LIFTLOC SAFETY INFUSION SET

K013394 · Specialized Health Products, Inc. · FPA · Nov 8, 2001 · General Hospital

Device Facts

• Record ID: K013394
• Device Name: LIFTLOC SAFETY INFUSION SET
• Applicant: Specialized Health Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Nov 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. The LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. The LiftLoc™ Safety Infusion Set should be changed per CDC guidelines, Oncology Nursing Society (ONS), Infusion Nurses Society (INS), or per hospital protocol for Huber needle IV administration sets. The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population.

Device Story

LiftLoc™ Safety Infusion Set is a non-coring right-angle Huber needle administration set for accessing surgically implanted vascular ports. Device facilitates fluid/drug infusion and blood sampling. Clinicians operate device in clinical settings. Following infusion/sampling, clinician uses one-handed technique to remove needle; integral safety mechanism activates upon removal, locking safety shield over needle to prevent needlestick injuries. Audible/visual confirmation indicates lockout. Device is sterile, single-use, and disposable. Benefits include reduced risk of accidental needlestick injuries to healthcare providers.

Clinical Evidence

Bench testing and simulated use study performed. 500 units successfully inserted into implantable ports through simulated tissue and activated. No sharps injuries or safety mechanism failures occurred. No clinical data.

Technological Characteristics

Right-angle Huber needle; integral safety shield mechanism; optional Y-injection site; optional Patient Comfort Pad. Materials meet ISO 10993 biocompatibility standards. Sterile, non-pyrogenic, single-use. Mechanical activation of safety shield.

Indications for Use

Indicated for use in any patient population requiring access to surgically implanted vascular ports for fluid/drug administration or blood sampling.

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)
• Butterfly Non-coring Needle Set (K863606)

Submission Summary (Full Text)

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for LiftLoc™ Safety Infusion Set

NOV 0 82001

#### SUBMITTER: Specialized Health Products®, Inc. 585 West 500 South Bountiful, Utah 84010

# ESTABLISHMENT REGISTRATION NUMBER:

1723684

# CONTACT:

Mark Nelson Manager, Quality and Regulatory Affairs Telephone: [phone] Fax: [phone] Email: [e-mail]

DATE PREPARED:

October 12, 2001

# NAME OF MEDICAL DEVICE:

Classification Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Proprietary Name: LiftLoc™ Safety Infusion Set

# DEVICE CLASSIFICATION:

Classification Panel: General Hospital and Personal Use Class: II Procode: FPA Regulation Number: 21 CFR 880.5440

# STATEMENT OF SUBSTANTIAL EQUIVALENCE:

- Millennium Huber Plus Safety Infusion Set (K993848). Millennium Medical ● Distribution, Inc., Kennett Square, PA.
- Butterfly Non-coring Needle Set (K863606), Cormed, Inc., Sub. C.R. Bard, . Inc.(currently marketed by Bard Access Systems, a division of C.R. Bard, as Winged Infusion Set), 591 Mahar St., Medina, NY 14103

#### DEVICE DESCRIPTION:

The LiftLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The LiftLoc™ Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood

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sampling. The LiftLoc™ Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.

Following conventional placement of the LiftLoc™ Safety Infusion Set's Huber needle into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal, the LiftLoc™ Safety Infusion Set may then be removed from the patient.

Conventional clinical practice is used to remove the LiftLoc™ Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the LiftLoc™ safety disc to stabilize the port. A one-handed (dominant hand) technique is then used to grasp the integral wings and pull upward to remove the Huber needle from the port. When the clinician's hands are positioned correctly over the LiftLoc™ safety disc and the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. An audible click or visual confirmation confirms the lockout of the safety shield over the needle. The LiftLoc™ Safety Infusion Set, now with a protected needle, is discarded in a sharps container.

The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad will also be available as an accessory.

#### INTENDED USE:

The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. The LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. The LiftLoc™ Safety Infusion Set should be changed per CDC guidelines, Oncology Nursing Society (ONS), Infusion Nurses Society (INS), or per hospital protocol for Huber needle IV administration sets. The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population.

# TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

It is Specialized Health Products®, Inc.'s conclusion that the LiftLoc™ Safety Infusion Set is substantially equivalent to the following Huber needle intravascular administration sets: Millennium Huber Plus Safety Infusion Set (K993848) and the Bard Access Systems Butterfly Non-coring Needle Set (K863606). A summary of the key technological comparisons follows:

- . The LiftLoc™ Safety Infusion Set utilizes a right angle Huber needle to access implanted vascular ports, as do both predicate devices cited in this submission.
- The LiftLoc™ Safety Infusion Set operates as a standard Huber needle intravascular . administration set, as does the Bard Access Systems Huber IV administration set: Butterfly Non-coring Needle Set (K863606). (Currently marketed by Bard Access Systems Systems, a division of C.R. Bard, as Winged Infusion Set).
- The LiftLoc™ Safety Infusion Set is manufactured from the same or similar materials . as the predicate devices, with the exception of the Patient Comfort Pad. All materials will meet ISO 10993 requirements for material safety and biocompatibility.

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- The LiftLoc™ Safety Infusion Set has a safety feature to help prevent accidental . needlestick injuries, as does the Millennium Huber Plus Safety Infusion Set (K993848).
#### SUMMARY OF PERFORMANCE TESTING:

Comparative testing has been performed on the LiftLoc™ Safety Infusion Set and two predicate devices. Test results indicate that the LiftLoc™ Safety Infusion Set performs in a substantially equivalent manner.

# SUMMARY OF SIMULATED USE STUDY:

A total of 500 LiffLoc™ Safety Infusion Sets were successfully inserted by clinicians into an actual implantable port through simulated tissue and activated. No sharps injuries or failures of the integral needlestick prevention feature/safety mechanism occurred.

#### CONCLUSION:

The material testing and simulated use data demonstrate that the LiftLoc™ Safety Infusion Set is safe and effective for its intended use, complies with medical device standards, and is substantially equivalent to the following Huber needle intravascular administration sets: Millennium Huber Plus Safety Infusion Set (K993848) and the Bard Access Systems Butterfly Non-coring Needle Set (K863606).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds or waves, arranged in a parallel formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2001

Mr. Mark Nelson Manager, Ouality and Regulatory Affairs Specialized Health Products, Incorporated 585 West 500 South Bountiful, Utah 84010

Re: K013394

Trade/Device Name: LiftLoc™ Safety Infusion Pump Regulation Number: 880.5440 and 880.5965 Regulation Name: Huber Needle Intravascular Administration Set Regulatory Class: II Product Code: FPA and LJT Dated: October 12, 2001 Received: October 15, 2001

Dear Mr. Nelson:

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.

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.

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Page 2 - Mr. Nelson

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 (OS) 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/adrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 0 8 2001 INDICATIONS FOR USE STATEMENT 113390 510(k) Number (if known):

Device Name: LiftLoc™ Safety Infusion Set

#### Indications for Use:

- The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set ● with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
- The integral LiftLoc™ Safety Infusion Set safety mechanism is manually activated ● during the removal of the LiftLoc™ Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
- The LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids . and drugs, or blood sampling through surgically implanted vascular ports.
- The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single ● use device.
- The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population. .

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuceniti

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

OR

**Prescription Use**
(Per 21 CFR 801.109)

Over-The-Counter Use