VANISHPOINT I.V. CATHETER

K051355 · Retractable Technologies, Inc. · FOZ · Sep 23, 2005 · General Hospital

Device Facts

• Record ID: K051355
• Device Name: VANISHPOINT I.V. CATHETER
• Applicant: Retractable Technologies, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 provides short-term vascular access; incorporates automated needle retraction mechanism to reduce risk of needlestick injuries. Device consists of catheter, needle, and retraction housing. Operated by clinicians in clinical settings. Upon successful venipuncture, user activates retraction mechanism; needle automatically retracts into housing, shielding sharp tip. Prevents accidental exposure to bloodborne pathogens. Benefits patient and clinician by minimizing sharps injury risk during and after catheter placement.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Intravascular catheter with integrated needle retraction mechanism. Materials and dimensions consistent with standard peripheral I.V. catheters. Manual activation of retraction mechanism. Non-powered, mechanical device.

Indications for Use

Indicated for short-term (<30 days) vascular access in any patient population, contingent upon adequate vascular anatomy and procedural appropriateness. Aids in prevention of needlestick injuries.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.

## Public Health Service

SEP 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michele M. Larios VP & General Counsel Retractable Technologies, Incorporated P.O. Box 9, 511 Lobo Lane Little Elm, Texas 75068-0009

Re: K051355

Trade/Device Name: Vanishpoint I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: II Product Code: FOZ Dated: August 10, 2005 Received: August 11, 2005

Dear Ms. Larios:

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.

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## Page 2 - Mr. Larios

Please be advised that FDA's issuance of a substantial equivalence determination does not r read that FDA has made a determination that your device complies with other requirements friedit that I Driving made statutes and regulations administered by other Federal agencies. or not rest of able 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 und illums (2) - ee it forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelies as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 OF IC Food 1000. This letter 'ntification. The FDA finding of substantial equivalence of your device to a premarket notification of the 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), 11 you donto the Office of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Clive
Shi, Jian, Ph.D.

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VanishPoint® I.V. Catheter

Indications for 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.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

15-

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Anton Dental Devices

510(k) Number: Jos 1355