(62 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML capabilities.
Yes.
The device 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" and "balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction," which are direct treatments for medical conditions.
No
The device is a dilatation catheter used for therapeutic procedures like balloon dilatation of coronary arteries and bypass grafts, not for diagnosing conditions.
No
The device description clearly details a physical catheter with a balloon, hypotube, coatings, and marker bands, which are all hardware components.
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 procedure performed within the body (in vivo) to treat coronary artery conditions. IVDs are used to examine specimens from the body (in vitro), such as blood, urine, or tissue samples, to provide information about a person's health.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels for mechanical dilatation. This is a therapeutic device, not a diagnostic one that analyzes samples.
- 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 Plus Coronary Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
LOX
Device Description
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- 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. This Special 510(k) describes the modification to the Sapphire NC PTCA catheters including a change to the hydrophilic coating and also a change in the brand name to Sapphire NC Plus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery, 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)
To support the hydrophilic coating change, both in vitro performance tests such as [balloon preparation, deployment, and retraction], balloon rated burst pressure, balloon fatigue, balloon compliance, catheter bond strength, tip pull strength, coating integrity, particulate evaluation, and also biocompatibility tests such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, complement activation, prothromboplastin time, [platelet and leukocyte counts], and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire NC Plus coronary dilatation catheter. The test results met all acceptance criteria, were similar to the predicate device, and ensure that the Sapphire NC Plus coronary dilatation 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.
Sapphire NC (K103808; cleared September 7, 2011)
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 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
OrbusNeich Medical, Inc. Mr. John Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, Florida 33309
Re: K162209
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: September 9, 2016 Received: September 12, 2016
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162209
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
Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) All stents should be deployed in accordance with the manufacturer's indications and instructions for use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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(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: | August 4, 2016 |
| Trade Name: | Sapphire NC Plus 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 Device: | Sapphire NC (K103808; cleared September 7, 2011) |
| Device Description: | 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-
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. This Special 510(k)
describes the modification to the Sapphire NC PTCA catheters
including a change to the hydrophilic coating and also a change in the
brand name to Sapphire NC Plus. |
510(k) Notification (21CFR 807.90(e))
4
| Intended Use: | 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 perfusionballoon dilatation of a coronary artery occlusion for the
treatment of acute myocardial infarctionin-stent restenosispost-delivery expansion of balloon expandable coronary
stentsNote: 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 device show that the
technological characteristics such as product performance, design, and
intended use are substantially equivalent to the currently marketed
predicate device. |
| Performance Data: | To support the hydrophilic coating change, both in vitro performance
tests such as [balloon preparation, deployment, and retraction], balloon
rated burst pressure, balloon fatigue, balloon compliance, catheter
bond strength, tip pull strength, coating integrity, particulate
evaluation, and also biocompatibility tests such as cytotoxicity,
sensitization, intracutaneous reactivity, acute systemic toxicity,
hemocompatibility (hemolysis, complement activation,
prothromboplastin time, [platelet and leukocyte counts], and in vivo
thromboresistance), pyrogenicity, and genotoxicity (bacterial
mutagenicity and in vitro mouse lymphoma) were conducted on the
Sapphire NC Plus coronary dilatation catheter. The test results met all
acceptance criteria, were similar to the predicate device, and ensure
that the Sapphire NC Plus coronary dilatation 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 Plus coronary dilatation catheter and the
predicate device described above. |