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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard PowerLoc* Clear Safety Infusion Set.

Important Note: This document is a 510(k) summary, which is a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical trial or performance study with specific device performance metrics in the way one might expect for a novel AI or diagnostic device. The "acceptance criteria" here refer more to meeting established engineering and regulatory standards rather than performance metrics like sensitivity/specificity for a diagnostic.

Acceptance Criteria and Device Performance

There is no table of specific acceptance criteria and reported device performance in the traditional sense of a diagnostic or risk-based AI device accuracy. Instead, the document states that the device was evaluated against various recognized standards and guidance documents. The "acceptance criteria" were met if the device demonstrated compliance with these standards and showed equivalence to predicate devices.

Acceptance Criteria Category (Derived from Standards)	Reported Device Performance Summary (Based on Text)
Intravascular Administration Set Performance	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Sharps Injury Prevention Features	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Ethylene Oxide Sterilization (Validation & Control)	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Biocompatibility (Biological Evaluation)	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Ethylene Oxide Sterilization Residuals	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Packaging Requirements (Materials, Barrier Systems)	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Packaging Validation (Forming, Sealing, Assembly)	Met predetermined acceptance criteria through testing examination, demonstrating substantial equivalence to predicate devices.
Risk Management (Application of ISO 14971)	Risks associated with use were found acceptable when evaluated through the risk management process including FMEA.

Study Details

It is important to understand that this is a 510(k) submission, not a detailed clinical study report for a diagnostic algorithm. The "study" here refers to "design verification evaluations through testing examination."

Sample Sizes Used for Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "verification testing" being performed but does not specify the number of devices or units tested for each standard.
- Data Provenance: Not applicable in the context of clinical patient data. The provenance relates to laboratory and engineering testing under controlled conditions, likely conducted by the manufacturer (Bard Access Systems, Inc.) or its designated testing facilities, presumably in the US (Salt Lake City, Utah). The testing would be prospective in the sense that new devices were manufactured and then tested according to the protocols.
Number of Experts and Qualifications for Ground Truth:
- Not applicable. This device is not a diagnostic system requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" here is adherence to engineering specifications and regulatory standards.
Adjudication Method for the Test Set:
- Not applicable. This is not a situation where expert adjudication of conflicting interpretations is required. Compliance with standards and specifications is typically determined by objective measurements and predefined pass/fail criteria.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The PowerLoc* Clear Safety Infusion Set is a physical medical device (needle and administration set) and does not involve human readers interpreting data.
Standalone (Algorithm Only) Performance:
- Not applicable. This device does not contain an AI algorithm. Its performance is entirely mechanical and material-based. The "algorithm" here is the design of the physical device itself and its interaction with the human user in terms of safety features.
Type of Ground Truth Used:
- The "ground truth" is defined by the FDA recognized standards (e.g., ISO 11135, ISO 10993-1, ISO 11607-1, etc.) and guidance documents referenced in Section 6.8. Compliance with these standards, through objective measurements and predefined acceptance criteria during verification testing, serves as the "ground truth" that the device is safe and effective for its intended use.
Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set for this type of device.

Summary

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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)[Wholly owned subsidiary of C.R. Bard, Inc.]
Address:	605 North 5600 WestSalt 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 Set21 CFR 880.5440 - Class IIFPA - 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 Set21 CFR 880.5440 - Class IIFPA - 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 Set21 CFR 880.5440 - Class IIFPA - 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.

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 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 indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

*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:

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.