SafeBreak® Vascular is intended to separate when is exerted across a peripheral IV administration set. When SafeBreak@ Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

Device Description

SafeBreak® Vascular is placed in-line with an intravenous 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 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.

The purpose of this special 510(k) is to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Characteristic)	Target / Specification (for K222791)	Reported Device Performance (for K222791)
Separation Force Tolerance	1-5 lbf	1-5 lbf
Indication for Use	Aid in reduction of peripheral IV mechanical complications requiring IV replacement. Used on peripheral IV catheters in adults and adolescent populations (18+) receiving intermittent or continuous infusions with an electronic pump.	Identical to target
Materials	Makrolon, Polycarbonate, Saint-Gobain, INEOS ABS Lustran, Silicone	Identical to target
Environment of Use	Hospital	Identical to target
Principle of Operation	Connects to needleless connector and IV administration set via luer. Separates upon tension, valves close to stop fluid/blood flow.	Identical to target
Vascular Access Type	Peripheral intravenous catheter	Identical to target
For Use with Electronic Pump	Yes	Identical to target
Single Use	Yes	Identical to target
Continuous and Intermittent Infusion	Yes	Identical to target

Explanation of the Primary Difference:
The K222791 device is a special 510(k) to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf. The predicate device (DEN190043) had a separation force of "4 ± 1 lbf." The reference device (K212064, Orchid SRV™) supported the expanded pull force range.

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

The document does not specify the exact sample size used for the performance testing.
The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. The testing appears to be primarily mechanical testing.

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

This information is not provided in the document. The testing described is mechanical performance (Separation Force Testing), which typically does not involve human experts establishing ground truth in the same way clinical studies or image analysis tasks would.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the testing described is mechanical performance. Adjudication methods are typically associated with subjective assessments or diagnostic studies.

5. 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

An MRMC comparative effectiveness study was not conducted. This device is a mechanical device, not an AI or diagnostic imaging device that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable as the device is a mechanical IV catheter force-activated separation device, not an algorithm or software. The performance testing was for the mechanical function of the device itself.

7. The Type of Ground Truth Used

The ground truth for the performance testing (mechanical testing) was the pre-defined engineering specification for the separation force range (1-5 lbf). The "ground truth" here is the physical measurement against a specified engineering tolerance.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a mechanical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided as there is no training set for a mechanical device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the seal of the Department of Health & Human Services - USA. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

March 16, 2023

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

Re: K222791

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

Dear Dawn Norman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 16, 2022. Specifically, FDA is updating this SE Letter for a correction to the 510(k) Summary as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. David Wolloscheck, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-1480, David.wolloscheck@fda.hhs.gov.

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Acting 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

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Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo. On the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

October 16, 2022

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

Re: K222791

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: September 15, 2022 Received: September 15, 2022

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

Payal Patel

Payal Patel 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222791

Device Name SafeBreak® Vascular

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C)	Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K222791

Date Prepared:	March 7, 2023
Company:	Lineus Medical179 North Church Ave, Suite 202Fayetteville, AR 72701
Primary Contact:	Dawn NormanPartner, MRC GlobalPhone: 618-604-3064Dawn.Norman@askmrcglobal.com
Company Contact:	Vance ClementChief Executive OfficerLineus MedicalPhone: 901-351-9270vance@lineusmed.com
Trade Name:Common Name:	SafeBreak® VascularIntravenous Catheter Force-Activated Separation Device
Classification:Regulation Number:Panel:Product Code:Primary Predicate:	Class II21 CFR 880.5220General HospitalQOIDEN190043, SafeBreak® VascularManufacturer: Lineus Medical
Reference Device:	K212064, Orchid SRV™Manufacturer: Linear Health Sciences, LLC

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.

The purpose of this special 510(k) is to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf.

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Indications for Use:

SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

Substantial Equivalence:

The subject SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. The separation force tolerance of SafeBreak® Vascular is being expanded to 1-5 lbf. The subject SafeBreak® Vascular is intended to aid in reduction in peripheral IV mechanical complications requiring IV replacement. The subject SafeBreak® Vascular has the same intended use, same or similar materials, same or similar technological characteristics, the same operating principle, as the predicate and reference devices, respectively.

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

	K222791	DEN190043	Assessment of Differences
	Subject	Predicate
General Device Characteristics
Indications forUse	SafeBreak® Vascular is intendedto aid in reduction of peripheralIV mechanical complicationsrequiring IV replacement.SafeBreak® Vascular is intendedto be used on peripheral IVcatheters in adults andadolescent populations eighteen(18) years of age and olderreceiving intermittent orcontinuous infusions with anelectronic pump.	SafeBreak® Vascular isintended to aid in reduction ofperipheral IV mechanicalcomplications requiring IVreplacement.SafeBreak® Vascular isintended to be used onperipheral IV catheters inadults and adolescentpopulations eighteen(18) years of age and olderreceiving intermittent orcontinuous infusions with anelectronic pump.	Identical; SubstantiallyEquivalent
Materials	• Makrolon• Polycarbonate• Saint-Gobain• INEOS ABS Lustran• Silicone	• Makrolon• Polycarbonate• Saint-Gobain• INEOS ABS Lustran• Silicone	Identical; SubstantiallyEquivalent

Device Comparison

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	K222791	DEN190043	Assessment of Differences
	Subject	Predicate
Separation force	1-5 lbf	$4 \pm 1$ lbf	Substantially equivalent.Both the predicate andreference devices havedemonstrated the safetyand effectiveness ofseparation forces. Thechange in tolerance of thesubject device separationforce does not raise anydifferent questions of safetyor effectiveness.
Environment ofUse	Hospital	Hospital	Identical; SubstantiallyEquivalent
Principle ofOperation	The subject SafeBreak Vascularconnects to the needlelessconnector found in the existingIV extension set and to theexisting IV administration set vialuer connectors. Uponinstallation of the SafeBreakVascular, infusion can occur.Upon tension the SafeBreakVascular separates and the valveon each end of the device closes,stopping flow.	The subject SafeBreak Vascularconnects to the needlelessconnector found in the existingIV extension set and to theexisting IV administration setvia luer connectors. Uponinstallation of the SafeBreakVascular, infusion can occur.Upon tension the SafeBreakVascular separates and thevalve on each end of thedevice closes, stopping flow.	Identical; SubstantiallyEquivalent
Vascular AccessType	Peripheral intravenous catheter	Peripheral intravenouscatheter	Identical; SubstantiallyEquivalent
For Use withElectronicPump	Yes	Yes	Identical; SubstantiallyEquivalent
Single Use	Yes	Yes	Identical; SubstantiallyEquivalent
Continuous andIntermittentInfusion	Yes	Yes	Identical; SubstantiallyEquivalent

Performance Testing:

Mechanical testing (i.e., Separation Force Testing) of the SafeBreak® Vascular supports the safety and effectiveness of the expansion of the pull force range in the subject device. The pull force range specification was supported by the reference device.

Conclusion:

The subject SafeBreak® Vascular has similar intended use, and identical materials, technological characteristics, and operating principle compared to the predicate device. In addition, performance testing and engineering analysis support the expansion of the separation force specification, compared to the reference device. The difference in technology does not affect the safety and effectiveness of the subject device.

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