(57 days)
Not Found
Not Found
No
The summary describes a mechanical device (infusion set) and makes no mention of AI or ML capabilities.
No.
The device is used for administration of fluids and withdrawal of blood, facilitating access to vascular ports and preventing needle stick injuries. It does not directly treat or diagnose a disease or condition.
No
The device description indicates its use for administering fluids and withdrawing blood, and preventing needle stick injuries, not for diagnosing medical conditions.
No
The device description clearly indicates a physical medical device ("All Safe Huber Safety Infusion Sets") used to access vascular ports, which involves hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes (collecting blood), not for testing samples in vitro (outside the body).
- Device Description: The description is of an infusion set, which is a medical device used for delivering substances into or withdrawing substances from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process that would be performed in vitro to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate access to the vascular system, not to perform analysis on a sample.
N/A
Intended Use / 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.
Product codes
FPA
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the department's mission of promoting health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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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