SAFESTEP MAX POWER-INJECTABLE INFUSION SET

K073050 · Specialized Health Products International, Inc. · FPA · Jan 25, 2008 · General Hospital

Device Facts

• Record ID: K073050
• Device Name: SAFESTEP MAX POWER-INJECTABLE INFUSION SET
• Applicant: Specialized Health Products International, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SafeStep® MAX™ Power-Injectable Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

Device Story

SafeStep® MAX™ is a non-coring Huber-type right-angle needle and administration set featuring a manually activated safety mechanism to shield the needle after use, reducing needlestick injury risk. Used in clinical settings by healthcare providers to access surgically implanted vascular ports for fluid/drug delivery, blood sampling, and power injection of contrast media. Operation involves priming with saline, inserting into port septum, and securing. Upon removal, the provider pulls a textured handle to lock the needle into a safety position before disposal. The device enables high-flow contrast delivery for diagnostic imaging, benefiting patients by facilitating both routine therapy and specialized radiological procedures through a single access point.

Clinical Evidence

Bench testing only. Verification testing performed per FDA guidance for intravascular administration sets and sharps injury prevention features. Testing confirmed performance equivalence to predicates regarding flow rates, safety mechanism activation, and structural integrity under power injection pressures.

Technological Characteristics

Non-coring right-angle Huber needle with manual safety shielding mechanism. Materials evaluated per ISO 10993 for externally communicating devices (>24h to 30 days). Sterilization via ethylene oxide (ISO 11135) or radiation (ISO 11137). Available in 19G, 20G, and 22G sizes.

Indications for Use

Indicated for patients requiring access to surgically implanted vascular ports for fluid/drug administration, blood sampling, and power injection of contrast media (when used with compatible ports). Contraindicated for use with ports not rated for power injection. Max infusion rates: 5 ml/s (19G/20G), 2 ml/s (22G).

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

• SafeStep Huber Needle Set (K040527)
• PowerLoc™ Safety Infusion Set (K060812)
• Lifeguard Safety Infusion Set (K062414)
• Gripper Plus® Power P.A.C. Needle (K070116)

Submission Summary (Full Text)

{0}------------------------------------------------

K073050

Page lot 5

Specialized Health Products International, Inc. 510(k) Premarket Notification Submission: SafeStep® MAX™ Power-Injectable Infusion Set

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for SafeStep® MAX™ Power-Injectable Infusion Set

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

#### ESTABLISHMENT REGISTRATION NUMBER: 1723684

JAN 25 / 00

#### CONTACT:

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

#### DATE PREPARED:

January 25, 2008

## NAME OF MEDICAL DEVICE:

Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Proprietary Name: SafeStep® MAX™ Power-Injectable Infusion Set

# DEVICE CLASSIFICATION:

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

## PREDICATE DEVICES:

Trade/Device Name: Luther Safety Huber Needle (Re-brunded as "SafeStep" Safety Huber Needle Set") (K040527, K021565) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440

Confidential

{1}------------------------------------------------

K073056 page 2 of 5

# Specialized Health Products International, Inc. 5 10(k) Premarket Notification Submission: SafeStep® MAX™ Power-Injectable Infusion Set

Trade/Device Name: PowerLoc™ Safety Infusion Set (K060812) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440

Trade/Device Name: Lifeguard Safety™ Infusion Set (K062414) Regulation Name: Intravascular Administration Set Common/Usual Name: Port Access Infusion Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440

Trade/Device Name: Gripper Plus® P.A.C. Needle (K070116) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440

#### DEVICE DESCRIPTION:

The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature.

The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.

The SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also

{2}------------------------------------------------

indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles. and 2 ml/s for 22 gauge needles.

The device functions in a similar manner to all the predicate devices. The insertion site is prepared and the device is primed using a 10 ml syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the base of the device by securely holding the base down and firmly pulling the textured handle up until you feel a firm stop and the needle is locked into the safety position. Dispose the set into a sharps container.

#### INTENDED USE:

The intended use of the SafeStep® MAX™ Power-Injectable Infusion Set has not changed when compared to the predicate devices. This is the same intended use as the predicates SafeStep Huber Needle Set(K040527), PowerLoc™ Safety Infusion Set (K060812). Lifeguard Safety® Safety Infusion Set (K062414) and Gripper Plus" Power P.A.C. Needle (K070116).

The SafeStep® MAX™ Power-Injectable Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The intended use has not changed from that of the predicate devices.

# INDICATIONS FOR USE:

The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.

The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

# TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.

{3}------------------------------------------------

K-73050 page 4 of 5

#### Specialized Health Products International, Inc. 510(k) Premarket Notification Submission: SafeStep® MAX™ Power-Injectable Infusion Set

Does the new device have the same indication statements? No. The Indications for Use for the infusion set were expanded to include power injection of contrast media into surgically implanted ports that are also indicated for power injection.

Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc.? Not in all regards. The SafeStep® MAX™ Power-Injectable Infusion Set has some minor differences from the predicate devices. The basic fundamental scientific technology of the device has not changed.

Could the new characteristics affect safety or effectiveness? Yes, the expanded indication to include power injection of contrast media through a power injection indicated port could affect safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.

The FDA's Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification] Submissions [510(k)], dated April ] 5, 2005.

Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, August 9. 2005.

Sterilization requirements of ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.

Sterilization requirements of ISO 11137: 2006, Sterilization of health care products -Radiation.

Biocompatibility requirements according to of ISO-10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating devices with an indirect blood path with a contact duration of >24 hours to 30 days.

These and other standards were used to determine the appropriate methods for evaluating the modified device's performance.

Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.

Confidential

{4}------------------------------------------------

\$\frac{1}{2} x + 2\$ \$\frac{1}{2} x - 5\$

Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrated that the SafeStep® MAX™ Power-Injectable Infusion Set is substantially equivalent to the noted predicate devices.

# CONCLUSION

The SafeStep® MAX™ Power-Injectable Infusion Set met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the SafeStep® MAX™ Power-Injectable Infusion Set is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices: SafeStep® Huber Needle Set(K040527), PowerLoc™ Safety Infusion Set (K060812), Lifeguard Safety Infusion Set (K062414) and Gripper Plus® Power P.A.C. Needle (K070116).

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

# JAN 25 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073050

Trade/Device Name: SafeStep® MAX™ Power-Injectable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2007 Received: October 29, 2007

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.

{6}------------------------------------------------

#### 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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), 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/industry/support/index.html.

Sincerely yours,

Clus

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

{7}------------------------------------------------

K07-305C

# Indications For Use

510(k) Number (if known):

Device Name: SafeStep® MAX™ Power-Injectable Infusion Set

Indications For Use:

The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.

The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

Prescription Use X (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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintia V,m

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

510(k) Number: 73054