The LifeShield® Latex-Free Microbore Extension Set consists of DEHP-plasticized polyvinyl tubing with a secure lock male adapter and air filter assembly on one end and locking female Luer adapter with removable CLAVE® Connector on the other end.

AI/ML Overview

The provided text is a 510(k) summary for the LifeShield® Latex-Free Microbore Extension Set. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for novel devices involving performance metrics.

Here's why and what information is available:

This is a Special 510(k) submission, which is generally used for modifications to a manufacturer's own legally marketed device. In such cases, the primary focus is on demonstrating that the modified device remains substantially equivalent to the predicate device, not necessarily on establishing new performance criteria or conducting extensive clinical studies with new acceptance criteria.
The document explicitly states: "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Fluid Delivery Tubing." This indicates that there aren't pre-defined regulatory performance benchmarks that the device needs to meet with specific acceptance criteria.
The "Statement of Safety and Effectiveness" simply declares that the device "meets the finances of the states the described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate LifeShield® Extension Sets." This reiterates the focus on substantial equivalence rather than fulfilling specific performance metrics against acceptance criteria.

Therefore, I cannot populate the requested table or sections related to a study proving acceptance criteria due to the absence of that information in the provided text.

The document is a submission to the FDA for market clearance based on substantial equivalence, which is a different process than demonstrating performance against established acceptance criteria for a novel device or a device with new performance claims.

Summary of available information (and absence of others):

1. Table of acceptance criteria and reported device performance:
* Not Applicable / Not Provided. The document does not describe specific acceptance criteria (e.g., flow rate, pressure resistance, leakage rate with defined thresholds) or a study reporting performance against such criteria. The submission is based on substantial equivalence to predicate devices, implying that their performance characteristics are considered acceptable.

2. Sample size used for the test set and data provenance:
* Not Applicable / Not Provided. No "test set" in the context of performance evaluation or clinical study is mentioned. The submission is based on device characteristics comparison to predicate devices, not on data from a test set of patients or samples.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not Applicable / Not Provided. No ground truth establishment or expert review for a test set is discussed.

4. Adjudication method for the test set:
* Not Applicable / Not Provided. No test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* Not Applicable / Not Provided. This type of study is irrelevant for a fluid delivery tubing submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not Applicable / Not Provided. This device is hardware; the concept of an "algorithm only" performance study is not relevant.

7. The type of ground truth used:
* Not Applicable / Not Provided. No ground truth for performance evaluation is mentioned. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:
* Not Applicable / Not Provided. No "training set" in the context of an AI/ML algorithm or clinical data is mentioned.

9. How the ground truth for the training set was established:
* Not Applicable / Not Provided. See above.

Key takeaway: This 510(k) submission relies on demonstrating substantial equivalence to existing, legally marketed devices. It does not present a study with specific acceptance criteria that the device's performance was measured against, as would be common for novel, performance-driven devices. The FDA clearance letter reinforces this by focusing on regulatory classification and labeling requirements based on the substantial equivalence determination.

Summary

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LifeShield® Latex-Free Microbore Extension Set Special 510(k) / September 2005

NOV - 2 2005

Special 510(k) Summary

Name of Submitter:

Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045 Owner/Operator #: 9063339

Manufacturer and Establishment Registration Number:

Manufacturer:	Sterilization Site:
Hospira Holdings De Costa Rica, LTDZona Franca GlobalLa Aurora De Heredia, Costa Rica	Hospira, Inc. - Rocky MountHwy. 301 NorthP.O. Box 2226Rocky Mount, NC 27801
Establishment Registration #: 9615050	Establishment Registration #: 1021343

Proprietary or Trade Name of Proposed Device: LifeShield® Latex-Free Microbore Extension Set Common Name: Fluid Delivery Tubing

Device Classification, Pancode and ProCode: Class II, 80-FPK

Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Fluid Delivery Tubing. Fluid Delivery Tubing is regulated within 21 CFR 880.5440.

Intended Use Indications for Use:

The LifeShield® Latex-Free Microbore Extension Set is intended for the delivery of fluids from a container to a patient's vascular system.

Proposed Device Description:

Summary of Substantial Equivalence

The LifeShield® Latex-Free Microbore Extension Set as described in this submission utilizes components (i.e., set tubing and High Pressure CLAVE) from the predicate LifeShield® Latex-Free, Primary IV Pump Set with Distal Microbore Patient Line (K033576) and is substantially equivalent to the predicate LifeShield® Microbore Extension Set (K912103) with respect to the following characteristics:

Similarities:

1. The extension sets are intended for the delivery of fluids from a container to a patient's vascular system.
1. The devices are provided with a non-pyrogenic, sterile fluid-path and are intended for one-time use.
1. The technology and operating principles (i.e., administration/infusion of intravenous medications to a patient's vascular system with the assistance of gravity or an infusion pump are the same, and
1. The materials of construction are the same.

Differences:

1. The inner and outer diameter of the set tubing for the modified LifeShield® Latex-Free Microboxe Extension Set is larger and the maximum infusion pressure for the set is specified on the package label.

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Statement of Safety and Effectiveness
The LifeShield® Latex-Free Microbore Extension Set meets the finances of the states the described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate LifeShield® Extension Sets.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by a series of three curved lines that resemble a human profile. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas Kozma, Ph.D. Associate Director, Global Device Regulatory Affairs Hospira, Incorporated Department 0389, Building H2 275 North Field Drive Lake Forest, Illinois 60045

Re: K052722

Trade/Device Name: Lifeshield Latex-free Microbore Extension Set, Model 14949 Regulation Number: 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA, FPK Dated: September 28, 2005 Received: September 29, 2005

NOV - 2 2005

Dear Dr. Kozma:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act. the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use with power injection and high power infusion systems have not been established.

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Page 2 - Dr. Kozma

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0343. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hlman, Ph.D., M.P.A. onna-B Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) Ko52722

LifeShield® Latex-Free Microbore Extension Set Device Name:

Indications for Use:

The LifeShield® Latex-Free Microbore Extension Set is intended for the delivery of fluids from a container to a patient's vascular system.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

Dianne Vontz

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

Page 1 of 1

510(k) Number: _ < < 3222323

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.