SAFETY SUBCUTANEOUS TISSUE INFUSION SET

K120195 · Multi Med · FPA · Jul 6, 2012 · General Hospital

Device Facts

• Record ID: K120195
• Device Name: SAFETY SUBCUTANEOUS TISSUE INFUSION SET
• Applicant: Multi Med
• Product Code: FPA · General Hospital
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Safety Subcutaneous Infusion Set is designed specifically for the delivery of medications to the subcutaneous tissue.

Device Story

Safety Subcutaneous Tissue Infusion Set facilitates subcutaneous medication delivery. Device consists of sterile kit containing infusion set and adhesive dressing. Features include luer lock, 90-degree needle mounted to butterfly stabilizer, and needle safety mechanism. Available in single, bifurcated, trifurcated, quadfurcated, 5, and 6 lumen configurations. Used in clinical or home settings for subcutaneous infusions; operated by healthcare providers or patients. Device provides secure medication administration path; safety feature reduces needle-stick risk. Single-use only.

Clinical Evidence

Bench testing only. Testing included foreign matter tests (Tappi standards), occlusion tests, leak tests, and safety button tests. No clinical data provided.

Technological Characteristics

Biocompatible materials; 90-degree needle with butterfly stabilizer; luer lock connection; multi-lumen configurations (1-6); integrated needle safety feature. Foreign matter testing per Tappi standards.

Indications for Use

Indicated for the delivery of medications to the subcutaneous tissue in patients requiring subcutaneous infusion 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

• Marcal Medical, Inc. (K082818)

Submission Summary (Full Text)

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# K120195

# 510(k) SUMMARY (as required by 807.92(c))

6 2012 JUL

### Regulatory Correspondent:

AJW Technology Consultants 962 Allegro Lane Apollo Beach, FL 33572 Tanya O'Brien [e-mail] 813-645-2855 813-677-4787

#### Submitter of 510(k):

Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

Intended Use:

Device Description:

# January 18, 2011

Keene, NH, 03431, USA

[e-mail]

Multi Med Inc. 26 Victoria Court

Sue Starkey

Safety Subcutaneous Tissue Infusion Set

Set, Administration, Intravascular

FPA

The Safety Subcutaneous Infusion Set is designed specifically for the delivery of medications to the subcutaneous tissue.

The safety subcutaneous needle infusion set consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The unique Single, Bifurcated, Trifurcated, Quadfurcated, 5 and 6 Lumen for the Sub-Q have a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end. The sets are convenient to use, associated with less trauma, and offer an opportunity to improve compliance cost-effectively through the use of a dedicated infusion set. The device is for single use only.

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## Predicate Device:

# Substantial Equivalence:

Performance Testing:

#### · Technical Comparison:

#### Marcal Medical, Inc. K082818

l

The Safety Subcutaneous Tissue Infusion Set is substantially equivalent in design and indications for use to Marcal Medical, Inc. K082818. They have the same indications for use. This device is substantially equivalent in design, material, intended use and function to the product listed as predicate devices.

Foreign Matter Tests (to Tappi Standards). Occlusion Test - no occlusions, Leak Test - no leaks, Safety Button Test - no failures.

The proposed Multi Med Sub Q Safety Set and the predicate devices are identical in that they both consist of needle set with wings and needle safety feature. Both the proposed product and the predicate devices have been designed for subcutaneous infusions. Both the proposed and predicate devices are available in a variety of sizes. The needle safety feature of the proposed and predicate devices are identical and are functionally equivalent devices. Both the proposed and predicate devices are made of biocompatible materials and have the same technological design and identical in materials.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Multi Med. Inc. Ms. Tanya O'Brien Clinical Affairs Specialist C/O AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, Florida 33572

6 2012 JUL

Re: K120195

Trade/Device Name: Safety Subcutaneous Tissue Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 29, 2012 Received: July 3, 2012

Dear Ms. O'Brien:

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 Eederal Register.

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Page 2- Ms. O'Brien

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.

fr

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Safety Subcutaneous Tissue Infusion Set - The Safety Subcutaneous Infusion Set is designed specifically for the delivery of medications to the subcutaneous tissue.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

W.C.C. 7/5/12
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

K120195

Multi Med Traditional 510(k) Sub Q Safety Set