(101 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter for dilating blood vessels. There is no mention of software, algorithms, image processing for analysis, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes.
Explanation: The device is intended to dilate stenosis in arteries and treat obstructive lesions, which are therapeutic actions aimed at improving patient health.
No
This device is a therapeutic device, specifically a balloon catheter used for dilating stenoses in arteries and arteriovenous fistulae. Its primary function is treatment, not diagnosis. The "Ingredients: Fluoroscopic visualization" refers to the method used to guide the placement of the therapeutic device, not that the device itself is performing a diagnostic function.
No
The device description clearly details a physical catheter with a balloon, radiopaque markers, Luer ports, and a guide wire lumen. This is a hardware medical device.
Based on the provided information, the Passeo-35 Peripheral Dilatation Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Passeo-35 Function: The Passeo-35 is a physical device used within the body (in vivo) to mechanically dilate blood vessels. It does not analyze biological samples or provide diagnostic information based on the examination of those samples.
- Intended Use: The intended use clearly states it's for dilating stenosis in arteries and treating obstructive lesions in dialysis fistulae. This is a therapeutic procedure performed directly on the patient's anatomy.
- Device Description: The description details the physical components and how it's used for mechanical dilatation, not for analyzing samples.
- Anatomical Site: The anatomical sites are within the patient's circulatory system.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device within the body, not to analyze samples.
Therefore, the Passeo-35 Peripheral Dilatation Catheter is a therapeutic medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LIT
Device Description
The Passec-35 Peripheral Dilatation Catheter (Passeo-35) is intended 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) 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 lumens contained within one tube. The smaller lumen is the balloon inflation/deflation 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) sizes according to the recommendations on the label. The balloon catheter has a silicone coating (hydrophobic) to improve the trackability characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native 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)
Biocompatibility Testing:
- Cytotoxicity: L929 cells incubated with test article extracts; no cytotoxic effects.
- Sensitization: Test article extracts administered topically to mice; no sensitization reactions.
- Irritation / Intracutaneous reactivity: Extracts injected into rabbits; no signs of irritation.
- Acute systemic toxicity: Extracts injected into mice; no compound-related mortalities, no significant body weight loss, no gross pathology of organs.
- Pyrogenicity: Extracts injected into rabbits; no temperature increase higher or equal to 0.5°C.
- Hemocompatibility: Test article placed in Heparin-anticoagulated whole human blood; no significant changes in cell counts, coagulation system activation value identical to reference, no evidence of hemolysis.
- Gas Chromatography - Mass Spectrometry: GC/MS fingerprint analysis of extractable semi-volatile organic compounds yielded no differences in the type of detected substances between old and new materials.
- Fourier Transform Infrared Spectroscopy (FT-IR) analysis: Materials had greater than 99% correlation according to FT-IR analysis, similar to predicate.
Mechanical Testing:
- Visual and Dimensional Inspection: Performed according to ISO 25539-2:2008, ASTM F2081-06, DIN EN ISO 10555-1:1995 + AM1:1999 + AM2:2004, ISO 10555-4:1996/2002 + Cor1:2002. Inspectional acceptance criteria were met.
- Crossing Profile (system profile): Conducted as per ISO 25539-2:2008 and ASTM F2081-6. Acceptance criteria for crossing profile were met, within specs of predicate.
- Simulated Use / Balloon Preparation, Deployment and Retraction: Qualitative evaluation of simulated use, flex/kink, pushability, torquability and trackability. Acceptance criteria were met. Device performs similar to predicate in a simulated use environment.
- Deflated Balloon Profile: Measured force required to insert and remove a deflated balloon. Acceptance criteria were met: withdrawal force is less than minimal tensile and deflated balloon diameter is less than max crossing profile.
- Trackability: Measured frictional force (N) over distance (mm) when tracked over a guide wire in arterial model. Acceptance criteria for comparison to the predicate were met.
- Pushability: Test device pushed through an anatomical model with a proximal force. Acceptance criteria for comparison to predicate devices were met.
- Torqueability / Torque Strength: Assessed rotation transfer to distal tip, inflation/deflation with torsion. Qualitative assessment showed rotation transfers to distal tip on average between 10 and 16 rotations and all balloons passed inflation test. Device meets torqueability and torque strength acceptance criteria.
- Pullback and reintroduction test: Measured friction to introduce and pullback device after inflation to RBP. Pullback and reintroduction was comparable or better than comparator product. Product specifications were met for 1st and 2nd pullback force values. Balloon can be safely retrieved after burst.
- Balloon Inflation / Deflation Time: Characterized inflation and deflation times to RBP. Inflation time was characterized and deflation time was determined to be according to specifications within the instructions for use.
- Flexibility and kink test: Catheter advanced over guidewire through a predefined curve. No kink occurred nor was the function of the device compromised. Guide wire was movable, and it was possible to inflate and deflate the balloon to and from NP.
- Particulate Evaluation: Measured sub-visible particulates released after simulated use. The number of particulates released by the Passeo-35 LE were either the same as (p-value >0.05) or were less than the comparator device (p-value
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
BIOTRONIK, Inc. Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K142379
Trade/Device Name: Passeo-35 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 4, 2014 Received: November 5, 2014
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
http://www.fda.gov/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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K142379 510(k) Number (if known):
Device Name: Passeo-35 Peripheral Dilatation 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 _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Passeo-35 Peripheral Dilatation Catheter Special 510(k) Premarket Notification 510(k) Summary
| Name and Address of Sponsor: | BIOTRONIK, Inc.
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: | December 5, 2014 |
| Device Name: | |
| Proprietary Name: | Passeo-35 Peripheral Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA)
Catheter |
| Classification: | Class II (21 CFR 870.1250) |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Product Code: | LIT |
Predicate Device:
| 510(k) # | Device Name | Manufacturer | Date of Clearance | |
|---|---|---|---|---|
| Predicate: | K082933 | Passeo-35 | BIOTRONIK | 3-Nov-2008 |
General Description:
The Passec-35 Peripheral Dilatation Catheter (Passeo-35) is intended 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) 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 lumens contained within one tube. The smaller lumen is the balloon inflation/deflation 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) sizes according to the recommendations on the label. The balloon catheter has a silicone coating (hydrophobic) to improve the trackability characteristics.
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Image /page/4/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in bold, dark blue letters, with a light blue circle containing the letters "BIO" to the left. Below the name is the phrase "excellence for life" in a smaller, light blue font.
Indication for Use:
The Passeo-35 Peripheral Dilatation Catheter is indicated to dilate stenosis in the renal, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Purpose of Submission:
BIOTRONIK submits this 510(k) for clearance of additional device size configurations for the Passeo-35 including additional balloon lengths up to 200mm. In addition, device and packaging materials changes are documented and labeling is updated for clarity as well as to reflect the new sizes and RBPs.
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | |||
|---|---|---|---|
| Parameters | Passeo-35 | ||
| K082933 | Passeo-35 | ||
| Subject Device | Rationale for Substantial | ||
| Equivalence | |||
| Proprietary name | Passeo-35 Peripheral | ||
| Dilatation Catheter | Passeo-35 Peripheral | ||
| Dilatation Catheter | Same | ||
| Common name | PTA catheter | PTA catheter | Same |
| Classification | Class II (21 CFR 870.1250) | Class II (21 CFR 870.1250) | Same |
| Classification | |||
| name | Catheter, angioplasty, | ||
| peripheral, transluminal | Catheter, angioplasty, | ||
| peripheral, transluminal | Same | ||
| Product code | LIT | LIT | Same |
| Intended use / Indications for Use | |||
| Intended use | The Passeo-35 Peripheral | ||
| Dilatation Catheter is intended | |||
| for dilatation of stenotic | |||
| segments in peripheral | |||
| vessels and arteriovenous | |||
| dialysis fistulae. | The Passeo-35 Peripheral | ||
| Dilatation Catheter is intended | |||
| for dilatation of stenotic | |||
| segments in peripheral | |||
| vessels and arteriovenous | |||
| dialysis fistulae. | Same | ||
| 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. | 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. | Same | ||
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | |||
| Parameters | Passeo-35 | ||
| K082933 | Passeo-35 | ||
| Subject Device | Rationale for Substantial | ||
| Equivalence | |||
| 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 | |||
| described in the national and | |||
| international guidelines of the | |||
| respective medical | |||
| associations apply. | 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 | |||
| Same | |||
| Intended user | Physicians competent in PTA | ||
| procedures | Physicians competent in PTA | ||
| procedures | Same | ||
| Method of | |||
| placement | Standard percutaneous | ||
| access to site over a guide | |||
| wire, with fluoroscopic | |||
| visualization | Standard percutaneous | ||
| access to site over a guide | |||
| wire, with fluoroscopic | |||
| visualization | Same | ||
| Sterilization / Shelf life / Packaging | |||
| Sterilization | EO gas | EO gas | Same |
| Sterilization | |||
| System | Sauter EO Sterilizer | Sauter EO Sterilizer | |
| or | |||
| Sterichem EO Sterilizer | Does not alter intended use. | ||
| Validation testing according to | |||
| design controls support | |||
| equivalence. BIOTRONIK | |||
| uses either sterilizer in | |||
| production. | |||
| SAL | 10-6 | 10-6 | Same |
| Shelf life | 3 years | 3 years | Same |
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | |||
| Parameters | Passeo-35 | ||
| K082933 | Passeo-35 | ||
| Subject Device | Rationale for Substantial | ||
| Equivalence | |||
| Protective sheath | Balloon has a protective | ||
| sheath. Spiral dispenser | |||
| sealed in a Tyvek® and | |||
| PET/PE pouch. | |||
| Product is packed in an outer | |||
| cardboard carton. | Balloon has a protective | ||
| sheath. Spiral dispenser | |||
| sealed in a Tyvek® and | |||
| PET/PE pouch. | |||
| Product is packaged in an | |||
| outer cardboard carton. | Same | ||
| Shelf life | 3 years | 3 years | Same |
| Instructions for | |||
| Use and labeling | As provided in K082933. | Minor wording & symbol | |
| changes | Changes do not alter intended | ||
| use, technological | |||
| characteristics, or raise | |||
| different questions of safety | |||
| and effectiveness. | |||
| Device Design | |||
| Device | |||
| description | Over the wire 2-lumen balloon | ||
| catheter | Over the wire 2-lumen balloon | ||
| catheter | Same | ||
| Radiopaque | |||
| markers | 2 – one at each end of the | ||
| balloon | |||
| Material: 90% Pt / 10% Ir | |||
| Length: 1.5 mm | 2 – one at each end of the | ||
| balloon | |||
| Material: 90% Pt / 10% Ir | |||
| Length: 1.5 mm | Same | ||
| Usable length | |||
| [cm] | 80 and 130 | 80, 90 and 130 | Does not alter intended use. |
| Performance testing | |||
| according to design controls | |||
| support equivalence. | |||
| Introducer | |||
| sheath | |||
| compatibility | 5F (Balloon Ø: 3 – 7 mm) | ||
| 6F (Balloon Ø: 8 – 10 mm) | 5F (Balloon Ø: 3 – 7 mm) | ||
| 6F (Balloon Ø: 8 – 10 mm) | Same | ||
| Crossing profile | Ø: 3-7mm: max. 0.074 inches | ||
| Ø: 8-10mm: max. 0.083 | |||
| inches | Ø: 3-7mm: max. 0.074 inches | ||
| Ø: 8-10mm: max. 0.083 | |||
| inches | Same | ||
| Guide wire | |||
| compatibility | 0.035" | 0.035" | Same |
| Shaft outer | |||
| diameter [F] | 5 | 5 | Same |
| Shaft inner | |||
| diameter [mm] | 0.96 | 0.98 | The larger inner diameter of |
| Passeo-35 LE does not alter | |||
| the intended use or raise | |||
| different safety and | |||
| effectiveness questions. | |||
| Performance testing data | |||
| showed substantial | |||
| equivalence to the predicate. | |||
| 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 | Same | ||
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | |||
| Passeo-35 | Passeo-35 | Rationale for Substantial | |
| Parameters | K082933 | Subject Device | Equivalence |
| Balloon length | |||
| [mm] | 20, 40, 60, 80, 100 | 20, 40, 60*, 80*, 100*, 120, | |
| 150, 170, 200 | |||
| (* new balloon lengths for | |||
| some balloon diameter sizes,) | Same intended use and does | ||
| not raise different safety and | |||
| effectiveness questions. | |||
| Performance testing data | |||
| demonstrate substantial | |||
| equivalence. | |||
| Balloon wrapping | 5 folds | 5 folds | Same |
| Balloon Nominal | |||
| pressure [atm] | 7 | 7 | Same |
| Balloon RBP | |||
| [atm] | 20 (Balloon Ø: 3 - 4 mm) | ||
| 16 (Balloon Ø: 5 - 6 mm) | |||
| 14 (Balloon Ø: 7 - 8 mm) | |||
| 12 (Balloon Ø: 9 - 10 mm) | 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) | Same intended use and does | ||
| not raise different safety and | |||
| effectiveness questions. | |||
| Performance testing data | |||
| demonstrate substantial | |||
| equivalence. | |||
| Materials of Construction (Direct and indirect patient contact) | |||
| Tip | Pebax 5533 SA01 | Pebax 5533 SA01 | Same |
| Balloon | Poly-Amide (PA) | Poly-Amide (PA) | Same |
| Catheter Shaft: | |||
| Outer | |||
| (2-lumen shaft) / | |||
| Shaft extension | |||
| tube: | Pebax 7033 SA01 | Pebax 7033 SA01 | Same |
| Inner shaft | Pebax 7233 SA01 | Pebax 7233 SA01 | Same |
| Hydrophobic | |||
| coating (shaft | |||
| and balloon) | Medical Grade Dispersion | ||
| hydrophobic coating with | |||
| heptane fraction | Medical Grade Dispersion | ||
| hydrophobic coating with | |||
| heptane fraction (new mixture | |||
| ratio) | Same coating, different ratio | ||
| of lubricant to heptane | |||
| fraction. Biocompatibility | |||
| supports change in coating. | |||
| Manifold (Luer | |||
| hub) | Polycarbonate | Polycarbonate | Same |
| UV adhesive | Polyurethane Oligomer | ||
| Mixture | Polyurethane Oligomer | ||
| Mixture | Same | ||
| Materials of Construction (non-patient contacting) | |||
| Radiopaque | |||
| markers | 2, Pt/Ir (90/10), length 1.5mm | 2, Pt/Ir (90/10), length 1.5mm | Same |
| Kink protector | Pebax 5533 SA01 | Pebax 5533 SA01 | Same |
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | |||
| Parameters | Passeo-35 | ||
| K082933 | Passeo-35 | ||
| Subject Device | Rationale for Substantial | ||
| Equivalence | |||
| Packaging Materials (non-patient contacting) | |||
| Protective | |||
| Sheath | Outer Layer | ||
| Poly-Amide (PA) | |||
| Middle Layer | |||
| Linear Low Density | |||
| Polyethylene, LDPE | |||
| Inner Layer | |||
| High density polyethylene, | |||
| HDPE | Outer Layer | ||
| Poly-Amide (PA) | |||
| Middle Layer | |||
| Maleic anhydride ethylene | |||
| copolymer | |||
| Inner Layer | |||
| HDPE - new supplier | Material change for packaging | ||
| does not alter safety and | |||
| effectiveness of the device. | |||
| Dispenser (spiral | |||
| ring and clips) | Ring: Polyethylene; | ||
| Clips: Marlex and HDPE mix | Ring: Polyethylene; | ||
| Clips: HDPE & LDPE mix | Materials and supplier change | ||
| for packaging does not alter | |||
| safety and effectiveness of the | |||
| device. | |||
| Tyvek pouch | Material: PerfecFlex | Material: 20/50 OPA/PE peel | |
| film | Materials supplier and | ||
| dimensional changes of | |||
| packaging do not alter safety | |||
| and effectiveness. |
Technological Comparison to Predicate Device:
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Image /page/6/Picture/0 description: The image shows the logo for Biotronik. The logo consists of the word "BIOTRONIK" in large, bold, dark blue letters. Below the word is the phrase "excellence for life" in a smaller, lighter blue font. To the left of the word "BIOTRONIK" is a circular symbol with the letters "BIO" inside.
7
Image /page/7/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in a dark blue sans-serif font, with the word "excellence" and "for life" in a smaller, lighter blue font underneath. To the left of the name is a circular logo with the letters "BIO" inside.
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Image /page/8/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in a dark blue font, with the tagline "excellence for life" in a smaller, lighter blue font underneath. To the left of the name is a circular symbol with the letters "BIO" inside.
Biocompatibility Testing
| Test Name | Test Description | Results |
|---|---|---|
| Cytotoxicity | L929 cells are incubated with test article extracts and | |
| evaluated for percentage of cell growth inhibition and | ||
| compared to a control sample (control: cells exposed | ||
| to extraction medium). | Growth analyses of cells | |
| cultured with test article | ||
| extract showed no cytotoxic | ||
| effects of the test article. | ||
| Sensitization | The test article is extracted polar/non-polar solution | |
| according to ISO 10993-12 and administered topically | ||
| to mice for 3 days. After 5 days mice are sacrificed | ||
| and lymph node cells are harvested and analysed to | ||
| compute stimulation index (SI) vs. a negative | ||
| sensitization control. | The stimulation index (SI), | |
| ratio of test article / negative | ||
| control, was calculated for | ||
| each concentration of the test | ||
| article extract. No reactions | ||
| were identified as sensitization | ||
| Irritation / Intracutaneous | ||
| reactivity | The test article is extracted with 0.9 % Sodium | |
| chloride solution (polar) and Cottonseed Oil (non- | ||
| polar) according to ISO 10993-12. Extracts are | ||
| injected into rabbits and rabbits are observed for | ||
| erythema and edema immediately after injection and | ||
| after 24, 48, and 72 hours. | There were no signs of | |
| irritation of the polar and non- | ||
| polar test article extracts | ||
| injected intracutaneously into | ||
| rabbits. | ||
| Test Name | Test Description | Results |
| Acute systemic toxicity | The test article is extracted with polar and non-polar | |
| extraction vehicles according to ISO 10993-12. Mice | ||
| are injected with extracts and observed for adverse | ||
| reactions immediately after dosing and again at 4, 24, | ||
| 48, and 72 hours after injection. At termination mice | ||
| were sacrificed and gross necropsy was carried out to | ||
| record gross pathological changes. | There were no compound | |
| related mortalities, no | ||
| significant body weight loss | ||
| was recorded and all animals | ||
| appeared clinically normal. At | ||
| necropsy no evidence of gross | ||
| pathology of organs was | ||
| found. The test article was | ||
| considered to have no acute | ||
| toxic characteristics. | ||
| Pyrogenicity | The test article is extracted with sterile, non-pyrogenic | |
| polar solution according to ISO 10993-12. Extract is | ||
| injected into rabbits and rectal body temperatures are | ||
| measured and recorded prior to injection and up to 3 | ||
| hours after injection. | No single animal showed a | |
| temperature increase higher | ||
| or equal to 0.5°C above its | ||
| initial temperature. The test | ||
| article is considered to be | ||
| non-pyrogenic. | ||
| Hemocompatibility | The test article is placed in a polymer tube filled with | |
| Heparin-anticoagulated whole human blood and | ||
| rotated on a modified chandler-unit. The effects of the | ||
| test article regarding TAT (thrombin-antithrombin | ||
| complex), cell count and the hemolysis are evaluated | ||
| by comparison to the predicate device. | There were no significant | |
| changes in the cell counts and | ||
| the coagulation system | ||
| activation value measured as | ||
| TAT complex generation of | ||
| the test article was identical in | ||
| comparison with the | ||
| reference. There was no | ||
| evidence of hemolysis. | ||
| Gas Chromatography - | ||
| Mass Spectrometry | The old materials are compared to the new materials. | |
| The test articles are extracted in different solvents | ||
| (polar and non-polar, e.g. purified water, isopropyl | ||
| alcohol and hexane) and the extracts are analyzed by | ||
| GC-MS fingerprint analysis. | GC/MS fingerprint analysis of | |
| extractable semi-volatile | ||
| organic compounds yielded no | ||
| differences in the type of | ||
| detected substances in the | ||
| extracts. There are no | ||
| significant differences | ||
| between old and new | ||
| materials | ||
| Fourier Transform | ||
| Infrared Spectroscopy | ||
| (FT-IR) analysis | Fourier Transform Infrared Spectroscopy (FT-IR) was | |
| utilized to compare the chemical composition of the | ||
| new materials and old materials The resulting FT-IR | ||
| spectra were compared. | Materials had greater than | |
| 99% correlation according to | ||
| FT-IR analysis. The new | ||
| materials are similar to the | ||
| predicate. | ||
| Test Name | Test Conditions / Specifications | Summary Results |
| Visual and Dimensional | ||
| Inspection | Test was performed according to ISO 25539-2:2008, | |
| ASTM F2081-06, DIN EN ISO 10555-1:1995 + | ||
| AM1:1999 + AM2:2004, ISO 10555-4:1996/2002 + | ||
| Cor1:2002 | ||
| The balloon catheter was visually inspected as | ||
| follows: | ||
| a) visual check of catheter surface for defects. | ||
| b) Correct printing on the device | ||
| c) homogeneity of coating on the catheter | ||
| d) Positioning of the X-ray markers | ||
| e) usable length of the balloon catheter | ||
| f) shaft inner diameter | ||
| g) shaft outer diameter (prox/mid/dist) along different | ||
| longitudinal paths (e.g., rotating test sample 90 | ||
| degrees for measurements) | Inspectional acceptance | |
| criteria were met. | ||
| Crossing Profile (system | ||
| profile) | This test was conducted as per ISO 25539-2:2008 | |
| and ASTM F2081-6. | ||
| The diameter of the device is measured by passing | ||
| the device through a ring-hole gauge. Crossing profile | ||
| (proximal end of the balloon and the distal tip of the | ||
| catheter) of the catheter evaluated in terms of | ||
| smallest French size compatibility. | Acceptance criteria for | |
| crossing profile were met. | ||
| Crossing profile is within | ||
| specs of predicate. | ||
| Simulated Use Testing | ||
| Simulated Use / Balloon | ||
| Preparation, Deployment | ||
| and Retraction | This test addresses the requirements for qualitative | |
| evaluation of simulated use, flex/kink, pushability, | ||
| torquability and trackability of the system. The test is | ||
| conducted by inserting, delivering and deploying the | ||
| balloon in the model and then withdrawing the system | ||
| while qualitatively evaluating pushability, torquability | ||
| and trackability. | Acceptance criteria for balloon | |
| prep, deployment and | ||
| retraction were met. Test | ||
| shows device performs similar | ||
| to predicate in a simulated use | ||
| environment. | ||
| Deflated Balloon Profile | The friction to introduce and pullback after inflation | |
| was assessed. The test is conducted by measuring | ||
| force required to insert and remove a deflated balloon | ||
| as the device is passed through a ring-hole gauge. | Acceptance criteria were met: | |
| withdrawal force is less than | ||
| minimal tensile and deflated | ||
| balloon diameter is less than | ||
| max crossing profile. | ||
| Trackability | All testing performed in a Crossover model. | |
| Trackability - recorded frictional force (N) over | ||
| distance (mm) when tracked over a guide wire in | ||
| arterial model and compared to predicates. | Acceptance criteria for | |
| comparison to the predicate | ||
| were met. | ||
| Pushability | The test device is pushed through an anatomical | |
| model with a proximal force while the distal reaction | ||
| force is measured. The pushing continues until a | ||
| proximal force threshold is reached. The pushability | ||
| force must be comparable or better (greater) than the | ||
| existing Passeo-35 range. | Acceptance criteria for | |
| comparison to predicate | ||
| devices were met. | ||
| Test Name | Test Conditions / Specifications | Summary Results |
| Torqueability / Torque | ||
| Strength | The catheter is preconditioned with simulated use | |
| then the proximal end of the device is rotated counter | ||
| clockwise until the first rotational movement at the | ||
| distal end is observed. In this torqued position, the | ||
| distal end of the device is clamped and the proximal | ||
| end is rotated another 5 times and the device inflated | ||
| and deflated to NP to verify that it can withstand the | ||
| torsion. | Qualitative assessment | |
| showed rotation transfers to | ||
| distal tip on average between | ||
| 10 and 16 rotations and all | ||
| balloons passed inflation test. | ||
| Device meets torqueability | ||
| and torque strength | ||
| acceptance criteria. | ||
| Pullback and | ||
| reintroduction test | The friction to introduce and pullback the device after | |
| inflation to RBP is measured. With the balloon in an | ||
| appropriate sheath, the friction to introduce and | ||
| pullback the device after inflation to RBP is evaluated. | ||
| Introduction and pullback are repeated three times | ||
| and on the third time, the balloon is intentionally burst | ||
| before pullback to test if balloon can be pulled back | ||
| safely in the event of a burst. | Pullback and reintroduction | |
| was comparable or better than | ||
| comparator product. | ||
| Product specifications were | ||
| met for 1st and 2nd pullback | ||
| force values. Balloon can be | ||
| safely retrieved after burst. | ||
| Balloon Inflation / | ||
| Deflation Time | Inflation and deflation times to RBP measured for | |
| characterization only. Inflation and deflation time are | ||
| measured with the device placed in an anatomical | ||
| model and a 50:50 mixture of contrast and saline are | ||
| used to inflate to RBP. The inflation time from 0.5 bar | ||
| to RBP is recorded. After holding the RBP for 30s, the | ||
| plunger is pulled to create a vacuum while the time | ||
| required for balloon to completely empty is recorded | ||
| as deflation time. | Inflation time was | |
| characterized and deflation | ||
| time was determined to be | ||
| according to specifications | ||
| within the instructions for use. | ||
| Flexibility and kink test | The catheter is advanced over a guidewire through a | |
| predefined curve, minimum radius of 20mm (clinically | ||
| relevant radius) until the shaft is located in the | ||
| corresponding radius. The guide wire movability is | ||
| checked, and, subsequently, the balloon is inflated to | ||
| NP and pressure is held for 30 s prior to deflation. | No kink occurred nor was the | |
| function of the device | ||
| compromised at the clinically | ||
| relevant radius of 20 mm. The | ||
| guide wire was movable | ||
| during testing and it was | ||
| possible to inflate and to | ||
| deflate the balloon to and from | ||
| NP. | ||
| Particulate Evaluation | Particles were measured using the methods | |
| described in USP . The process of balloon | ||
| delivery, deployment and retraction is simulated using | ||
| an in-vitro peripheral crossover model consisting of a | ||
| specially designed tortuous path to represent the iliac | ||
| arteries and the crossover radius at the abdominal | ||
| aortic bifurcation. The number of sub-visible | ||
| particulates is evaluated by an optical counter for | ||
| solution samples collected after track, after retraction | ||
| and cleaning. A statistical evaluation using the "t-test" | ||
| analysis is conducted to compare the number of | ||
| particulates measured of the Passeo-35 LE devices to | ||
| predicate and marketed comparator devices. | The number of particulates | |
| released by the Passeo-35 LE | ||
| were either the same as (p- | ||
| value >0.05) or were less than | ||
| the comparator device (p- | ||
| value |