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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Becton Dickinson VACUTAINER® Brand Pronto™ Needle Holder:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Key Attribute)	Description	Reported Device Performance (Summary)
Overtorque	Torque required to activate the release mechanism prematurely.	Results indicated acceptable product performance.
Activation Force	Force necessary to activate the mechanism to release the needle after venipuncture.	Results indicated acceptable product performance.
Spinout	Security of the needle after insertion.	Results indicated acceptable product performance.

Note: The document states that "results indicating acceptable product performance" for all three attributes. However, it does not provide specific numerical thresholds for "acceptable product performance" for each attribute, nor does it provide the measured values for these attributes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: A total of 30 holders were tested.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given the context of a 510(k) submission to the FDA in the USA for a US-based manufacturer, it is highly probable the testing was conducted in the USA as part of a prospective design verification study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study described is a mechanical testing study of the device's physical attributes, not a study requiring expert interpretation of results or clinical outcomes. Therefore, the concept of "ground truth established by experts" as typically applied in clinical or diagnostic studies is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As noted above, this was a mechanical testing study, not a study involving human interpretation of results requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a mechanical testing study of the device itself, not a study involving human readers or assessment of human performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done, and it is not applicable. This device is a mechanical medical instrument (needle holder), not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The "ground truth" for this study was established by pre-defined engineering specifications and established BDVS procedures for mechanical testing of overtorque, activation force, and spinout. The performance of the devices was measured against these internal specifications to determine "acceptable product performance."

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a mechanical instrument, and the study described is a design verification test, not a study involving a "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as there was no training set for this type of device and study.

Summary

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K980098

Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885 (201) 847-4500

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: .

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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

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

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
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.(b)
Classification. Class II.