VANISHPOINT I.V. CATHETER

K081420 · Retractable Technologies, Inc. · FOZ · Nov 7, 2008 · General Hospital

Device Facts

• Record ID: K081420
• Device Name: VANISHPOINT I.V. CATHETER
• Applicant: Retractable Technologies, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.

Device Story

VanishPoint® I.V. Catheter is a safety-engineered intravascular catheter. Device functions like a conventional catheter for vascular access; features an integrated spring-loaded safety mechanism. Upon needle removal, caregiver activates mechanism to retract needle into handle/introducer assembly, preventing accidental needlestick injuries. Used in clinical settings by healthcare providers. Output is established vascular access; device design minimizes exposure to contaminated needles post-procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular catheter with spring-actuated needle retraction mechanism. Materials are equivalent to predicate. Manual activation by clinician. Standalone device.

Indications for Use

Indicated for patients requiring short-term (less than 30 days) vascular access, subject to vascular anatomy and procedure appropriateness. No specific age or gender contraindications noted.

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

• VanishPoint® I.V. Catheter (K051355)

Submission Summary (Full Text)

{0}------------------------------------------------

Retractable Technologics, Inc. 510(k) Submission Date: 05/16/08

NOV - 7 2008

## 1081420 PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR VANISHPOINT® I.V. CATHETER (As Required By 21 CFR 807.93)

Contact Person:

Rhonda Wells Regulatory Affairs Manager

Date of Summary Preparation: May 16, 2008

Trade Name: VanishPoint® I.V. Catheter Common Name: Intravenous Catheter Classification Name: Intravascular Catheter

Device Classification: Class II

Legally Marketed Substantially Equivalent Device:

VanishPoint® I.V. Catheter (K051355)

Description of Device:

The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.

Intended Use:

The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.

{1}------------------------------------------------

## Page 2 of 2 Premarket Notification 510(k) Summary of Safety and Effectiveness for VanishPoint® I.V. Cathetcr

Comparison of Technical Characteristics:

The subject VanishPoint I.V. Catheter and the VanishPoint I.V. Catheter predicate device are very similar in design and technological characteristics. The different materials are equivalent and the intended use is identical.

Substantial Equivalence:

The VanishPoint I.V. Catheter is being expanded to offer additional customer preference options. There is no substantive differences between the predicate device and subject device that would raise new issues of safety and effectiveness. The devices are substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2008

Ms. Rhonda Wells Regulatory Affairs Manager Retractable Technologies, Incorporated 511 Lobo Lane Little Elm, Texas 75068

Re: K081420

Trade/Device Name: VanishPoint® I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 10, 2008 Received: October 16, 2008

Dear Ms. Wells:

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.

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 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 Federal Register,

{3}------------------------------------------------

## Page 2 - Ms. Wells

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.

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Suette Y. Michien-Davis
FOR DR. CHIU LIN

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known):

Device Name: VanishPoint® I.V. Catheter

Indications for Use:

The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Antony D. rent

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

510(k) Number: K481420