(49 days)
The SUBMARINE™ PLUS 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.
The SUBMARINE PLUS Balloon Dilatation Catheter is a catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 inch (0.45 mm). The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. 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 is hydrophilic coated (balloon excluded). The SUBMARINE PLUS Balloon Dilatation Catheter is available in different balloon sizes (balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm and balloon lengths of 20, 40, 60, 80 and 120mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.018" and the usable catheter length is 130 or 90 cm.
The SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter demonstrated its safety and effectiveness through in vitro testing.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Balloon Compliance | Testing conducted. Results are indicative of safety and effectiveness. |
| Balloon Burst Pressure | Testing conducted. Results are indicative of safety and effectiveness. |
| Balloon Fatigue | Testing conducted. Results are indicative of safety and effectiveness. |
| Shaft Burst Pressure | Testing conducted. Results are indicative of safety and effectiveness. |
| Bond Strength | Testing conducted. Results are indicative of safety and effectiveness. |
| Catheter Dimensions | Testing conducted. Results are indicative of safety and effectiveness. |
| Guidewire Compatibility | Testing conducted. Results are indicative of safety and effectiveness. |
| Introducer Compatibility | Testing conducted. Results are indicative of safety and effectiveness. |
| Biocompatibility | |
| Biocompatibility Assessment | All materials used are biocompatible based on biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes in vitro testing. Therefore, there is no "test set" in the context of human patient data. The sample sizes for each specific in vitro test (e.g., number of catheters tested for burst pressure) are not explicitly stated in this summary. The data provenance is from laboratory testing performed by Invatec Innovative Technologies, based in Roncadelle (BS) Italy. This testing is prospective in nature, as it was conducted specifically to demonstrate the device's characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. As the study involved in vitro testing, there was no human test set requiring expert ground truth establishment for clinical outcomes. The "ground truth" for each test was determined by established engineering and material science standards and measurements.
4. Adjudication Method:
Not applicable. There was no clinical data or expert review requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done for this device. This is an in vitro performance study for a medical device (catheter), not an AI algorithm requiring human reader performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical medical instrument (catheter), not a software algorithm.
7. Type of Ground Truth Used:
The ground truth used for this study was based on engineering specifications, material science standards, and direct physical measurements obtained during the in vitro testing. For example, balloon burst pressure would be compared against a defined maximum pressure, and dimensions against designed specifications.
8. Sample Size for the Training Set:
Not applicable. As this is an in vitro performance study of a physical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the reasons stated above.
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K042537
page 1 of 2
510(k) Summary
SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter
| 510(k) Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21 C.F.R §807.92. |
|---|---|
| Applicant(Manufacturer) | Invatec Innovative TechnologiesVia Martiri della Libertà, 725030 Roncadelle (BS) ItalyTel: +39 030 258 93 11Fax: +39 030 258 93 12www.invatec.cominfo@invatec.com |
| Submitter | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398 7000Fax: (763) 398 7200 |
| Contact Person | Mike WinegarTel: (763) 398-7225Fax: (763) 398-7200E-mail: mwinegar@ev3.net |
| Date Prepared | September 17th, 2004 |
| Device Trade Name | SUBMARINE PLUS Percutaneous Transluminal Angioplasty(PTA) Catheter |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class IIProduct Code: LIT |
| Classification Panel | Cardiovascular |
| Predicate Device | Cordis SAVVY™ Balloon Dilatation Catheter |
| Intended use | The SUBMARINE PLUS Balloon Dilatation Catheter is intended todilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries and for the treatment of obstructive lesionsof native or synthetic arteriovenous dialysis fistulae. |
| Device Description | The SUBMARINE PLUS Balloon Dilatation Catheter is a catheterwith a semi-compliant inflatable balloon mounted at the distal tip.It has a coaxial lumen. The central lumen of the catheter, whichterminates at the distal tip, is used to pass the catheter over aguidewire with a maximum outer diameter of 0.018 inch (0.45 mm).The other lumen is the balloon inflation lumen, which is used toinflate and deflate the dilatation balloon with a mixture of contrastmedium and saline solution. 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 balloon |
| page dot d | |
| positioning within the vessel. The distal catheter shaft is hydrophiliccoated (balloon excluded). The SUBMARINE PLUS BalloonDilatation Catheter is available in different balloon sizes (balloondiameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm andballoon lengths of 20, 40, 60, 80 and 120mm). Nominal balloondiameter and length are printed on the hub. The maximumrecommended guidewire diameter is 0.018" and the usable catheterlength is 130 or 90 cm. | |
| Biocompatibility | All material used in SUBMARINE PLUS PercutaneousTransluminal Angioplasty (PTA) Catheter are biocompatible basedon the biocompatibility testing. |
| Performance data | In vitro testing was conducted to demonstrate the safety andeffectiveness of SUBMARINE PLUS Percutaneous TransluminalAngioplasty (PTA) Catheter. The testing included ballooncompliance, balloon burst pressure, balloon fatigue, shaft burstpressure, bond strength, catheter dimensions and guidewire andintroducer compatibility. |
| Summary of SubstantialEquivalence | The SUBMARINEPLUS Balloon Dilatation Catheter is similar tothe predicate with respect to the intended use, and with respect totheir physical characteristics, such the catheter and balloondimensions and catheter design and material. SAILOR PLUSBalloon Dilatation Catheter is therefore substantially equivalent tothe Predicate device. Further, the mechanical and biocompatibilitytesting data is indicative of the safety and effectiveness ofSUBMARINE PLUS Balloon Dilatation Catheter. Therefore basedon its own performance characteristics and the technologicalsimilarities, SUBMARINE PLUS Balloon Dilatation Catheter isexpected to perform similar to the predicate device and othercomparable, currently marketed PTA catheters. |
| Conclusion | SUBMARINE PLUS Balloon Dilatation Catheter is substantiallyequivalent to the Predicate device and other currently marketed PTAcatheters. |
Submarine Plus OTW PTA Balloon Catheter
Traditional 510(k) 510(k) Summary
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Image /page/2/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Invatec Innovative Technologies c/o Mr. Mike Winegar Vice President, International RA ev3 Inc. 4600 Nathan Lane North Plymouth, MN 55442
Re: K042537
KU42337
SUBMARNE PLUSTM Percutaneous Transluminal Angioplasty (PTA) Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 17, 2004 Received: September 20, 2004
Dear Mr. Winegar:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained in the tabstantially equivalent (for the indications
referenced above and have determined the device is substantial in intersta referenced above and nave declinined the arrased predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment at the Federal Food. Dou commerce prior to May 28, 1970, the chactinent and of the Federal Food. Drug, devices that have been recults in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of the You may, therefore, market the device, subject to the gentlation annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act morate requirements.
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 If your device is classified (see above) mo exisi crows in trepulations affecting your device can
may be subject to such additional controls. Tim may be subject to such additions. Laisung major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Pederal Regaraters, concerning your device in the Federal Register.
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Page 2 - Mr. Mike Winegar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed alla i termination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or uny I cather 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 CFK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also quarty 25 cool provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product including in begin marketing your device as described in your Section 510(k) This icter will anow you to begin inding of substantial equivalence of your device to a legally promaticated 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 If you docure 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 other general informational 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,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K04 2537
Device Name: SUBMARINE™ PLUS PTA Balloon Dilatation Catheter
Indications For Use:
The SUBMARINE™ PLUS 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 (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)
Blommor
Sivision Sign-Off) Division of Cardiovascular Devices 510(k) Number_
Page I of
Submarine Plus PTA Balloon Catheter Traditional 510(k) 510(k) Body
§ 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).