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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the OPN NC PTCA Dilatation Catheter, demonstrating its substantial equivalence to a predicate device (NC Euphora Rapid Exchange Balloon Dilatation Catheter).

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a tabulated format with corresponding "reported device performance" against numerical targets. Instead, it states that "The in vitro bench tests demonstrated that the OPN NC PTCA Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device." This implies that the acceptance criteria were based on established engineering and performance standards for PTCA dilatation catheters, and the device successfully met these standards.

Based on the "NON-CLINICAL TESTING/PERFORMANCE DATA" section, the following tests were performed, and the implicit acceptance criterion for all of them was that the device performs as intended and similarly to the predicate device, demonstrating substantially equivalent safety and effectiveness/performance.

Acceptance Criteria (Implicit)	Reported Device Performance
Dimensional Verification (e.g., balloon diameters, lengths)	Met all acceptance criteria; performed similarly to predicate. Specifically, balloon diameters: 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, and 4.5mm. Balloon lengths: 10, 15, and 20mm. Useable length: 147cm.
Simulated Use	Met all acceptance criteria; performed similarly to predicate.
Compliance (of balloon)	Met all acceptance criteria; performed similarly to predicate.
Coating Integrity	Met all acceptance criteria; performed similarly to predicate.
Particulate	Met all acceptance criteria; performed similarly to predicate.
Inflation/Deflation (characteristics and time)	Met all acceptance criteria; performed similarly to predicate. Nominal pressure: 10 atm. Rated burst pressure: 35 atm.
Corrosion	Met all acceptance criteria; performed similarly to predicate.
Abrasion/Puncture Resistance	Met all acceptance criteria; performed similarly to predicate.
Lubricity/Pinch Testing	Met all acceptance criteria; performed similarly to predicate.
Flex/Kink	Met all acceptance criteria; performed similarly to predicate.
Torque	Met all acceptance criteria; performed similarly to predicate.
Tensile Strength	Met all acceptance criteria; performed similarly to predicate.
Rated Burst Pressure	Met all acceptance criteria; performed similarly to predicate. Reported as 35 atm.
In-Stent Rated Burst Pressure	Met all acceptance criteria; performed similarly to predicate.
Balloon Fatigue	Met all acceptance criteria; performed similarly to predicate.
In-Stent Balloon Fatigue	Met all acceptance criteria; performed similarly to predicate.
Radiopacity	Met all acceptance criteria; performed similarly to predicate. Achieved with 2 Platinum/Iridium markers.

The biocompatibility tests also showed the device to be biocompatible, which is a key acceptance criterion for medical devices.

Study Details for Acceptance Criteria Proof:

Sample size used for the test set and data provenance:
- The document does not specify the exact sample sizes (number of devices or components) used for each non-clinical bench test.
- The data provenance is from non-clinical laboratory testing (bench tests). No geographical origin for the testing lab is explicitly stated, but the applicant is based in Switzerland. The data is retrospective in the sense that it's reported from completed tests for regulatory submission.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This question is not applicable as the study described is a non-clinical, bench testing study. Ground truth, in the context of expert consensus, multi-reader studies, or pathology, is typical for clinical performance studies or diagnostic device evaluations. For bench testing, "ground truth" is established by defined physical and engineering specifications and validated test methods.
Adjudication method for the test set:
- This question is not applicable as the described study is non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when multiple readers evaluate images or patient data.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The described study is non-clinical bench testing comparing the device's physical and performance characteristics to a predicate device. MRMC studies are relevant for evaluating the impact of AI-assisted diagnostic devices on human performance.
Effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as no MRMC or AI-assisted study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a medical catheter, not an AI algorithm.
The type of ground truth used:
- For the non-clinical testing, the "ground truth" is based on engineering specifications, material science principles, established performance standards, and validated test methods. The device's performance is compared against these predetermined criteria and the known performance of the predicate device to establish substantial equivalence.
The sample size for the training set:
- This question is not applicable as the device is a physical medical catheter, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K212393

Device Name

OPN NC PTCA Dilatation Catheter

Indications for Use (Describe)

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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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 AGHungerbüelstrasse 12aCH-8500 FrauenfeldSwitzerland
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 DilatationCatheter, K141090

INTENDED USE/INDICATIONS FOR USE:

DEVICE DESCRIPTION:

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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 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 DilatationCatheter	NC Euphora RapidExchange Balloon DilatationCatheter
Manufacturer		SIS Medical AG	Medtronic Inc.
510(k)		K212393	K141090
Catheter ShaftCharacteristics	Indications for Use	Indicated for balloon dilatation ofthe stenotic portion of thecoronary artery or bypass graftfor the purpose of improvingmyocardial perfusionThe balloon dilatation catheter isalso indicated for post-deployment expansion of balloonexpandable coronary stents	Indicated for balloon dilatationof the stenotic portion of acoronary artery or bypass graftfor the purpose of improvingmyocardial perfusionThe balloon dilatation catheter isalso indicated for post-deployment expansion ofballoon expandable stents
	Device Design	Rapid Exchange PTCA catheter	Rapid Exchange PTCAcatheter
	RadiopaqueMarker(s)	2 Platinum/Iridium	2 Platinum/Iridium
	Useable Length	147cm	142cm

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	Subject		Predicate
BalloonCharacteristics	Name of Device	OPN NC PTCA DilatationCatheter	NC Euphora RapidExchange Balloon DilatationCatheter
	Manufacturer	SIS Medical AG	Medtronic Inc.
	510(k)	K212393	K141090
	Balloon Diameters	1.5, 2.0, 2.5, 3.0, 3.5, 4.0, and4.5mm	2.00, 2.25, 2.50, 2.75, 3.00,3.25, 3.50, 3.75, 4.00, 4.50and 5.00mm
	Balloon Lengths	10, 15 and 20mm	6, 8, 12, 15, 20 and 27mm
	Rated BurstPressure	35atm	20atm
	Hydrophilic coating	No	Coating present, typeunavailable
	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:

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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.

Regulation Number and Section

§ 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.