(74 days)
The Fibrex™ Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.
The Fibrex™ Catheter Patcncy Device is a tri-axial delivery catheter assembly comprised of an outer catheter storing an inner guide structure and an inner stripping coil. The inner guide structure is for directing and guiding the stripping coil through the catheter to the free end of the catheter and back up around the exterior surface of the vascular catheter. The stripping coil is formed of a shape memory or super-elastic material, wherein the stripping coil is preformed to assume a helical shape wrapping about the outer surface of the vascular catheter in a manner providing for the stripping of build-up from the outer surface of the vascular catheter when the stripping coil is moved relative to the vascular catheter. The tri-axial delivery catheter assembly is attached to an injection molded plastic hand assembly that controls the movement of the guide catheter and subsequent insertion of the stripping coil. The delivery catheter assembly is adapted for selectively coupling to a luer connector secured to the venous lumen of a traditional vascular catheter. The outer catheter of the Fibrex™ device is made from a biocompatible Polyimid/PTFF. composite. The inner dual lumen tube is made from nylon. A Nitinol wire is housed in one lumen of the guide curve catheter to provide directional memory for the actuation and operation of the Nitinol stripping coil . Both the outer catheter and the guide catheter contain distal marking bands made from gold.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fibrex™ Catheter Patency Device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it frames the testing as a comparison to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Fibrin stripping capabilities (Qualitative) | "The Fibrex™ Catheter Patency Device was subjected to an animal study to evaluate the fibrin stripping capabilities of the device." "The results of the testing indicated that they are comparable to the predicate device." |
| Ring retention (Qualitative) | "It was also subjected to ring retention, and tensile tests." "The results of the testing indicated that they are comparable to the predicate device." |
| Tensile strength (Qualitative) | "It was also subjected to ring retention, and tensile tests." "The results of the testing indicated that they are comparable to the predicate device." |
| Technical Equivalence to Predicate Device | Examinined attributes: - Intended use - French Sizes - Length - Lumens - Distal end configuration - Intended anatomical location of distal end - Proximal end configuration - Materials - Labeling Result: "found to be comparable to the predicate device." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document mentions an "animal study" but does not specify the number of animals or the specific experimental setup (e.g., number of catheters tested, number of observations).
- Data Provenance: The study was an "animal study," implying it was conducted in a controlled laboratory environment. The country of origin is not specified but is likely the US given the submission to the FDA. The study is implicitly prospective for the duration of the animal experiment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for evaluating the results of the animal study or the other functional and safety tests. The determination of "comparable to the predicate device" would have involved expert assessment, but details are not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth for the test set. Given the nature of the tests (animal study, ring retention, tensile tests), it's likely standard laboratory protocols were followed, but no specific adjudication process like 2+1 or 3+1 is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The device is a physical medical device (catheter) and not an AI-based diagnostic or assistive technology that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the Fibrex™ Catheter Patency Device is a physical medical device, not an algorithm or software. Its performance is inherent to its mechanical and material properties, not an algorithm's output. The "standalone performance" is essentially the results of the functional and safety tests described.
7. Type of Ground Truth Used
The ground truth for the animal study (fibrin stripping capabilities) would have been established through direct observation and measurement within the animal model, potentially involving histological analysis or other methods to quantify fibrin sheath disruption. For ring retention and tensile tests, the ground truth is established by physical measurement against engineering specifications or observed performance characteristics. The overarching "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to a legally marketed predicate device.
8. Sample Size for the Training Set
This question is not applicable. The Fibrex™ Catheter Patency Device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for a physical medical device.
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Ko40427
MAY - 3 2004
Rev .: April 23, 2004
| 510(k) SUMMARY | ||
|---|---|---|
| APPLICANT: | Medical Device Technologies, Inc.3600 SW 47th AvenueGainesville, FL 32608 | |
| CONTACT: | Karl SwartzQuality Assurance Manager | |
| TELEPHONE: | (352)338-0440fax (352)338-0662 | |
| TRADE NAMES: | Fibrex™ Catheter Patency Device | |
| COMMON NAME: | Intravascular therapeutic catheter | |
| CLASSIFICATION NAME: | Catheter,intravascular,therapeutic,short, Regulation Number880.5200 | |
| PRODUCT CODE: | FOZ | |
| PANEL: | General Hospital | |
| SUBSTANTIAL EQUIVALENCE: | ||
| Company Name | Product Name | 510(k) No. |
En-Snare™ Endovascular Snare and Catheter K021606 Medical Device Technologies
DESCRIPTION OF DEVICE:
The Fibrex™ Catheter Patcncy Device is a tri-axial delivery catheter assembly comprised of an outer catheter storing an inner guide structure and an inner stripping coil. The inner guide structure is for directing and guiding the stripping coil through the catheter to the free end of the catheter and back up around the exterior surface of the vascular catheter. The stripping coil is formed of a shape memory or super-elastic material, wherein the stripping coil is preformed to assume a helical shape wrapping about the outer surface of the vascular catheter in a manner providing for the stripping of build-up from the outer surface of the vascular catheter when the stripping coil is moved relative to the vascular catheter.
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Korlove 1
Rev .: April 23, 2004
The tri-axial delivery catheter assembly is attached to an injection molded plastic hand assembly that controls the movement of the guide catheter and subsequent insertion of the stripping coil. The delivery catheter assembly is adapted for selectively coupling to a luer connector secured to the venous lumen of a traditional vascular catheter.
The outer catheter of the Fibrex™ device is made from a biocompatible Polyimid/PTFF. composite. The inner dual lumen tube is made from nylon. A Nitinol wire is housed in one lumen of the guide curve catheter to provide directional memory for the actuation and operation of the Nitinol stripping coil . Both the outer catheter and the guide catheter contain distal marking bands made from gold.
INDICATIONS FOR USE:
The Fibrex™ Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.
FUNCTIONAL & SAFETY TESTING:
The Fibrex™ Catheter Patency Device was subjected to an animal study to evaluate the fibrin stripping capabilities of the device. It was also subjected to ring retention, and tensile tests. The results of the testing indicated that they are comparable to the predicate device.
TECHNICAL COMPARISON:
The following attributes of the Fibrex™ Catheter Patency Device were examined and found to be comparable to the predicate device:
- Intended use 1.
-
- French Sizes
- Length 3.
- র্বা Lumens
- Distal end configuration ડ .
- Intended anatomical location of distal end 6.
- Proximal end configuration 7.
-
- Materials
- ் Labeling
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Medical Device Technologies, Inc. c/o Mr. Karl Swartz Quality Assurance Manager 3600 SW 47th Avenue Gainsville, FL 32608
K040427 Re: FibrexTM Catheter Patency Device Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: February 19, 2004 Received: February 19, 2004
Dear Mr. Swartz:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Karl Swartz
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dmina R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Keyour7
Page 1 of 1
510(k) Number (if known): K040427
Device Name: Fibrex™ Catheter Patency Device
Indications for Use:
The Fibrex™ Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna D. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
Page ___ of ___
510(k) Number_k040477
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).