BIO-PLEXUS DROP-IT NEEDLE HOLDER by BIO-PLEXUS, INC.

The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle disposal. This is a non-sterile reusable device recommended for a maximum of 100 uses.

Device Description

The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder comprised of an assembly of 5 plastic injection molded parts. The device rigidly holds a blood collection needle during the venipuncture procedure and also allows the needle to be released by use of a pushbutton rather than by unwinding. This device is for use with standard blood collection needles including Punctur-Guard® blood collection needles and winged sets. Standard blood collection needles include the Becton Dickinson Vacutainer® Needle, the Sherwood Monoject® Needle and the Terumo Venoject® Needle. The DROP-IT® Needle Holder performs the same functions as other legally marketed needle holders, for example, the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510.

AI/ML Overview

This 510(k) summary for the Bio-Plexus DROP-IT® Needle Holder does not contain explicit acceptance criteria or a detailed study to prove the device meets such criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices already on the market.

However, based on the information provided, we can infer some aspects and highlight what is missing:

Inferred Acceptance Criteria and Reported Device Performance (based on Section 0):

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Functionality	1. Rigidly holds a blood collection needle during venipuncture: The device must effectively secure various standard blood collection needles, preventing dislodgement during the procedure. 2. Allows for needle release via pushbutton: The device must enable the user to easily and reliably release the needle by pressing a button, rather than requiring an unwinding motion. 3. Compatibility with standard blood collection needles: The device must successfully mate with common needles from manufacturers like Becton Dickinson (Vacutainer®), Sherwood (Monoject®), and Terumo (Venoject®), as well as Punctur-Guard® blood collection needles and winged sets. 4. Compatibility with Bio-Plexus Needle Disposal Container: The device should seamlessly integrate with the Bio-Plexus Needle Disposal Container for safe disposal.	The device is described as "rigidly holds a blood collection needle during the venipuncture procedure" and "allows the needle to be released by use of a pushbutton rather than by unwinding." It "is for use with standard blood collection needles including Punctur-Guard® blood collection needles and winged sets. Standard blood collection needles include the Becton Dickinson Vacutainer® Needle, the Sherwood Monoject® Needle and the Terumo Venoject® Needle." It also "mates with the Bio-Plexus Needle Disposal Container for easy needle disposal."
Safety/Effectiveness Equivalence	1. Performs the same functions as legally marketed predicate devices: The device should demonstrate equivalent performance to predicate devices such as the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510 in terms of its core functionality (holding and releasing needles).	"The DROP-IT® Needle Holder performs the same functions as other legally marketed needle holders, for example, the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510." This statement implies that its performance is comparable to these devices.
Durability/Lifespan	1. Reusability for a maximum of 100 uses: The device must maintain its functionality and structural integrity for at least 100 uses.	"This is a non-sterile reusable device recommended for a maximum of 100 uses."
Sterility	1. Non-sterile: The device is intended to be non-sterile.	"This is a non-sterile reusable device..."
User Profile	1. Usability by healthcare workers familiar with phlebotomy: The device should be intuitive and safe for use by its intended user group.	"The DROP-IT® Needle Holder is to be used by healthcare workers who are familiar with the art of phlebotomy in healthcare facilities or in the home healthcare setting."

Missing Information Regarding the Study:

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a new clinical or performance study with acceptance criteria. As such, most of the requested information about a specific study is not present in this document.

Here's why and what is missing:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document asserts that the device "performs the same functions as other legally marketed needle holders." This typically implies comparison to existing devices, but details of any specific performance testing dataset (size, origin, retrospective/prospective nature) are absent. This 510(k) focuses on mechanical function and equivalence, which might rely on bench testing rather than human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not stated. Given the nature of a needle holder, "ground truth" as it's typically understood for diagnostic devices (e.g., in image analysis) isn't directly relevant. Functional performance would likely be assessed through engineering tests or direct comparison to predicate devices, not expert adjudication of a "truth."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. Adjudication methods are relevant for subjective assessments, often in diagnostic studies. For a mechanical device like a needle holder, performance would be measured objectively (e.g., successful needle retention, force required for release, number of cycles before failure).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. Not applicable. This is a diagnostic study design typically used for AI-powered interpretation of medical images. The Bio-Plexus DROP-IT® Needle Holder is a mechanical venipuncture device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to the performance of an algorithm without human input, relevant for AI. The device is a human-operated mechanical tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for a "test set." For a mechanical device, the "ground truth" of its performance would be its actual measurable function (e.g., securely holding a needle for X force, successfully releasing a needle upon button press, enduring 100 uses without failure). This would be established through engineering specifications and bench testing, not expert consensus in the diagnostic sense.
The sample size for the training set:
- Not applicable/Not stated. "Training set" is a term from machine learning/AI. For a mechanical device, there isn't a training set in this context. Design and testing are based on engineering principles and regulatory requirements.
How the ground truth for the training set was established:
- Not applicable/Not stated. As above, this concept doesn't apply to a mechanical non-AI device.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence by stating that the Bio-Plexus DROP-IT® Needle Holder performs the same functions as several legally marketed predicate devices and listing its features and intended use. It does not include a detailed study report with explicit acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader studies as would be found for more complex diagnostic or AI-driven medical devices. The "proof" for this type of device typically comes from engineering testing, comparison to established standards, and demonstration that it meets design specifications analogous to the predicate devices.

Summary

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510(k) SUMMARY JUN - 6 1997

Bio-Plexus Inc. 129 Resevoir Road Vernon, CT 06066 CONTACT: Carl R. Sahi (President) Date Submitted: 9/13/96

963748

Revised:

11/27/96

Proprietary Name: Classification Name: Regulation #: Class: Panel Code: Product Code: Reason for submission: Bio-Plexus Inc. Registration Number: Bio-Plexus DROP-IT® Needle Holder Needle Holder 880.5570 II 80 FMI New device 1224632

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 1997

Mr. Carl R. Sahi ·President Bio-Flexus, Incorported P.Ü. Box 560 Vernon, Connecticut 06066

K963748 Re : Bio-Plexus Drop-it Needle Holder Trade Name: Regulatory Class: II FMI Product Code: Dated: May 20, 1997 Received: May 23, 1997

Dear Mr. Sahi:

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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.

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Page 2 - Mr. Sahi

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 premarket notification" (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) 638-4041 or at (301) 443-6597.

Sincerely yours,

Timothy A. Ulatowski

Timothy A. ulatowsk Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K963748

Device Name: BIO-PLEXUS DROP-IT® NEEDLE HOLDER

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Patricia Crucente
Division of Dental, Infection Control,
and General Hospital Devices 963748

510(k) Numb

Prescription Use (Per 21 CFR 801 109)

Over -The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).