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.

Device Description

The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopague 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 (guidewire 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 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.

AI/ML Overview

This 510(k) K130161 is for a Special 510(k) notification, indicating that the device (Passeo-35 PTA Catheter) is a modification of a previously cleared device (Passeo-35 PTA Catheter, K082933).

Crucially, the document states:

"The determination of substantial equivalency on this subject device does not rely upon the nonclinical test data. There is no nonclinical test data submitted in this application."
"The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application."

This means that no new studies (clinical or non-clinical) were conducted or submitted to demonstrate that the modified device meets any acceptance criteria. The substantial equivalence is based solely on the fact that the changes are minor (only labeling changes) and the device's technological characteristics, materials, and manufacturing remain unchanged from the previously cleared predicate device.

Therefore, the requested information about acceptance criteria and studies cannot be provided from this document, as none were performed for this specific 510(k) submission. Any original studies or acceptance criteria would have been part of the original K082933 submission.

For completeness, if this were a submission requiring new clinical or non-clinical data, the table and details would be structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

Acceptance Criteria (e.g., specific endpoints for safety/effectiveness)	Reported Device Performance
No new criteria or performance data for this submission.	N/A

2. Sample size used for the test set and the data provenance

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

Sample Size (Test Set): N/A
Data Provenance: N/A (e.g., country of origin, retrospective/prospective)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

Number of Experts: N/A
Qualifications: N/A

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

Adjudication Method: N/A

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 as no new studies were conducted for this Special 510(k). This is also not an AI device.)

MRMC Study Conducted: No
Effect Size: N/A

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 as no new studies were conducted for this Special 510(k). This is not an AI device.)

Standalone Study Conducted: No

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

Type of Ground Truth: N/A

8. The sample size for the training set

(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)

Training Set Sample Size: N/A

9. How the ground truth for the training set was established

(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)

Ground Truth Establishment (Training Set): N/A

Summary

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K130161 p. 1 of 2

APR 2 3 2013

Passeo-35 PTA Catheter Special 510(k) Premarket Notification 510(k) Summary

BIOTRONIK, Inc. Name and Address of Sponsor: 6024 Jean Road Lake Oswego, OR 97035 510(k) Contact Person and Phone Number: Jon Brumbaugh Vice President Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone: (888) 345-0374 Fax: (503) 635-9936 jon.brumbaugh@biotronik.com

Date Prepared:

Device Name:

Proprietary Name: Common Name: Catheter Classification: Classification Name: Product Code:

January 21, 2013

Passeo-35 Percutaneous Transluminal Angioplasty (PTA)

Class II (21 CFR 870.1250) Catheter, angioplasty, peripheral, transluminal LIT

Predicate Device:

BIOTRONIK indicates Passeo-35 was previously cleared through 510(k) notification and it is its own predicate device for this Special 510(k) changes being effected labeling changes:

BIOTRONIK's Passeo-35 PTA Catheter (K082933, cleared November 3, 2008). .

General Description:

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 (guidewire 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 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.

Page 1 of 2

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Indication for Use:

The indications for use statement may be found in Appendix 01.

This device is prescription only device as stated on the IFU, "Caution: Federal (USA) law restricts this device to sale by or on the order of a physician". The Passeo-35 peripheral dilatation catheter was cleared with the indication for use of, "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."

Technological Characteristics

The subject device as the predicate device, Passeo-35 PTA Catheter (K082933, cleared November 3, 2008). The only differences pertain to the changes in the IFU and labeling, the materials, manufacture and technology have remained unchanged.

Nonclinical Test Data

The determination of substantial equivalency on this subject device does not rely upon the nonclinical test data. There is no nonclinical test data submitted in this application.

Clinical Test Data

The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application.

Conclusion

Based on the minor nature of the labeling changes, the subject Passeo-35 catheter is substantially equivalent to the predicate Passeo-35 catheter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

April 23, 2013

BIOTRONIK. Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs & Compliance 6024 Jean Road Lake Oswego, OR 97224

Re: K130161

Trade/Device Name: Passeo-35 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: January 21, 2013 Received: January 23, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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Page 2 - Mr. Jon Brumbaugh

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

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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K130161

Indications for Use

510(k) Number (if known):

K130161

Device Name:

Passeo-35 PTA Catheter

Indications For Use:

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)

Matthew G割訓llebrenner

Page 1 of 1_____________________________________________________________________________________________________________________________________________________________

Page 33 of 86

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).