(33 days)
The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter. The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.
The provided text is a 510(k) premarket notification for the BIOTRONIK Passeo-35 PTA Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application or a more comprehensive clinical trial report.
Therefore, the input does not contain the specific information required to complete the detailed table and answer all questions related to acceptance criteria, study design, and performance. The document primarily describes the device, its intended use, and identifies predicate devices.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. 510(k) submissions typically rely on design verification and validation testing (bench and/or animal studies) to demonstrate that a new device performs as intended and is as safe and effective as a predicate device. Specific acceptance criteria and quantitative performance results for a clinical study with human subjects, in the format requested, are not included.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document. There is no mention of a clinical "test set" with human subjects for the Passeo-35, nor details on data provenance. The submission focuses on device characteristics and substantial equivalence to predicates.
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):
This information is not available in the provided document. "Ground truth" establishment by experts is a concept typically associated with studies involving diagnostic accuracy or image interpretation, which is not the focus of this device (a PTA catheter).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided document. Adjudication methods are relevant for studies where expert consensus is needed for outcome assessment, which, again, is not detailed here.
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:
This information is not available in the provided document. An MRMC study is not relevant for a PTA catheter, nor is AI assistance mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. A "standalone algorithm" is not applicable to an interventional medical device like a PTA catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document. As a physical device for dilatation, the concept of "ground truth" for the device's performance often relates to physical and mechanical properties (e.g., balloon diameter at pressure, burst strength, trackability), verified through engineering and bench testing, rather than clinical "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical trial.
8. The sample size for the training set:
This information is not available in the provided document. The concept of a "training set" is typically associated with machine learning or AI models, which are not described here.
9. How the ground truth for the training set was established:
This information is not available in the provided document for the reasons stated above.
Summary based on available information:
The document describes the BIOTRONIK Passeo-35 PTA Catheter as a device for dilating stenotic segments in peripheral vessels (renal, iliac, femoral, popliteal, infrapopliteal arteries) and for treating obstructive lesions in arteriovenous dialysis fistulae.
The device's safety and effectiveness are established through demonstration of substantial equivalence to predicate devices:
The submission implies that the device meets its intended performance through its design, materials, and manufacturing, consistent with the cleared predicate devices. Specific clinical acceptance criteria and results from human studies are not detailed in this 510(k) summary. The FDA's clearance (K082933) indicates that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.
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K6r2933
BIOTRONIK, Passeo-35, Special 510(k)
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November 3, 2008
Passeo-35 PTA Catheter Special 510(k) Premarket Notification
1. 510(K) SUMMARY
Name and Address of Sponsor:
Establishment Registration Number:
Applicant Name and Address:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
1028232
BIOTRONIK AG Ackerstraße 6 8180 Bülach Switzerland
Passeo-35
Device Name:
Proprietary Name: Common Name: Classification: Classification Name: Product Code:
Date Prepared:
DQY
Class II (21 CFR 870.1250)
Percutaneous Transluminal Angioplasty (PTA) Catheter
Catheter, angioplasty, peripheral, transluminal
November 3, 2008
General Description:
The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.
The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.
Predicate Devices:
BIOTRONIK proposes the following PTA catheters cleared through 510(k) notifications as the predicate devices for the Passeo-35 PTA Catheter:
- . BIOTRONIK's Pheron PTA Catheter (K033217, cleared October 31, 2003 and K052757, cleared October 28, 2005)
- BIOTRONIK's Passeo-18 PTA Catheter (K072765, cleared December 12, 2007) .
Indication for Use:
The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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| Name and Address of Manufacturer: | BIOTRONIK AG (reg. no. 8043892)Ackerstrasse 68180 Bülach, Switzerland |
|---|---|
| Manufacturer's Registration Number: | 8043892 |
| Manufacturing Site Contact Person and Phone Number: | Marcel SchaeferBIOTRONIK AGAckerstraße 68180 Bülach, Switzerland011-41-44-864-51-78marcel.schaefer@biotronik.com |
| 510(k) Contact Person and Phone Number: | Jon BrumbaughVice President, Regulatory Affairs and ComplianceBIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035Phone: (888) 345-0374Fax: (503) 635-9936jon.brumbaugh@biotronik.com |
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2008
대한민국 대학교 대학교 대학교 대학교 동문 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학 대학 대학 대학
Biotronik, Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
Re: K082933
Trade/Device Name: Passeo-35 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: September 30, 2008 Received: October 1, 2008
Dear Mr. Brumbaugh:
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, Drug, 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, FDA 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 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
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
R. Vahner
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
and service and color controlled in a comments and commental commental de la ministrative in the manus and comments of consistence in consistence in consideration in consider
510(k) Number (if known):
1082933
Device Name:
Passeo-35 PTA Catheter
Indications For Use:
The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Vicines
(Division Sinn-Off) (Division of Cardiovascular Devices
510(K) Number K082933
§ 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).