(246 days)
The Sapphire NC 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
Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be deployed in accordance with the manufacturer's indications and instructions for use.
The Sapphire NC 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 2.0-4.0mm 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 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Sapphire NC Coronary Dilatation Catheter (a PTCA Catheter)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Performance Tests Conducted | Reported Device Performance |
|---|---|---|
| In Vitro Performance Tests | Dimensional verification, balloon preparation, deployment, and retraction, 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, particulate evaluation, within stent balloon burst pressure, within stent stent balloon fatigue. | "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire NC PTCA catheter design and construction are suitable for its intended use..." |
| Biocompatibility Tests | Cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity. | "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire NC PTCA catheter design and construction are suitable for its intended use..." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes in vitro performance tests and biocompatibility tests. It does not mention a "test set" in the context of patient data or clinical images. The testing was performed on the device itself.
- Sample Size: Not explicitly stated as a number of devices/units, but implied to be sufficient for rigorous testing.
- Data Provenance: The tests are in vitro and biocompatibility, meaning they were conducted in a laboratory setting, not on patient data. Therefore, there is no country of origin or retrospective/prospective designation relevant to the data provenance in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable. The device is a physical medical device (catheter) and the testing described is primarily mechanical/physical performance and biocompatibility. "Ground truth" in the context of expert consensus on diagnostic imaging or clinical outcomes is not relevant here.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes pre-market testing for a medical device (catheter) based on in vitro performance and biocompatibility, not a diagnostic imaging AI algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by the predefined specifications and acceptance criteria for each in vitro and biocompatibility test. These criteria are likely based on industry standards, regulatory guidance (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters), and performance of predicate devices.
8. Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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长103808
SEP - 1 2011
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).
| Submitter: | OrbusNeich Medical, Inc.5363 NW 35th AvenueFort Lauderdale, FL 33309Phone: 954.730.0711Fax: 954.730.7601 |
|---|---|
| Contact Person: | John D. Pazienza |
| Date Prepared: | September 1, 2011 |
| Trade Name: | Sapphire NC Coronary Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR870.5100(a), Product Code LOX) |
| Predicate Devices: | NC Sprinter RX (P790017 S095; cleared October 10, 2008)Voyager NC (P810046 S226; cleared august 21, 2008)Quantum Maverick (P860019 S182; cleared October 1, 2002)NC Quantum Apex (P860019 S241; cleared April 16, 2010)Dura Star (P880003 S089; cleared August 29, 2007) |
| Device Description: | The Sapphire NC 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 2.0-4.0mm 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 balloonThe catheter is compatible with 5F or larger guidingsegment.catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire. The proximal part of the guidewire enters thecatheter tip and advances coaxially out the catheter proximal port,thereby allowing both coaxial guidance and rapid exchange ofcatheters with a single standard length guidewire. Two markedsections are located on the hypotube shaft to indicate catheter positionrelative to the tip of either a brachial or femoral guiding catheter. Thedesign of this dilatation catheter does not incorporate a lumen for distaldye injections or distal pressure measurements. |
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| Intended Use: | The Sapphire NC 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 coronarystentsNote: The subject device was tested on the bench with the OrbusNeichBlazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should bedeployed in accordance with the manufacturer's indications andinstructions for use. |
|---|---|
| Technological Characteristics: | 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,balloon preparation, deployment, and retraction, balloon rated burstpressure, balloon fatigue, balloon compliance, balloon inflation anddeflation time, catheter bond strength, tip pull strength, flexibility andkinking, torque strength, radiopacity, coating integrity, particulateevaluation, within stent balloon burst pressure, within stent balloonfatigue, and also biocompatibility tests such as cytotoxicity,sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity,and intracutaneous reactivity were conducted on the Sapphire NCPTCA catheter. The test results met all acceptance criteria, weresimilar to predicate devices, and ensure that the Sapphire NC PTCAcatheter design and construction are suitable for its intended use asrecommended by the Class II Special Controls Guidance Document forCertain Percutaneous Transluminal Coronary Angioplasty (PTCA)Catheters (FDA; September 8, 2010). |
| Conclusion: | This information supports a determination of substantial equivalencebetween the Sapphire NC PTCA catheter and the predicate devicesdescribed above. |
.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OrbusNeich Medical, Inc. c/o Mr. John D. Pazienza Director, Product Development 5363 NW 35" Avenue Fort Lauderdale, FL 33309
SEP. - 1 2011
Re: K103808
Trade/Device Name: Sapphire NC Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheters Regulatory Class: Class II (two) Product Code: LOX Dated: August 26, 2011 Received: August 29, 2011
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. 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.
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
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Page 2 – Mr. John D. Pazienza
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 (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing
practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
KC
/B
D
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: | K103808 |
|---|---|
| Device Name | Sapphire NC Coronary Dilatation Catheter |
| Indications for Use: | The Sapphire NC 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 perfusionballoon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarctionin-stent restenosispost-delivery expansion of balloon expandable coronary stents Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be deployed in accordance with the manufacturer's indications and instructions for use. |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
LL
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K103808
Sapphire NC PTCA
510(k) Notification (21CFR 807.90(e))
§ 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.