(121 days)
No
The device description and performance studies focus on the mechanical aspects of a balloon catheter and do not mention any AI or ML components or functionalities.
Yes.
The device is indicated for "balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which is a therapeutic intervention.
No
The device is a therapeutic balloon dilatation catheter designed to improve myocardial perfusion by dilating stenotic portions of coronary arteries or bypass grafts, not to diagnose medical conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, hypotube, luer hub, and coatings, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a therapeutic procedure (balloon dilatation of coronary arteries and bypass grafts, and post-delivery expansion of stents) performed directly on the patient's body.
- Device Description: The description details a catheter with a balloon designed for mechanical intervention within the circulatory 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 screening.
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 NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).
Product codes
LOX
Device Description
The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a low compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) guidewire to facilitate catheter advancement to and through the stenosis or stent that is to be dilated. The proximal portion of the catheter is a sinqle-lumen, stainless steel hypotube that includes a sinqle luer hub for balloon inflation/deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip is aids advancement to and through the stenosis or stent. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aids for the placement of the catheter's balloon. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just proximal of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Native coronary artery or bypass graft stenosis
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 NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification
- Stimulated Use
- In-Stent Rated Burst Pressure
- In-Stent Balloon Fatigue
- Balloon Inflation and Deflation Time
- Flexibility and Kink
- Radiopacity
- Particulate
- Component Dimensional
- Compatibility
- Rated Burst Pressure
- Balloon Fatique
- Compliance
- Bond Strength (including Tip Pull)
- Torque
- Coating Integrity
The in vitro bench tests demonstrated that the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrated that the device functions as intended and has a safety and effectiveness profile that is substantially equivalent to the predicate device.
Biocompatibility testing was also performed:
- Cytotoxicity
- Intracutaneous Reactivity
- Complement Activation (SC5b-9)
- Material Mediated Pyrogenicity
- Partial Thromboplastin Time
- Sensitization
- Hemolysis (Direct and Extract)
- Thrombogenicity
- Acute Systemic Toxicity
- Heparinized Blood Platelet and
- Leukocyte Count Assay
The results from the testing performed showed the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2022
Sino Medical Sciences Technology Inc. % Semih Oktay President and CEO CardioMed Device Consultants LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401
Re: K222538
Trade/Device Name: NC ROCKSTARTM Non-Compliant 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: August 19, 2022 Received: August 22, 2022
Dear 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 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.
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2022.12.21
0':connell -S 10:07:37 -05'00'
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) K222538
Device Name
NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter
Indications for Use (Describe)
The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
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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Image /page/3/Picture/1 description: The image shows the Sinomed logo with the words "Innovation for health" underneath. The logo is blue and features a stylized design. The text "K222538 Page 1 of 5" is located in the upper right corner of the image.
510(k) Summary
(as required by 21 CFR 807.92)
Non-Compliant PTCA Balloon Dilatation Catheter
510(k) K222538
| Date Prepared: | August 19, 2022 |
|---|---|
| Applicant: | SINO Medical Sciences Technology Inc. |
| Contact Name: | H. Semih Oktay, Ph.D. |
| Title: | President, CardioMed Device Consultants |
| Email: | soktay@cardiomedllc.com |
| Telephone: | (410) 271-2088 |
| Fax: | (410) 674-2133 |
| Trade Name: | NC ROCKSTAR™ Non-Compliant 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 Emerge™ Monorail™ PTCA Dilatation Catheter |
INTENDED USE/INDICATIONS FOR USE:
The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).
DEVICE DESCRIPTION:
The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a low compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) guidewire to facilitate catheter advancement to and through the stenosis or stent that is to be dilated. The proximal portion of the catheter is a sinqle-lumen, stainless steel hypotube that includes a sinqle luer hub for balloon inflation/deflation. The balloon design provides for an inflatable
4
Image /page/4/Picture/1 description: The image features the Sinomed logo in blue, with the tagline "Innovation for health" underneath. To the right of the logo, the text "K222538 Page 2 of 5" is displayed. The logo and text are positioned against a white background.
segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip is aids advancement to and through the stenosis or stent. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aids for the placement of the catheter's balloon. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just proximal of the balloon.
COMPARISON WITH PREDICATE DEVICES:
Comparison of the NC ROCKSTAR Non-Compliant PTCA Balloon 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 device. The intended use of the subject device and the predicate are the same.
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Image /page/5/Picture/1 description: The image shows the Sinomed logo with the tagline "Innovation for health" underneath. The logo is in blue and features a stylized "S" and "M". To the right of the logo, there is the text "K222538" and "Page 3 of 5". The text is in black and appears to be a document identifier and page number.
Table 5-1: Comparison of NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter and Predicate Device
| Subject | Predicate | ||
|---|---|---|---|
| Name of Device | NC ROCKSTAR™ | ||
| Non- Compliant PTCA Balloon | |||
| Dilatation Catheter | NC Emerge™ Monorail™ PTCA | ||
| Dilatation Catheter | |||
| Manufacturer | SINO Medical Sciences | ||
| Technology Inc. | Boston Scientific Corporation | ||
| 510(k) | TBD | K141236 | |
| Indications for Use | The NC ROCKSTAR Non- | ||
| Compliant PTCA Balloon Dilatation | |||
| Catheter is indicated for the balloon | |||
| catheter dilatation of the stenotic | |||
| portion of a native coronary artery | |||
| or bypass graft stenosis for the | |||
| purpose of improving myocardial | |||
| perfusion in patients with | |||
| atherosclerosis. | The NC Emerge OTW and NC | ||
| Emerge MR PTCA Dilatation | |||
| Catheters are indicated for the | |||
| balloon catheter dilatation of the | |||
| stenotic portion of a native | |||
| coronary artery or bypass graft | |||
| stenosis for the purpose of | |||
| improving myocardial perfusion in | |||
| patients with atherosclerosis. | |||
| The NC ROCKSTAR Non- | |||
| Compliant PTCA Balloon Dilatation | |||
| Catheter is also indicated for the | |||
| post-delivery expansion of balloon | |||
| expandable stents (bare metal and | |||
| drug-eluting). | The NC Emerge OTW and NC | ||
| Emerge MR PTCA Dilatation | |||
| Catheters (balloon models | |||
| 2.00mm-5.00mm) are also | |||
| indicated for the post-delivery | |||
| expansion of balloon expandable | |||
| stents (bare metal and drug- | |||
| eluting). | |||
| Catheter Shaft | |||
| Characteristics | Device | ||
| Design | Rapid Exchange PTCA Catheter | Rapid Exchange PTCA Catheter | |
| Radiopaque | |||
| Marker(s) | 2 Platinum/Iridium | 2 Platinum/Iridium | |
| Useable | |||
| Length | 145cm | 143cm | |
| Balloon | |||
| Characteristics | Balloon | ||
| Diameters | 2.00,2.25,2.50,2.75,3.00,3.25, | ||
| 3.50,3.75,4.00,4.50, and 5.00mm | 2.00,2.25,2.50,2.75,3.00,3.25, | ||
| 3.50,3.75,4.00,4.50,5.00,5.50, and | |||
| 6.00mm | |||
| Balloon | |||
| Lengths | 8, 12, 15, and 20mm | 6, 8, 12, 15, 20, and 30mm | |
| Rated Burst | |||
| Pressure | Diameter 2.00-4.00mm, | ||
| RBP is 22atm; | |||
| Diameter 4.50-5.00mm, | |||
| RBP is 20atm; | Diameter 2.00-4.00mm, | ||
| RBP is 20atm; | |||
| Diameter 4.50-6.00mm, | |||
| RBP is 18atm; | |||
| Hydrophilic coating | Yes | Yes | |
| Hydrophobic coating | Yes | Yes | |
| Guide catheter | |||
| compatibility | Diameter 2.00-4.00mm: | ||
| 0.056in (1.42mm); | |||
| Diameter 4.50-5.00mm: | |||
| 0.066in (1.68mm) | Diameter 2.00-4.00mm: | ||
| 0.056in (1.42mm); | |||
| Diameter 4.50-6.00mm: | |||
| 0.066in (1.68mm) | |||
| Guidewire compatibility | ≤0.36mm (0.014 inches) | ≤0.36mm (0.014 inches) | |
| Sterilization Method | EO Sterilization | EO Sterilization |
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Image /page/6/Picture/1 description: The image shows the Sinomed logo in blue, with the tagline "Innovation for health" underneath. To the right of the logo, there is the text "K222538" and "Page 4 of 5". The logo and text are positioned at the top of the image.
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification ●
- Stimulated Use ●
- In-Stent Rated Burst Pressure ●
- In-Stent Balloon Fatigue ●
- Balloon Inflation and Deflation Time ●
- Flexibility and Kink ●
- Radiopacity ●
- Particulate ●
- Component Dimensional ● Compatibility
- Rated Burst Pressure ●
- Balloon Fatique ●
- Compliance ●
- Bond Strength (including Tip Pull) ●
- Torque ●
- Coating Integrity
The in vitro bench tests demonstrated that the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrated that the device functions as intended and has a safety and effectiveness profile that is substantially equivalent to the predicate device.
BIOCOMPATIBILITY:
Testing was performed to assess biocompatibility of the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter. The following tests were performed:
- Cytotoxicity ●
- Intracutaneous Reactivity ●
- Complement Activation (SC5b-9) ●
- Material Mediated Pyrogenicity
- Partial Thromboplastin Time ●
- Sensitization ●
- Hemolysis (Direct and Extract) ●
- Thrombogenicity ●
- Acute Systemic Toxicity
- Heparinized Blood Platelet and ● Leukocyte Count Assay
The results from the testing performed showed the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter to be biocompatible.
7
Image /page/7/Picture/1 description: The image shows the Sinomed logo in blue, with the words "Innovation for health" underneath. The text "K222538" and "Page 5 of 5" are located in the upper right corner of the image. The logo is a stylized representation of the company's name.
CONCLUSION:
The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter has the same intended use and 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 NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter has substantially equivalent safety, effectiveness, and performance outcomes as the legally marketed predicate device.
Therefore, the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is substantially equivalent to the predicate device.