. Does not impact safety<br>or effectiveness |
| Mechanism of Action | The neriaTM guard Infusion Set is an<br>infusion administration set, connecting<br>to a reservoir/infusion pump and<br>inserted in the subcutaneous tissue of<br>a user. | The Unomedical InsetTM Subcutaneous<br>Infusion Set is an infusion<br>administration set, connecting to a<br>reservoir/infusion pump and inserted<br>in the subcutaneous tissue of a user. | Same |
| Technology<br>Overview | Serter:<br>• Subcutaneous insertion of soft<br>cannula by introducer needle<br>situated inside soft cannula at a 90°<br>insertion angle. | Serter:<br>• Subcutaneous insertion of soft<br>cannula by introducer needle<br>situated inside soft cannula at a 90°<br>insertion angle. | Serter:<br>• Same angle of insertion and use<br>of introducer needle and cannula |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neria™ guard Infusion Set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | |
| | • insertion of soft cannula: 2 user<br>steps for insertion: remove<br>protective cap for base and press<br>release button | • insertion of soft cannula: 3 manual<br>user steps for insertion: loading,<br>inserting and retraction. | • Both devices use an insertion<br>device to insert the soft cannula,<br>the proposed device has an<br>insertion mechanism preloaded<br>and ready for insertion by simply<br>pressing the activation button<br>after removing the safeguard. This<br>technical difference is not<br>clinically significant as while this<br>additional safety feature does<br>have a minor impact upon the<br>method of operation of the device<br>it does not introduce any new<br>questions of safety or<br>effectiveness. |
| | • The Base Set in neria™ guard<br>Infusion Set is made of two<br>components, the Fluid Part and the<br>Base Part | • The Base Set used in Unomedical<br>inset™ is moulded as one | • The fluid part of the neria™ guard<br>Infusion Set assembly is inserted<br>into the base assembly (on body).<br>This step is not required for the<br>Unomedical inset™ Infusion Set.<br>This technical difference is not<br>clinically significant as the<br>additional required step for the<br>proposed device does not<br>significantly impact the method of |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neria™ guard Infusion Set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | |
| | • The neria™ guard Infusion Set is<br>delivered ready to use in a pre-<br>loaded insertion device with<br>automatic needle retraction. The<br>newly developed mechanism allows<br>the needle to be hidden from the<br>user and/or caregiver before and<br>after insertion. | • The Unomedical Inset™<br>Subcutaneous Infusion Set does not<br>have a mechanism for automatic<br>needle retraction and the needle is<br>visible to the user. | • The insertion needle and soft<br>cannula of neria™ guard Infusion<br>Set are hidden from the user<br>before, during and after insertion<br>of the soft cannula. This feature<br>helps prevent needle stick injuries.<br>This technical difference does not<br>introduce any new questions<br>regarding safety and effectiveness<br>of the device. The additional<br>safety feature does not impact the<br>method of operation of the<br>device. |
| | Administration Set:<br>The administration set attaches to the<br>reservoir by means of a "tubing<br>connector", and subcutaneously in to<br>the user through an indwelling<br>catheter made of<br>polytetrafluoroethylene (PTFE). The<br>tubing is made of two layers: the inner<br>layer is polyethylene; the outer is<br>polyurethane. The indwelling catheter<br>is introduced into the subcutaneous | Administration Set:<br>The administration set attaches to the<br>reservoir by means of a "tubing<br>connector", and subcutaneously in to<br>the user through an indwelling<br>catheter made of<br>polytetrafluoroethylene (PTFE). The<br>tubing is made of two layers: the inner<br>layer is polyethylene; the outer is<br>polyurethane. The indwelling catheter<br>is introduced into the subcutaneous | Same technology used in both<br>devices for the administration set. It<br>should be noted that the cannula<br>from the subject device and the<br>predicate are identical (same<br>materials from the same suppliers,<br>same manufacturing process, same<br>sterilization, same intended use). |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neriaTM guard Infusion Set | Unomedical InsetTM Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | |
| | tissue by a removable 27 gauge<br>introducer needle (cannula) made of<br>AISI 304 stainless steel. | tissue by a removable 27 gauge<br>introducer needle (cannula) made of<br>AISI 304 stainless steel. | |
| Anatomical Location | Standard recommended sites for<br>subcutaneous infusion of medication<br>i.e. subcutaneous sites are selected<br>based on the presence of adequate<br>adipose tissue. The choice of insertion<br>site depends on treatment and patient<br>specific factors as recommended by<br>HCP. Preference is given to sites that<br>do not affect the patient's mobility,<br>the insertion site has to be free of skin<br>irritation and inflammation such as<br>redness, scar tissue and bleeding.<br>Site selection: the abdomen, in a<br>roughly semicircular area around and<br>below the umbilicus is preferred as an<br>application site. Other insertion sites<br>include the upper leg, upper buttocks,<br>hips, upper arms and lower back and<br>occasionally the chest when others<br>sites have edema. | Standard recommended sites for<br>subcutaneous infusion of medication<br>i.e. subcutaneous sites are selected<br>based on the presence of adequate<br>adipose tissue. The choice of insertion<br>site depends on treatment and patient<br>specific factors as recommended by<br>HCP. Preference is given to sites that<br>do not affect the patient's mobility,<br>the insertion site has to be free of skin<br>irritation and inflammation such as<br>redness, scar tissue and bleeding.<br>Site selection: the abdomen, in a<br>roughly semicircular area around and<br>below the umbilicus is preferred as an<br>application site. Other insertion sites<br>include the upper leg, upper buttocks,<br>hips, upper arms and lower back and<br>occasionally the chest when others<br>sites have edema. | Same |
| Manufacturer | Unomedical | Unomedical | Device Comparison |
| Trade Name | neria™ guard Infusion Set | Unomedical Inset™ Subcutaneous<br>Infusion Sets (formerly known as The<br>Unomedical Monica Infusion Set) | |
| | particularly important in patients with<br>many years use, since the overuse of<br>skin sites has an influence on<br>absorption variability. | particularly important in patients with<br>many years use, since the overuse of<br>skin sites has an influence on<br>absorption variability. | |
| Material | Materials include:<br>Polypropylene, polyoxymethylene,<br>stainless steel,<br>polytetraflouroethylene, nonwoven<br>polyester/polyacrylate,<br>polyethylene, silicone, Methyl<br>Methacrylate Acrylonitrile Butadiene<br>Styrene(MABS), Terlux 2802 HD,<br>transp., medical grade paper,<br>polycarbonate | Materials include:<br>Polypropylene, Stainless Steel,<br>Polyethylene, Polyurethane, Silicone,<br>Polycarbonate,<br>Polytetrafluoroethylene, Methyl<br>Methacrylate Acrylonitrile Butadiene<br>Styrene(MABS), Terlux 2802 HD,<br>transp., Medical Grade Paper, UV-<br>cured Glue, Colour Pigments | Differences in material were<br>evaluated with the appropriate<br>biocompatibility testing per ISO<br>10993-1. |
| Sterile | Yes – EO – SAL 10-6 | Yes – EO – SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Complies with ISO<br>10993-1 | Yes | Yes | Same |
| Soft Cannula Length | 6 and 9mm | 6 and 9mm | Same |
| Tubing:<br>ID<br>OD | 0.385 mm,<br>1.50 mm | 0.385 mm,<br>1.50 mm | Same |
| Soft Cannula OD | 0.68 mm | 0.68 mm | Same |
| Manufacturer | Unomedical | Unomedical…