(49 days)
The SAILOR™ PLUS 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.
The SAILOR PLUS Balloon Dilatation Catheter is OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. Two radiopaque markers indicate the dilating portion of the balloon and help in correctly positioning the balloon within the vessel. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. 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 130. 80 and 40cm
Here's an analysis of the acceptance criteria and study information for the SAILOR PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter, based on the provided text:
This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel clinical trials with predefined acceptance criteria for AI/ML performance. For a medical device like a PTA catheter, the "acceptance criteria" primarily relate to engineering and biocompatibility performance data, ensuring it functions safely and effectively as intended, similar to existing devices.
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) Summary, the acceptance criteria and reported device performance are related to in-vitro testing and biocompatibility, demonstrating the device's functional integrity and safety. Specific numerical acceptance criteria are not explicitly stated in this summary, but the general performance categories are listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (In-vitro) | |
| Balloon Compliance | Testing was conducted to demonstrate safety and effectiveness. (Details on specific compliance values or thresholds are not provided in this summary.) |
| Balloon Burst Pressure | Testing was conducted to demonstrate safety and effectiveness. (Details on specific burst pressure values or thresholds are not provided in this summary.) |
| Balloon Fatigue | Testing was conducted to demonstrate safety and effectiveness. (Details on specific fatigue cycles or thresholds are not provided in this summary.) |
| Shaft Burst Pressure | Testing was conducted to demonstrate safety and effectiveness. (Details on specific burst pressure values or thresholds are not provided in this summary.) |
| Bond Strength | Testing was conducted to demonstrate safety and effectiveness. (Details on specific bond strength values or thresholds are not provided in this summary.) |
| Catheter Dimensions | Testing was conducted to demonstrate safety and effectiveness, including comparisons to predicate device characteristics. (No specific numerical dimensions are provided as "acceptance criteria" in this summary, but the device description outlines dimensions like balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm, and catheter lengths of 130, 80 and 40cm.) |
| Guidewire & Introducer Compatibility | Testing was conducted to demonstrate safety and effectiveness. (The maximum recommended guidewire diameter is 0.035" as per device description.) |
| Biocompatibility | All materials used in SAILOR PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter are biocompatible based on the biocompatibility testing. (No specific tests or thresholds are detailed in this summary.) |
It is important to note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device. For such devices, the "acceptance criteria" are generally met by showing that the new device performs similarly and safely in the specified in-vitro tests and materials are biocompatible, aligning with the predicate device and established standards. Specific numerical acceptance criteria would typically be found in detailed test reports, not usually in a high-level 510(k) summary.
Here's the additional information requested, based on the provided text, recognizing that this is for a physical medical device (a catheter), not an AI/ML algorithm. Therefore, many questions related to AI/ML studies (like test sets, ground truth experts, MRMC studies) are not applicable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device and submission. The "test set" for this device refers to physical prototypes undergoing in-vitro testing, not a dataset for an AI/ML algorithm. The summary does not specify the number of devices tested in vitro, nor does it provide details on the provenance of test data beyond stating it was "in vitro 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 is a physical catheter, not an AI/ML diagnostic or predictive tool. "Ground truth" in the context of AI/ML algorithms, established by expert consensus or pathology, is not relevant for the in-vitro performance testing of a PTA catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This question relates to the adjudication of expert labels for AI/ML ground truth, which is not relevant for the in-vitro performance testing of a physical medical device.
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. An MRMC study is designed for evaluating diagnostic accuracy, particularly with AI assistance, which is outside the scope of this device (a physical interventional catheter).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this physical device, "ground truth" concerning in-vitro performance would be defined by engineering specifications, material properties, and physical measurements/observations during testing, not clinical expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML diagnostics.
8. The sample size for the training set
- Not applicable. There is no "training set" for this physical device as it does not involve AI/ML.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this physical device as it does not involve AI/ML.
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K042538
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510(k) Summary SAILOR 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 | SAILOR 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 OPTA™ PRO Balloon Dilatation Catheter |
| Intended use | The SAILOR PLUS PTA Balloon Dilatation Catheter is intended todilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructivelesions of native or synthetic arteriovenous dialysis fistulae. |
| Device Description | The SAILOR PLUS Balloon Dilatation Catheter is OTW PTАcatheter with a semi-compliant inflatable balloon mounted at thedistal tip. It has a dual lumen catheter with a guidewire lumen anda balloon inflation lumen. Two radiopaque markers indicate thedilating portion of the balloon and help in correctly positioning theballoon within the vessel. The catheter tip is tapered to ease entryinto peripheral arteries and to facilitate the crossing of tightstenoses. The maximum recommended guidewire diameter is0.035". The device is available in balloon diameters of 3-12mm,balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengthsof 130. 80 and 40cm |
| Biocompatibility | All material used in SAILOR PLUS Percutaneous TransluminalAngioplasty (PTA) Catheter are biocompatible based on thebiocompatibility testing. |
| Performance data | In vitro testing was conducted to demonstrate the safety andeffectiveness of SAILOR 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 SAILOR PLUS Balloon Dilatation Catheter is similar to thepredicate with respect to intended use and to physicalcharacteristics, such as catheter and balloon dimensions and catheterdesign and materials. Further, the mechanical and biocompatibilitytesting data is indicative of the safety and effectiveness of SAILORPLUS Balloon Dilatation Catheter. |
| Conclusion | SAILOR PLUS Balloon Dilatation Catheter is substantiallyequivalent to the Predicate device |
| Sailor Plus PTA Balloon Dilatation Catheter Traditional 510(k)
510(k) Summary
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04533
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the 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: K042538
K042336
SAILOR PLUS™ 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 indication We have reviewed your Section J I (t), I premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivaled referenced above and nave detenmitted the devices marketed in interstate for use stated in the enclosure) to tegally inanced to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent and or or the Federal Food. Drug, devices that have been reclassified in accordance who areas approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include required whileities anainet mis general controls provisions of the Act morade requirement.
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 aove) mits chass in expendsions affecting your device can
may be subject to such additional controls. Existing major regulations allection, may be subject to such adultional controlis: Extrems, "And to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, 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 Ticase oc advised that I Dr Pressunt to syour device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must or any I cacal statutes and regainents and limited to: registration and listing (21 Comply with an the Act 8 requirements) (1); good manufacturing practice requirements as set CFR Part 6077, adoning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product including on to begin marketing your device as described in your Section 510(k) rms letter will and w you've obgen finding of substantial equivalence of your device to a legally promative noticate 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 desire spocific ac ripliance 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 sales and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(2017-15-05) fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blummenfor
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:
Device Name: SAILOR™ PLUS PTA Balloon Dilatation Catheter
Indications For Use:
The SAILOR™ PLUS 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 V (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)
Bhummmmar
(Division Sign Off)
(Division Sign-Off) Division of Cardlovascular Devices 510fk) Number KO *
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§ 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).