LUTHER SAFETY HUBER NEEDLE SET

K021565 · Luther Research Partners · FPA · Nov 14, 2002 · General Hospital

Device Facts

• Record ID: K021565
• Device Name: LUTHER SAFETY HUBER NEEDLE SET
• Applicant: Luther Research Partners
• Product Code: FPA · General Hospital
• Decision Date: Nov 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

Device Story

The Luther Safety Huber Needle Set is a right-angle Huber needle and administration set used to deliver medication from a container to a subcutaneous implanted port. It is operated by healthcare practitioners in clinical settings. The device features a manually activated safety cover designed to shield the needle after use, thereby reducing the risk of accidental needlestick injuries to the clinician. It is supplied sterile for single-patient use. The device functions as a standard infusion set with an integrated mechanical safety mechanism.

Clinical Evidence

Bench testing and a simulated use clinical trial were conducted. In the simulated trial, 692 units were used with zero incidences of sharps injury or safety feature failure.

Technological Characteristics

Right-angle Huber needle and administration set. Constructed from conventional medical-grade, biocompatible materials. Features a manually activated needle cover for sharps injury prevention. Supplied sterile for single use.

Indications for Use

Indicated for patients requiring drug administration via subcutaneous implanted ports. For prescription use only.

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.

Predicate Devices

• Millennium Huber Plus Safety Infusion Set (K993848)

Submission Summary (Full Text)

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### Attachment E - 510(k) Summary

# 510(k) Summary

K02/565

NOV 1 4 2002

- Luther Research Partners LLC Submitted by: 3199 Airport Loop Drive, Unit E Costa Mesa, California 92626-3414 Phone: [phone] Fax: [phone]
- Greg Holland Contact Person: Requiatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax [phone]

### Device Name:

Classification Name: Classification: Product Code: Regulation Number: Proprietary 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:

Millennium Huber Plus Safety Infusion Set K993848

# 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.

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## 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. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

## Performance Data:

Information was supplied to support substantial equivalence to the predicate device. Part of this support was a simulated use clinical trial in which 692 Luther Safety Huber Needle Sets were used resulting in no incidences of sharps injury or incidences where the safety feature failed to activate.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle, there is a stylized graphic of three human profiles facing to the right, stacked one behind the other.

Public Health Service

ood and Drug Administratio 200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2002

Luther Research Partners, LLC C/O Mr. Greg Holland Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K021565

Trade/Device Name: Luther Safety Huber Needle Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA and LJS Dated: September 16, 2002 Received: September 16, 2002

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 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. 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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]_ Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Runner

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Response to Questions K021565, Luther Safety Huber Needle Set

Attachment D - Revised Indications for Use Statement

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K021565

Device Name: Luther Safety Huber Needle Set

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. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

Valeria Crescenti

Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _

(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)

OR

Over-The Counter Use

(Optional Format 1-2-96)