(25 days)
Not Found
No
The summary describes a mechanical safety feature for a needle and does not mention any computational or learning capabilities.
No
The device is intended to administer drugs and prevent needlestick injuries, not to treat a medical condition.
No
The device is described as an administration set designed to deliver drugs to a patient, not to diagnose a condition. Its primary function is drug delivery with a safety feature to prevent needle sticks.
No
The device description clearly states it is a "standard right angle Huber needle and administration set with a needlestick prevention feature," indicating it is a physical medical 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 to "administer drugs to a patient from a container through a subcutaneous implanted port." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details a "standard right angle Huber needle and administration set with a needlestick prevention feature." This is a medical device used for accessing a port for infusion, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition in vitro (outside the living body).
Therefore, the Luther Safety Huber Needle Set is a medical device for drug administration, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
Product codes
FPA
Device Description
The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials, The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.
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
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
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
Attachment A: Revised
MAR 2 6 2004
Luther Needlesafe Products, Inc.
3199 Airport Loop Drive, Unit E Costa Mesa, CA 92626 Phone 714-434-4561 FAX 714-434-1557
510(k) Summary
Submitted by: Luther Needlesafe Products, Inc. 3199 Airport Loop Drive, Unit E Costa Mesa, California 92626-3414 Phone: 714-434-1564 Fax: 714-434-1557
Contact Person: Greq Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax 949-552-2821
Device Name:
Classification Name: Classification: Product Code: Requlation Number: Proprietarv Name: Common Name:
Set, Administration, Intravascular Class II FPA 21 CFR 880.5440 Luther Safety Huber Needle Set Safety Huber Needle and Administration Set
Predicate Device:
Luther Safety Huber Needle Set K021565
Device Description:
The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials, The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner.
1
It is supplied sterile for single use only.
Indications for Use:
The Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
Summary of the technological characteristics of this device compared to the predicate, original, device:
The old and the new design have similar technological characteristics and are equivalent.
There is no change in the following items:
Indications for Use Patient contact or fluid path materials Safety activation feature Instructions for Use Sizes and options for gauge, length and needless Y site
There are changes in following items:
Overall height of device is lower Clear body of device allows user to check insertion
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2004
Luther Needlesafe Products, Incorporated C/O Mr. Greg Holland Consultant Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K040527
Trade/Device Name: Low Profile Luther Safety Huber Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 27, 2004 Received: March 1, 2004
Dear Mr. Holland:
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 vour 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.
3
Page 2 -Mr. Holland
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. or the Act of any I each s requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF er rett in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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 premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-5618. 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
4
Page
510(k) Number (if known):_ Koyo≤27
Device Name:_Low Profile Luther Safety Huber
Indications For Use:
Intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually subcularleodo implanted to feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use OR (Optional Format 1-2-96)
Vick Hubbard for Anthony Wilson, B.C.
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: KO