(246 days)
P790017 S095, P810046 S226, P860019 S182, P860019 S241, P880003 S089
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The stated "Intended Use / Indications for Use" directly describes therapeutic actions such as "balloon dilatation of the stenotic portion of a coronary artery" and "treatment of acute myocardial infarction," which are interventions aimed at improving a patient's health condition.
No
The device description and intended use clearly state that this is a balloon dilatation catheter used for therapeutic purposes (e.g., improving myocardial perfusion, treating acute myocardial infarction) by physically dilating stenotic portions of coronary arteries or bypass grafts. It is an interventional device, not one designed to gather diagnostic information.
No
The device description clearly details a physical catheter with a balloon, hypotube, coatings, and marker bands, indicating it is a hardware 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 in vivo (within the body) for a therapeutic procedure (balloon dilatation of coronary arteries). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical catheter designed to be inserted into the body and manipulated within the coronary arteries. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
The device is a therapeutic medical device used for interventional cardiology procedures.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
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 The catheter is compatible with 5F or larger guiding segment. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Both in vitro performance tests such as 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 balloon fatigue, and also biocompatibility tests such as cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, and intracutaneous reactivity were conducted on the Sapphire NC PTCA catheter. 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 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): 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.
P790017 S095, P810046 S226, P860019 S182, P860019 S241, P880003 S089
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.
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
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 Avenue
Fort Lauderdale, FL 33309
Phone: 954.730.0711
Fax: 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 CFR
870.5100(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 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
The catheter is compatible with 5F or larger guiding
segment.
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. |
1
| Intended 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 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. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 balloon
fatigue, and also biocompatibility tests such as cytotoxicity,
sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity,
and intracutaneous reactivity were conducted on the Sapphire NC
PTCA catheter. 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 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 Sapphire NC PTCA catheter and the predicate devices
described above. |
.
2
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
3
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
4
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))