VACUTAINER BRAND PRONTO NEEDLES HOLDER

K980098 · Becton Dickinson Vacutainer Systems · JKA · Feb 5, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980098
• Device Name: VACUTAINER BRAND PRONTO NEEDLES HOLDER
• Applicant: Becton Dickinson Vacutainer Systems
• Product Code: JKA · Clinical Chemistry
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection Set during venipuncture. The holder has a quick release feature which allows the contaminated needle to be disengaged with a simple one handed push-button technique.

Device Story

Non-sterile, reusable needle holder; attaches to VACUTAINER® needles or blood collection sets; features quick-release push-button mechanism for one-handed needle disengagement; used during venipuncture; reduces risk of needle-stick injury by facilitating safe needle removal; operated by healthcare professionals.

Clinical Evidence

Bench testing only. Mechanical verification conducted on 30 units per BDVS procedures. Attributes tested: overtorque, activation force, and spinout. Results indicated acceptable product performance.

Technological Characteristics

Non-sterile, reusable plastic needle holder; mechanical push-button quick-release mechanism; manual operation; no electronic components or software.

Indications for Use

Indicated for use as a needle holder for VACUTAINER® brand needles or blood collection sets during venipuncture procedures.

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

• Drop-It™ Needle Holder (K963748)

Reference Devices

• AUTODROP®

Submission Summary (Full Text)

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K980098

Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885 [phone]

# CITY SUMMARY OF SAFETY AND EFFECTIVENESS

# I. GENERAL INFORMATION

This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

# ESTABLISHMENT:

Contact Person:

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- Becton Dickinson VACUTAINER Systems Address: Becton Drive Franklin Lakes, NJ 07417-1885 Registration Number: 2243072
- John Schalago Regulatory Affairs Specialist Telephone no .: 201-847-6173 Fax No. 201-847-4858
- Date of Summary: ◀

January 8, 1998

## DEVICE

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- VACUTAINER® Brand Pronto™ Needle Trade Name: . Holder
- Blood Specimen Collection Device Classification Name:
- Class II Classification:
- None Established under 514 of the Food, Performance Standards: ● Drug and Cosmetic Act

## SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE II. SUBSTANTIAL EQUIVALENCE DETERMINATION

SUBSTANTIAL EQUIVALENCE DECLARATION:

The term "Substantial Equivalence" as used in this 510(k) Premarket

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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 sdmission against interest under the US Patent Laws or their application by the courts.

#### Device Description: .

The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection set during venipuncture. The holder has a quick release feature which allows the contaminated needle to be disengaged with a simple one handed push-button technique.

Intended Use: .

The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to strack and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection Set during venipuncture. The holder has a quick release feature which allows the contaminated needle to be disengeged with a simple one handed push-button technique.

### Synopsis of Test Methods and Results .

In accordance with 21 CFR § 820.30 Design Verification requirements, mechanical testing was conducted to confirm product performance for three key attributes: overtorque (the torque required to activate the release mechanism prematurely), activation force (the force necessary to activate the mechanism to release the needle after venipuncture), and spinout (security of needle after insertion). A total of 30 holders were tested according to established BDVS procedures for these attributes, with results indicating acceptable product performance.

## . Substantial Equivalence

Based on comparison of the device features, the VACUTAINER® Brand Pronto™ Needle Holder can be shown to be substantially equivalent to the commercially available predicate devices, the Bio-Plexus Drop-It™ Needle Holder and SAGE® Needle Holder. The predicate devices, K number, and clearance date are identified below:

| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---------------------|------------------------|----------|----------------|
| SAGE PRODUCTS, INC. | AUTODROP® | N/A | N/A |
| Bio-Plexus | Drop-It™ Needle Holder | K963748 | 6/6/97 |

Regulatory Affairs Specialist Regulatory Affairs Department

**Date**

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Image /page/2/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo is simple and iconic, representing the department's role in health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 5 1998 John Schalago Requlatory Affairs Specialist Becton Dickinson 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

K980098 Re : Vacutainer® Brand Pronto™ Needle Holder Regulatory Class: II Product Code: JKA Dated: January 9,1998 Received: January 12, 1998

Dear Mr. Schalago:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regulation calertion" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (IF KNOWN): _

DEVICE NAME: _______________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

INDICATIONS FOR USE:

The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device I ne VIOU attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection Set during venipuncture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Or

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use_

(Per 21 CFR § 801.109)

(Optional format 1-2-96)

(Division Sign-Off)

Division of Clinical Labo 510(k) Number