SUB-Q SUBCUTANEOUS TISSUE INFUSION SET

K140131 · Emed Technologies Corporation · FPA · Apr 3, 2014 · General Hospital

Device Facts

• Record ID: K140131
• Device Name: SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
• Applicant: Emed Technologies Corporation
• Product Code: FPA · General Hospital
• Decision Date: Apr 3, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SUB-Q Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.

Device Story

SUB-Q Subcutaneous Tissue Infusion Set facilitates subcutaneous delivery of medication from external infusion pumps or syringes. Device consists of sterile kit containing infusion set and adhesive dressing. Infusion set features luer lock for pump/syringe connection, PVC tubing, and 24g or 27g stainless steel needles treated with medical-grade silicone lubricant for insertion comfort. Configurations include 1 to 6 lumens using PVC bi-furcator/tri-furcator connectors, various tubing/needle lengths, and optional wing-stabilizers or slide clamps. Used in clinical or home settings by patients or healthcare providers. Device provides a fluid path for medication administration; does not perform active sensing or automated control. Benefits include flexible configuration options to meet individual patient infusion needs.

Clinical Evidence

Bench testing only. Non-clinical performance testing included leakage, occlusion, and joint strength assessments to verify design modifications against predicate performance criteria.

Technological Characteristics

Materials: PVC (luer, tubing, wings, connectors), Polypropylene (luer cap, locking wings), Stainless Steel (needles), ABS (slide clamp), Loctite 3341 (bonding). Lubricant: Dow Corning 360 polydimethylsiloxane. Sterilization: Validated process to SAL 10^-6. Configuration: 1-6 lumens, 24g/27g needles, 2"-36" tubing. Connectivity: Mechanical luer lock. Single-use, sterile.

Indications for Use

Indicated for patients requiring subcutaneous infusion of medicine delivered via an external infusion pump or syringe. Prescription 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

• Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530)

Submission Summary (Full Text)

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Section 5. 510(k) Summary

# K Number K140131

# APR 0 3 2014

Submission Date:

January 14, 2014

## General Information

Classification

Class II

FPA, Class II

Trade Name

SUB-Q Subcutaneous Tissue Infusion Set

Common Name:

I.V. Administration Set

Classification Name and Reference:

Intravascular Administration Set 21 CFR §880.5440

Product Code and Class

Predicate Device

Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530)

Submitter

Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, Ca 95762 Tel: [phone] x114 916.932.0074 Fax:

#### Purpose of Submission

This submission is intended to provide notification of modifications to our current legally marketed SUB-Q Subcutaneous Tissue Infusion Set device cleared under K020530. These modifications are the result of variations to the original device, resulting in a selection of infusion sets intended to satisfy individual user needs. Label changes are to reflect current corporate identity of the SUB-Q Subcutaneous Tissue Infusion Set.

#### Device Description

The EMED SUB-Q Subcutaneous Tissue Infusion Set (SUB-Q Set) device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. Each infusion set has a luer lock at one end and a 90 degree 24g or 27g needle

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mounted to a standard or closing wing-stabilizer at the distal end of one or more lumens. Each lumen is connected by lengths of tubing and a number connectors, depending on configuration. The luer lock is used to connect to the infusion source. The needles are treated with medical grade silicone for ease of insertion into the skin. The device is for single use.

#### Intended-Use

The SUB-Q Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.

This is the same intended use as previously cleared for the Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530).

### Technological Characteristics

The EMED SUB-Q Set has the same intended use as previously cleared for the predicate device (K020530).

The EMED SUB-Q Set incorporates the core design, same operating principle, and same materials as the predicate product (see K020530).

The EMED SUB-Q Set is assembled at the same facility as the predicate, under the same manufacturing processes as the predicate, and are tested against the same performance and batch release criteria as the predicate.

The EMED SUB-Q Set is packaged in the same manner using the same packaging materials and process as the predicate product (see K020530).

The EMED SUB-Q Sets are be sterilized to a sterility assurance level (SAL) of 10th using the same validated process as the predicate, and have the same specified storage conditions and 5 year shelf-life as the predicate (see K020530).

The EMED SUB-Q Set contains the following modifications to the predicate device (K020530):

- Various numbers of lumens were made available as configuration options. -
- PVC bi-furcator and tri-furcator tubing connectors were added to the design to create from 2 to 6 lumens.
- 24g needle was made an available configuration option, with a corresponding ・ change to tubing diameter.
- Needles received application of medical grade silicone lubricant to aid in insertion ﺖ
- and increase patient comfort and satisfaction.
- Various needle lengths were made available configuration options ﺴ
- Various tubing length variations were made available as configuration options. -

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- A proprietary wing closure mechanism was made an available configuration option to aid in handling and disposal.
- Open end slide clamps to stop flow. -
- Labeling updated to reflect the additional available configurations and current corporate identity (new ownership, logos, address, etc.).

The fundamental scientific technology, indications for use, materials, design, sterilization and packaging are not impacted by these changes, and remain identical between the proposed and predicate devices.

Table 5-1 below provides a comparison of technological and other characteristics of the EMED SUB-Q Set and the predicate (K020530).

| | EMED SUB-Q Subcutaneous<br>Tissue Infusion Set | Evans SUB-Q Subcutaneous<br>Tissue Infusion Set (K020530) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Intended to provide subcutaneous<br>infusion of medicine from an<br>external infusion pump or syringe.<br><br>The device is supplied sterile, for<br>singly use only. It is a<br>prescription device. | Intended to provide subcutaneous<br>infusion of medicine from an<br>external infusion pump or syringe.<br><br>The device is supplied sterile, for<br>singly use only. It is a<br>prescription device. |
| Material/<br>Components | Biocompatible, non-toxic<br>materials widely used in medical<br>products, such as:<br>Luer: PVC<br>Luer Cap: Polypropylene<br>Tubing: PVC<br>Wings: PVC (std) and<br>Polyproylene (locking)<br>Connectors: PVC<br>Needlès: Stainless Steel<br>Slide Clamp: ABS<br>Bonding Agent: Loctite 3341 | Biocompatible, non-toxic<br>materials widely used in medical<br>products, such as:<br>Luer: PVC<br>Luer Cap: Polypropylene<br>Tubing: PVC<br>Wings: PVC<br>Connectors: None<br>Needles: Stainless Steel<br>Slide Clamp: None<br>Bonding Agent: Loctite 3341 |
| Device<br>Length | Ranging from 2" - 36"<br>(based on configuration) | 42" |
| Tubing ID | 0.200" (27g) | 0.200" (27g) |

Table 5-1

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| | EMED SUB-Q Subcutaneous Tissue Infusion Set | Evans SUB-Q Subcutaneous Tissue Infusion Set (K020530) |
|------------------|----------------------------------------------------|--------------------------------------------------------|
| | 0.260 (24g) | |
| Needle gage | 24 gage and 27 gage | 27 gage |
| Needle Lengths | Ranging from 6 mm - 16 mm (based on configuration) | 6 mm |
| Number of Lumens | 1 - 6 | 1 |
| Wing type | Standard and Closing | Standard |
| Clamp Type | Slide | None |
| Needle Lubricant | Dow Corning 360<br>polydimethylsiloxane | None |

#### Device Performance

To date, no performance standards that affect this device have been finalized under Section 514 of the Act.

Non-clinical testing of the EMED SUB-Q Set included leakage, occlusion, and jointstrength which demonstrated the device meets the requirements for its intended use. The testing also demonstrates that the EMED SUB-Q Set meets performance criteria and is substantially equivalent to the predicate device as related to device performance.

## Summary of Substantial Equivalence

The EMED Technologies Corporation SUB-Q Subcutaneous Tissue Infusion sets have the same basic design, fundamental scientific technology, indications for use, materials, sterilization, and packaging as the predicate, and therefore are substantially equivalent to the commercially available predicate device. Any differences between the EMED SUB-O Subcutaneous Tissue Infusion Set and the predicate do not raise any new issues of safety or effectiveness.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

### April 3, 2014

EMED Technologies Corporation C/O Peter Kollings Director Regulatory Affairs and Quality Assurance 1264 Hawks Flight Court, Suite 200 El Dorado Hills, CA 95762

Re: K140131

Trade/Device Name: SUB-Q Subcutaneous Tissue Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 10, 2014 Received: March 12, 2014

Dear Mr. Kollings:

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. 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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Page 2 - Mr. Kollings

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner - S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K140131

Device Name

SUB-O Subcutaneous Tissue Infuset Set

#### Indications for Use (Describe)

SUB-Q Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.

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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| FOR FDA USE ONLY | | |
|------------------------------------------------------------------------------|---------------------|--|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |
| Image: FDA logo | Digitally signed by | |
| | Richard C. Chapman | |
| | Date: 2014.04.03 | |
| | 10:58:53 -04'00' | |

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