(29 days)
The ADMIRAL XTREME™ (PTA) Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ADMIRAL XTREME™ PTA Catheter is an OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It is a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft and balloon cones are hydrophilic coated (balloon excluded). The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 80 and 130cm.
The provided text describes a 510(k) summary for the ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty (PTA) Catheter. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a novel device's performance.
Therefore, many of the requested details about acceptance criteria, clinical studies, sample sizes, and expert validation are not applicable as this submission is for a medical device cleared via the 510(k) pathway, which relies on demonstrating equivalence to an already approved device rather than proving clinical efficacy or diagnostic accuracy through a standalone study.
However, I can extract the relevant information regarding the performance data provided to establish equivalence.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are related to in vitro engineering performance equivalence rather than clinical outcomes or diagnostic metrics. The document states that the testing "met the specified requirements" and were "comparable with the predicate device." Specific numerical acceptance values are not provided in this summary.
| Performance Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate Device & Met Specified Requirements) | Reported Device Performance |
|---|---|---|
| Balloon Compliance | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Balloon Burst Pressure | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Balloon Fatigue | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Shaft Burst Pressure | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Bond Strength | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Catheter Dimensions | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Deflation Time | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Guidewire Compatibility | Compatible with 0.035" guidewires; met specified requirements | Demonstrated equivalent performance |
| Introducer Compatibility | Comparable to predicate device; met specified requirements | Demonstrated equivalent performance |
| Biocompatibility | All materials used are biocompatible based on testing results | All materials are biocompatible |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the in vitro tests.
- Data Provenance: The testing was "in vitro," implying laboratory testing rather than human subject data. Country of origin not specified, but the manufacturer is Invatec Innovative Technologies in Roncadelle (BS) Italy, and the submitter is ev3 Inc. in Plymouth, MN, USA.
- Retrospective or Prospective: Not applicable for in vitro laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device's performance was evaluated through engineering in vitro testing; it does not involve expert-established ground truth like in a diagnostic AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human expert adjudication of test results in the context of diagnostic accuracy.
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 is a physical medical device (catheter), not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the performance evaluation of this catheter was based on established engineering specifications and benchmarks to demonstrate equivalence to the predicate device. For example, balloon burst pressure would have a specified engineering tolerance rather than an expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
{0}------------------------------------------------
KOG2809 p. 4x(2
510(k) Summary
per of 21 C.F.R § 807.92
| Manufacturer's Name andAddress | Invatec Innovative TechnologiesVia Martiri della Libertà, 725030 Roncadelle (BS) ItalyTel: +39 030 258 93 11Fax: +39 030 258 93 12www.invatec.cominfo@invatec.comOCT 1 8 2006 |
|---|---|
| Submitter's Name andAddress | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398 7000Fax: (763) 398 7200 |
| Contact Person | David WorrellManager, Regulatory AffairsTel: (763) 398-7344Fax: (763) 398-7200e-mail: dworrell@ev3.net |
| Date Prepared | September 18, 2006 |
| Device Trade Name | ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty(PTA) Catheter |
| Device Common Name | Percutaneous Transluminal Angioplasty (PTA) Balloon DilatationCatheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device ClassificationClassification Panel | Regulatory Class: Class II |
| Product Code: LITCardiovascular | |
| Predicate Device | SAILOR PLUS™ Percutaneous Transluminal Angioplasty (PTA)Catheter - K042538, cleared November 8, 2004 |
| Intended use | The ADMIRAL XTREME™ (PTA) Catheter is intended to dilatestenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal,and renal arteries, and for the treatment of obstructive lesions ofnative or synthetic arteriovenous dialysis fistulae. |
| Device Description | The ADMIRAL XTREME™ PTA Catheter is an OTW PTAcatheter with a semi-compliant inflatable balloon mounted at thedistal tip. It is a dual lumen catheter with a guidewire lumen and aballoon inflation lumen. The catheter tapers beneath the balloonsegment to achieve the lowest possible deflated profile. Tworadiopaque marker bands are placed under the balloon segment ofthe catheter shaft to provide visual reference points for balloonpositioning within the vessel. The distal catheter shaft and ballooncones are hydrophilic coated (balloon excluded). The maximumrecommended guidewire diameter is 0.035". The device is availablein balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80and 120mm and catheter lengths of 80 and 130cm. |
| Biocompatibility | All materials used in the ADMIRAL XTREME™ PTA Catheter are |
| Performance data | biocompatible based on biocompatibility testing results.In vitro testing was conducted to demonstrate equivalentperformance of the ADMIRAL XTREME™ PercutaneousTransluminal Angioplasty (PTA) Catheter with the predicate device.The testing included balloon compliance, balloon burst pressure,balloon fatigue, shaft burst pressure, bond strength, catheterdimensions, deflation time and guidewire and introducercompatibility. |
| Summary of SubstantialEquivalence | The ADMIRAL XTREME™ Percutaneous TransluminalAngioplasty (PTA) Catheter is identical to the predicate device withrespect to intended use, catheter design and balloon dimensions.The mechanical and biocompatibility testing data met the specifiedrequirements for the ADMIRAL XTREME™ PercutaneousTransluminal Angioplasty (PTA) Catheter and are comparable withthe predicate device. |
| Conclusion | Based on the intended use and the technological characteristics, theADMIRAL XTREME™ PTA Catheter has been shown to besubstantially equivalent to the SAILOR PLUS™ PTA Catheter(K0402538, cleared November 8, 2004). |
{1}------------------------------------------------
and the comments of the comments of the comments of the comments of
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Invatec Innovative Technologies c/o ev3 Inc. Attn: David Worrell 9600 54th Avenue North Plymouth, MN 55442-2111
OCT 1 8 2006
Re: K062809
Trade/Device Name: ADMIRAL XTREME™ PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 18, 2006 Received: September 19, 2006
Dear Mr. Worrell:
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, Trug, 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, EDA 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 not the Act
{3}------------------------------------------------
Page 2 – Mr. David Worrell
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duna R. Vachner
Image /page/3/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines, possibly resembling a stylized letter or signature. The symbol is drawn with a thick stroke, giving it a bold appearance. The overall impression is abstract and difficult to interpret without additional context.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): Kolo2809
Device Name: ADMIRAL XTREME™ PTA Catheter
Indications for Use:
The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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)
Donna R. Vorhies
Division Sich-Off) Division of Cardiovascular Devices
510/k) Number_K062809
Page 1 of 1
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).