(77 days)
The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.
The device consists of a Protector cap, female Luer lock, PVC tubing, two each 4 inch, or one 8 inch tubing length and ( .3 mm) ID, a pinch clamp, with and without a needle free y- site, a butterfly wing, a safety needle guard, an AISI 304 (19ga., 20ga., 22ga.) stainless steel needle, and a needle sheath.
The provided text is a 510(k) premarket notification summary for a medical device, the "HuberPRO™ Safety Huber Infusion Set." This type of submission focuses on demonstrating substantial equivalence to pre-existing devices rather than detailing specific studies with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, the document does not describe acceptance criteria for device performance or a study proving the device meets those criteria in the way one might expect for an AI/machine learning medical device.
Instead, the document asserts: "Based on the fact that the HuberPRO™ Safety Huber Infusion Sets utilizes similar and equivalent designs, components, manufacturing Processes as currently legally marketed Products, the Safety Huber Infusion Set is safe and effective when used as intended." This statement serves as the justification for its safety and effectiveness, relying on the substantial equivalence principle rather than new performance data with discrete acceptance criteria.
Consequently, I cannot fill out the requested table and sections as they pertain to performance metrics and studies typical for AI/ML devices. The information simply isn't present in this 510(k) document.
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K0335/5
JAN 2 2 2004
November 3, 2003.
To whom it may concern:
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Trade Name - HuberPRO тм Safety Huber Infusion Set Common Name - Huber Infusion Set Classification Name - Intravascular Administration Set
The HuberPRO тм Safety Huber Infusion Sets are intended to be used to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal. The device consists of a Protector cap, female Luer lock, PVC tubing, two each 4 inch, or one 8 inch tubing length and ( .3 mm) ID, a pinch clamp, with and without a needle free y- site, a butterfly wing, a safety needle guard, an AISI 304 (19ga., 20ga., 22ga.) stainless steel needle, and a needle sheath. The components and the Processes used to manufacture these solution administration sets are substantially equivalent to like Products currently legally marketed by Horizon Medical Products, İnc. K013871 LifeGuard тм Safety Infusion Set, and Micro Med, Inc. K950597 Core Resistant Huber Infusion Set, The HuberPRO TM Safety Huber Infusion Sets sets will be packaged in a Tyvek/polyethylene pouch and sterilized per AAMI / ISO guidelines.
Based on the fact that the HuberPRO тм Safety Huber Infusion Sets utilizes similar and equivalent designs, components, manufacturing Processes as currently legally marketed Products, the Safety Huber Infusion Set is safe and effective when used as intended.
Best regards, Command Medical Products
Joyce Vytlacil
Joyce Vytlacil Operations Manager
Image /page/0/Picture/11 description: The image shows the word "CONFIDENTIAL" in all caps. The letters are bold and black. The word is centered in the image.
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Image /page/1/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" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
Ms. Joyce Vytlacil Operations Manager Command Medical Products, Incorporated 15 Signal Avenue Ormond Beach, Florida 32174
Re: K033515
Trade/Device Name: HuberPRO ™ Saftey Huber Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 24, 2003 Received: January 12, 2004
Dear Ms. Vytlacil:
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 enclosurc) 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 - Ms. Vytlacil
Please be adviscd 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
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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Indications for Use
510(k) Number (if known): K033515
Device Name: HuberPRO TM Safety Huber Infusion Set
Indications For Use:
The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Viole Hibbard, Interim Branch Chief
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Dev
510(k) Number: K033515
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§ 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.