Passeo-18 is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae

Device Description

The Passeo-18 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. Two radiopaque markers are located at either end of the ballon 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 tapend of 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 has a two lumen co-axial design. The outer lumen is the balloon inflation/deflation lumen. The inner lumen permits the use of guide wires with diameters up to a maximum of 0.018" to facilitate advancement of the balloon catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducers sizes according to the recommendations on the label. The balloon cather has a silicone coating to improve the trackability and pushability characteristics.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The Passeo-18 PTA Catheter is substantially equivalent to the predicate devices (BIOTRONIK's Pheron peripheral PTA catheter, [K033217](https://510k.innolitics.com/search/K033217) and [K052757](https://510k.innolitics.com/search/K052757)) based on indications for use and general specifications.",
    "Reported Device Performance": "The FDA determined that the Passeo-18 PTA catheter is substantially equivalent to its predicate devices for the indicated uses, indicating it meets the acceptance criteria for safety and effectiveness."
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not applicable. This is a 510(k) premarket notification for a medical device (PTA catheter), not an AI/ML diagnostic device study involving a test set of data. The submission relies on demonstrating substantial equivalence to a predicate device, not on clinical performance data derived from a specific test set.",
  "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 document pertains to a medical device (PTA catheter) and not an AI/ML diagnostic device requiring expert interpretation for ground truth.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This document pertains to a medical device (PTA catheter) and not an AI/ML diagnostic device requiring adjudication of expert interpretations.",
  "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 document pertains to a medical device (PTA catheter) and not an AI/ML diagnostic device, so no MRMC study was conducted or is relevant.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This document pertains to a physical medical device (PTA catheter) and not an algorithm or AI. Performance is evaluated through bench testing and comparison to predicate devices, not through standalone algorithm performance.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. For a 510(k) of this nature, 'ground truth' largely refers to established engineering standards, biocompatibility testing results, and performance characteristics (e.g., inflation diameter at pressure, flexibility, trackability) demonstrated to be equivalent to the predicate device. These are not typically established by expert consensus of patient data, pathology, or outcomes in the same way an AI/ML diagnostic device's ground truth would be.",
  "8. The sample size for the training set": "Not applicable. This is a 510(k) for a medical device (PTA catheter), not an AI/ML diagnostic device. Therefore, there is no training set in the context of an algorithm.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a 510(k) for a medical device (PTA catheter), not an AI/ML diagnostic device. Therefore, there is no training set and no ground truth establishment for a training set."
}

Summary

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Passeo-18 PTA Catheter Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Name and Address of Sponsor: BIOTRONIK, Inc. DEC 1 2 2007 6024 Jean Road Lake Oswego, OR 97035 Applicant Name and Address: Biotronik AG. Ackerstraße 6 8180 Bülach Switzerland Establishment Registration Number: 8043892 Device Name: Proprietary Name: Passeo-18 Common Name: Percutaneous Transluminal Angioplasty (PTA) Catheter Class II (21 CFR 870.1250) Classification: Classification Name: Percutaneous Catheter Product Code: LIT 510(k) Number: Date Prepared: September 27, 2007

General Description:

Predicate Devices:

BIOTRONIK proposes its Pheron peripheral PTA catheter cleared through the following 510(k) notifications as the predicate device for the Passeo-18 PTA Catheter:

. K033217, cleared October 31, 2003
K052757, cleared October 28, 2005

Indication for Use:

The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popilteal and infrapopliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

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BIOTRONIK., Passeo-18, Special 510(k)

September 27, 2007

Name and Address of Manufacturing Site:

BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland

Manufacturing Site Contact Person and Phone Number:

Marcel Schaefer BIOTRONIK AG Ackerstraße 6 8180 Bülach, Switzerland 011-41-44-864-51-78

510(k) Contact Person and Phone Number:

Jon Brumbaugh BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 (888) 345-0374

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is composed of three curved lines, and it is facing to the right.

DEC 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biotronik, Inc. c/o Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035

Re: K072765 Trade/Device Name: Passeo-18 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: November 13, 2007 Received: November 14, 2007

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.

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Page 2 - Mr. Jon Brumbaugh

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 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 the reporting 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,

Dina R. Holmes

Image /page/3/Picture/5 description: The image contains what appears to be a signature or stylized symbol. It features a curved line at the top that resembles a loop or a stylized letter, possibly an 'S'. Below the curved line, there are a few smaller, wavy lines that add complexity to the design. A straight, diagonal line extends from the bottom of the symbol, giving it a sense of direction or grounding.

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 (if known):

K072765

Device Name:

Indications For Use:

Passeo-18 PTA catheter

Passeo-18 is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal 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 801 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. Richter

(Distron Sign-Off) Division of Cardiovascular Devices

10/1 Number_4072365

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Regulation Number and Section

§ 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).