(58 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.
Yes
The device is clearly indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
The device is a treatment device (dilatation catheter) used for improving myocardial perfusion by dilating stenotic portions of coronary arteries or bypass grafts. It is not designed to diagnose a condition.
No
The device description clearly details a physical catheter with various material components, dimensions, and mechanical properties, 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:
- Intended Use: The intended use is for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion." This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The description details a physical catheter designed to be inserted into the body to perform a mechanical action (balloon inflation).
- 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 outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Selethru™ NC 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.
Product codes
LOX
Device Description
The SelethruTM NC 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.
And it is a sterile, single-use, intravascular medical device with a working length of 142cm. The non-compliant balloons are available in diameters 2.0 and 5.0mm and lengths from 6-30mm, and have a rated burst pressure of 22 atm for φ2.0 mm and 20 atm for φ5.0mm.
The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability 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. Moreover, 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.
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
Prescription Use
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)
Both in vitro performance tests, such as dimensional verification, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation, and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, complement activation, and in vivo thromboresistance), pyrogenicity were conducted. The test results met all acceptance criteria and ensure that the Selethru™ NC 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2021
Kossel Medtech (Suzhou) Co., Ltd. Maggie Xu Deputy Manager of Regulatory Affairs F2-3, BLDG 6, No. 8, Jinfeng Road Suzhou New District, Jiangsu Province P.R. China
Re: K211393
Trade/Device Name: Selethru™ NC 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: April 29, 2021 Received: May 5, 2021
Dear Maggie Xu:
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
1
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 medical devices and radiation-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,
For:
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K211393
Device Name
Selethru™ NC PTCA Balloon Dilatation Catheter
Indications for Use (Describe)
The Selethru™ NC 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.
| 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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5 510(K) SUMMARY OR 510(K) STATEMENT
| Submitter: | Kossel Medtech (Suzhou) Co., Ltd.
F2-3, BLDG 6, No. 8 Jinfeng Road
Suzhou New District, JiangSu Province, P.R. China |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maggie Xu
F2-3, BLDG 6, No. 8 Jinfeng Road
Suzhou New District, JiangSu Province, P.R. China
Phone: +86 150 5147 6125
E-mail: 916176651@qq.com |
| Prepared Date: | April 29th, 2021 |
| Trade Name: | SelethruTM NC PTCA Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR 870.5100), Class II (special controls)
Product Code: LOX |
| Predicate Device: | Primary Predicate: NC EmergeTM Monorail (MR) PTCA Dilatation Catheter (K141236; cleared August 7, 2014) |
| Reference Device: | Single Reference Device: Apollo Balloon Dilatation Catheter (K153742; cleared August 8, 2016) |
| Device Description: | The SelethruTM NC 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.
And it is a sterile, single-use, intravascular medical device with a working length of 142cm. The non-compliant balloons are available in diameters 2.0 and 5.0mm and lengths from 6-30mm, and have a rated burst pressure of 22 atm for φ2.0 mm and 20 atm for φ5.0mm.
The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability 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. Moreover, 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 |
| Intended Use: | 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.
The Selethru™ NC 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. |
| Technological
Characteristics: | Comparisons of the new and predicate devices show that the
technological characteristics such as product performance, design, and
intended use are substantially equivalent to the currently marketed
predicate devices. |
| Performance Data: | Both in vitro performance tests, such as dimensional verification, balloon
rated burst pressure, balloon fatigue, balloon compliance, balloon
inflation and deflation time, catheter bond strength, tip pull strength,
flexibility and kinking, torque strength, radiopacity, coating integrity, and
particulate evaluation, and also biocompatibility tests, such as
cytotoxicity, sensitization, intracutaneous reactivity, acute systemic
toxicity, hemocompatibility (hemolysis, complement activation, and in
vivo thromboresistance), pyrogenicity were conducted. The test results
met all acceptance criteria and ensure that the Selethru™ NC 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). |
| Conclusion: | This information supports a determination of substantial equivalence
between the Selethru™ NC PTCA Balloon Dilatation Catheter and the
predicate devices described above. |
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