The BD Hypoint™ Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The BD Hypoint™ Needles are offered in various gauge sizes and needle lengths. The BD Hypoint™ Needle is sterilized by gamma irradiation (Cobalt-60). The BD Hypoint™ Needle is Non-Toxic, Non-Pyrogenic, Disposable and intended for Single Use.

AI/ML Overview

This document describes the BD Hypoint™ Hypodermic Needle, a physical medical device, not an AI/ML software. Therefore, many of the requested categories (such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established") are not applicable.

Here's the information that can be extracted from the provided text for this medical device:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for the BD Hypoint™ Needle against its predicate device. However, it indicates that "Bench testing was performed to confirm the BD Hypoint™ Needle equivalence to the predicate device." The overall acceptance criterion is substantial equivalence to the predicate device (BD PrecisionGlide™ Needle, K021475).

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Material Equivalence	Materials are comparable to predicate device.	Not explicitly detailed, but implied by the statement of substantial equivalence.
Design Equivalence	Design features (e.g., single lumen hypodermic needle, various gauge sizes and lengths) are comparable to predicate device.	Device is described as a "hypodermic single lumen needle...offered in various gauge sizes and needle lengths," implying consistency with predicate.
Intended Use Equivalence	Intended use is identical to predicate device.	"Intended for use with syringes and injection devices for general purpose fluid injection / aspiration" - identical to predicate's likely intended use.
Performance Equivalence	Bench testing demonstrates comparable performance to predicate device.	"Bench testing was performed to confirm the BD Hypoint™ Needle equivalence to the predicate device." Concluded as "safe and effective."
Sterilization Method	Sterilized by gamma irradiation (Cobalt-60).	"The BD Hypoint™ Needle is sterilized by gamma irradiation (Cobalt-60)."
Biocompatibility	Non-Toxic	"The BD Hypoint™ Needle is Non-Toxic."
Pyrogenicity	Non-Pyrogenic	"The BD Hypoint™ Needle is Non-Pyrogenic."
Single Use	Disposable and intended for Single Use.	"Disposable and intended for Single Use."

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

Sample Size: Not specified in the provided text. The phrase "Bench testing was performed" is used, but the number of needles tested is not disclosed.
Data Provenance: The document does not specify country of origin for the bench testing data. It mentions "extensive market history of this device outside of the United States," but this refers to prior use and not specifically the provenance of data for this particular submission's bench tests. The bench testing itself is for the US submission.
Retrospective or Prospective: Not explicitly stated, but bench testing on a new device would typically be considered prospective for the purpose of demonstrating equivalence.

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

This concept is not applicable to a physical medical device like a hypodermic needle undergoing bench testing for substantial equivalence. "Ground truth" in this context would refer to objective measurements of physical properties and performance characteristics, not expert interpretation of data. The "Medical Affairs Department" assessed the need for clinical analysis, but this is a different role than establishing ground truth for individual test results.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretation of qualitative data, often in clinical studies or image analysis. Bench testing for a physical device involves objective measurement, not expert adjudication in this sense.

5. 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:

Not applicable, as this is a physical medical device and not an AI/ML software.

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

Not applicable, as this is a physical medical device and not an AI/ML software.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on objective physical and performance measurements obtained during bench testing. These tests would evaluate characteristics such as needle sharpness, glide force, hub strength, needle integrity, sterility, etc., and compare them against the predicate device or established standards.

8. The Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML software that requires a "training set."

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

Not applicable, as this is a physical medical device and not an AI/ML software.

Summary

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K070440 1 of 3

Attachment 5

510(k) 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:

Address: BD Medical - Pharmaceutical Systems . 1 Becton Drive Franklin Lakes, NJ 07417-1885
2243072
. Registration Number:
Contact Person: .

Aileen Gilbert Senior Regulatory Affairs Specialist Telephone No .: 201-847-7197 Fax No.: 201-847-7040 E-Mail: aileen_gilbert@BD.com

Date of Summary: .

Device

Trade Name: .
. Common Name
. Classification Name:
. Classification:
Performance Standards: ●

February 14, 2007

BD Hypoint™ Hypodermic Needle Single Lumen Hypodermic Needle Class II None Established under 514 of the Food, Drug and Cosmetic Act

Confidential & Proprietary

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K070440 2013

II. Safety and Effectiveness Information Supporting Substantial Equivalence

· Device Description
The BD Hypoint™ Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The BD Hypoint™ Needles are offered in various gauge sizes and needle lengths. The BD Hypoint™ Needle is sterilized by gamma irradiation (Cobalt-60). The BD Hypoint™ Needle is Non-Toxic, Non-Pyrogenic, Disposable and intended for Single Use.
· Intended Use
The BD Hypoint™ Needle is intended for use with svringes and iniection devices for general purpose fluid injection / aspiration.
· Synopsis of Performance Study Results
Bench testing was performed to confirm the BD Hypoint™ Needle equivalence to the predicate device. The need for clinical analysis of the BD Hypoint™ Needle was assessed by the BD Medical Pharmaceutical Systems. Medical Affairs Department and with consideration to the extensive market history of this device outside of the United States, with the same intended use, the substantial device and design history on these other markets was the justification for not performing a clinical investigation for this device modification submission in the U.S. Therefore, based on the performance test results, the BD Hypoint TM Needle is safe and effective when used as intended.

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K070440 3of3

III. Predicate Device Summary Table

· Substantial Equivalence

Based on comparison of the device features, materials, intended use and performance, the BD Hypoint™ Needle has shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, 510(k) number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	510(k)Number	Clearance Date
BectonDickinson andCompany	BD PrecisionGlide™Needle	K021475	July 19, 2002

Aileen Gilbert, RAC Senior Regulatory Affairs Specialist BD Medical - Pharmaceutical Systems Becton Dickinson and Company

2/14/2007
Date

Confidential & Proprietary

0034

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DEPARTMENT OF HEALTH & HUMAN SERVICES

.. . .

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Aileen C. Gilbert Senior Regulatory Affairs Specialist Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1889

MAR 16 2007

Re: K070440

Trade/Device Name: BD Hypoint™ Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: February 14, 2007 Received: February 16, 2007

Dear Ms. Gilbert:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Gilbert

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

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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Special 510(k) - BD Hypoint™

.. . .

B. INDICATIONS FOR USE

KO70440 510(K) Number (IF Known): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME: BD Hypoint™ Needle

INDICATIONS FOR USE:

The BD Hypoint™ Needle is intended for use with syringes and injection devices for general purpose fluid injection / aspiration.

(Please do not Write Below This Line-Continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE	X	OR OVER-THE-COUNTER USE
------------------	-----------------------------------------	-------------------------	--

(PER 21 CFR § 801.109)
(OPTIONAL FORMAT 1-2-96)
Confidential & Proprietary

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).