(290 days)
No
The device description focuses on the physical components and mechanical properties of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are standard in vitro and biocompatibility tests for this type of device.
Yes
The device is designed for "Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion," which is a direct treatment aimed at improving physiological function.
No
The "Intended Use / Indications for Use" section describes the device as a "Coronary Dilatation Catheter" used for "Balloon dilatation" of various coronary conditions, such as stenoses, occlusions, and in-stent restenosis, and for "Post-delivery expansion of balloon expandable coronary stents." These actions are therapeutic interventions aimed at treating conditions, rather than diagnosing them.
No
The device description clearly details a physical catheter with a balloon, guidewire, and other hardware components. There is no mention of software as the primary or sole component.
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 within the body for a therapeutic procedure (balloon dilatation of coronary arteries). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter with a balloon designed for mechanical intervention within the coronary arteries. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Sapphire NC ULTRA Coronary Dilatation Catheter is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:
∙ Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
∙ Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
∙ In-stent restenosis.
∙ Post-delivery expansion of balloon expandable coronary stents.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.
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)
The following performance data were provided in support of the substantial equivalence determination.
- In vitro performance tests were conducted on subject A device in accordance with FDA guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" issued on September 8, 2010, including:
- Visual Inspection
- Particulate Evaluation
- Dimensional Verification
- Balloon Compliance
- Hub leakage test
- Balloon Preparation, Deployment, and Retraction.
- Balloon Inflation and Deflation Time.
- Coating Integrity
- Balloon Fatigue (in-stent)
- Balloon Fatigue
- Balloon Rated Burst Pressure (in-stent).
- Balloon Rated Burst Pressure.
- Shaft burst
- Catheter Bond Strength
- Tip Pull Strength
- Flexibility and Kink
- Torque Strength
- Marker Band Radiopacity
- A Biocompatibility testing, conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a Risk Management Process" issued on June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, included:
- Cytotoxicity
- Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
- Pyrogenicity
- Hemocompatibility
- Hemolysis
- Partial thromboplastin time
- Platelet and leukocyte counts
- Complement activation
- Toxicological Risk Assessment (TRA) of Extractable Chemicals
- Packaging and sterilization validation
- Shelf life
The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use.
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.
K162209, K192344, K163114, K173680
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
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August 16, 2024
OrbusNeich Medical (Shenzhen) Co., Ltd. Jerry Cheung Senior Director of Regulatory Affairs No.1 Jinkui Road Futian Free Trade Zone Shenzhen, 518038 China
Re: K233499
Trade/Device Name: Sapphire NC ULTRA Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: July 16, 2024 Received: July 16, 2024
Dear Jerry Cheung:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Brian D. Pullin -S
for Lydia Glaw 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
2
Indications for Use
Submission Number (if known)
Device Name
Sapphire NC ULTRA Coronary Dilatation Catheter
Indications for Use (Describe)
The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:
· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
· Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction.
· In-stent restenosis.
· Post-delivery 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)
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3
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Submitter: | OrbusNeich Medical (Shenzhen) Co., Ltd.
No.1 Jinkui Road
Futian Free Trade Zone
Shenzhen 518038, China
Phone: +86-755-83580181
Fax: +86-755-83580169 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Name: Jerry Cheung
Job Title: Senior Director of Regulatory Affairs
Email: jcheung@orbusneich.com |
| Date Prepared: | October 30, 2023 |
| Device: | Device Name: Sapphire NC ULTRA Coronary Dilatation
Catheter
Regulation Name: Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheter
Trade Name: Sapphire NC ULTRA
Regulation Number: 21 CFR 870.5100(a)
Regulatory Class: II
Product Code: LOX |
| Predicate Device: | Sapphire NC 24 Coronary Dilatation Catheter
(K211807, LOX; cleared Oct.14, 2021)
This predicate has not been subject to a design-related recall. |
| Reference Devices: | Sapphire NC Plus Coronary Dilatation Catheter
(K162209; cleared Oct.06, 2016)
(K192344; cleared Sep.19, 2019)
Sapphire II Pro Coronary Dilatation Catheter
(K163114; cleared Jan.05, 2017)
(K173680; cleared Mar.1, 2018) |
| Device Description: | The Sapphire NC ULTRA Coronary Dilatation Catheter is
designed to allow easy exchange of the catheter using a
standard length 0.014 inch guidewire. Balloon diameters
range from 1.75mm to 5.0mm. The balloon material is made
of a minimally compliant material, 1.75mm to 4.0mm
balloons have a rated burst pressure of 20 atmospheres, and
4.5mm to 5.0mm balloons have a rated burst pressure of 18 |
4
atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.
Indications for Use: The indications for use for Sapphire NC ULTRA Coronary Dilatation Catheter remain the same as the predicate device (Sapphire NC 24):
The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:
- Balloon dilatation of the stenotic portion of a coronary ● artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
- Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
- In-stent restenosis
- Post-delivery expansion of balloon expandable coronary stents
The subject device has the following similarities to the Technological Characteristics: predicate devices:
- · Same indications for use
- · Same catheter design
- · Same sterilization method
The following technological differences exist between the subject and predicate device:
- Materials of construction
- · Performance specifications
- · Shelf life
Performance Data: The following performance data were provided in support
5
of the substantial equivalence determination.
- In vitro performance tests were conducted on subject A device in accordance with FDA guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" issued on September 8, 2010, including:
- · Visual Inspection
- Particulate Evaluation
- · Dimensional Verification
- Balloon Compliance
- · Hub leakage test
- Balloon Preparation, Deployment, and Retraction .
- Balloon Inflation and Deflation Time .
- · Coating Integrity
- . Balloon Fatigue (in-stent)
- . Balloon Fatigue
- Balloon Rated Burst Pressure (in-stent) .
- Balloon Rated Burst Pressure .
- . Shaft burst
- Catheter Bond Strength
- · Tip Pull Strength
- Flexibility and Kink
- · Torque Strength
- · Marker Band Radiopacity
- A Biocompatibility testing, conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a Risk Management Process" issued on June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA, included:
- Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
- Pyrogenicity
- Hemocompatibility
- Hemolysis ●
- . Partial thromboplastin time
- . Platelet and leukocyte counts
6
| Complement activation Toxicological Risk Assessment (TRA) of Extractable Chemicals | |
|---|---|
| Packaging and sterilization validation Shelf life | |
| The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use. | |
| Conclusion: | This information supports a determination of substantial equivalence between the subject device and the predicate device described above. |