MINILOC SAFETY INFUSION SET

K050600 · Specialized Health Products, Intl. · FPA · May 12, 2005 · General Hospital

Device Facts

• Record ID: K050600
• Device Name: MINILOC SAFETY INFUSION SET
• Applicant: Specialized Health Products, Intl.
• Product Code: FPA · General Hospital
• Decision Date: May 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MiniLoc™ 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 MiniLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. The MiniLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. The MiniLoc™ 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 MiniLoc™ Safety Infusion Set may be used in any appropriate patient population.

Device Story

MiniLoc™ Safety Infusion Set is a sterile, single-use, non-coring right-angle Huber needle administration set for accessing surgically implanted vascular ports. Device facilitates fluid/drug infusion and blood sampling. Operation involves manual insertion into the port; upon completion, clinician uses a one-handed technique to withdraw the needle. During withdrawal, an integral safety mechanism automatically activates, locking a shield over the needle to prevent accidental needlestick injuries. Confirmation of lockout is provided via tactile feel, audible click, and visual inspection. Used in clinical settings by healthcare professionals. Benefits include reduced risk of sharps injuries to clinicians during needle removal. Available in configurations with or without Y-injection sites and needleless adapters.

Clinical Evidence

Bench testing and simulated use study only. A simulated use study of 500 units demonstrated successful insertion and activation of the safety mechanism by clinicians with zero sharps injuries.

Technological Characteristics

Right-angle Huber needle; integral manual-activation safety shield; sterile, non-pyrogenic, single-use. Materials meet ISO 10993 biocompatibility standards. Configurations include optional Y-injection site and needleless adapter. Mechanical operation; no electronic or software components.

Indications for Use

Indicated for any patient population requiring access to surgically implanted vascular ports for fluid/drug administration or blood sampling. No specific contraindications listed.

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

• LiftLoc® Safety Infusion Set (K013394 and K042234)

Submission Summary (Full Text)

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# MAY 1 2 2005 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for MiniLocTM Safety Infusion Set

# 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:

March 7, 2005

## NAME OF MEDICAL DEVICE:

Classification Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Proprietary Name: MiniLoc™ 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:

LiftLoc® Safety Infusion Set, Specialized Health Products, Inc., Bountiful, UT 84054, (K013394 and K042234).

# DEVICE DESCRIPTION:

The MiniLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The MiniLocTM 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. The MiniLocTM Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.

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

Conventional clinical practice is used to remove the MiniLoc™ Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the MiniLoc™ finger tabs 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. As the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. A tactile feel, an audible click and/or visual confirmation verifies the lockout of the safety shield over the needle. The MiniLoc™ Safety Infusion Set, now with a protected needle, is discarded in a sharps container.

The product has three configurations: A set with and without an adaptable Y-injection site and a set with a needleless adapter attached to the Y-site.

## INTENDED USE:

The MiniLoc™ 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 MiniLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

The MiniLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. The MiniLoc™ 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 MiniLoc™ 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 MiniLoc™ Safety Infusion Set is substantially equivalent to the following Huber needle intravascular administration set: LiftLoc® Safety Infusion Set (K013394 and K042234), Specialized Health Products, Inc., Bountiful, UT 84054.

A summary of the key technological comparisons follows:

- The MiniLoc™ Safety Infusion Set utilizes a right angle Huber needle to access . implanted vascular ports, as does the predicate device cited in this submission.
- . The MiniLoc™ Safety Infusion Set operates as a standard Huber needle intravascular administration set, as does the Specialized Health Product's Safety Infusion set: LiftLoc® Safety Infusion Set (K013394 and K042234).
- . The MiniLoc™ Safety Infusion Set is manufactured from the same or similar materials as the predicate device. All materials will meet ISO 10993 requirements for material safety and biocompatibility.
- The MiniLoc™ Safety Infusion Set has a safety feature to help prevent accidental . needlestick injuries, as does the LiftLoc® Safety Infusion Set (K013394 and K042234).

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# SUMMARY OF PERFORMANCE TESTING:

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

## SUMMARY OF SIMULATED USE STUDY:

A total of 500 MiniLoc™ Safety Infusion Sets were successfully inserted by clinicians into simulated tissue and activated. No sharps injuries of the integral needlestick prevention feature/safety mechanism occurred.

# CONCLUSION:

The material testing and simulated use data demonstrate that the MiniLoc™ 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 set: the LiftLoc® Safety Infusion Set (K013394 and K042234).

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2005

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

Re: K050600

Trade/Device Name: MiniLoc™ Safety Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 7, 2005 Received: March 10, 2005

Dear Mr. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nate 10 row 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 mersure comments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to actives 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 upprovisions of the Act. The general controls provisions of the Act include Controls providents of a 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 MA), it may of subject to base of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh 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 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 and libing (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicellents as lectronic 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), 11 yea 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/industry/support/index.html.

Sincerely yours,

Sputte y. Michie Oms.

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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# Indications For Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: MiniLoc™ Safety Infusion Set

Indications For Use:

- The MiniLoc™ 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 MiniLoc™ Safety Infusion Set safety mechanism is manually . activated during the removal of the MiniLoc™ 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 MiniLoc™ Safety Infusion Set is intended for use in the administration of . fluids and drugs, as well as blood sampling through surgically implanted ports.
- The MiniLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device.
- The MiniLoc™ 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 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEL

Concurrence of CDRH, Office of Device Evaluation (ODE)

Upton Dm

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

510(k) Number:_1545

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