SafeBreak Vascular

K222791 · Lineus Medical, LLC · QOI · Oct 16, 2022 · General Hospital

Device Facts

• Record ID: K222791
• Device Name: SafeBreak Vascular
• Applicant: Lineus Medical, LLC
• Product Code: QOI · General Hospital
• Decision Date: Oct 16, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5220
• Device Class: Class 2

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.

Device Story

SafeBreak Vascular is an in-line mechanical device placed between a peripheral IV catheter and an administration set. It functions as a force-activated breakaway connector. When excessive tension is applied to the IV line, the device separates into two segments; internal valves automatically close on both ends to stop fluid flow from the pump and blood flow from the patient. Used in hospital settings, it prevents catheter dislodgement and associated mechanical complications. The device is single-use and sterile. It requires no active power or electronic integration; it operates purely via mechanical force thresholds. By preventing accidental catheter removal, it reduces the need for IV site replacement, thereby minimizing patient discomfort and potential infection risks associated with repeated cannulation.

Clinical Evidence

Bench testing only. Mechanical separation force testing was conducted to validate the safety and effectiveness of the expanded pull force range (1-5 lbf). No clinical data was required or provided.

Technological Characteristics

In-line mechanical breakaway connector. Materials: Makrolon, Polycarbonate, Saint-Gobain, INEOS ABS Lustran, Silicone. Sterilization: Ethylene Oxide. Single-use. Mechanical valve-based flow cessation upon separation. No software or electronic components.

Indications for Use

Indicated for adults and adolescents (≥18 years) with peripheral IV catheters receiving intermittent or continuous infusions via electronic pump to reduce mechanical complications requiring IV replacement.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, intravenous catheter force-activated separation device is subject to the following special controls:

*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.

Predicate Devices

• SafeBreak® Vascular (DEN190043)

Reference Devices

• Orchid SRV™ (K212064)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <table><tr><td><div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) </div></td><td><div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) </div> |
| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) </div> | |

> 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 Medical<br>179 North Church Ave, Suite 202<br>Fayetteville, AR 72701 |
| Primary Contact: | Dawn Norman<br>Partner, MRC Global<br>Phone: [phone]<br>[e-mail] |
| Company Contact: | Vance Clement<br>Chief Executive Officer<br>Lineus Medical<br>Phone: [phone]<br>[e-mail] |
| Trade Name:<br>Common Name: | SafeBreak® Vascular<br>Intravenous Catheter Force-Activated Separation Device |
| Classification:<br>Regulation Number:<br>Panel:<br>Product Code:<br>Primary Predicate: | Class II<br>21 CFR 880.5220<br>General Hospital<br>QOI<br>DEN190043, SafeBreak® Vascular<br>Manufacturer: Lineus Medical |
| Reference Device: | K212064, Orchid SRV™<br>Manufacturer: Linear Health Sciences, LLC |

#### 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.

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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 for<br>Use | SafeBreak® Vascular is intended<br>to aid in reduction of peripheral<br>IV mechanical complications<br>requiring IV replacement.<br>SafeBreak® Vascular is intended<br>to be used on peripheral IV<br>catheters in adults and<br>adolescent populations eighteen<br>(18) years of age and older<br>receiving intermittent or<br>continuous infusions with an<br>electronic pump. | SafeBreak® Vascular is<br>intended to aid in reduction of<br>peripheral IV mechanical<br>complications requiring IV<br>replacement.<br>SafeBreak® Vascular is<br>intended to be used on<br>peripheral IV catheters in<br>adults and adolescent<br>populations eighteen<br>(18) years of age and older<br>receiving intermittent or<br>continuous infusions with an<br>electronic pump. | Identical; Substantially<br>Equivalent |
| Materials | • Makrolon<br>• Polycarbonate<br>• Saint-Gobain<br>• INEOS ABS Lustran<br>• Silicone | • Makrolon<br>• Polycarbonate<br>• Saint-Gobain<br>• INEOS ABS Lustran<br>• Silicone | Identical; Substantially<br>Equivalent |

## Device Comparison

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| | K222791 | DEN190043 | Assessment of Differences |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject | Predicate | |
| Separation force | 1-5 lbf | $4 \pm 1$ lbf | Substantially equivalent.<br>Both the predicate and<br>reference devices have<br>demonstrated the safety<br>and effectiveness of<br>separation forces. The<br>change in tolerance of the<br>subject device separation<br>force does not raise any<br>different questions of safety<br>or effectiveness. |
| Environment of<br>Use | Hospital | Hospital | Identical; Substantially<br>Equivalent |
| Principle of<br>Operation | The subject SafeBreak Vascular<br>connects to the needleless<br>connector found in the existing<br>IV extension set and to the<br>existing IV administration set via<br>luer connectors. Upon<br>installation of the SafeBreak<br>Vascular, infusion can occur.<br>Upon tension the SafeBreak<br>Vascular separates and the valve<br>on each end of the device closes,<br>stopping flow. | The subject SafeBreak Vascular<br>connects to the needleless<br>connector found in the existing<br>IV extension set and to the<br>existing IV administration set<br>via luer connectors. Upon<br>installation of the SafeBreak<br>Vascular, infusion can occur.<br>Upon tension the SafeBreak<br>Vascular separates and the<br>valve on each end of the<br>device closes, stopping flow. | Identical; Substantially<br>Equivalent |
| Vascular Access<br>Type | Peripheral intravenous catheter | Peripheral intravenous<br>catheter | Identical; Substantially<br>Equivalent |
| For Use with<br>Electronic<br>Pump | Yes | Yes | Identical; Substantially<br>Equivalent |
| Single Use | Yes | Yes | Identical; Substantially<br>Equivalent |
| Continuous and<br>Intermittent<br>Infusion | Yes | Yes | Identical; Substantially<br>Equivalent |

## 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.