(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI/ML components or data processing capabilities.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which describes a therapeutic action.
No
The device is described as a PTCA rapid exchange system with a balloon used for therapeutic purposes such as balloon dilatation of stenotic coronary arteries or bypass grafts, and post-delivery expansion of balloon-expandable stents. It is used for improving myocardial perfusion, which is a treatment not a diagnosis.
No
The device description clearly describes a physical catheter with a balloon, Luer port, lumen, and radiopaque markers, 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pantera Pro and Pantera LEO are physical devices (balloon catheters) used within the body (in vivo) to mechanically dilate blood vessels and assist with stent placement. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic procedure performed directly on the patient's coronary arteries or bypass grafts.
- Device Description: The description details the physical components of a catheter designed for insertion into the body.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body during a procedure.
Therefore, the Pantera Pro and Pantera LEO are interventional medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.
Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Coronary artery or bypass graft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Pantera Pro and Pantera LEO Catheters to ensure that the devices conforms to the design specification and to support a determination of substantial equivalence to the predicate devices.
- . Product performance - coating integrity and particulates
- . Biocompatibility
- . Microbiological - Bioburden
- . Shelf-Life - coating integrity and particulates
The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance durinq its intended use. In addition, the collective bench testing demonstrates that the proposed device does 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pantera Pro (K160985), Pantera LEO (K163660)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2024
Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035
Re: K242969
Trade/Device Name: Pantera Pro: Pantera LEO Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 26, 2024 Received: September 26, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is for Lydia S. Glaw -S. The date of the signature is 2024.10.25, and the time is 15:22:32 -04'00'.
2
Lydia Glaw 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
3
Indications for Use
Submission Number (if known)
Device Name
Pantera Pro; Pantera LEO
Indications for Use (Describe)
The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
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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4
Special 510(k) Premarket Notification
| Date Prepared: | October 23, 2024 |
|---|---|
| Contact: | Jon Brumbaugh |
| Vice President, Regulatory 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 Names: | Pantera Pro and Pantera LEO |
| Generic/Common | |
| Names: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheter, transluminal coronary angioplasty, percutaneous |
| Product Code: | LOX |
| Predicate Device: | Pantera Pro (K160985) and Pantera LEO (K163660). |
510(K) SUMMARY: Pantera Pro and Pantera LEO Catheters
Device Description
Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.
Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.
Indications for Use
The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
5
The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
| Description | Pantera Pro
(K160985 -
Predicate) | Pantera LEO
(K163660 -
Predicate) | Subject Devices
Rationale for
Substantial
Equivalence |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 510(k) Number | K160985 | K163660 | K242969 |
| Classification | Class II | Class II | Identical |
| Product Code | LOX | LOX | Identical |
| Regulation | 21 CFR 870.5100 | 21 CFR 870.5100 | Identical |
| Device Description | Pantera Pro is a
PTCA rapid exchange
system with a
balloon at the distal
end of the catheter.
A Luer port at the
proximal end
enables the
attachment of an
inflation device for
the inflation of the
balloon. The
catheter provides a
lumen, which
enables the use of a
guide wire to
position the
catheter.
Radiopaque balloon
markers aid in the
placement of the
catheter's balloon
segment under
fluoroscopy. | Pantera LEO is a
PTCA rapid exchange
system with a
balloon at the distal
end of the catheter.
A Luer port at the
proximal end
enables the
attachment of an
inflation device for
the inflation of the
balloon. The
catheter provides a
lumen, which
enables the use of a
guide wire to
position the
catheter.
Radiopaque balloon
markers aid in the
placement of the
catheter's balloon
segment under
fluoroscopy. | Identical |
| Indications for Use | The Pantera Pro is
indicated for balloon
dilatation of the
stenotic portion of a
coronary artery or
bypass graft
stenosis for the
purpose of
improving
myocardial
perfusion. The
Pantera Pro (balloon
diameter 2.0 – 4.0
mm) is also
indicated for post- | The Pantera LEO is
indicated for balloon
dilatation of the
stenotic portion of a
coronary artery or
bypass graft
stenosis for the
purpose of
improving
myocardial perfusion
and for post
dilatation of
coronary stents. | Identical |
| | | | |
| | delivery expansion
of balloon
expandable stents. | | |
| Principle of
Operation | Device operates on
the principle of
hydraulic
pressurization
applied through an
inflatable balloon
attached to the
distal end | Device operates on
the principle of
hydraulic
pressurization
applied through an
inflatable balloon
attached to the
distal end | Identical |
| Catheter Type | Percutaneous
Transluminal
Coronary
Angioplasty (PTCA)
Catheter | Percutaneous
Transluminal
Coronary
Angioplasty (PTCA)
Catheter | Identical |
| Guiding catheter
compatibility | Single Device: 5F
(0.056 inch/1.42
mm) | Single Device: 5F
(0.056 inch/1.42
mm) | Identical |
| Balloon Material | Polyamide 12 | Polyamide 12 | Identical |
| Balloon Diameter | 1.25, 1.5, 2.0, 2.5,
3.0, 3.5, 4.0 | 2.0, 2.25, 2.5, 2.75,
3.0, 3.25, 3.5, 3.75,
4.0, 4.5, 5.0 | Identical |
| Balloon Length | 6, 10, 15, 20, 25, 30 | 8, 12, 15, 20, 30 | Identical |
| Radiopaque Markers | Ø1.25 - 1.5 mm: One
marker band
Ø >1.5 mm: Two
marker bands | Ø all sizes: Two
marker bands | Identical |
| Usable Length | 140 | 145 | Identical |
| Guide wire
compatibility | 0.014 inch (0.36
mm) | 0.014 inch (0.36
mm) | Identical |
| Balloon Nominal
pressure [atm] | all sizes: 7 atm | all sizes: 14 atm | Identical |
| Balloon RBP [atm] | all sizes: 14 atm | Ø: 2.0-4.0 mm: 20 atm
Ø: 4.5-5.0 mm: 18
atm | Identical |
| Distal outer shaft
coating | Hydrophilic Coating
Slip Coat Base
Coat Type 90174 B
Slip Coat Top Coat
Type 90172 A | Hydrophilic Coating
Slip Coat Base
Coat Type 90174 B
Slip Coat Top Coat
Type 90172 A | Similar – alternative
basecoat
formulation.
Top coat remains
unchanged |
| Balloon coating | Ø 1.25 – 2.0 mm:
Hydrophilic coating
Ø 2.5 - 4.0 mm:
Hydrophobic coating | all sizes:
Hydrophobic coating | Identical |
| Sterilization Method | EO gas | EO Gas | Identical |
| Single Use | Single-Use | Single-Use | Identical |
Comparison of Technological Characteristics with Predicate Devices
6
7
Performance Data
All necessary performance testing was conducted on the Pantera Pro and Pantera LEO Catheters to ensure that the devices conforms to the design specification and to support a determination of substantial equivalence to the predicate devices.
- . Product performance - coating integrity and particulates
- . Biocompatibility
- . Microbiological - Bioburden
- . Shelf-Life - coating integrity and particulates
The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance durinq its intended use. In addition, the collective bench testing demonstrates that the proposed device does 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 Pantera Pro and Pantera LEO catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.