(60 days)
The Selethru PTCA Balloon Dilatation Catheter 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 Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Selethru is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional pushability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semi-compliant balloons are available in diameters ranging from 1.5-4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16 atm. The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire. Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
This is a medical device submission, not an AI/ML product. The document describes a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter (Selethru PTCA Balloon Dilatation Catheter). Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not applicable.
The document does, however, provide information about the acceptance criteria and performance of this traditional medical device.
Here's an analysis of the provided text, focusing on the device's performance and acceptance criteria:
1. Table of acceptance criteria and the reported device performance:
The document states that both in vitro performance tests and biocompatibility tests were conducted. The crucial summary statement is: "The test results met all acceptance criteria and ensure that the Selethru Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."
While specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas where performance was assessed against established criteria.
| Type of Performance Test | Specific Tests Conducted | Acceptance Criteria (Implied: Met) | Reported Device Performance (Implied: Met) |
|---|---|---|---|
| In Vitro | Dimensional verification | Met established specifications for dimensions. | Suitable for intended use |
| Balloon rated burst pressure | Met established pressure limits. | Suitable for intended use | |
| Balloon fatigue | Demonstrated durability under repeated inflation/deflation cycles. | Suitable for intended use | |
| Balloon compliance | Met specified inflation characteristics. | Suitable for intended use | |
| Balloon inflation and deflation time | Met specified time limits for inflation/deflation. | Suitable for intended use | |
| Catheter bond strength | Met established strength requirements for bonded components. | Suitable for intended use | |
| Tip pull strength | Met established strength requirements for the catheter tip. | Suitable for intended use | |
| Flexibility and kinking | Maintained integrity and functionality under bending/kinking stress. | Suitable for intended use | |
| Torque strength | Met established resistance to twisting forces. | Suitable for intended use | |
| Radiopacity | Visible under fluoroscopy at required levels. | Suitable for intended use | |
| Coating integrity | Maintained functional coating without degradation. | Suitable for intended use | |
| Particulate evaluation | Met limits for particulate matter. | Suitable for intended use | |
| Biocompatibility | Cytotoxicity | Non-toxic to biological cells. | Suitable for intended use |
| Sensitization | Did not cause allergic reactions. | Suitable for intended use | |
| Intracutaneous reactivity | Caused minimal local tissue irritation. | Suitable for intended use | |
| Acute systemic toxicity | Did not cause adverse systemic effects. | Suitable for intended use | |
| Hemocompatibility (hemolysis, complement activation, and in vivo thromboresistance) | Did not cause significant damage to blood components (red cells, complement), and resisted clot formation. | Suitable for intended use | |
| Pyrogenicity | Did not induce fever. | Suitable for intended use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For in vitro and biocompatibility tests, sample sizes would typically be determined by relevant ISO standards or FDA guidance documents for medical devices. The data provenance would be laboratory testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this is a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis. Biocompatibility and in vitro test results are evaluated against established scientific and engineering standards by qualified laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as this is not an AI/ML device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro tests, the "ground truth" is defined by engineering specifications and performance standards (e.g., burst pressure measured by a transducer, dimensional measurements validated against design drawings). For biocompatibility tests, the "ground truth" is defined by biological response measurements against established safety thresholds (e.g., cell viability in cytotoxicity tests, hemolysis rates, pyrogenicity assays) based on recognized standards (e.g., ISO 10993 series).
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML product that undergoes a "training" phase.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML product.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 26, 2018
Kossel Medtech (Suzhou) Co., Ltd. % Ms. Jessica Schultz Senior Project Manager North American Science Associates (NAMSA) 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426
Re: K182699
Trade/Device Name: Selethru PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 26, 2018 Received: September 27, 2018
Dear Ms. Schultz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 2018.11.26 19:10:46 -05'00' For
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182699
Device Name Selethru PTCA Balloon Dilatation Catheter
Indications for Use (Describe)
The Selethru PTCA Balloon Dilatation Catheted for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 201 CFR 201 Subpart D) | ☒ |
|---|---|
| Over-The-Counter Use (21 CFR 330) | □ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| 510(K) SUMMARY | |
|---|---|
| Submitter: | Kossel Medtech (Suzhou) Co., LtdF3, BLDG 6, No. 8 Jinfeng RoadSuzhou New District, JiangSu Province, China |
| 510(k) Number: | K182699 |
| Contact Person: | Jessica Schultz400 Highway 169 South, Suite 500,Minneapolis, MN 55426Phone: (763) 287-3830jschultz@namsa.com |
| Date Prepared: | September 26, 2018 |
| Trade Name: | Selethru PTCA Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR870.5100), Class II (special controls)Product Code: LOX |
| Predicate Device: | Primary Predicate: Sapphire II PRO (K163114; cleared January 5, 2017) |
| Device Description: | The Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX)PTCA Balloon Catheter used for the purpose of dilatation of the stenoticportion of a coronary artery or bypass graft stenosis for the purpose ofimproving myocardial perfusion.The Selethru is a sterile, single-use, intravascular medical device with aworking length of 142cm. The proximal shaft is PTFE coated stainlesssteel tube, which allows for exceptional pushability and a smoothtransition to the distal shaft, which is composed of an outer tube, an innertube, and a balloon. A hydrophilic coating is applied to the distal section.The semi-compliant balloons are available in diameters ranging from 1.5-4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16atm.The proximal shaft of the catheter has two marker sections of 5mmlength that aid in gauging dilatation catheter position relative to theguiding catheter tip (marker located closest to the dilatation catheteradaptor is for femoral guiding catheters and the other marker is forbrachial guiding catheters).The distal shaft of the catheter has an integrated shaft system. The shafthas a combination of single lumen and dual lumen tubing. One lumen isused for inflation of the balloon with contrast medium. The other lumen,in the distal shaft, permits the use of a guide wire to facilitate |
| advancement of the dilatation catheter to and through the stenosis to bedilated. The guidewire enters the catheter tip and advances coaxially outthe distal Rx port, thereby allowing both coaxial guidance and rapidexchange of the catheter with a single standard length guidewire.Two radiopaque Platinum/Iridium marker bands are located within theballoon segment to aid in positioning the balloon in the stenosis, and aredesigned to provide an expandable segment of known diameter andlength at a specific pressure. The design of this dilatation catheter doesnot incorporate a lumen for distal dye injections and distal pressuremeasurements. | |
| Intended Use: | The Selethru PTCA Balloon Dilatation Catheter is indicated for balloondilatation of the stenotic portion of a coronary artery or bypass graftstenosis for the purpose of improving myocardial perfusion. |
| TechnologicalCharacteristics: | Comparisons of the new and predicate devices show that thetechnological characteristics such as product performance, design, andintended use are substantially equivalent to the currently marketedpredicate devices. |
| Performance Data: | Both in vitro performance tests, such as dimensional verification, balloonrated burst pressure, balloon fatigue, balloon compliance, ballooninflation and deflation time, catheter bond strength, tip pull strength,flexibility and kinking, torque strength, radiopacity, coating integrity, andparticulate evaluation, and also biocompatibility tests, such ascytotoxicity, sensitization, intracutaneous reactivity, acute systemictoxicity, hemocompatibility (hemolysis, complement activation, and invivo thromboresistance), and pyrogenicity were conducted. The testresults met all acceptance criteria and ensure that the Selethru Catheterdesign and construction are suitable for its intended use as recommendedby the Class II Special Controls Guidance Document for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheters(FDA; September 8, 2010). |
| Conclusion: | This information supports a determination of substantial equivalencebetween the Selethru PTCA Balloon Dilatation Catheter and the predicatedevice described above. |
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§ 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.