INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE

K013800 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Dec 21, 2001 · General Hospital

Device Facts

• Record ID: K013800
• Device Name: INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

Device Story

Peripheral IV catheters (Insyte, Angiocath, Autoguard, Intima, Saf-T-Intima lines) consist of slender tubes with luer-locking adapters; inserted into patient vascular system for short-term (<30 days) blood sampling, pressure monitoring, or fluid administration. Devices include standard catheters and needle-shielding variants; constructed from FEP polymer or Vialon material. Used in clinical settings by healthcare professionals. Modification involves 'ozone friendly' lubrication system. Output is vascular access for clinical intervention; benefits include reliable fluid delivery and diagnostic monitoring.

Clinical Evidence

Bench testing only. Side-by-side comparison of modified and unmodified devices evaluated penetration, tip adhesion, and catheter/adapter separation force. Results demonstrated substantial equivalence in performance and biocompatibility.

Technological Characteristics

Peripheral IV catheters; FEP polymer or Vialon material; luer-locking adapters; needle-shielding features on specific models; 'ozone friendly' lubrication system. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring short-term (<30 days) vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration. Use requires consideration of vascular anatomy and procedure appropriateness.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Insyte IV Catheter (K013800)
• Angiocath IV Catheter (K013800)
• Insyte Autoguard IV Catheter (K013800)
• Angiocath Autoguard IV Catheter (K013800)
• Autoguard Pro IV Catheter (K013800)
• Intima IV Catheter (K013800)
• Saf-T-Intima IV Catheter (K013800)

Submission Summary (Full Text)

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

# KO13800

## DEC 2 1 2001

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### Premarket Notification [510(k)] Summary of Safety and Effectiveness for Insyte™, Angiocath™, Insyte™ Autoguard™, Angiocath™ Autoguard™, Autoguard™ Pro, Intima™, and Saf-T-Intima™ IV Catheters

| Submitter: | Becton Dickinson Infusion Therapy Systems Inc. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9450 South State Street<br>Sandy, UT 84070 |
| Contact Person: | Leslie Wood, Manager, Regulatory Affairs |
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| Date Summary Prepared: | October 29, 2001 |
| Trade Names: | Insyte™ IV Catheter; Angiocath™ IV Catheter;<br>Insyte™ Autoguard™ IV Catheter; Angiocath ™<br>Autoguard™ IV Catheter; Autoguard™ Pro IV<br>Catheter; Intima™ IV Catheter; and Saf-T-Intima™<br>IV Catheter |
| Common Name: | Peripheral Intravascular Catheter or<br>IV Catheter |
| Classification Name: | Intravascular Catheter |
| Predicate Devices: | Same as trade names listed above. |

#### Product Descriptions:

The products identified in this 510(k) notification include both standard catheters and catheters with a needle-shielding feature. The catheters listed have either a FEP polymer or Vialon™ material catheter. All have luerlocking adapters to which an IV line or accessories may be attached.

#### Intended Use:

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

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## 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 the following attributes: penetration, tip adhesion and catheter / adapter separation force.

#### 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2001

Ms. Leslie Wood Manger, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Inc 9450 South State Street Sandy, Utah 84070

Re: K013800

Trade/Device Name: Insyte,™ IV Catheter; Angiocath,™ IV Catheter; Insyte,™ Autoguard,™ IV Catheter; Angiocath,™ Autoguard,™ IV Catheter; Autoguard,™ Pro IV Catheter; Intima, TM IV Catheter; and Saf-T-Intima, TM IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 14, 2001 Received: November 15, 2001

Dear Ms. Wood :

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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls providents 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 (1 mr), it 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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Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advised that I DA 3 issualled on that your device complies with other requirements mean that IDA nas made a december and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Fee b required to to to the man 801); good manufacturing practice and listing (21 CFR Part 607), laceming (21 cm (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.

This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to begin maneting 'y of substantial equivalence of your device to 510(K) premarket nouriedion: "110 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 If you desire specific ad rise for your for in vitro diagnostic devices), please contact the and additionally 21 CPR Part 00710 108 ... Additionally, for questions on the promotion and Office of Comphance at es office of Compliance at [phone]. advertising or your are the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (21CFR Part 60197). the Act may be obtained from and Brumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/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

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## INDICATIONS FOR USE

Device Name:

- BD Insyte™ Intravascular Catheter
- BD Angiocath™ Intravascular Catheter
- BD Insyte™ Autoguard™ Intravascular Catheter
- BD Angiocath™ Autoguard™ Intravascular Catheter
- BD Autoquard™ Pro Intravascular Catheter
- BD Intima™ Intravascular Catheter
- BD Saf-T-Intima™ Intravascular Catheter

As provided in 21 CFR 880.5200, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with innsideration given to adequacy of vascular anatomy and appropriateness of procedure.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: _ X (per 21 CFR 801.109) OR

Over-The Counter Use: _

Alberto Ciconetti

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

510(k) Lubrication System Indications for Use 11/13/01