VANISHPOINT BLOOD COLLECTION SET

K122355 · Retractable Technologies, Inc. · JKA · Aug 23, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122355
• Device Name: VANISHPOINT BLOOD COLLECTION SET
• Applicant: Retractable Technologies, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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. The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). 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, non-pyrogenic safety device for vascular access; used for blood specimen collection or short-term (up to 2 hours) IV fluid administration. Device features integrated needle retraction mechanism to aid in prevention of needlestick injuries. Available with 7" or 12" tubing and 19G, 21G, 23G, or 25G needles. Operated by healthcare professionals in clinical settings. Device provides reliable vascular access; needle retraction feature protects clinicians from accidental injury post-use.

Clinical Evidence

Bench testing only. Simulated use study performed with healthcare professionals confirmed suitability for the additional indication of short-term IV fluid administration. Biocompatibility and sterilization validation (SAL 10^-6) completed per applicable standards.

Technological Characteristics

Sterile, non-pyrogenic blood collection set. Features integrated needle retraction mechanism. Available in 19G, 21G, 23G, 25G needle sizes with 7" or 12" tubing. Materials and design identical to previously cleared version. Sterilization via validated process (SAL 10^-6).

Indications for Use

Indicated for patients of any age requiring vascular access for blood specimen collection or intermittent/short-term (up to 2 hours) intravenous fluid administration. Use depends on vascular anatomy and procedure appropriateness.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• BD Vacutainer Push Button Blood Collection Set (K030573)
• VanishPoint® Blood Collection Set (K112512)

Submission Summary (Full Text)

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K122355

08/02/13

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

| Applicant Name: | Retractable Technologies, Inc.<br>511 Lobo Lane<br>Little Elm, TX 75068 |
|------------------------------|-------------------------------------------------------------------------|
| Phone: | 972-294-1010 |
| Contact Person: | Rhonda Wells<br>Regulatory Affairs Manager |
| Date of Summary Preparation: | January 23, 2013 |

AUG 2 3 2013

| Trade Name: | VanishPoint® Blood Collection Set |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Collection Set |
| Classification Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Classification: | Class II |
| Legally Marketed Substantially Equivalent Device: | K030573 - BD Vacutainer Push Button Blood Collection Set<br>K112512 - VanishPoint® Blood Collection Set |
| Description of Device: | The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" length needles and gauge sizes of 19, 21, 23 and 25. |
| 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. The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.<br><br>The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.<br><br>The BD Vacutainer is indicated for both blood collection and intravenous administration of fluids. The VanishPoint® BCS was originally cleared for blood collection only. |

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| Engineering Testing: | The VanishPoint® Blood Collection Set was previously cleared as<br>substantially equivalent to the BD Vacutainer Push Button Blood<br>Collection Set with 510(k) K112512. For the purpose of this<br>submission only testing pertaining to the additional indication will be<br>provided. All other information can be referenced in the Predicate<br>Device Section. |
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| Simulated Use Study: | A simulated use study utilizing healthcare professionals was<br>performed using the VanishPoint® Blood Collection set in a variety<br>of uses. The subject device was found suitable for the intended uses<br>and is as safe and effective and performs at least as safely and<br>effectively as the legally marketed predicate device. |

#### Comparison of Technical Characteristics:

The subject VanishPoint® Blood Collection Set and the BD Vacutainer predicate device are similar in design, technological characteristics and materials. The subject device that is the purpose of this 510(k) submission is identical to the previously cleared VanishPoint® BCS device. To support the addition of the new indication, an extractable study was performed with acceptable results. Biocompatability testing was performed under the . previously cleared 510k submission. All three devices are labeled to obtain blood specimens from patients. The subject device and BD Vacutainer predicate device are also indicated for intravenous administration of fluid.

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 when used as labeled. The intended use of the predicate and subject devices is virtually identical. It is our opinion that the devices are substantially equivalent.

Conclusion: The purpose of this submission is to add an additional indication to allow intermittent or short-term intravenous administration of fluid. The addition of this indication does not affect any of the previously presented functional testing such as needle pullout force, trigger force, ubing connection strength, tubing strength, air, liquid leakage and complete needle retraction. A Simulated Use Study was performed to ensure the subject device is suitable for the additional indication. In addition Biocompatibility testing was performed and the Sterilization Validation was completed (SAL 10") according to the applicable standards. The information included within this premarket notification demonstrates that the VanishPoint® Blood Collection Set is substantially equivalent to the predicate devices for the intended usage.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person, with a wavy line underneath.

Public Health Service

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

#### August 23, 2013

Retractable Technologies, Incorporated Ms. Rhonda Wells Regulatory Affairs Manager 511 Lobo Lane LITTLE ELM TX 75608

Re: K122355

Trade/Device Name: VanishPoint® Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA, FPA Dated: August 20, 2013 Received: August 21, 2013

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 mav, 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 cither 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ | 22355

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.

The VanishPoint® Blood Collection Set is also indicated for intermittent or shortterm intravenous administration of fluid (up to 2 hours). 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)

Richard C. Chapman 2013.08.23 12:59:10 -04'00'

(Optional Format 3-10-98)

Olvision Slan-Off) livision of Anssthasiology, General Hospital

ifection Control, Dental Davices

510(k) Number_K122355

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