(888 days)
Not Found
No
The device description and performance studies focus on mechanical components and physical testing, with no mention of AI or ML.
Yes
The device is indicated for the "mechanical removal of thrombus," which directly treats a medical condition.
No
The device is described as a mechanical system for removing thrombus, which is a therapeutic function, not a diagnostic one. Its purpose is to treat an existing condition rather than to identify or characterize it.
No
The device description clearly outlines multiple hardware components including a catheter, hand-held Control Module with a motor, battery, circuitry, indicators, valves, and manifolds. It is a physical device with mechanical and electrical components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The X-SIZER Catheter System is a mechanical device used inside the body (in vivo) to physically remove thrombus (blood clots) from synthetic hemodialysis grafts. It does not analyze or test biological specimens.
- Intended Use: The intended use clearly states "mechanical removal of thrombus in synthetic hemodialysis grafts," which is an interventional procedure, not a diagnostic test.
The device description and performance studies further support that this is a therapeutic device for removing blockages, not a diagnostic tool for analyzing samples.
N/A
Intended Use / Indications for Use
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The X-SIZER System is a single-use, disposable medical device intended for the selective removal of thrombus from blood vessels. The device consists of a 135cm coaxial, dual lumen hydrophilic coated outer catheter shaft connected to a hand-held Control Module. The inner lumen of the catheter is composed of a hollow torque cable encapsulated in a polyamide tube (flexible drive shaft). A helical cutter is contained within the cutter housing located at the distal tip of the catheter. The outer lumen of the catheter is the path in which the excised debris is removed by vacuum. In use, the cutter is rotated at approximately 2,100 pm by the motor, which is powered by a 9-volt alkaline battery. In addition to turning the helical cutter, the inner lumen provides the space through which a coronary guidewire is placed. The hand-held Control Module contains the motor, battery, circuitry, indicators, and various valves and manifolds for the vacuum removal of thrombotic debris. The X-SIZER System is available in the 1.5mm and 2.0mm diameter models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels (specifically synthetic hemodialysis grafts)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 X-SIZER Catheter System was subjected to in vitro bench tests including: basic functional operation, leak tests, battery life test, corrosion resistance, motor current and trackability test, hydrophilic coating test, flow rate test, device output test, kink resistance test, tensile tests, bond tests, joint tests, torque tests, flexibility (deflection) tests, shaft torque resistance, cutter/housing binding, and bench top thrombus cutting (extraction).
Comparative performance testing was performed with the X-SIZER Catheter System and a predicate device. the Edwards Lifesciences Thrombex PMT System, in a bench model simulating synthetic hemodialysis grafts. The X-SIZER Catheter System performed equivalently to the Thrombex PMT System when assessing clot extraction and safety within a synthetic graft material.
Additionally, the X-SIZER Catheter System and the predicate device, the Thrombex PMT System, were evaluated in an in vivo animal model utilizing thrombosed hemodialysis grafts. The X-SIZER System performed equivalently to the Thrombex PMT System when assessing vessel trauma, distal embolization, and overall device performance for the removal of thrombus in occluded dialysis grafts.
The results of the in vitro and in vivo tests performed demonstrate the device is as safe and effective as the legally marketed predicate devices.
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.
Not Found
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
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
PREMARKET NOTIFICATION 510(k) SUMMARY (Per 21 CFR Part 807.92)
| Submitter's Name: | ev3 Inc. |
|---|---|
| Address: | 4600 Nathan Lane North |
| Plymouth, MN 55442 USA | |
| Telephone No.: | 763-398-7000 |
| Facsimile No.: | 763-398-7200 |
| Contact Person: | Jill Munsinger |
| Date Summary Prepared: | June 9, 2004 |
| Trade Name: | X-SIZER® Catheter System |
| Common or Usual Name: | Thrombectomy Device |
| Classification Name: | Catheter, Peripheral, Atherectomy (MCW) |
| (21 CFR Part 870.4875) |
Legally marketed devices to which ev3 Inc. claims substantial equivalence:
| Edwards Lifesciences Thrombex PMT™ System | 510(k) No. K993816 |
|---|---|
| Solera Bacchus Thrombectomy Catheter (BTC) | 510(k) No. K003570 |
| Possis AngioJet® LF140 Catheter | 510(k) No. K960970 |
Description of the device that is the subject of this Premarket Notification:
The X-SIZER System is a single-use, disposable medical device intended for the selective removal of thrombus from blood vessels. The device consists of a 135cm coaxial, dual lumen hydrophilic coated outer catheter shaft connected to a hand-held Control Module. The inner lumen of the catheter is composed of a hollow torque cable encapsulated in a polyamide tube (flexible drive shaft). A helical cutter is contained within the cutter housing located at the distal tip of the catheter. The outer lumen of the catheter is the path in which the excised debris is removed by vacuum. In use, the cutter is rotated at approximately 2,100 pm by the motor, which is powered by a 9-volt alkaline battery. In addition to turning the helical cutter, the inner lumen provides the space through which a coronary guidewire is placed. The hand-held Control Module contains the motor, battery, circuitry, indicators, and various valves and manifolds for the vacuum removal of thrombotic debris. The X-SIZER System is available in the 1.5mm and 2.0mm diameter models.
Intended Use:
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.
1
Contraindications:
The X-SIZER Catheter System is contraindicated under the following circumstances and clinical conditions:
- . Grafts that cannot be accessed with an 0.014" diameter guidewire.
- Grafts with reference diameters by visual estimation less than the minimum . recommended diameters.
- A Prolonged Prothrombin Time (PPT) or Partial Prothrombin Time (PTT) or . other documented anticoagulation state or disorder.
- . Graft Infection
- Significant cardiopulmonary vascular compromise. .
- Allergy or other contraindication to procedure related medications. .
Technological Characteristics:
The X-SIZER Catheter System has the same technological characteristics as the predicate Edwards Lifesciences Thrombex PMT System, the Solera Bacchus Thrombectomv Catheter (BTC), and the Possis AngioJet LF140 Catheter. All of these devices, except the Possis AngioJet, use mechanical rotary motion to remove thrombotic materials from dialysis grafts. The X-SIZER Catheter System, the Thrombex PMT System, and the Possis AngioJet LF140 Catheter are constructed of stainless steel and PEBAX materials. All of the devices are designed for use over a guidewire and are packaged as sterile, single use devices.
Performance Data:
The X-SIZER Catheter System was subjected to in vitro bench tests including: basic functional operation, leak tests, battery life test, corrosion resistance, motor current and trackability test, hydrophilic coating test, flow rate test, device output test, kink resistance test, tensile tests, bond tests, joint tests, torque tests, flexibility (deflection) tests, shaft torque resistance, cutter/housing binding, and bench top thrombus cutting (extraction).
Comparative performance testing was performed with the X-SIZER Catheter System and a predicate device. the Edwards Lifesciences Thrombex PMT System, in a bench model simulating synthetic hemodialysis grafts. The X-SIZER Catheter System performed equivalently to the Thrombex PMT System when assessing clot extraction and safety within a synthetic graft material.
Additionally, the X-SIZER Catheter System and the predicate device, the Thrombex PMT System, were evaluated in an in vivo animal model utilizing thrombosed hemodialysis grafts. The X-SIZER System performed equivalently to the Thrombex PMT System when assessing vessel trauma, distal embolization, and overall device performance for the removal of thrombus in occluded dialysis grafts.
The results of the in vitro and in vivo tests performed demonstrate the device is as safe and effective as the legally marketed predicate devices.
2
ev3 Inc. X-SIZER 510(k) Amendment K021096/A7
Summary of Substantial Equivalence:
The X-SIZER Catheter System is substantially equivalent to the predicate Edwards Lifesciences Thrombex PMT System, the Solera Bacchus Thrombectomy Catheter (BTC), and the Possis AngioJet LF140 Catheter. The indications for use, principles of operation, methods of manufacture and materials are substantially equivalent to these legally marketed devices.
.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
ev3. Inc. c/o Ms. Brenda Johnson Senior Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442
Re: K021096 X-SIZER Regulation Number: 21 CFR 870.4875 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II Product Code: MCW Dated: June 9, 2004 Received: June 10, 2004
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreationery to ttg_mg actment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterers, missus of the Act include requirements for annual registration, listing of general controlo provided the 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 If your device is elassince (600 at 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.
4
Page 2 -- Ms. Brenda Johnson
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) 594-4646. 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,
Durina D. Vochner
(A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K021096
Device Name:_X-SIZER® Catheter System
Indications For Use:
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Lochner
(Division Sign. Off) (Division Of Cardiovascular Devices
510(K) Number_K02109 (609
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