(79 days)
Not Found
No
The device is a purely mechanical accessory for needle removal and containment, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is designed to aid in the removal and containment of used needles to prevent needle stick injuries, not to treat or diagnose a medical condition.
No
The device is designed for the safe removal and containment of Huber needles from implanted ports to prevent needle stick injuries, not to diagnose medical conditions.
No
The device description clearly states it is a single injection molded plastic component, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and containment of needles from implanted ports to prevent needle stick injuries. This is a physical manipulation and safety function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is described as an accessory for removing and containing needles. It's a mechanical device designed for a specific physical task.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the mechanical function of the device (force to engage/disengage) and its ability to prevent needle stick injuries during simulated use. These are not studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
LJT, FMI, FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals familiar with the intended use of the device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivty, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG 2 9 2002
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.
1
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 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.
5. Intended Use of the Device:
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.
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 Huber | ||
| needles up to 19 gauge, | ||
| 1-1/2" length. | Compatible with 90- | |
| degree winged Huber | ||
| needles up to 19 gauge, | ||
| 1-1/2" length. | ||
| Material | One piece, made of | |
| Polystyrene plastic | Three pieces, made of | |
| Polystyrene plastic | ||
| How Provided | Sterile, single-use, | |
| disposable | Sterile, single-use, | |
| disposable |
2
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.
3
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.
4
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
5
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:
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.
(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