VANISHPOINT BLOOD COLLECTION SET

K112512 · Retractable Technologies, Inc. · FPA · Oct 20, 2011 · General Hospital

Device Facts

• Record ID: K112512
• Device Name: VANISHPOINT BLOOD COLLECTION SET
• Applicant: Retractable Technologies, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® Blood Collection Set aids in the prevention of needlestick injuries.

Device Story

VanishPoint® Blood Collection Set is a sterile, single-use device for venous blood collection. It features an integrated needle retraction mechanism designed to prevent needlestick injuries. Available in 19, 21, 23, and 25 gauge sizes with 7" or 12" tubing. Operated by healthcare professionals in clinical settings. The device provides vascular access; after blood collection, the user activates the retraction mechanism to withdraw the needle into the device housing, shielding the sharp. This protects the clinician from accidental exposure to bloodborne pathogens. Benefits include reduced risk of sharps injuries during and after phlebotomy procedures.

Clinical Evidence

No clinical data. Evidence consists of bench performance testing (needle pullout force, trigger force, tubing strength, leakage, and retraction function) and a simulated use study involving healthcare professionals to confirm suitability for the intended use.

Technological Characteristics

Blood collection set with integrated needle retraction mechanism. Materials are biocompatible. Available in 19, 21, 23, 25 gauge needles with 7" or 12" tubing. Mechanical operation; no energy source or software.

Indications for Use

Indicated for any patient population requiring vascular access for blood specimen collection, contingent upon adequate vascular anatomy and procedural appropriateness.

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

• BD Vacutainer Push Button Blood Collection Set (K030573)

Submission Summary (Full Text)

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# KII2512

OCT 2 0 2011

# Retractable Technologies, Inc. 510(k) Submission Date: 10/12/11

#### PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR VANISHPOINT® BLOOD COLLECTION SET (21 CFR 807.92)

| Applicant Name: | Retractable Technologies, Inc. |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 511 Lobo Lane |
| | Little Elm, TX 75068 |
| Phone: | 972-294-1010 |
| Contact Person: | Rhonda Wells |
| | Regulatory Affairs Manager |
| Date of Summary Preparation: | October 12, 2011 |
| Trade Name: | VanishPoint® Blood Collection Set |
| Common Name: | Blood Collection Set |
| Classification Name:<br>Collection | Tubes, Vials, Systems, Serum Separators, Blood |
| Device Classification: | Class II |
| Legally Marketed Substantially Equivalent Device: | |
| | K030573 - BD Vacutainer Push Button Blood Collection Set |
| Description of Device: | The VanishPoint® Blood Collection Set is designed to collect<br>blood specimens from patients. The VanishPoint® Blood<br>Collection Set aids in the prevention of needlestick injuries<br>through its retraction mechanism. The device will initially be<br>available with either 7" or 12" tubing, ¾" length needles and<br>gauge sizes of 19, 21, 23 and 25. |
| Intended Use: | The intended use of the VanishPoint® Blood Collection Set is<br>to provide safe and reliable access to the vascular system to<br>obtain blood specimens from patients. It may be used for any<br>patient population with consideration given to adequacy of<br>vascular anatomy and appropriateness of procedure. |
| | The VanishPoint® Blood Collection Set aids in the prevention of<br>needlestick injuries. |
| | The predicate device is indicated for both blood collection and<br>intravenous administration of fluids |
| Engineering Testing: | Various applicable performance tests were performed on the<br>VanishPoint® Blood Collection Set. Some of the tests are<br>needle pullout force, trigger force, tubing connection strength,<br>tubing strength, air, liquid leakage and complete needle<br>retraction. The subject device performed as expected in all areas<br>of testing. |

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## Retractable Technologies, Inc. 510(k) Submission Date: 10/12/11

#### Simulated Use Study:

A simulated use study utilizing healthcare professionals was performed using the VanishPoint® Blood Collection set in a variety of uses. The subject device was found suitable for the intended use.

## Comparison of Technical Characteristics:

The subject VanishPoint® Blood Collection Set and the predicate device are similar in design, technological characteristics and materials. Biocompatibility testing was performed on all materials in the subject device with acceptable results. Both devices labeled to obtain blood specimens from patients.

#### Substantial Equivalence:

The operation, similar design and materials between the predicate devices and the subject device do not raise new issues of safety and effectiveness. The difference in indications does not affect the safety and effectiveness of the subject device when used as labeled. It is our opinion that the devices are substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

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

Re: K112512

Trade/Device Name: VanishPoint® Blood Collection Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, JKA Dated: August 23, 2011 Received: August 31, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Winter

Anthony D. Watson, B.S., M.S., M.B.A. 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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Retractable Technologies, Inc. 510(k) Submission Date: 08/19/11

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VanishPoint® Blood Collection Set

Indications for Use:

The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rili C. An 10/9/11

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

510(k) Number: K112512

(Optional Format 3-10-98)