The intended use of this device is for the removal of 90 degree winged infusion sets, manufactured by Harmac Medical Products and having a 1-1/2" needle or shorter, from implanted ports and the containment of the used needle until placed in an appropriate sharps container. When used in this manner this device is intended to aid in the prevention of needle stick injuries.

Device Description

The Harmac Medical Huber Needle Safety Device is designed as an accessory to Harmac Huber Needle Infusion Sets to assist in the removal and containment of ninety-degree Huber needles from implanted IV ports. The device consists of a single injection molded plastic component incorporating a stabilizing foot and an internal design to capture the proprietary needle hub of the Harmac Medical Infusion Set as it is slid up a receiving slot in one side. Only one version of the device will be marketed and will accommodate a range of Harmac Huber needles up to 19 gauge, 1-1/2" in length. The Huber Needle Safety Device is used by placing the open slot over the hub of the Harmac Infusion Set needle and using the foot of the device to stabilize the patient's skin via downward pressure with one hand. The other hand is used to grasp the wings of the Huber needle and draw it upward into the Safety Device. As the Huber needle reaches the top of the device the proprietary head locks into place. As the needle is drawn upwards it is also turned slightly to the side to keep the needle from protruding through the receiving slot. This method of operation requires two hands but eliminates the rebound reflex by locking the needle hub and keeping the other hand behind the device at all times. The Huber Needle Safety Device is provided as a sterile accessory packaged only with Harmac Infusion Sets. It is provided as a disposable, single use device.

AI/ML Overview

The Harmac Huber Needle Safety Device's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Bench Testing:	Bench Testing:
- Sufficient force to engage the safety device (implicitly, should not be too high to prevent activation).	- Average force to engage the safety device: 2.91 lbs.
- Sufficient force to disengage the safety device (implicitly, should be high enough to prevent accidental disengagement).	- Average force to disengage the safety device: 15.51 lbs.
- High confidence level that accidental disengagement is extremely unlikely.	- Separation of engaging and disengaging forces by more than six standard deviations, providing high confidence against accidental disengagement.
- Design and material characteristics adequate to withstand required forces during use.	- Demonstrated adequacy of design and material characteristics to withstand required forces during use.
Simulated Clinical Studies:	Simulated Clinical Studies:
- No needle stick injuries during simulated use.	- 0 (NO) needle stick injuries.
- No significant problems with the safety feature that could lead to an injury.	- 0 (NO) significant problems with the safety feature that may have led to an injury.
- Overall performance demonstrating the device is safe and effective for its intended use, performing as well or better than the predicate device.	- Demonstrated that the device is safe and effective for its intended use and performs as well or better than the predicate device. Will reduce the incidence of needle stick injuries when used as labeled.
- Device provides an additional level of safety during needle removal and assists in compliance with current OSHA Safety Regulations (Implied outcome of meeting the above performance criteria).	- Designed to provide an additional level of safety during needle removal and to assist in compliance with current OSHA Safety Regulations. Implied outcome of reported performance.

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

Bench Testing: The document does not specify an exact sample size (number of devices or tests performed) for the Instron tester measurements, but it refers to "bench studies," implying multiple tests were conducted to determine average forces and standard deviations.
Simulated Clinical Studies: Over 480 safety devices were tested.
Data Provenance: The studies were conducted retrospectively as part of the design control phase at Harmac Medical Products, Inc. The location of the test (Harmac facilities) does not specify country of origin for data, but implies the studies were conducted internally for product development.

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

Number of Experts: The simulated clinical studies involved "health care professionals familiar with the intended use of the device as well as the predicate device." The exact number of individual health care professionals is not specified, only that "health care professionals" participated.
Qualifications of Experts: They were "health care professionals familiar with the intended use of the device as well as the predicate device." No further specific qualifications (e.g., years of experience, specific medical roles) are provided. They received "in-service training."

4. Adjudication Method for the Test Set:

The document does not explicitly state an adjudication method (such as 2+1 or 3+1) for the simulated clinical studies. The health care professionals filled out a "detailed evaluation form during the study," implying direct observation and reporting of events (needle sticks, problems with safety feature) by these professionals, rather than a separate adjudication process of their findings. The outcome of 0 needle stick injuries and 0 significant problems suggests a clear-cut result rather than a need for complex adjudication.

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:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a mechanical safety accessory, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the typical sense of medical imaging or clinical decision support. The study focused on the device's ability to prevent needle stick injuries during its intended use.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

N/A. This device is a physical safety accessory, not an algorithm. Its function inherently involves human interaction (removing a needle). The bench testing could be considered a "standalone" mechanical performance test in a highly controlled environment, but the simulated clinical studies involved human users.

7. The Type of Ground Truth Used:

Bench Testing: Engineering measurements (force to engage/disengage from Instron tester).
Simulated Clinical Studies: Direct observation and self-reporting by health care professionals regarding the occurrence of needle stick injuries and functional problems with the safety device during simulated use on port trainers. This is essentially empirical, real-world (simulated) outcome data on injury prevention and device function.

8. The Sample Size for the Training Set:

None applicable in the context of an AI training set. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the machine learning sense. The "design control phase" involves iterative design, prototyping, and testing, which refine the product but are not "training" an algorithm.

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

N/A. As there is no AI training set, there is no ground truth established for such a set.

Summary

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AUG 2 9 2002

K021916

MEDICAL PRODUCTS, INC.

2201 Bailey Avenue · Buffalo, NY, U.S.A. 14211-1797

Phone: (716) 897-4500 ext. 301 · Fax: (716) 893-8395 · Email: cizzo@harmac.com

510(k) Summary

This summary is submitted in support of the Harmac Huber Needle Safety Device and in conformance with the format described in 21 CFR Part 807.92 last revised on April 1, 2001.

1. Date Submitted:

24 May 2002

Submitted By:

Harmac Medical Products, Inc. 2201 Bailey Avenue Buffalo, NY 14211

Contact Person:

Christopher Izzo Sr. QA/RA Engineer (716) 897-4500 ext. 301 - voice (716) 893-8395 – fax cizzo@harmac.com - email

2. Name of Device:

Harmac Huber Needle Safety Device

Classification Name:

IV Administration Set/Accessory

3. Identification of Predicate Devices:

510(k) Number: K950895 Trade Name: Huber Needle Infusion Set Regulatory Class: II Product Code: FPA Harmac Medical Products, Inc.

510(k) Number: K973497 Trade Name: Huberloc Regulatory Class: Unclassified Product Code: LJT MedCare Medical Group, Inc.

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Image /page/1/Picture/0 description: The image shows the logo for Harmac Medical Products, Inc. The word "Harmac" is in large, bold, black letters. Below that, in smaller letters, is the text "MEDICAL PRODUCTS, INC."

Phone: (716) 897-4500 ext. 301 • Fax: (716) 893-8395 • Email: cizzo@harmac.com

CAL PRODUC

Description of Device Subject to Premarket Notification:

The Huber Needle Safety Device is used by placing the open slot over the hub of the Harmac Infusion Set needle and using the foot of the device to stabilize the patient's skin via downward pressure with one hand. The other hand is used to grasp the wings of the Huber needle and draw it upward into the Safety Device. As the Huber needle reaches the top of the device the proprietary head locks into place. As the needle is drawn upwards it is also turned slightly to the side to keep the needle from protruding through the receiving slot.

This method of operation requires two hands but eliminates the rebound reflex by locking the needle hub and keeping the other hand behind the device at all times.

The Huber Needle Safety Device is provided as a sterile accessory packaged only with Harmac Infusion Sets. It is provided as a disposable, single use device.

5. Intended Use of the Device:

6. Comparison to Predicate Device

The technological characteristics of the Harmac Huber Needle Safety device are the same as the predicate device(s) designated in section 3, above, as illustrated in the table below:

	"New" Harmac Device	Huberloc
Design	Compatible with 90-degree winged Huberneedles up to 19 gauge,1-1/2" length.	Compatible with 90-degree winged Huberneedles up to 19 gauge,1-1/2" length.
Material	One piece, made ofPolystyrene plastic	Three pieces, made ofPolystyrene plastic
How Provided	Sterile, single-use,disposable	Sterile, single-use,disposable

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Image /page/2/Picture/0 description: The image shows the logo for Harmac Medical Products, Inc. The word "Harmac" is in large, bold, black letters. Below that, in smaller letters, is the text "MEDICAL PRODUCTS, INC."

Phone: (716) 897-4500 ext. 301 • Fax: (716) 893-8395 • Email: cizzo@harmac.com

Energy Source	Mechanical, provided by user	Mechanical, provided by user
Safety	Removed needle locked in place for disposal	Removed needle locked in place for disposal

7. Device Testing

The device underwent both bench testing and simulated clinical studies during the design control phase at Harmac according to the guidance in "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features" published by the General Hospital Devices Branch in March 1995.

Bench studies using an Instron tester to simulate use demonstrated that the average force to engage the safety device was 2.91 Ibs. and the average force to disengage the safety device was 15.51 lbs. The separation of these forces by more than six standard deviations gives a high confidence level that accidental disengagement is extremely unlikely to occur. Also, this study demonstrated that the design and material characteristics of the device are adequate to withstand the required forces during use.

Simulated clinical studies were performed with health care professionals familiar with the intended use of the device as well as the predicate device. Health care professionals received in-service training and filled out a detailed evaluation form during the study. Over 480 safety devices were tested on port trainers with NO (0) needle stick injuries and NO (0) significant problems with the safety feature that may have lead to an iniury.

Due to the similarity between this device and the predicate device, the intended use, and the performance testing, it was determined that clinical data was not required and the simulated use study alone is acceptable for drawing the conclusions given below.

The testing above demonstrates that the device is safe and effective for its intended use and performs as well or better than the predicate device. As a safety accessory to the Harmac Huber Needle design, this device is designed to provide an additional level of safety during needle removal and to assist in compliance with current OSHA Safety Requlations. The implication of the device labeling is that this device will reduce the incidence of needle stick injuries when used according to the labeling in conjunction with a Harmac Huber Needle Infusion Set.

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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with flowing lines below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2002

Mr. Christopher Izzo Senior Ouality Assurance & Regulatory Affairs Engineer Harmac Medical Products, Incorporated 2201 Bailey Avenue Buffalo, New York 14211

Re: K021916

Trade/Device Name: Harmac Huber Needle Safety Device Regulation Number: 880.5965, 880.5570 and 880.5440 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter, Hypodermic Single Lumen Needle and Intravascular Administration Set Regulatory Class: II Product Code: LJT, FMI and FPA Dated: May 24, 2002 Received: June 11, 2002

Dear Mr. Mr. Moran:

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.

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.

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Page 2 - Mr. Moran

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 (OS) 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timot 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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Image /page/5/Picture/0 description: The image shows the logo for Harmac Medical Products, Inc. The word "Harmac" is in large, bold, black letters. Below that, in smaller letters, is the text "MEDICAL PRODUCTS, INC." The logo is simple and professional.

Phone: (716) 897-4500 ext. 301 · Fax: (716) 893-8395 · Email: cizzo@harmac.com

Indications for Use Statement

510(k) Number (if known):

Page 1 of 1

Device Name: Harmac Huber Needle Safety Device

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alvaro Cincunegui

Sivision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K021916

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-the-Counter Use

Harmac Medical Products, Inc. Huber Needle Safety Device

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.