EZ SET INFUSION SET

K012754 · Animas Corp. · FPA · Aug 27, 2001 · General Hospital

Device Facts

• Record ID: K012754
• Device Name: EZ SET INFUSION SET
• Applicant: Animas Corp.
• Product Code: FPA · General Hospital
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Animas EZ Set Infusion Set is intended for the infusion of medicine, including insulin, from an external infusion pump. This device is intended for home use and is a prescription device.

Device Story

Animas EZ Set Infusion Set is a subcutaneous infusion administration set. It connects an external infusion pump reservoir to the patient's subcutaneous tissue. The device comprises an infusion site assembly (cannula housing with self-adhesive pad, soft 22-gauge cannula, and detachable insertion needle) and a tubing connector assembly (flexible PVC tubing with polyethylene liner, female Luer Lock, and needle hub). The insertion needle facilitates subcutaneous placement of the soft cannula, then is removed. The needle hub connects to the cannula housing via a quick-release mechanism, allowing temporary disconnection for activities like bathing. Medication flows from the pump through the tubing, needle, and cannula into the patient. Used in home settings by patients or caregivers to manage medication delivery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Infusion administration set consisting of a 22-gauge soft flexible cannula, cannula housing with adhesive pad, and tubing connector assembly. Materials include polyvinyl chloride (PVC) tubing with co-extruded polyethylene liner. Features a quick-release connector and elastomeric septum. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring subcutaneous infusion of medication, including insulin, from an external infusion pump. Intended for home use by prescription.

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 Paradigm Silhouette Infusion Set
• Maersk Medical Comfort Infusion Set
• Disetronic Tender Infusion Set

Submission Summary (Full Text)

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AUG 2 7 2001

K012754

## Section 1 – Information Required by the Safe Medical Devices Act of 1990

## 1.1 510(k) Summary

Submitter: Animas Corporation, 590 E. Lancaster Avenue, Frazer, PA 19355

Michael J. Andrews, Ph.D., Director, Regulatory Affairs, Contact: Telephone: [phone], ext 166, Fax: [phone], Email: [e-mail]

Name of Device: Animas EZ Set Infusion Set

- Predicate Device: MiniMed Paradigm Silhouette Infusion Set, Maersk Medical Comfort Infusion Set, Disetronic Tender Infusion Set
Description of the New Device: The Animas EZ Set Infusion Set is an infusion adminstration set with the proximal end connecting to a medicine reservoir syringe within an infusion pump and the distal end inserted in the subcutaneous itssue of a user.

The device consists of two components, an infusion site assembly and a tubing connector assembly. The infusion site assembly consists of a cannula housing with a disposable insertion hub assembly. The main body of the cannula housing has a thin self-adhesive pad for attachment to the skin. A soft flexible 22 gauge cannula extends below the flat bottom of the housing to penetrate the skin at a slight angle. A detachable insertion needle assembly is intitially connected to the cannula housing assembly to insert the soft flexible cannula subcutaneously. It is then removed and replaced by the needle hub assembly to deliver medication. An elastomeric septum seals the entrance to the cannula when the needle hub assembly is removed.

The tubing connector assembly consists of a length of flexible plastic tubing made from polyvinyl chloride with a co-extruded polyethylene liner. The tubing is attached to a female Luer Lock connector at one end and a short needle mounted in the main body of the needle hub at the opposite end. The main body provides a means to align and attach the needle hub to the cannula housing assembly by means of a quick release connector. When the cannula housing and the needle hub are connected, the needle penetrates the septum allowing medication to flow from the pump through the flexible tubing, the needle, and the cannula into the patient's body. The needle hub assembly may be easily released from the cannula housing by squeezing the resilient side members deflecting the retaining band above a bump on the cannula housing. This allows the needle housing to slide freely off the cannula housing. The quick release

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connector allows the user to temporarily disconnect the tubing at the insertion site for activities such as dressing or bathing.

In addition to complete administration sets, infusion site sets without the tubing i and quick release connector will also be available.

Intended Use of the New Device: The Animas EZ Set Infusion Set is intended intended ose of the Now Dones infusion of medicine, including insulin, from an external infusion pump.

This device is intended for home use and is a prescription device.

Comparision of the Technological Features of the New Device and the Companision of the Toolinerogical < othe predicate devices are substantially Fredicate Devroe. The how ats, Jocking mechanisms, coextruded tubing, Luer Similar in in terms of vomponently tooking most on the industry of the introducer Connections to the modified from substantially similar materials. The needle. The devices are ochotractou from Services subcutaneously from an external infusion pump to the user.

The differences between the new device and the predicate devices do not affect the safety or effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2001

Animas Corporation C/O Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re : K012754 EZ Set Infusion Set Trade/Device Name: 21 CFR 880.5440 Regulation Number: Requlatory Class: II Product Code: FPA Dated: May 30, 2001 Auqust 16, 2001 Received:

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 che chat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provible therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Mosenkis

his response to your premarket notification submission does not response co four prom you might have under sections 531 not arress any the Act for devices under the Electronic chilough 542 or che noorol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production of mits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regardiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] of at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely

Timothy A. Ulatowski

ny Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 1.3

510(k) Number: __ KO12754_____________________________________________________________________________________________________________________________________________________

Animas EZ Set Infusion Set Device Name:

Indications for Use: The Animas EZ Set Infusion set is intended to provide moleations for Occ. The Anmas e including insulin, from an external infusion pump.

This device is intended for home use and is a prescription device.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrice Cicerite
Division Size - 28

ivision of Dental, Infection Control. and General Hospital Devices 510(k) Number