(224 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 software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended 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 dilatation catheter intended for balloon dilatation of stenotic portions of coronary arteries or bypass grafts. Its purpose is therapeutic (improving myocardial perfusion and post-deployment expansion of stents), not diagnostic.
No
The device description clearly details a physical catheter with a balloon, lumens, shaft, and hub, indicating it is a hardware medical 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 for balloon dilatation of coronary arteries and bypass grafts to improve blood flow, and for post-deployment expansion of coronary stents. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon designed for mechanical intervention within the cardiovascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable coronary stents.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The OPN NC PTCA Dilatation Catheter is a sterile, single use, rapid exchange catheter with a distal non-compliant double layer balloon attached to a flexible distal polymer shaft. The balloon is made from Polyamide and is available in diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 and 4.5mm and in balloon lengths of 10, 15 and 20mm.
The distal polymer shaft consists of a two coaxial lumens, with one lumen for inflation and the other to enable the use of a quide wire for positioning the catheter. The catheter is compatible with a 0.014" guidewire, which enters at the distal tip of the catheter and exists at the RX port.
The proximal portion of the catheter is formed from a hypotube containing the inflation lumen. At the proximal end, a hub with luer connector is attached to the hypotube, allowing connection to an inflation device. Radiopaque balloon marker bands enable accurate positioning of the device. Shaft markers for brachial and femoral techniques are also in place.
The OPN NC comes in a single useable length of 147cm. The device nominal pressure is 10 atm and the rated burst pressure is 35 atm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Non-clinical laboratory testing was performed on the OPN NC PTCA Dilatation Catheter to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification
- Simulated Use
- Compliance
- Coating Integrity
- Particulate
- Inflation/deflation
- Corrosion
- Abrasion/Puncture resistance
- Lubricity/pinch testing
- Flex/Kink
- Torque
- Tensile Strength
- Rated burst pressure
- In-Stent rated burst pressure
- Balloon fatigue
- In-Stent balloon fatigue
- Radiopacity
The in vitro bench tests demonstrated that the OPN NC PTCA Dilation Catheter met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and has substantially equivalent safety and effectiveness/performance outcomes to the predicate device.
Biocompatibility testing was also performed and included:
- Cytotoxicity
- Intracutaneous Reactivity
- Complement Activation (SC5b-9)
- Material Mediated Pyrogenicity
- Sensitization
- Hemolysis (Direct and Extract)
- Thrombogenicity
- Acute Systemic Toxicity
The results from the testing performed showed the OPN NC PTCA Dilatation Catheter to be biocompatible.
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.
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 contains 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, 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.
March 14, 2022
SIS Medical AG c/o H. Semih Oktay President CardioMed Device Consultants, LLC 1783 Forest Drive Suite 254 Annapolis, Maryland 21401
Re: K212393
Trade/Device Name: OPN NC PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: February 7, 2022 Received: February 8, 2022
Dear H. Semih Oktay:
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.
1
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 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 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.
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)
Device Name
OPN NC PTCA Dilatation Catheter
Indications for Use (Describe)
The OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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 (as required by 21 CFR 807.92)
Image /page/3/Picture/3 description: The image shows the logo for SIS Medical. The logo consists of the letters "SIS" in black, followed by a pink and gray heart-shaped symbol. To the right of the heart is the word "MEDICAL" in black. The logo appears to be for a medical company.
Swiss | Interventional
OPN NC PTCA Dilatation Catheter
510(k) K212393
| Date Prepared: | March 4, 2022 |
|---|---|
| Applicant: | SIS Medical AG |
| Hungerbüelstrasse 12a | |
| CH-8500 Frauenfeld | |
| Switzerland | |
| Contact Name: | H. Semih Oktay, PhD |
| Title: | President, CardioMed Device Consultants |
| Email: | soktay@cardiomedllc.com |
| Telephone: | (410) 271-2088 |
| Fax: | (410) 674-2133 |
| Trade Name: | OPN NC PTCA Dilatation Catheter |
| Device Classification: | Class II per 21 CFR §870.5100 |
| Classification Name: | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Product Code: | LOX |
| Predicate Devices: | NC Euphora Rapid Exchange Balloon Dilatation |
| Catheter, K141090 |
INTENDED USE/INDICATIONS FOR USE:
The OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable coronary stents.
DEVICE DESCRIPTION:
The OPN NC PTCA Dilatation Catheter is a sterile, single use, rapid exchange catheter with a distal non-compliant double layer balloon attached to a flexible distal polymer shaft. The balloon is made from Polyamide and is available in
4
diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 and 4.5mm and in balloon lengths of 10, 15 and 20mm.
The distal polymer shaft consists of a two coaxial lumens, with one lumen for inflation and the other to enable the use of a quide wire for positioning the catheter. The catheter is compatible with a 0.014" guidewire, which enters at the distal tip of the catheter and exists at the RX port.
The proximal portion of the catheter is formed from a hypotube containing the inflation lumen. At the proximal end, a hub with luer connector is attached to the hypotube, allowing connection to an inflation device. Radiopaque balloon marker bands enable accurate positioning of the device. Shaft markers for brachial and femoral techniques are also in place.
The OPN NC comes in a single useable length of 147cm. The device nominal pressure is 10 atm and the rated burst pressure is 35 atm.
COMPARISON WITH PREDICATE DEVICES:
Comparison of the OPN NC Dilatation Catheter and predicate device show that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate and reference devices. The intended use of the subject device and the predicate are the same.
| Subject | Predicate | ||
|---|---|---|---|
| Name of Device | OPN NC PTCA Dilatation | ||
| Catheter | NC Euphora Rapid | ||
| Exchange Balloon Dilatation | |||
| Catheter | |||
| Manufacturer | SIS Medical AG | Medtronic Inc. | |
| 510(k) | K212393 | K141090 | |
| Catheter Shaft | |||
| Characteristics | Indications for Use | Indicated for balloon dilatation of | |
| the stenotic portion of the | |||
| coronary artery or bypass graft | |||
| for the purpose of improving | |||
| myocardial perfusion | |||
| The balloon dilatation catheter is | |||
| also indicated for post- | |||
| deployment expansion of balloon | |||
| expandable coronary stents | Indicated for balloon dilatation | ||
| of the stenotic portion of a | |||
| coronary artery or bypass graft | |||
| for the purpose of improving | |||
| myocardial perfusion | |||
| The balloon dilatation catheter is | |||
| also indicated for post- | |||
| deployment expansion of | |||
| balloon expandable stents | |||
| Device Design | Rapid Exchange PTCA catheter | Rapid Exchange PTCA | |
| catheter | |||
| Radiopaque | |||
| Marker(s) | 2 Platinum/Iridium | 2 Platinum/Iridium | |
| Useable Length | 147cm | 142cm |
5
| Subject | Predicate | ||
|---|---|---|---|
| Balloon | |||
| Characteristics | Name of Device | OPN NC PTCA Dilatation | |
| Catheter | NC Euphora Rapid | ||
| Exchange Balloon Dilatation | |||
| Catheter | |||
| Manufacturer | SIS Medical AG | Medtronic Inc. | |
| 510(k) | K212393 | K141090 | |
| Balloon Diameters | 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, and | ||
| 4.5mm | 2.00, 2.25, 2.50, 2.75, 3.00, | ||
| 3.25, 3.50, 3.75, 4.00, 4.50 | |||
| and 5.00mm | |||
| Balloon Lengths | 10, 15 and 20mm | 6, 8, 12, 15, 20 and 27mm | |
| Rated Burst | |||
| Pressure | 35atm | 20atm | |
| Hydrophilic coating | No | Coating present, type | |
| unavailable | |||
| Hydrophobic coating | Yes | unavailable | |
| Guide catheter compatibility | 1.5 – 3.5mm diameter: | ||
| 6F (0.071" or 1.8mm) | |||
| 4.0 - 4.5mm diameter: | |||
| 7F (0.081" or 2.06mm) | Not known | ||
| Guidewire compatibility | 0.014" (0.36mm) | 0.014" (0.36mm) | |
| Sterilization Method | EO | E-beam |
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the OPN NC PTCA Dilatation Catheter to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification ●
- Simulated Use
- Compliance ●
- Coating Integrity ●
- Particulate ●
- Inflation/deflation ●
- Corrosion
- Abrasion/Puncture resistance ●
- Lubricity/pinch testing .
- Flex/Kink ●
- Torque ●
- Tensile Strength
- Rated burst pressure ●
- In-Stent rated burst pressure ●
- Balloon fatigue ●
- In-Stent balloon fatigue
- Radiopacity ●
The in vitro bench tests demonstrated that the OPN NC PTCA Dilation Catheter met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and has substantially equivalent safety and effectiveness/performance outcomes to the predicate device.
BIOCOMPATIBILITY:
Testing was performed to assess biocompatibility of the OPN NC PTCA Dilatation Catheter. The following tests were performed:
6
- Cytotoxicity ●
- Intracutaneous Reactivity ●
- Complement Activation (SC5b-9) ●
- Material Mediated Pyrogenicity
- Sensitization ●
- . Hemolysis (Direct and Extract)
- . Thrombogenicity
- . Acute Systemic Toxicity
The results from the testing performed showed the OPN NC PTCA Dilatation Catheter to be biocompatible.
CONCLUSION:
The OPN NC PTCA Dilatation Catheter has the same intended use and the same or similar technological characteristics such as components, design, materials, and operating principles as the predicate device. Performance data demonstrates that the device functions as intended. The conclusions drawn from the nonclinical tests demonstrate that the OPN NC has substantially equivalent safety and effectiveness/performance outcomes to the legally marketed predicate device.
Therefore, the OPN NC PTCA Dilatation Catheter is substantially equivalent to the predicate device.