(218 days)
No
The 510(k) summary describes a mechanical balloon dilatation catheter and does not mention any AI or ML components or functionalities.
Yes
The device is indicated to dilate stenosis in arteries and for the treatment of obstructive arteriovenous dialysis fistulae, which are therapeutic actions.
No
The device is a dilatation catheter used to treat stenosis in arteries and fistulae, not to diagnose conditions. Its intended use is therapeutic (dilatation), not diagnostic.
No
The device description clearly describes a physical catheter with lumens and a balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dilate stenosis in blood vessels and arteriovenous fistulae. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a balloon dilatation catheter, a physical tool used for mechanical intervention within the body.
- Mechanism of Action: The device works by physically expanding a balloon to open narrowed vessels. This is a mechanical action, not a diagnostic test performed on a sample outside the body.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device within the body, not to analyze a biological sample.
- Anatomical Site: The device is used within the patient's circulatory system.
- Performance Studies: The performance studies focus on the physical properties and functionality of the catheter (burst pressure, flexibility, trackability, etc.), not on the accuracy of a diagnostic measurement.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Passeo-35 is also recommended for post-dilatation of balloon expanding stents in the peripheral vasculature.
Product codes
LIT
Device Description
BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo 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 Xeo Catheter towards and through the lesion(s) to be dilated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians competent in PTA procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing was conducted on the BIOTRONIK Passeo-35 Xeo Peripheral Dilatation Catheter to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device. The nonclinical bench testing included:
- Design Verification O
- Balloon Rated Burst Pressure
- Balloon Rated Burst Pressure in Stent ●
- Balloon Fatigue .
- Balloon Fatigue in Stent ●
- Flexibility and Kink Test
- Torque Strength
- Compatibility to Accessories
- Crossing Profile
- . Simulated Use
- Tensile strength
- Retraction Force ●
- . Trackability
- . Pushability
- Biocompatibility Testing O
In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results of the non-clinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Passeo-35 Xeo Catheters meet the established specifications necessary for consistent performance during its intended use. The collective bench testing demonstrates that the Passeo-35 Xeo Catheters do not introduce new issues of safety or effectiveness when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2023
BioTronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035
Re: K222065
Trade/Device Name: Passeo-35 Xeo Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 9, 2023 Received: January 10, 2023
Dear Jon 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S 08:51:08-05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222065
Device Name Passeo-35 Xeo Peripheral Dilatation Catheter
Indications for Use (Describe)
The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Passeo-35 is also recommended for post-dilatation of balloon expanding stents in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(K) Summary: BIOTRONIK Passeo-35 Xeo Peripheral Dilatation Catheter | |||||
|---|---|---|---|---|---|
| K222065) | |
|---|---|
| ---------- | -- |
| Date Prepared: | January 6, 2023 |
|---|---|
| Contact: | Jon Brumbaugh |
| Vice President, Requlatory Affairs & New Product Development | |
| BIOTRONIK, Inc. | |
| 6024 Jean Road | |
| Lake Oswego, OR 97035 USA | |
| Phone (888) 345-0374 | |
| Fax (800) 913-6993 | |
| Email: jon.brumbaugh@biotronik.com | |
| Trade Name: | Passeo-35 Xeo Peripheral Dilatation Catheter |
| Generic/Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal |
| Classification & Panel: | Class II / 21 CFR § 870.1220, Cardiovascular |
| Product Code: | LIT |
| Predicate Device: | BIOTRONIK Passeo-35 Percutaneous Transluminal Angioplasty |
| (PTA)Catheter (K142379, cleared December 5, 2014) |
Device Description
BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo 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 Xeo Catheter towards and through the lesion(s) to be dilated.
Indications for Use
The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the illiac, femoral, popliteral and infrapopliteral arteries and for the treatment of obstructive lesions of native and synthetic arteriovenous dialysis fistulae.
Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.
Comparison of Technological Characteristics with the Predicate Devices
The BIOTRONIK Passeo-35 Xeo Peripheral Dilatation Catheter is substantially equivalent to the predicate device BIOTRONIK Passeo-35 Percutaneous Transluminal Angioplasty (PTA)Catheter (K142379, cleared December 5, 2014). The indications for use are similar,
4
with only minor differences. The Passeo-35 Xeo and the predicate device have substantially equivalent safety and technological features as mentioned below.
The minor device design differences do not introduce new issues of safety or effectiveness as demonstrated by the Passeo-35 Xeo Peripheral Dilatation Catheter performance testing.
| Comparison of Passeo-35 Xeo to Predicate Device Passeo-35 | ||||
|---|---|---|---|---|
| Characteristic | Predicate Device | Subject Device | Comparison | |
| Proprietary name | Passeo-35 | |||
| (K142379) | Passeo-35 Xeo | |||
| (K222065) | New Name | |||
| Common name | PTA catheter | Unchanged | ||
| Classification | Class II (21 CFR 870.1250) | Unchanged | ||
| Classification name | Catheter, angioplasty, peripheral, transluminal | Unchanged | ||
| Product code | LIT | Unchanged | ||
| Intended use | The Passeo-35 peripheral | |||
| dilatation catheter is intended | ||||
| for dilatation of stenotic | ||||
| segments in peripheral vessels | ||||
| and arteriovenous dialysis | ||||
| fistulae for the purpose of | ||||
| improving perfusion. | The Passeo-35 Xeo peripheral | |||
| dilatation catheter is intended | ||||
| for dilatation of stenotic | ||||
| segments in peripheral vessels | ||||
| and arteriovenous dialysis | ||||
| fistulae for the purpose of | ||||
| improving perfusion. | Updated to reflect | |||
| device name | ||||
| Indications for Use | The Passeo-35 peripheral | |||
| dilatation catheter is indicated | ||||
| to dilate stenosis in the renal, | ||||
| iliac, femoral, popliteal and infra | ||||
| (popliteal arteries and for the | ||||
| treatment of obstructive lesions | ||||
| of native or synthetic | ||||
| arteriovenous dialysis fistulae. | The Passeo-35 Xeo peripheral | |||
| dilatation catheter is indicated | ||||
| to dilate stenosis in the iliac, | ||||
| femoral, popliteal and | ||||
| infrapopliteal arteries and for | ||||
| the treatment of obstructive | ||||
| lesions of native or synthetic | ||||
| arteriovenous dialysis fistulae. | ||||
| Passeo-35 is also recommended | ||||
| for post-dilatation of balloon | ||||
| expandable and self-expanding | ||||
| stents in the peripheral | ||||
| vasculature. | Comparable | |||
| Contraindications | All general contraindications for | |||
| percutaneous transluminal | ||||
| angioplasty (PTA) are | ||||
| contraindications for this | ||||
| device. Contraindications for | ||||
| this device and peripheral | ||||
| dilatation catheters in general | ||||
| are: | ||||
| • Lesions that cannot be | ||||
| reached or treated with the | ||||
| system | ||||
| • Large amounts of acute or | ||||
| subacute thrombus at the | ||||
| target lesion | ||||
| • Perforated vessels | ||||
| • Lesion that lies within or | ||||
| adjacent to an aneurysm | ||||
| • Uncorrected bleeding | ||||
| disorders | ||||
| • Renal insufficiency or an | ||||
| allergy to contrast media | ||||
| Furthermore, all procedure- | ||||
| related contraindications as | Passeo-35 Xeo is | |||
| contraindicated for use in | ||||
| patients with: | ||||
| • A lesion that cannot be | ||||
| reached or treated with the | ||||
| dilatation catheter. | ||||
| • Large amounts of acute or | ||||
| sub-acute thrombus at the | ||||
| target lesion. | ||||
| • Perforated vessels. | ||||
| • A lesion that lies within or | ||||
| adjacent to an aneurysm. | ||||
| • Uncorrected bleeding | ||||
| disorders. | ||||
| • A renal insufficiency or an | ||||
| allergy to contrast media. | ||||
| Furthermore, all general PTA | ||||
| and procedure-related | ||||
| contraindications as described | ||||
| in the national and international | ||||
| guidelines of the respective | ||||
| medical associations apply. | Comparable | |||
| Comparison of Passeo-35 Xeo to Predicate Device Passeo-35 | ||||
| Characteristic | Predicate Device | Subject Device | Comparison | |
| described in the national and | ||||
| international guidelines of the | ||||
| respective medical associations | ||||
| apply. | ||||
| Intended user | Physicians competent in PTA procedures | Unchanged | ||
| Method of | ||||
| placement | Standard percutaneous access to site over a guide wire, with | |||
| fluoroscopic visualization | Unchanged | |||
| Sterilization / Shelf | ||||
| Life / Packaging | 3 years | Unchanged | ||
| Sterilization | EO gas | Unchanged | ||
| SAL | 10-6 | Unchanged | ||
| Shelf life | 3 years | Unchanged | ||
| Protective sheath | Balloon has a HDPE protective sheath. HDPE spiral dispenser | |||
| sealed in a Tyvek® and PET/PE pouch. | ||||
| Product is packed in an outer cardboard carton. | Unchanged | |||
| Device description | Over the wire 2-lumen balloon catheter | Unchanged | ||
| Radiopaque | ||||
| markers | 2 markers– one at each end of the balloon | |||
| Material: 90% Pt / 10% Ir | ||||
| Length: 1.5 mm | Unchanged | |||
| Usable length [cm] | 80, 90 and 130 | 90, 130, and 170 | Comparable | |
| Crossing profile | Ø: 3-7mm: max. 0.074 inches | |||
| Ø: 8-10mm: max. 0.083 inches | Unchanged | |||
| Guide wire | ||||
| compatibility | 0.035" | Unchanged | ||
| Shaft outer | ||||
| diameter [F] | 5 | Unchanged | ||
| Balloon diameter | ||||
| [mm] | 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, | |||
| 10.0 | 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, | |||
| 10.0 and 12.0 | Comparable | |||
| Balloon length | ||||
| [mm] | 20, 40, 60, 80, 100, 120, 150, | |||
| 170, 200 | 20, 40, 60, 80, 100, 120, 150, | |||
| 170, 200 and 250 | Comparable | |||
| Balloon wrapping | 5 folds | 3-5 folds | Comparable | |
| Balloon Nominal | ||||
| pressure [atm] | 7 | Unchanged | ||
| Balloon RBP [atm] | 20 (Balloon Ø: 3mm) | |||
| 18 (Balloon Ø: 4mm) | ||||
| 16 (Balloon Ø: 5 - 6 mm) | ||||
| 14 (Balloon Ø: 7 - 8 mm) | ||||
| 12 (Balloon Ø: 9mm) | ||||
| 11 (Balloon Ø: 10 mm) | 21 (Balloon Ø: 3mm) | |||
| 18 (Balloon Ø: 4mm) | ||||
| 16 (Balloon Ø: 5 - 6 mm) | ||||
| 14 (Balloon Ø: 7 - 8 mm) | ||||
| 12 (Balloon Ø: 9mm) | ||||
| 11 (Balloon Ø: 10 mm) | Comparable |
5
Performance Data
All necessary performance testing was conducted on the BIOTRONIK Passeo-35 Xeo Peripheral Dilatation Catheter to ensure that the device conforms to the design specification
6
and to support a determination of substantial equivalence to the predicate device. The nonclinical bench testing included:
- Design Verification O
- Balloon Rated Burst Pressure
- Balloon Rated Burst Pressure in Stent ●
- Balloon Fatigue .
- Balloon Fatigue in Stent ●
- Flexibility and Kink Test
- Torque Strength
- Compatibility to Accessories
- Crossing Profile
- . Simulated Use
- Tensile strength
- Retraction Force ●
- . Trackability
- . Pushability
- Biocompatibility Testing O
In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results of the non-clinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Passeo-35 Xeo Catheters meet the established specifications necessary for consistent performance during its intended use. The collective bench testing demonstrates that the Passeo-35 Xeo Catheters do not introduce new issues of safety or effectiveness when compared to the predicate device.
Conclusions
Based on the performance testing and the technological characteristics, it can be concluded that the BIOTRONIK Passeo-35 Xeo Peripheral Dilatation Catheter meets its established performance for its intended use and is substantially equivalent to the predicate device.