The LifeGuard™ Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard™ Safety Infusion Set facilitates safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.

Device Description

The LifeGuard™ Infusion Set is a standard 90° non-coring needle intravascular administration set with a sharps injury protection. The LifeGuard™ Infusion Set is designed for use with vascular access devices. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. The components that comprise the LifeGuard™ Safety Infusion Set includes the following: a PVC tubing set; a white clamp to prevent fluid flow; a universal female luer lock connector to connect to infusion/aspiration devices; a white cap to close the female luer; a winged needle holder to secure the infusion set to the patient with a pre-attached 90° non-coring needle to access the implanted port and allow the user to pull the needle up into the safety position; a needle trap encapsulates the needle after de-accessing the needle from the implanted port; and a needle guard shrouds the needle before use. Some models include a Ysite as an alternate female luer injection site with an additional white cap and white clamp to prevent fluid flow. A thermoformed tray with a heat sealed tyvek lid provides a sterile barrier. The LifeGuard™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The LifeGuard™ Safety Infusion Sets are supplied as sterile, non-latex, nonpyrogenic, intended for single use only and are manufactured out of non-DEHP PVC. De-accessing the needle is done as with any standard non-coring needle, using a one-handed (dominant hand) technique to remove the needle while stabilizing the port with the nondominate hand. As the needle is removed, the passive sharps injury protection feature is actuated by sliding the needle holder upward, · which encapsulates the needle within the needle trap.

AI/ML Overview

The provided text describes a medical device, the LifeGuard™ Safety Infusion Set, and details its performance through a "Simulated Use Study". This study focuses on the effectiveness of the sharps injury protection feature.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Failure rate of sharps injury protection	Less than 1.1% (at 95% confidence) or less than 1.5% (at 99% confidence)

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: n=500 for the Simulated Use Study.
- Data Provenance: The document does not specify the country of origin. It is a "Simulated Use Study," implying controlled conditions rather than retrospective or prospective patient data from real-world usage.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide details on the number or qualifications of experts used to establish ground truth for this specific "Simulated Use Study." The study focuses on a measurable mechanical failure rate of the safety feature.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set. Given the nature of a "failure rate" for a mechanical safety feature, an adjudication process involving human interpretation is unlikely in the same way it would be for diagnostic imaging.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a mechanical infusion set with a safety feature, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable. The device is a physical medical device, not an algorithm. The "Simulated Use Study" evaluates the physical device's performance, which inherently includes human interaction (users pulling the needle up) to actuate the safety feature but measures the device's mechanical success.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the Simulated Use Study appears to be based on the direct observation and quantification of the mechanical failure of the sharps injury protection feature. There is no indication of expert consensus, pathology, or outcomes data being used to establish this specific ground truth. It's a binary outcome: the safety feature either successfully encapsulates the needle or it fails.
The sample size for the training set:
- The document does not mention a "training set." The study described is a "Simulated Use Study" to test the performance of the final device, not to train a machine learning model.
How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned in the context of this device's evaluation.

Summary

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K013871

MAR 2 9 2002 Proprietary to Horizon Medical Products, Inc. 510(k) Summary of Safety and Effectiveness LifeGuard™ Safety Infusion Set

Date Summary
Was Prepared:	March 5, 2002
Submitter's
Information:	Horizon Medical Products, Inc.
	One Horizon Way
	Manchester, Georgia 31816
Telephone Number:	706-846-3126
Fax Number:	706-846-3180
Contact Person:	Patricia Jones, Regulatory Affairs Associate
Device Trade Name:	LifeGuard™ Safety Infusion Set
Device Common Name:	Safety Infusion Set
Classification Name:	Intravascular Administration Set
Classification Panel:	General Hospital Use

Legally Marketed Devices To Which Substantial Equivalence Is Claimed To:

The LifeGuard™ Safety Infusion Set is substantially equivalent to

Horizon Medical Products LifePort® Infusion Set (K921674) .
Millennium Safety Non-coring Plus Infusion Set (K993848) .

Device Description:

Horizon Medical Products, Inc. Amendment to 510(k)# K013871 for LifeGuard™ Safety Infusion Set Predicate 510(k)s: LifePort® Infusion Set (K921674) and Millennium Non-coring Plus Safety Infusion Set (K993848) March 5, 2002

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Proprietary to Horizon Medical Products, Inc.

The components that comprise the LifeGuard™ Safety Infusion Set includes the following: a PVC tubing set; a white clamp to prevent fluid flow; a universal female luer lock connector to connect to infusion/aspiration devices; a white cap to close the female luer; a winged needle holder to secure the infusion set to the patient with a pre-attached 90° non-coring needle to access the implanted port and allow the user to pull the needle up into the safety position; a needle trap encapsulates the needle after de-accessing the needle from the implanted port; and a needle guard shrouds the needle before use. Some models include a Ysite as an alternate female luer injection site with an additional white cap and white clamp to prevent fluid flow. A thermoformed tray with a heat sealed tyvek lid provides a sterile barrier.

The LifeGuard™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The LifeGuard™ Safety Infusion Sets are supplied as sterile, non-latex, nonpyrogenic, intended for single use only and are manufactured out of non-DEHP PVC.

De-accessing the needle is done as with any standard non-coring needle, using a one-handed (dominant hand) technique to remove the needle while stabilizing the port with the nondominate hand. As the needle is removed, the passive sharps injury protection feature is actuated by sliding the needle holder upward, · which encapsulates the needle within the needle trap.

Indication for Use:

Horizon Medical Products, Inc. Amendment to 510(k)# K013871 for LifeGuard™ Safety Infusion Set Honzon Modiour Tousion Ret (K921674) and Millennium Non-coring Plus Safety Infusion Set (K993848) March 5, 2002

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Technological Characteristics:

The LifeGuard™ Safety Infusion Set is manufactured from the same materials as the LifePort® Infusion Set. The current LifePort® Infusion Set does not have a sharps injury protection. The LifeGuard™ Safety Infusion set needle; components and safety mechanism are all fabricated out of medical grade materials. The LifeGuard™ Safety Infusion Set operates the same as a standard non-coring needle with the addition of a safety feature to help prevent needlestick injuries.

Performance Data

Horizon Medical Products, Inc. certifies that the materials used to manufacture the winged needle holder, base and needle trap are the same materials used in the manufacture of the LifePort® Infusion Set predicate device (refer to Biocompatibility Matrix). The same manufacturing process and type of sterilization that are used for the manufacture of Horizon's predicate device and Horizon's other legally marketed medical devices will be used to manufacture and sterilize the LifeGuard™ Infusion Set. The cannula tubing, Y-connector (minus synthetic polyisoprene injection port with shinkwrap), non-coring needle, female luer connector, white clamp and white cap remain identical to the LifePort® Infusion set predicate device. Since the critical features of the device have not changed, performance results will be identical to the predicate device (LifePort® Infusion Set). Testing was performed on the LifeGuard™ Safety Infusion Set to show adequacy of the device design and substantial equivalency.

A Simulated Use Study (n=500) demonstrated that the failure rate of the sharps injury protection feature is less than 1.1% (at 95% confidence) or less than 1.5% (at 99% confidence). Test results demonstrated that the LifeGuard™ Safety Infusion Set is substantially equivalent to the noted predicate devices commercially in distribution for the same intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2002

Ms. Patricia D. Jones Regulatory Affairs Associate Horizon Medical Products, Incorporated 1 Horizon Way Manchester, Georgia 31816

Re: K013871

Trade/Device Name: LifeGuard™ Safety Infusion Set Regulation Number: 880.5440 and 880.5965 Regulation Name: Intravascular Administarion Set Regulatory Class: II Product Code: FPA and LJT Dated: March 5, 2002 Received: March 6, 2002

Dear Ms. Jones:

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.

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.

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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 ifound (1) 02 reading 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Runns

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Proprietary to Horizon Medical Products, Inc.

Indication for Use Statement IV.

PREMARKET NOTIFICATION

INDICATION FOR USE STATEMENT

510(k) Number:

LifeGuard™ Safety Infusion Set Device Name:

K013871

Indication for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use ___________ (Per 21 or Prescription Use CFR 801.109)

Atuan Cuscinito

ision Sign-Off) vision of Dental, Infection Control, Ceneral Hospital Devices Number_ A 0/30

004

Horizon Medical Products, Inc. Traditional 510(k) for LifeGuard™ Safety Infusion Set Honzon Modioal Produced Infortrailed (VS2(674) and Millennium Huber Plus Safety Infusion Set (K993848) November 20, 2001

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.