BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER

K013304 · Becton Dickinson Infusion Therapy Systems, Inc. · DBY · Jan 2, 2002 · Immunology

Device Facts

• Record ID: K013304
• Device Name: BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: DBY · Immunology
• Decision Date: Jan 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5520
• Device Class: Class 1

Intended Use

An introducer catheter is used to facilitate the placement of devices such as guide wires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

Device Story

BD Introsyte™ Precision and Autoguard™ Shielded Introducers are splittable, polyethylene introducer catheters (14-24 gauge) used to facilitate vascular access for guidewires and various catheters. The Autoguard™ variant features a spring-activated, user-initiated needle-shielding mechanism to reduce needlestick risk, consisting of a barrel, spring, needle hub, flash chamber, and hydrophobic flow control plug. Devices are used in clinical settings by healthcare professionals. The primary modification from previous versions involves an 'ozone friendly' lubrication system. Performance and biocompatibility were verified via side-by-side bench testing against unmodified predicate devices.

Clinical Evidence

Bench testing only. Side-by-side testing of modified and unmodified devices was conducted to compare product attributes and biocompatibility, demonstrating substantial equivalence.

Technological Characteristics

Splittable polyethylene introducer catheters; 14-24 gauge. Autoguard™ model includes spring-activated needle-shielding mechanism (barrel, spring, needle hub, flash chamber, hydrophobic flow control plug). Modified 'ozone friendly' lubrication system. Mechanical device; no software or energy source.

Indications for Use

Indicated for facilitating the placement of guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. Prescription use only.

Regulatory Classification

Identification

An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

Submission Summary (Full Text)

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K013304/

BD Medical Systems 9450 South State Street Sari y, Utah 84070 tel: [phone] fax: [phone] www.bd.com

JAN 0 2 2002

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# Premarket Notification [510(k)] Summary of Safety and Effectiveness for BD Introsyte™ Precision Introducer and BD Introsyte™ Autoguard™ Shielded Introducer

Becton Dickinson Infusion Therapy Systems Inc. Submitter: 9450 South State Street Address: Sandy, UT 84070 Leslie Wood, Manager, Regulatory Affairs Contact Person: [phone] Telephone Number: [phone] FAX Number: September 27, 2001 Date Summary Prepared: BD Introsvte™ Precision Introducer Trade Names: BD Introsyte ™ Autoguard™ Shielded Introducer Introducer Catheter Common Name: Introducer Catheter Classification Name: Same as trade names listed above. Predicate Devices:

#### Product Descriptions:

The products identified in this 510(k) notification are splittable, polyethylene introducer catheters. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate springactivated needle-shielding technology. The Autoguard component incorporates a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber and hydrophobic flow control plug, and a needle. The useractivated Autoguard™ product has a button, which the user pushes to initiate the needle's retraction into the needle-shielding barrel.

The Introsyte introducers are available in sizes ranging from 14 to 24 gauge.

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## Intended Use:

An introducer catheter is used to facilitate the placement of devices such as guide wires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

#### Technological Characteristics Comparison:

The catheter design and technological characteristics have not changed. The lubrication systems used have been modified to make the manufacturing process 'ozone friendly.'

## Nonclinical Tests Support Substantial Equivalence:

Side-by-side testing of modified and unmodified devices was conducted to compare product attributes.

#### Conclusions from Nonclinical Tests:

Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 0 2 2002

Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Theraphy Systems Inc. 9450 South State Street Sandy, UT 84070

K013304 Re: R01350":
BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DBY Dated: October 3, 2001 Received: October 4, 2001

Dear Ms. Wood:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beener of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use blated in the encreat , 1976, the enactment date of the Medical Device Amendments, or to conimered province 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can inter be back as been a seem 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Ms. Leslie Wood

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 premarket notification" (21CFR Part 807.97). Other general 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] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Oerke Tell

Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

BD Introsyte™ Precision Introducer Device Name: BD Introsyte™ Autoguard™ Shielded Introducer

To facilitate the placement of devices such as guidewires, indwelling central 10 facilitate the placemont of covereed central catheters, and midline catheters into the vascular system.

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use: _ (per 21 CFR 801.109)

OR

Over-The Counter Use: ________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K013304

510(k) Lubrication System Indications for Use 8/1/01