MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET

K042234 · Specialty Health Products, Inc. · FPA · Sep 8, 2004 · General Hospital

Device Facts

• Record ID: K042234
• Device Name: MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
• Applicant: Specialty Health Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Special
• 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

Non-coring Huber needle infusion set with integral safety shield; used to access surgically implanted vascular ports for fluid/drug delivery or blood sampling. Clinician inserts needle into port; upon removal, manual one-handed technique activates safety mechanism, locking shield over needle. Audible/visual confirmation of lockout provided. Used in clinical settings by healthcare professionals. Benefits include reduction of accidental needlestick injuries. Device includes needle, plastic base, integral wings, and optional Y-injection site or Patient Comfort Pad.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Non-coring right angle Huber needle; medical-grade silicone lubrication; integral manual safety shield mechanism; sterile, non-pyrogenic, single-use; includes plastic base and optional Y-injection site/Patient Comfort Pad.

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

• LiftLock Safety Infusion Set (K013394)

Submission Summary (Full Text)

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# SECTION 3.0

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SEP = 8 2004 (21 CFR 807.92) for the LiftLoc® Safety Infusion Set

# SUBMITTER: Specialized Health Products®, Inc. 585 West 500 South, Suite 200 Bountiful, Utah 84010

#### ESTABLISHMENT REGISTRATION NUMBER: 1723684

#### CONTACT:

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

#### DATE PREPARED:

August 17, 2004

### NAME OF MEDICAL DEVICE:

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

#### DEVICE CLASSIFICATION:

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

PREDICATE DEVICE: LiftLock) Safety Infusion Set (K013394), Specialized Health Products®, Inc., Bountiful, UT 84010.

### DEVICE DESCRIPTION AND COMPARISON TO CLEARED DEVICE:

The LiftLoc® Safety Infusion Set is a non-coring Huber 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 sampling.

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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 Infusion Set's plastic base 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"s plastic base 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.

All aspects of the device are the same as the predicate device including intended use and the fundamental scientific technology. The presence of lubrication on the needle (medical grade silicone) is the only difference in the modified device compared to the cleared device. Enhanced labeling is also included in this submission.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Mr. Mark Nelson Director, Quality and Regulatory Affairs Specialized Health Products® Incorporated 585 West 500 South #200 Bountiful, Utah 84010

Re: K042234

Trade/Device Name: Modification to: LiftLoc® Safety Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 17, 2004 Received: August 27, 2004

Dear Mr. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have 10 rowse your and have determined the device is substantially equivalent (for the referenced a o the anclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Intersule confinered pross 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 approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 will), it may of cash of Federal Regulations, Title 21, Parts 800 to 898. In your device tax may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Nelson

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease oc acvisod that 1 Dr. o levice complies with other complies with other requirements Incall that I DAT has mude a december and regulations administered by other Federal agencies. of the Act of ally I oderal states and equirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF Part 807), and ality systems (QS) regulation (21 CFR Part 820); and if requirents us set form in arouv tradiation 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) I mis letter will anow Jourse Journal in equivalence of your device to a promatics notified.com - The First 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), If you desire specific at 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 may obtain 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,

Claire Liu, 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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Ko42234

# Indications for Use

510(k) Number (if known): ¥042234

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 LiftLock 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Igor Timofeev

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

510(k) Number:_Kou223y

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