(888 days)
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.
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.
The provided document describes the X-SIZER® Catheter System, a thrombectomy device. However, it does not include detailed acceptance criteria or a study designed to explicitly prove the device meets these criteria in a quantitative, statistical manner as would be expected for a typical AI/software device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparative performance testing.
Therefore, many of the requested fields cannot be directly populated from the input provided. I will fill in what can be inferred or directly stated and note when information is unavailable.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance Study for X-SIZER® Catheter System
The provided documentation details the X-SIZER® Catheter System's premarket notification (510(k)) for substantial equivalence to legally marketed predicate devices. The performance data presented focuses on demonstrating that the X-SIZER® Catheter System is as safe and effective as these predicate devices, rather than meeting pre-defined quantitative acceptance criteria with specific threshold values for performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria with numerical thresholds are not provided, the table below reflects the comparative performance assessment described in the document.
| Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| In vitro Bench Tests | Basic functional operation is satisfactory. | "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" were subjected to testing. |
| Thrombus Cutting/Extraction (Bench) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) in clot extraction and safety within synthetic graft material. | "The X-SIZER Catheter System performed equivalently to the Thrombex PMT System when assessing clot extraction and safety within a synthetic graft material." |
| Vessel Trauma (In vivo) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) in minimizing vessel trauma. | "The X-SIZER System performed equivalently to the Thrombex PMT System when assessing vessel trauma..." |
| Distal Embolization (In vivo) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) in minimizing distal embolization. | "...distal embolization..." |
| Overall Device Performance (In vivo) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) for thrombus removal in occluded dialysis grafts. | "...and overall device performance for the removal of thrombus in occluded dialysis grafts." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in terms of number of samples/cases. The document refers to "a bench model simulating synthetic hemodialysis grafts" and "an in vivo animal model utilizing thrombosed hemodialysis grafts" for comparative testing. Specific numbers of grafts or experimental runs are not provided.
- Data Provenance: The studies were in vitro (bench model) and in vivo (animal model). The country of origin is not specified but is presumably overseen by the US regulatory system given the FDA submission. These appear to be prospective studies conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is established through direct physical measurements and observations in in vitro and in vivo models, not through expert review of data/images. The assessment of "equivalence" would involve technical experts (engineers, scientists, veterinarians) conducting and analyzing the tests. Their number or specific qualifications beyond general expertise in medical device testing are not detailed.
4. Adjudication method for the test set
Not applicable. As the performance assessment is based on physical and physiological measurements/observations in bench and animal models rather than expert interpretation of data, there is no expert adjudication method like 2+1 or 3+1.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical thrombectomy catheter, not an AI or imaging device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical thrombectomy catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth or reference standard for this device's performance is based on:
- In vitro measurements: Direct quantitative measurements from bench tests (e.g., flow rate, output, tensile strength, battery life, corrosion resistance, clot extraction efficiency).
- In vivo observations/measurements: Direct observations and possibly post-procedure analysis (e.g., histology for vessel trauma, assessment of distal embolization, overall efficacy in thrombus removal) in the animal model.
8. The sample size for the training set
Not applicable. This device is a mechanical thrombectomy catheter, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
PREMARKET NOTIFICATION 510(k) SUMMARY (Per 21 CFR Part 807.92)
| Submitter's Name: | ev3 Inc. |
|---|---|
| Address: | 4600 Nathan Lane NorthPlymouth, 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
Page 1 of 1
§ 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).