MAERSK MEDICAL CONTOUR INFUSION SET

K991759 · Maersk Medical A/S · FPA · Jun 25, 1999 · General Hospital

Device Facts

• Record ID: K991759
• Device Name: MAERSK MEDICAL CONTOUR INFUSION SET
• Applicant: Maersk Medical A/S
• Product Code: FPA · General Hospital
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion set is neither intended nor indicated for use with blood or blood products.

Device Story

Contour Infusion Set is an infusion administration set for subcutaneous delivery of medicine (e.g., insulin) from an external infusion pump. The device connects to a medicine reservoir syringe via a female Luer connector. It features an indwelling 25-gauge PTFE catheter inserted into subcutaneous tissue using a removable 27-gauge AISI 304 stainless steel introducer needle. The tubing consists of an inner polyethylene layer and an outer polyurethane layer. The device is used by patients or clinicians to facilitate continuous subcutaneous infusion. It is not intended for blood or blood products.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: PTFE (catheter), polyethylene (inner tubing), polyurethane (outer tubing), AISI 304 stainless steel (introducer needle). Connectivity: Standard Luer connector for external infusion pump reservoirs. Form factor: Microbore infusion set with indwelling catheter and removable needle. Non-electronic/mechanical device.

Indications for Use

Indicated for subcutaneous delivery of appropriately labeled fluids or solutions from an external infusion pump.

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

• Maersk Medical Comfort™ Infusion Set

Submission Summary (Full Text)

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Maersk Medical A/S Premarket Notification - 510(k) Contour Infusion Set

May 20, 1999

## Part C. 510(k) Summary

Submitter: Maersk Medical A/S Infusion Devices, Aaholmvej 1-3, Osted, DK-4000 Roskilde, Denmark

Maersk Contact: Mr. John M. Lindskog, General Manager, Maersk Medical A/S Infusion Devices Telephone: + 45 48 16 70 00.

U.S. Contact: Don Selvey [phone] (v/f); [e-mail].

Name of Device: Maersk Medical Contour™ Infusion Set.

Predicate Device: Maersk Medical Comfort™ Infusion Set

Description of the New Device: The Contour Infusion Set is an infusion administration set, connecting to a medicine reservoir syringe (such as the MiniMed® reservoir, model 103, that is placed in an external infusion pump such as the MiniMed insulin pump) and inserted in the subcutaneous tissue of a user. The Maersk Medical Contour Infusion Set may be used with any microbore infusion pump reservoir which utilizes a standard Luer connector.

The administration set attaches to the reservoir/syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane.

The 25 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub.

Intended Use of the New Device: The Contour infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion set is neither intended nor indicated for use with blood or blood products.

Comparison of the Technological Features of the New Device and Predicate Device: The Contour infusion set is substantially similar to the Comfort infusion set (a lawfully marketed predicate device). Both are intended for subcutaneous delivery of insulin or other appropriately labeled medicines from an infusion pump to the pump user. Both sets attach proximally to a reservoir by means of a Luer connector, and insert distally into the device user's subcutaneous tissues with a removable stainless steel needle and flexible cannula. The devices are made of similar materials.

Signed,

John M. Lindskog 5-20-99
date

John M. Lindskog General Manager Maersk Medical A/S

te

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DEPA

JUN 25 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maersk Medical A/S c/o Don Selvev Consultant Department of Clinical and Requlatory Affairs MiniMed Incorporated 12744 San Fernando Road Sylmar, California 91342

Re: K991759 Trade Name: Maersk Medical Contour™ Infusion Set Requlatory Class: II Product Code: FPA Dated: May 20, 1999 Received: May 24, 1999

Dear Mr. Selvey:

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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Selvey

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control 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 finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda_gov/cdrh/dsmamain.html" .

Sincerely yours,

Timothy A. Ulatowski

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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Maersk Medical A/S Premarket Notification - 510(k) Contour Infusion Set

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May 20, 1999

## INDICATIONS FOR USE

510(k) Number:

| Device Name: | Maersk Medical Contour Infusion Set |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Maersk Medical Contour infusion set is indicated for<br>subcutaneous delivery of appropriately labeled fluids or<br>solutions from an external infusion pump. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Fabiano Ciccerelli

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ C