(57 days)
The AllSafeTM Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The AllSafeTM Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries.
All Safe Huber Safety Infusion Sets
This is a 510(k) premarket notification letter from the FDA regarding a medical device called "All Safe Huber Safety Infusion Sets". It is not a study report and therefore does not contain the information requested about acceptance criteria, device performance, study design, or ground truth establishment.
A 510(k) letter primarily indicates that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not provide details of performance studies in the way a clinical trial report or a scientific publication would.
To answer the prompt, one would need access to the actual studies conducted by Nexus Medical, LLC to support their 510(k) submission, which are not provided in this document.
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Public Health Service
DEC 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Al Boedeker Director, Regulatory Affairs Quality Assurance Nexus Medical. LLC 11315 Strang Line Road Lenexa, Kansas 66215
Re: K041844
Trade/Device Name: All Safe Huber Safety Infusion Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 27, 2004 Received: August 31, 2004
Dear Mr. Boedeker:
This letter corrects our substantially equivalent letter of September 3, 2004 regarding the incorrect Indications for Use statement that was sent to you.
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 (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 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 - Mr. Boedeker
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. 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 continue 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 (240) 276-0115. 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.
Suser Gunner
Colia Llin, Ph.D.
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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Image /page/2/Picture/0 description: The image shows the logo for Nexus Medical. The logo features the word "NEXUS" in bold, sans-serif font, with a stylized graphic to the left that resembles curved lines emanating from a central point. Below "NEXUS" is the word "MEDICAL" in a smaller, sans-serif font. The letters are all capitalized and black.
11315 Strang Line Road, Lenexa, KS
510(k) Number: K041844 Description: All Safe Huber Safety Infusion Sets, K041844 Responses to Reviewers Fax of 7/30/04 8/27/04 Response
Indications for Use Statement
| Applicant: | Nexus Medical LLC |
|---|---|
| 510(k) Number (if known): | K041844 |
| Device Name: | All Safe Huber Safety Infusion Sets |
| Indications For Use: |
The AllSafeTM Huber Safety Infusion Sets are used to access surgically implanted vascular ports for
the administration of fluids and withdrawal of blood. The AllSafeTM Huber Safety Infusion Sets
facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control. Dental Devices | |
| 510(k) Number | K041844 |
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-21-
§ 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.