(88 days)
No
The device description and intended use focus on a purely mechanical function (separation under tension) and do not mention any computational or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device's primary function is to physically separate to stop fluid flow when excessive tension is applied, preventing complications and aiding in the reduction of IV/IO replacement, rather than directly treating a disease or condition.
No
The device is described as an in-line component for IV and IO administration sets that prevents fluid flow upon separation due to excessive tension, thereby reducing mechanical complications. Its function is to manage fluid and blood flow in response to physical forces, not to diagnose medical conditions.
No
The device description clearly states it is a physical device placed in-line with IV/IO catheters and administration sets, designed to separate under tension. It is provided sterilized and is single-use, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that SafeBreak® Vascular is placed in-line with IV and IO administration sets to prevent complications related to tension. It interacts with the fluid flow and the patient's catheter, but it does not analyze or test any biological samples from the patient.
- The purpose is mechanical. The device's function is to physically separate when excessive force is applied, stopping fluid and blood flow. This is a mechanical action, not a diagnostic test performed on a specimen.
The device is a medical device intended for use in the administration of fluids to a patient, not for diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QOI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric populations two (2) weeks of age and older
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 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.
| 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)
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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 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.
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.
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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 IV | |||
| catheters, midlines, peripherally | than one (1) year of age receiving | ||
| intermittent or continuous | safety and effectiveness of the subject | ||
| device 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. | |||
| K231957 | |||
| Subject | K223486 | ||
| Predicate | Assessment of Differences | ||
| Materials | • Makrolon | ||
| • Polycarbonate | |||
| • Saint-Gobain | |||
| • INEOS ABS Lustran | |||
| • Silicone | Identical | Substantially Equivalent | |
| Subject and predicate materials are | |||
| unchanged and identical. | |||
| Separation force | 1-5 lbf | 1-5 lbf | Identical; |
| Substantially Equivalent | |||
| Environment of | |||
| Use | Hospital | Hospital | Identical; |
| Substantially Equivalent | |||
| Principle of | |||
| Operation | The subject SafeBreak® Vascular | ||
| connects to the needleless | |||
| connector found in the existing IV | |||
| or IO extension set and to the | |||
| existing IV or IO administration | |||
| set via luer connectors. Upon | |||
| installation of the SafeBreak® | |||
| Vascular, an infusion can occur. | |||
| Upon tension the SafeBreak® | |||
| Vascular separates and the valve | |||
| on each end of the device closes, | |||
| stopping flow. | The subject SafeBreak® Vascular | ||
| connects to the needleless | |||
| connector found in the existing IV | |||
| extension set and to the existing | |||
| IV administration set via luer | |||
| connectors. Upon installation of | |||
| the SafeBreak® Vascular, infusion | |||
| can occur. Upon tension the | |||
| SafeBreak® Vascular separates | |||
| and the valve on each end of the | |||
| device closes, stopping flow. | Identical; | ||
| Substantially Equivalent |
7
8
| | K231957
Subject | K223486
Predicate | Assessment of Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vascular
Access
Type | Peripheral intravenous catheter,
central venous catheter,
intraosseous catheter | Peripheral intravenous catheter | 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,
this change in vascular access type does
not raise any different questions
of
safety or
effectiveness. |
| For Use with
Electronic
Pump | Yes | Yes | Identical;
Substantially Equivalent |
| Single Use | Yes | Yes | Identical;
Substantially Equivalent |
| Continuous and
Intermittent
Infusion | 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.