(59 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 technologies.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis" and "balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction," which are therapeutic interventions aimed at improving myocardial perfusion.
No
The device is a coronary dilatation catheter, designed for therapeutic intervention (balloon dilatation) to treat stenotic or occluded coronary arteries, rather than for diagnosis.
No
The device description clearly details a physical catheter with a balloon, hypotube, coatings, and marker bands, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Sapphire II PRO coronary dilatation catheter is a device used within the body (percutaneous transluminal) to physically dilate a coronary artery or bypass graft. It is a mechanical intervention, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Sapphire II PRO coronary dilatation catheter is a therapeutic medical device used for a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sapphire II PRO 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
Product codes
LOX
Device Description
The Sapphire II PRO coronary dilatation catheter is a percut aneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a PTFE co ated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.5-4.0mm and l engths from 10-30mm, 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 (there is only one centrally located marker band for the Ø1.5mm configurations). The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accept s a standard 0.014 inch PTCA guidewire. The proximal part of t he 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 l ocated on the hypotube shaft to indicate catheter position relative to the tip of either a brach ial 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
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 a s 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, and particulate evaluation, and also b iocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire II PRO coronary dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire II PRO coron ary dilatation catheter design and construction are suitable for its intended use as recommended by the Class II Special Control s Guidance Document for Ce rtain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 05, 2017
OrbusNeich Medical Inc. John Pazienza Senior Director. Engineering 5363 NW 35th Avenue Fort Lauderdale, Florida 33309
Re: K163114
Trade/Device Name: Sapphire II Pro 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: November 4, 2016 Received: November 7, 2016
Dear John 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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.
Sincerelv.
M.G. Willemsen
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) K163114
Device Name
Sapphire II PRO Coronary Dilatation Catheter
Indications for Use (Describe)
The Sapphire II PRO 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
| 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(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: | November 4, 2016 |
| Trade Name: | Sapphire II PRO 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 (K103657; cleared August 9, 2011)
Sapphire NC (K103808; cleared September 1, 2011)
Sapphire NC Plus (K162209; cleared October 6, 2016) |
| Device Description: | The Sapphire II PRO coronary dilatation catheter is a percut aneous
transluminal coronary angioplasty (PTCA) balloon catheter with a
working length of 140cm. The proximal shaft is a PTFE co ated
stainless steel hypotube. Hydrophilic lubricious coatings are applied to
the distal section. The semi-compliant balloons, available in diameters
from 1.5-4.0mm and l engths from 10-30mm, 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 (there is only one centrally located marker band
for the Ø1.5mm configurations). The catheter is compatible with 5F
or larger guiding catheters. The internal lumen of the catheter accept s
a standard 0.014 inch PTCA guidewire. The proximal part of t he
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 l ocated on the hypotube shaft to indicate
catheter position relative to the tip of either a brach ial or femoral
guiding catheter. The design of this dilatation catheter does not
incorporate a lumen for distal dye injections or distal pressure
measurements. |
| Intended Use: | The Sapphire II PRO Coronary Dilatation Catheter is indicated for:
balloon dilatation of the stenotic portion of a co ronary artery
●
or bypass graft stenosis in patients evidencing coronary
ischemia for the purpose of improving myocardial perfusion
balloon dilatation of a co ronary artery occlusion for the
●
treatment of acute myocardial infarction |
4
- Comparisons of the new and predicate devices show that t he Technological Characteristics: technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
- Both in vitro performance tests, such a s dimensional verification, Performance Data: 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, and particulate evaluation, and also b iocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire II PRO coronary dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire II PRO coron ary dilatation catheter design and construction are suitable for its intended use as recommended by the Class II Special Control s Guidance Document for Ce rtain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010). Conclusion: This information supports a determination of substantial equivalence between the Sapphire II PRO coronary dilatation catheter and the predicate devices described above.