SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE by BEECH MEDICAL PRODUCTS, INC.

The SELFSHIELD HN™ Self Sheathing Hypodermic Needle is indicated for non patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock).

Device Description

The SelfShield HN™ device incorporates a standard hypodermic needle which adapts to piston syringe standard luer fittings. The device embodies a spring loaded needle shield which automatically covers the needle tip prior to and after each use. It helps reduce the occurrence of accidental needlesticks to healthcare workers when the product is used as directed. The user activates the device by placing the tip of the shield against a rubber injection site, clockwise rotating the device by at least 40° and pushing the shield back until the needle tip penetrates into and beyond the injection site rubber plug. Once fluid, drug, agent or blood is drawn, the unit is removed from the injection site. The needle shield automatically advances covering and protecting the sharp tip for transport. The device is reactivated again against another injection site until disposed in an approved sharps container. The device is supplied sterile in a peelable Tyvek-nylon blister package.

AI/ML Overview

The provided text describes the SelfShield HN™ Self Sheathing Hypodermic Needle and its acceptance criteria, along with a study supporting its performance.

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Sharps Injury Prevention	Meeting the test requirements of the FDA guidance document on devices with sharps injury prevention features, specifically regarding the absence of sharps injuries and proper shield activation.	The device performed as indicated in its labeling 548 times without any sharps injuries reported or failure of the shield activation feature. This directly meets the test requirements of the FDA guidance document.
User Effectiveness Rating	Rated as "very effective" (score = 10) by a significant percentage of user-evaluators.	Rated as "very effective" (score = 10) by 50% of user-evaluators.
User Acceptability Rating	Generally rated as "acceptable" (score = 8 and above) by a high percentage of user-evaluators.	Generally rated as "acceptable" (score = 8 and above) by 93% of user-evaluators.
User Satisfaction (Safety & Ease of Use)	Positive feedback on safety and ease of use, with indications of repeated aseptic fluid transfer and easy disposal/training.	User-evaluators were positive about the safety and ease of use of the device. They indicated it will repeatedly transfer fluids aseptically until easily disposed of and that users can be easily trained.
Usability for Left/Right Handed Users	Effective for both left and right-handed users.	Analysis of the data demonstrates that it can be used effectively by either left or right-handed users.
Comparative Usability vs. Predicate Device	Rated as easier and requiring less time to use than the predicate device by a majority of current predicate device users.	Rated as easier and requiring less time to use by the majority of user-evaluators compared to the predicate device for fluid transfer applications.
Recommendation for Use vs. Predicate Device	Recommended for use over the predicate device for fluid transfer by a high percentage of current predicate device users.	Recommended 98% of the time over the predicate device for fluid transfer applications by users who currently use the predicate device.
Mechanical Strength (Tensile Load)	Tensile loads needed to separate the shield from the unit should be more than adequate to reduce potential for failure by pulling.	Tensile loads needed to separate the shield are more than adequate and "well above the force that can be reasonably applied by hand in a clinical setting."
Mechanical Strength (Compressive Load)	Peak compressive load to expose the needle tip should be sufficiently high to prevent accidental override of the lock during transport.	The device's peak compressive load needed to expose the needle tip is approximately 10 times higher than the predicate device while in the temporary locked position, indicating "substantially more force to override the lock."

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

Sample Size for Simulated Clinical Test: The device was tested "548 times." This refers to 548 uses of the device in a simulated clinical setting.
Sample Size for User-Evaluators: "User-evaluators" were involved in rating the device, with percentages given for their feedback (50% rated very effective, 93% rated acceptable, majority found it easier to use, 98% recommended it). However, the absolute number of user-evaluators is not explicitly stated.
Data Provenance: The study was conducted as a "simulated clinical test." The country of origin of the data is not explicitly stated, but given the FDA submission, it is highly probable the data was collected in the United States. The study appears to be prospective as it involves active testing and user evaluation of the device.

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

The term "experts" here refers to the "experienced users of the predicate device" who participated in the simulated clinical test and provided feedback.

Number of Experts: The absolute number of "experienced users" is not explicitly stated. However, their collective feedback (e.g., 50% rated very effective, 93% satisfactory, 98% recommended) suggests a group of evaluators.
Qualifications of Experts: They are described as "experienced users of the predicate device." This implies they are healthcare professionals familiar with the type of device and its application in a clinical setting. Specific certifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The text does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth from multiple expert opinions. Instead, it relies on aggregate user ratings and reported observations from the simulated clinical test. The "ground truth" regarding safety (no sharps injuries) and shield activation failure was based on direct observation during the 548 uses. User ratings for effectiveness and acceptability were presented as percentages of the user-evaluator group.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The text does not describe a formal MRMC comparative effectiveness study in the typical sense of evaluating diagnostic accuracy with AI vs. without AI. It does, however, contain a comparative user evaluation section:

The SelfShield HN™ device was compared to the predicate device (Sherwood Monoject® Safety Syringe) in terms of ease of use, time required, and recommendation for fluid transfer applications.
Effect Size of Human Readers Improve with AI vs. without AI assistance: This metric is not applicable here as the device is not an AI-assisted diagnostic tool. Instead, the comparison is between two medical devices with different safety features, and the "human readers" are "user-evaluators" assessing the usability and safety of the devices.
- User perceived ease of use: The SelfShield HN™ device was rated as "easier and requiring less time to use by the majority of user-evaluators" compared to the predicate device.
- Recommendation rate: The SelfShield HN™ device was recommended "98% of the time than the predicate device for fluid transfer applications" by users who currently use the predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable as the described device is a physical medical device (hypodermic needle with a safety shield), not an algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

The ground truth used is a combination of:

Observed Outcomes (Safety and Functionality): For the sharps injury prevention aspect, the ground truth was the absence of reported sharps injuries and the successful activation of the shield over 548 uses.
User Perceptions/Ratings: For effectiveness, acceptability, ease of use, and recommendations, the ground truth was derived from the aggregated responses and ratings of the "experienced users" (user-evaluators).
Bench Test Results: For mechanical properties like tensile and compressive loads, the ground truth was established through physical measurements in laboratory (bench) tests.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical device and not an AI system that requires a "training set" of data. The "training" mentioned refers to training human users on the device's technique, not training an algorithm.

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

This question is not applicable for the same reason as above. There is no training set for an AI algorithm in this context.

Summary

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K 77 2467

510(k) Summary

Date: 30 June 1997

AUG 27 1997

Contact Name: John Romano, President

Submitter: Beech Medical Products, Inc. 241 Lackland Drive Middlesex, NJ 08846 tel: 908-563-0303 fax: 908-563-1115

Proprietary Name: SelfShield HNTM Self Sheathing Hypodermic Needle

Common Name: Shielded Hypodermic Needle

Classification Name: Hypodermic Single Lumen Needle

Predicate Device: Sherwood Monoject® Safety Syringe (1, 3, 6 and 12 cc sizes)

Both the SelfShield HNTM device and the predicate device use the same hypodermic needle and are gamma sterilized , single patient use, and disposable devices. However, the needle shield of the Self Shield HN™ device automatically extends forward over the needle tip into a terrippary locked position after each use whereas the predicate device's needle shield must be manually extenced forward to the temporary locked position. The automatic return of the shield to the temporary locked position does not require a conscious effort by the user whereas the predicate device does. However, since the needle tip is not exposed so that it can be used to pierce the skin under visual control, the Self Shield HN™ indications are limited to non-skin transfers such as from a drug vial to the injection cap on an IV catheter. On the other hand, the predicate device can be used for both skin and non-skin administration of drugs or direct blood draw since the needle is initially exposed to view.

The results from comparative bench tests indicate that tensile loads needed to separate the shield from either the SelfShield HNTM unit or the predicate device are more than adequate in reducing the potential for failure by pulling since the loads are well above the force that can be reasonably applied by hand in a clinical setting. The SelfShield HN™ device's peak compressive load needed to expose the needle tip is approximately 10 times higher than the predicate device while in the temporary locked position.

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Therefore, when transporting a filled syringe the SelfShield HN™ unit requires substantially more force to override the lock compared to the predicate device, which relies on a less robust detent feature to hold the shield in position during transport. The SelfShield HN™ device was tested in a simulated clinical test by experienced users of the predicate device. It performed as indicated in its labeling 548 times without any sharps injuries reported or failure of the shield activation feature and therefore meets the test requirements of the FDA guidance document on devices with sharps injury prevention features. The SelfShield HNTM needle was rated as very effective (score =10) by 50% and is generally rated as acceptable (score =8 and above) by 93% of the user-evaluators, who were positive about the safety and ease of use of the device. They indicated that it will repeatedly transfer fluids aseptically until easily disposed of in a sharps container and that users can be easily trained on the technique. Analysis of the data demonstrates that it can be used effectively by either left or right handed users. Among users who currently use the predicate device, the SelfShield HNTM device was rated as easier and requiring less time to use by the majority of user-evaluators and recommending it 98% of the time than the predicate device for fluid transfer applications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

电网 27 ppg

Mr. John Romano President Beech Medical Products, Incorporated ----241 Lackland Drive Middlesex, New Jersey 08846

K972469 Re : Selfshield HN Self Sheathing Hypodermic Trade Name: Needle Requlatory Class: II Product Code: FMI Dated: June 30, 1997 Received: July 1, 1997

Dear Mr. Romano:

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. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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

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Page 2 - Mr. Romano

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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):	K 972469
Device Name:	Self Shield HN
Indications For Use:

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IPLEASE 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
510(k) Number	K978469

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

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Over-The-Counter Use________

(Optional Format 1-2-96)

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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).