SafeBreak® Vascular is intended to separate when excessive tension is exerted across intravenous (IV) and intraosseous (IO) administration sets. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV or IO catheter.

SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement.

SafeBreak® Vascular is intended to be used on peripheral IV catheters, midlines, peripherally inserted central catheter (PICCs), central venous catheters (CVCs), IV ports and port needles, and IOs in adults and pediatric populations two (2) weeks of age and older receiving intermittent or continuous infusions with an electronic pump.

Device Description

SafeBreak® Vascular is placed in-line with an intravenous or intraosseous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV or IO catheter.

SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.

AI/ML Overview

This document is a 510(k) summary for the SafeBreak® Vascular device (K231957). It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K223486). The primary purpose of this 510(k) is to expand the indications for use, not to introduce a new device or demonstrate the initial performance of a novel technology. Therefore, the information provided focuses on the differences in indications and how these changes do not raise new questions of safety or effectiveness, rather than presenting a de novo study proving the device's initial performance against specific acceptance criteria.

Based on the provided text, a direct table of acceptance criteria and reported device performance from a new study is not available, as the submission focuses on validating an expanded indication rather than a new device or a new primary performance study. The document refers to prior clinical studies for the predicate device.

Here's an analysis of the information available relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria or detailed reported device performance for K231957. The entire submission is a comparative assessment against the predicate device (K223486) to justify expanding its "Indications for Use" to include a broader range of vascular access types and patient ages.

The key performance characteristic mentioned for both the subject and predicate devices is the "Separation force" of 1-5 lbf. This is the functional acceptance criterion that the device is designed to meet, ensuring it separates when excessive tension is applied.

Implied Acceptance Criteria for Expanded Indications:

The document implicitly argues that the proposed expanded indications do not negatively impact the device's safety and effectiveness. This implies that the device, under the expanded indications, must continue to meet the established safety and performance requirements of the predicate device. These include:

Effective separation when excessive tension is applied.
Stopping fluid flow from the infusion pump and blood flow from the patient's catheter upon separation.
Aiding in the reduction of mechanical complications.
Maintaining biocompatibility and sterility.

Table: Acceptance Criteria (Implied) and Performance (Reported for Predicate/Subject)

Acceptance Criteria (Implied from Predicate and Subject Comparison)	Reported Device Performance (as stated in comparison)
Separation Force: Device separates at 1-5 lbf.	1-5 lbf (Identical for Subject and Predicate)
Functionality upon Separation: Stops fluid flow from pump and blood flow from catheter.	Yes (Identical for Subject and Predicate)
Aids in reduction of mechanical complications: (demonstrated in prior studies for predicate)	Yes (Implicitly maintained through substantial equivalence)
Biocompatibility & Sterility: (Not explicitly detailed here but assumed for all medical devices)	Yes (Sterilized by Ethylene Oxide, single use)
Expanded Indications Safety/Effectiveness: Maintain safety and effectiveness across new patient populations and vascular access types.	"All data, benefit-risk assessment, and clinical literature support the safety and effectiveness of the subject device in peripheral IV catheters, midlines, PICCs, CVCs, IV ports and port needles, and IOs."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The randomized and non-randomized clinical studies sponsored and conducted by Lineus Medical on the SafeBreak® Vascular device in the previous DEN190043 support the safety and effectiveness of the device in adolescents and adults."

Test Set Sample Size: Not specified in this document. It refers to "clinical studies" from a previous submission (DEN190043). To get the exact sample size, one would need to review the DEN190043 submission.
Data Provenance: The studies were "sponsored and conducted by Lineus Medical." The country of origin is not specified but generally, FDA submissions rely on data from studies conducted in the US or in compliance with international standards accepted by the FDA. The studies were clinical, implying prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text. Clinical studies typically involve healthcare professionals for data collection and assessment, but the number and specific qualifications of experts establishing a "ground truth" (e.g., for image interpretation or diagnosis) are not mentioned, especially since this is a mechanical device. The clinical studies likely focused on direct patient outcomes and device performance during use.

4. Adjudication Method for the Test Set

This information is not provided in the given text. For clinical studies, adjudication methods (e.g., by an independent clinical events committee) are common, but details are not included here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study is typically relevant for interpretative devices like imaging diagnostics. This is a mechanical device. Therefore, a MRMC study is not applicable and not mentioned in the document. The "clinical studies" mentioned would likely have focused on clinical outcomes, complication rates, and device functionality in a real-world setting.

6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

This is a mechanical device, not an algorithm, so the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance (e.g., separation force, flow cessation) would be evaluated in laboratory and clinical settings.

7. The Type of Ground Truth Used

For the previous clinical studies on the predicate device:

The "ground truth" would likely be objective clinical outcomes such as actual rates of IV/IO mechanical complications, successful separation events, and confirmation of flow cessation.
The document also states: "Review of clinical literature and pediatric extrapolation supports the use of the device..." This indicates that existing medical consensus and established data from scientific literature also serve as a form of "ground truth" for the expanded indications.

8. The Sample Size for the Training Set

This concept is primarily relevant for machine learning algorithms. For a mechanical device, there isn't a "training set" in the same sense. The device's design is likely refined through engineering studies, bench testing, and potentially pilot clinical evaluations. The clinical studies on the predicate device (DEN190043) would represent performance validation, not a "training set" for an algorithm. Therefore, not applicable in the context of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As with point 8, this question is primarily relevant for algorithm development. For a mechanical device, the design and engineering specifications define its intended function. Performance is then validated against these specifications through various tests. Thus, not applicable for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

September 29, 2023

Lineus Medical % Dawn Norman Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K231957

Trade/Device Name: SafeBreak® Vascular Regulation Number: 21 CFR 880.5220 Regulation Name: Intravenous Catheter Force-Activated Separation Device Regulatory Class: Class II Product Code: QOI Dated: June 30, 2023 Received: July 3, 2023

Dear Dawn Norman:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K231957

Device Name SafeBreak® Vascular

Indications for Use (Describe)

SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary K231957

Date Prepared:	September 29, 2023
Company:	Lineus Medical
	179 North Church Ave, Suite 202
	Fayetteville, AR 72701
Primary Contact:	Dawn Norman, MS
	Partner, MRC Global
	Phone: 618-604-3064
	Dawn.Norman@askmrcglobal.com
Company Contact:	Vance Clement
	Chief Executive Officer
	Lineus Medical
	Phone: 901-351-9270
	vance@lineusmed.com
Trade Name:	SafeBreak® Vascular
Common Name:	Intravenous Catheter Force-Activated Separation Device
Classification:	Class II
Regulation Number:	21 CFR 880.5220
Panel:	General Hospital
Product Code:	QOI
Primary Predicate:	K223486, SafeBreak® Vascular
	Manufacturer: Lineus Medical
Reference Device:	K230266, Orchid Safety Release Valve
	Manufacturer: Lineus Health Sciences

Device Description:

SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.

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

The purpose of this 510(k) is to expand the indications for use of the product to include use in peripheral IV catheters, midlines, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), IV ports and port needles, and IOs, in adult and pediatric populations two (2) weeks of age and older.

Indications for Use:

SafeBreak® Vascular is intended to separate when excessive tension is exerted across intravenous (IV) or intraosseous (IO) administration sets. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV or IO catheter. SafeBreak® Vascular is intended to aid in reduction of IV and IO mechanical complications requiring IV and IO replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters, midlines, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), IV ports and port needles, and IOs, in adults and pediatric populations two (2) weeks of age and older receiving intermittent or continuous infusions with an electronic pump.

Substantial Equivalence:

SafeBreak® Vascular is intended to separate when excessive tension is exerted across an IV or IO administration set. SafeBreak® Vascular is intended to aid in reduction in IV or IO mechanical complications requiring IV or IO replacement. The subject SafeBreak® Vascular has the identical materials, technological characteristics, and operating principle, as the predicate device.

The safety and effectiveness of the subject device has been verified and validated and all are substantially equivalent. Thus, it can be concluded that the subject SafeBreak® Vascular does not raise different questions about safety and effectiveness.

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

Device Comparison

	K231957	K223486	Assessment of Differences
	Subject	Predicate
	SafeBreak® Vascular is intended	SafeBreak® Vascular is intended to	Substantially Equivalent
	to separate when excessive	separate when excessive tension is
	tension is exerted across	exerted across a peripheral IV	Device usage modified to include use in
	intravenous (IV) and intraosseous	administration set. When	midlines, PICCs CVCs, IV ports, and IOs, in
	(IO) administration sets. When	SafeBreak® Vascular separates,	addition to peripheral IV catheters.
	SafeBreak® Vascular separates,	fluid flow is stopped from the
	fluid flow is stopped from the	infusion pump and blood flow is	Patient population modified from greater
	infusion pump and blood flow is	stopped from the patient's IV	than one (1) year of age to two (2) weeks of
	stopped from the patient's IV or	catheter. SafeBreak® Vascular is	age and older.
	IO catheter. SafeBreak® Vascular	intended to aid in reduction of
	is intended to aid in reduction of	peripheral IV mechanical	The safety and effectiveness of use of the
	IV and IO mechanical	complications requiring IV	reference device in the patient population
	complications requiring IV and IO	replacement. SafeBreak® Vascular	of two (2) weeks and older has been
	replacement.	is intended to be used on	established.
		peripheral IV catheters in adults
Indications for Use	SafeBreak® Vascular is intended	and pediatric populations greater	Data and clinical literature support the
	to be used on peripheral IVcatheters, midlines, peripherally	than one (1) year of age receivingintermittent or continuous	safety and effectiveness of the subjectdevice in peripheral IV catheters, midlines,
	inserted central catheters	infusions with an electronic pump.	PICCs, CVCs, IV ports, and IOs, in adult and
	(PICCs), central venous catheters		pediatric patient populations two (2)
	(CVCs), IV ports and port needles,		weeks of age and older. The change does
	and IOs in adult and pediatric		not raise any different questions of safety
	populations two (2) weeks of age		or effectiveness.
	and older, receiving intermittent
	or continuous infusions with an
	electronic pump.
	K231957Subject	K223486Predicate	Assessment of Differences
Materials	• Makrolon• Polycarbonate• Saint-Gobain• INEOS ABS Lustran• Silicone	Identical	Substantially EquivalentSubject and predicate materials areunchanged and identical.
Separation force	1-5 lbf	1-5 lbf	Identical;Substantially Equivalent
Environment ofUse	Hospital	Hospital	Identical;Substantially Equivalent
Principle ofOperation	The subject SafeBreak® Vascularconnects to the needlelessconnector found in the existing IVor IO extension set and to theexisting IV or IO administrationset via luer connectors. Uponinstallation of the SafeBreak®Vascular, an infusion can occur.Upon tension the SafeBreak®Vascular separates and the valveon each end of the device closes,stopping flow.	The subject SafeBreak® Vascularconnects to the needlelessconnector found in the existing IVextension set and to the existingIV administration set via luerconnectors. Upon installation ofthe SafeBreak® Vascular, infusioncan occur. Upon tension theSafeBreak® Vascular separatesand the valve on each end of thedevice closes, stopping flow.	Identical;Substantially Equivalent

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

{8}------------------------------------------------

	K231957Subject	K223486Predicate	Assessment of Differences
VascularAccessType	Peripheral intravenous catheter,central venous catheter,intraosseous catheter	Peripheral intravenous catheter	All data, benefit-risk assessment, andclinical literature support the safety andeffectiveness of the subject device inperipheral IV catheters, midlines, PICCs,CVCs, IV ports and port needles, and IOs,this change in vascular access type doesnot raise any different questionsofsafety oreffectiveness.
For Use withElectronicPump	Yes	Yes	Identical;Substantially Equivalent
Single Use	Yes	Yes	Identical;Substantially Equivalent
Continuous andIntermittentInfusion	Yes	Yes	Identical;Substantially Equivalent

{9}------------------------------------------------

Clinical Data:

The randomized and non-randomized clinical studies sponsored and conducted by Lineus Medical on the SafeBreak® Vascular device in the previous DEN190043 support the safety and effectiveness of the device in adolescents and adults. Review of clinical literature and pediatric extrapolation supports the use of the device in intravenous (midlines, PICCs, IV ports,) and intraosseous administration lines in adults and pediatric populations.

Conclusion:

The subject SafeBreak® Vascular has the identical materials, technological characteristics, dimensions, and construction, and similar operating principle, to the predicate device, as demonstrated through performance and clinical testing. The subject and predicate devices are intended to separate upon application of tension to stop fluid flow in both directions between the administration set tubing and extension tubing, thus, the expansion in the indications for use does not affect the safety and effectiveness of the subject device.

The conducted benefit-risk assessment and clinical literature review demonstrate that the differences in the indications for use do not raise any new or different questions of safety or effectiveness. The information provided in this submission demonstrates that the subject device, SafeBreak® Vascular is substantially equivalent to its predicate device, SafeBreak® Vascular, cleared under K223486.

Therefore, it is concluded that the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device.

Regulation Number and Section

§ 880.5220 Intravenous catheter force-activated separation device.

(a)
Identification. An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Separation force testing;
(ii) Validation of anti-reconnect features;
(iii) Air and liquid leakage testing, both before and after separation;
(iv) Luer connection testing;
(v) Flow rate testing;
(vi) Particulate testing; and
(vii) Microbial ingress testing.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(6) Device labeling must include:
(i) Instructions for use; and
(ii) A discussion of catheter dressings intended to be used with the device.