POWERLOC CLEAR SAFETY INFUSION SET
Device Facts
| Record ID | K082306 |
|---|---|
| Device Name | POWERLOC CLEAR SAFETY INFUSION SET |
| Applicant | C.R. Bard, Inc. |
| Product Code | FPA · General Hospital |
| Decision Date | Aug 28, 2008 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PowerLoc* Clear Safety 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
PowerLoc Clear Safety Infusion Set is an intravascular administration set featuring a non-coring Huber right-angle needle and a manually activated needle-stick safety mechanism. Used in clinical settings to access surgically implanted vascular ports; operated by healthcare professionals. Device is primed with saline, inserted into port septum, and secured. Upon removal, the safety mechanism is manually activated to shield the needle, reducing accidental needle-stick injury risk. Supports fluid/drug administration, blood sampling, and power injection of contrast media when used with Bard PowerPort devices. Benefits include clinician safety via needle shielding and compatibility with high-pressure contrast injection.
Clinical Evidence
Bench testing only. Verification testing performed per FDA guidance for intravascular administration sets and sharps injury prevention features. Evaluated against ISO standards for sterilization (ISO 11135), biocompatibility (ISO 10993), packaging (ISO 11607), and risk management (ISO 14971). Results met all predetermined acceptance criteria.
Technological Characteristics
Non-coring Huber right-angle needle; manually activated needle-stick safety mechanism. Materials evaluated per ISO 10993. Sterilization via ethylene oxide (ISO 11135). Packaging validated per ISO 11607. Compatible with power injection at specified flow rates (5 ml/s for 19/20G, 2 ml/s for 22G).
Indications for Use
Indicated for accessing surgically implanted vascular ports for fluid/drug administration and blood sampling. When used with PowerPort devices, indicated for power injection of contrast media into the central venous system. Max infusion rates: 5 ml/s (19G, 20G needles), 2 ml/s (22G needles).
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
Submission Summary (Full Text)
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AUG 2 8 2008
Bard PowerLoc* Clear Safety Infusion Set Special 510(k)
# Section 6 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a)
### General Information 6.1
| Submitter Name: | Bard Access Systems, Inc. (BAS)<br>[Wholly owned subsidiary of C.R. Bard, Inc.] |
|-----------------------|---------------------------------------------------------------------------------|
| Address: | 605 North 5600 West<br>Salt Lake City, Utah 84116 |
| Telephone Number: | (801) 595-0700 ext. 5428 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Henry Boland |
| Date of Preparation: | 11 August 2008 |
| Registration Numbers: | |
| Bard Access Systems: | 3006260740 |
| C. R. Bard: | 2212754 |
### Subject Device Information 6.2
| DeviceTrade Name: | PowerLoc* Clear Safety Infusion Set |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Huber Needle Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set<br>21 CFR 880.5440 - Class II<br>FPA - Intravascular Administration Set |
| Classification Panel: | General Hospital |
### Primary Predicate Device Information 6.3
| Device/Trade Name: | PowerLoc* Safety Infusion Set |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Huber Needle Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set<br>21 CFR 880.5440 - Class II<br>FPA - Intravascular Administration Set |
| Classification Panel: | General Hospital |
| 510(k) Clearance: | K060812, concurrence date 14 July 2006 |
### Secondary Predicate Device Information 6.4
.
| Device/Trade Name: | Huber Clear* Safety Infusion Set |
|-----------------------|----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Huber Needle Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set<br>21 CFR 880.5440 - Class II<br>FPA - Intravascular Administration Set |
| Classification Panel: | General Hospital |
| 510(k) Clearance: | K051009, concurrence date 12 July 2005 |
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K082346 (P,2 w^4)
Bard
Bard PowerLoc* Clear Safety Infusion Set Special 510(k)
#### 6.5 Device Description
The PowerLoc* Clear Safety Infusion Set is comprised of a standard non-coring Huber type needle and administration set with an integral needle-stick safety mechanism.
The PowerLoc* Clear Safety Infusion Set is a standard intravascular administration set with a non-coring Huber right angle needle and a manually activated needle-stick safety mechanism which reduces the risk of accidental needle-stick injuries by shielding the needle after use. The device is used to access surgically implanted vascular ports and indicated for use in the administration of fluids and drugs, as well as blood sampling.
The PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system through the Bard PowerPort* device family. The maximum recommended infusion rate is 5 mils for 19 gauge and 20 gauge, and 2 mils for 22 gauge needles.
The device functions in a similar manner to the predicate devices. The insertion site is prepared and the device is primed using a 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 implanted port with non-dominant hand and removing the device while simultaneously activating the needle-stick safety mechanism with the dominant hand.
#### Intended Use 6.6
The PowerLoc* Clear Safety 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 of the PowerLoc* Clear Safety Infusion Set has not changed when compared to the PowerLoc* and Huber Clear * Safety Infusion Sets.
#### 6.7 Indications for Use
The indications for use of the PowerLoc* Clear Safety Infusion Set has not changed when compared to the predicate PowerLoc* Safety Infusion Set device.
The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports.
The PowerLoc* Clear Safety 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 the PowerPort* device family, the PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum
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recommended infusion rate is 5 mils for 19 Ga. and 20 Ga. needles and 2 mils for 22 Ga. needles.
### 510(k) Substantial Equivalence Decision Tree 6.8
New device is compared to Marketed Device? Yes. The subject device is compared to legally marketed predicate devices.
Does the new device have the same indication? Yes. The subject device and predicate PowerLoc* Safety Infusion Set device indication statements are identical.
Does the new device have the same technological characteristic, e.g. design, materials, etc.? No, not in all regards. The fundamental scientific technology of the device is the same as the predicate devices. None of the noted design differences have a major effect on the safety and effectiveness of the subject device or preclude its substantial equivalence to any significant degree.
Could the new characteristics affect safety or effectiveness? Yes. The design changes could affect safety or effectiveness.
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 following FDA recognized standards were used to evaluate the device performance:
Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)], dated April 15, 2005
Guidance for Industry and FDA Staff - Medical Devices with Sharps Injury Prevention Features, dated August 9, 2005
ISO 11135:2007 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
ISO 10993-1:2003 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
ISO 10993-7:1995 - Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
ISO 11607-1:2006 - Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
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ISO 14971:2007 - Medical Devices - Application of Risk Management to Medical Devices
These and other standards were used to determine the appropriate methods for evaluating the subject 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, with favorable performance examination results available as objective evidence in each test category.
Performance data demonstrate equivalence? Yes. Performance data gathered in design verification met predetermined acceptance criteria and thus demonstrated that the subject PowerLoc* Clear device is substantially equivalent to the predicate PowerLoc* and Huber Clear* devices. The risks associated with use of the new device were found acceptable when evaluated through the risk management process including FMEA.
## Conclusion
The subject PowerLoc* Clear Safety Infusion Set met all predetermined acceptance criteria of design verification evaluations through testing examination. Based on the FDA's decision tree, it is logically concluded through evidence that the subject device is substantially equivalent to the predicate devices, PowerLoc* Safety Infusion Set (K060812) and Huber Clear* Safety Infusion Set (K051 009).
* PowerLoc, Huber Clear and PowerPort are trademarks and/or registered trademarks of C.R. Bard, Inc. or an affiliate.
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Image /page/4/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
C.R. Bard, Incorporated Mr. Henry Boland Associate Regulatory Affairs Specialist Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116
Re: K082306
Trade/Device Name: PowerLoc* Clear Safety Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 11, 2008 Received: August 13, 2008
Dear Mr. Boland:
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. Boland
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chin S. Lin, Ph.D.
Chiu S. Lin. Ph. D Division 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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## Section 5 Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
AUG 2 8 2008
Device Name: PowerLoc* Clear Safety Infusion Set
Indications for Use:
The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports.
The PowerLoc* Clear Safety 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 the PowerPort* device, the PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles and 2 ml/s for 22 Ga. needles.
*PowerPort and PowerLoc are trademarks and/or registered trademarks of C.R. Bard, Inc. or an affiliate.
Prescription Use _ × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Centras D, nunt
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
