(21 days)
The Sapphire NC Plus 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 Sapphire NC Plus coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0- 5.0mm and lengths from 8-18mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F (6F for Ø4.5-5.0mm) or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. This Special 510(k) describes the addition of the Ø4.5- 5.0mm balloon configurations to the Sapphire NC Plus PTCA catheter family.
The provided text is a 510(k) Summary for a medical device, the "Sapphire NC Plus Coronary Dilatation Catheter." This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device for regulatory clearance. It does not describe an AI/ML-based medical device.
Therefore, the information requested in the prompt, which pertains to AI/ML device validation (e.g., acceptance criteria for diagnostic accuracy, sample sizes for AI model training/testing, expert adjudication, MRMC studies, ground truth establishment methods), is not present in the provided text.
The document discusses performance data related to the physical properties and functionality of the balloon catheter, such as:
- Shelf-Life Performance Testing
- Visual Inspection
- Dimension Inspection
- Balloon Preparation, Deployment, and Retraction
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance
- Balloon Inflation and Deflation Time
- Catheter Bond Strength
- Tip Pull Strength
- Particulate Evaluation
- Balloon Rated Burst Pressure (within stent)
- Balloon Fatigue (within stent)
The "Performance Data" section states, "The Sapphire NC Plus test results met all acceptance criteria and were similar to the predicate devices." However, it does not provide a table of these acceptance criteria or the specific numerical results. It only generically states that testing was performed and met criteria.
To answer your request, here's what can be extracted based on the provided text, and what cannot:
What Can Be Inferred/Stated from the Text (within the context of a physical medical device, not AI):
- Acceptance Criteria and Reported Device Performance: The document states that "The Sapphire NC Plus test results met all acceptance criteria and were similar to the predicate devices." However, it does not provide a specific table of these criteria or the numerical performance results of the catheter (e.g., specific burst pressure values, inflation times, etc.). These would typically be detailed in a separate test report referenced by the 510(k) but not included in this summary.
- Sample sizes used for the test set and the data provenance: Not explicitly stated. The tests are for the physical device properties and would involve a sample of manufactured catheters. The provenance would be the manufacturing site.
- Training/Test Set Information (for AI): Not applicable, as this is a physical medical device, not an AI/ML diagnostic.
- Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for a physical device is established through engineering and scientific testing standards.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: The performance data listed (e.g., burst pressure, fatigue) represent the standalone performance of the device itself. No human interaction for "reading" or "interpreting" is involved in these specific tests.
- Type of ground truth used: Engineering specifications, material properties, and established test standards for medical devices (e.g., ISO standards, ASTM standards).
- Sample size for the training set (for AI): Not applicable.
- How the ground truth for the training set was established (for AI): Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (coronary dilatation catheter) and does not contain the information requested about AI/ML device acceptance criteria or validation studies.
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September 19, 2019
OrbusNeich Medical Trading, Inc. Mr. John Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, FL 33309
Re: K192344
Trade/Device Name: Sapphire NC Plus 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: August 28, 2019 Received: August 29, 2019
Dear Mr. Pazienza:
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/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,
For
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)
K192344
Device Name Sapphire NC Plus Coronary Dilatation Catheter
Indications for Use (Describe)
The Sapphire NC Plus 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) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K192344
This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).
| Submitter: | OrbusNeich Medical Trading, Inc.5363 NW 35th AvenueFort Lauderdale, FL 33309Phone: 954.730.0711Fax: 954.730.7601 |
|---|---|
| Contact Person: | John D. Pazienza |
| Date Prepared: | August 28, 2019 |
| Trade Name: | Sapphire NC Plus Coronary Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous21 CFR 870.5100(a) |
| Product Code: | LOX |
| Device Class: | Class II (special controls) |
| Predicate Device: | Sapphire NC Plus (K162209; LOX; cleared October 6, 2016) |
| Reference Device: | NC Euphora (K141090; LOX; cleared August 14, 2014) |
| Device Description: | The Sapphire NC Plus coronary dilatation catheter is a percutaneoustransluminal coronary angioplasty (PTCA) balloon catheter with aworking length of 140cm. The proximal shaft is a polymer coatedstainless steel hypotube. Lubricious coatings are applied to the distalsection. The non-compliant balloons, available in diameters from 2.0-5.0mm and lengths from 8-18mm, can be inflated by injecting dilutecontrast media solution through the trailing hub of the catheter. Tworadiopaque platinum marker bands are located within the balloonsegment. The catheter is compatible with 5F (6F for Ø4.5-5.0mm) orlarger guiding catheters. The internal lumen of the catheter accepts astandard 0.014 inch PTCA guidewire. The proximal part of theguidewire enters the catheter tip and advances coaxially out thecatheter proximal port, thereby allowing both coaxial guidance andrapid exchange of catheters with a single standard length guidewire.Two marked sections are located on the hypotube shaft to indicatecatheter position relative to the tip of either a brachial or femoralguiding catheter. The design of this dilatation catheter does notincorporate a lumen for distal dye injections or distal pressuremeasurements. This Special 510(k) describes the addition of the Ø4.5-5.0mm balloon configurations to the Sapphire NC Plus PTCA catheterfamily. |
| Intended Use: | The Sapphire NC Plus Coronary Dilatation Catheter is indicated for:balloon dilatation of the stenotic portion of a coronary arteryor bypass graft stenosis in patients evidencing coronaryischemia for the purpose of improving myocardial perfusion balloon dilatation of a coronary artery occlusion for thetreatment of acute myocardial infarction in-stent restenosis post-delivery expansion of balloon expandable coronarystents |
| Technological Characteristics: | At a high level, the subject and predicate devices are based on the sametechnological elements:indications for use rapid exchange catheter design non-compliant balloon nominal pressure 0.014" guidewire compatibility specific materials selected catheter working length hydrophilic coating EO sterilization The following technological differences exist between the subject andpredicate device:balloon diameter range exact dimensions of components and catheter rated burst pressure |
| Performance Data: | Testing was performed to support the use of the Sapphire NC Plus:Shelf-Life Performance Testing Visual Inspection Dimension Inspection Balloon Preparation, Deployment, and Retraction Balloon Rated Burst Pressure Balloon Fatigue Balloon Compliance Balloon Inflation and Deflation Time Catheter Bond Strength Tip Pull Strength Particulate Evaluation Balloon Rated Burst Pressure (within stent) Balloon Fatigue (within stent) The Sapphire NC Plus test results met all acceptance criteria and weresimilar to the predicate devices. |
| Conclusion: | This information supports a determination of substantial equivalencebetween the Sapphire NC Plus coronary dilatation catheter and thepredicate device 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.