ALL SAFE HUBER SAFETY INFUSION SETS

K041844 · Nexus Medical, LLC · FPA · Sep 3, 2004 · General Hospital

Device Facts

• Record ID: K041844
• Device Name: ALL SAFE HUBER SAFETY INFUSION SETS
• Applicant: Nexus Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Sep 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

AllSafe Huber Safety Infusion Sets are sterile, single-use devices designed to access surgically implanted vascular ports. The device consists of a Huber needle integrated with a safety mechanism to facilitate safe needle removal and reduce the risk of accidental needle stick injuries during clinical use. It is operated by healthcare professionals in clinical settings to administer fluids or withdraw blood from the port. The safety mechanism is intended to protect the clinician during the withdrawal process, thereby improving workplace safety while maintaining standard vascular access functionality.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set featuring a Huber needle and integrated safety mechanism for needle retraction/shielding. Class II device under 21 CFR 880.5440.

Indications for Use

Indicated for accessing surgically implanted vascular ports for fluid administration and blood withdrawal in patients requiring such access.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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 AllSafe^TM Huber Safety Infusion Sets are used to access surgically implanted vascular ports for
the administration of fluids and withdrawal of blood. The AllSafe^TM Huber Safety Infusion Sets
facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries.

| Prescription Use | <u>X</u> | 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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