(179 days)
No
The description focuses on a mechanical device that separates under tension and does not mention any computational or learning capabilities.
No.
The device prevents mechanical complications and stops fluid flow, but it does not directly treat a disease or medical condition.
No
The device is designed to separate and stop fluid/blood flow when excessive tension occurs, preventing mechanical complications. It does not provide information for diagnosis.
No
The device description clearly states it is a physical device placed in-line with an IV catheter and administration set, designed to separate under tension. It is provided sterilized and is single-use, indicating a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that physically separates to stop fluid flow in a peripheral IV administration set. This is a mechanical function related to the delivery of fluids to a patient, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces the mechanical nature of the device, highlighting its placement in-line with an IV catheter and administration set and its separation function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, SafeBreak® Vascular is a medical device used in the administration of fluids, not an in vitro diagnostic device.
N/A
Intended Use / 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 pediatric populations greater than one (1) year of age receiving intermittent or continuous infusions with an electronic pump.
Product codes
QOI
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 510(k) submission is to expand the indications for use of the product to include pediatric populations greater than one (1) year of age.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral IV catheters
Indicated Patient Age Range
adults and pediatric populations greater than one (1) year of age
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
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 support that the adult data may be extrapolated to support the use of the device in pediatric populations.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 19, 2023
Lineus Medical % Dawn Norman Partner MRC Global, LLC 9085 E Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K223486
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: April 17, 2023 Received: April 18, 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 (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
1
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,
Danil 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
Enclosure
2
Indications for Use
510(k) Number (if known) K223486
Device Name SafeBreak® Vascular
Indications for Use (Describe)
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 pediations greater than one (1) year of age receiving intermittent or continuous infusions with an electronic pump.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) |
---|
☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Lineus Medical SafeBreak® Vascular
510(k) Summary K223486
Date Prepared: | May 19, 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 |
Classification Name: | Intravenous Catheter Force-Activated Separation Device |
Regulation Number: | 21 CFR 880.5220 |
Panel: | General Hospital |
Product Code: | QOI |
Primary Predicate: | K222791, SafeBreak® Vascular |
Manufacturer: Lineus Medical |
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 510(k) submission is to expand the indications for use of the product to include pediatric populations greater than one (1) year of age.
4
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 pediatric populations greater than one (1) year of age receiving intermittent or continuous infusions with an electronic pump.
Substantial Equivalence:
SafeBreak® Vascular is intended to separate when excessive tension is exerted across a peripheral IV administration set. SafeBreak® Vascular is intended to aid in reduction in peripheral IV mechanical complications requiring IV replacement. The subject SafeBreak® Vascular has the identical intended use, materials, technological characteristics, and operating principle, as the predicate device.
No design changes have been made since the previous clearance of the device (K222791). The safety and effectiveness of the subject device has been verified and validated and are all substantially equivalent. Thus, it can be concluded that the subject SafeBreak® Vascular does not raise different questions about safety and effectiveness.
K223486 | K222791 | Assessment of Differences | |
---|---|---|---|
Subject | Predicate | ||
General Device Characteristics | |||
Indications for Use | 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 three (3) | |||
years of age and older receiving | |||
intermittent or continuous | |||
infusions with an electronic | |||
pump. | 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. | Different | ||
Patient population modified | |||
from 18 years of age and | |||
older to greater than one (1) | |||
year of age. | |||
Data and clinical literature | |||
supports the safety and | |||
effectiveness of the subject | |||
device in adult and pediatric | |||
patient populations greater | |||
than one (1) years of age. | |||
The pediatric extrapolation | |||
assessment concluded that | |||
this change does not raise | |||
any different questions of | |||
safety or effectiveness. | |||
Materials | • Makrolon | ||
• Polycarbonate | |||
• Saint-Gobain | |||
• INEOS ABS Lustran | |||
• Silicone | • Makrolon | ||
• Polycarbonate | |||
• Saint-Gobain | |||
• INEOS ABS Lustran | |||
• Silicone | Identical; Substantially | ||
Equivalent |
Device Comparison
5
| | K223486
Subject | K222791
Predicate | Assessment of Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 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 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. | 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 |
| Vascular Access
Type | Peripheral intravenous catheter | Peripheral intravenous
catheter | Identical; Substantially
Equivalent |
| 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 |
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 support that the adult data may be extrapolated to support the use of the device in pediatric populations.
Conclusion:
The subject SafeBreak® Vascular has the identical intended use, materials, technological characteristics, operating principle, dimensions, and construction to the predicate device, as demonstrated through performance and clinical testing. Review of clinical literature and FDA guidelines support the extrapolation of adult data to expand the indications for use to include adults and the pediatric population greater than one (1) year of age.
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.