(29 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon dilatation catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a balloon dilatation catheter used for balloon pre-dilatation and dilatation of stenotic portions of arteries and bypass grafts to improve myocardial perfusion, and for percutaneous transluminal angioplasty in the peripheral vasculature. These actions directly treat physiological conditions.
No
The device is a balloon dilatation catheter used for therapeutic purposes (dilatation of stenotic or occluded arteries), not for diagnosis. The device description explicitly states it does not incorporate a lumen for distal dye injections or distal pressure measurements, which are common diagnostic features.
No
The device description clearly outlines a physical balloon dilatation catheter with various hardware components (balloon, catheter shaft, guidewire lumen, inflation lumen, hub, marker band). It is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this is a balloon dilatation catheter used for percutaneous transluminal angioplasty. This is a procedure performed inside the body to widen narrowed blood vessels. It is a therapeutic device, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Sapphire® II PRO balloon dilatation catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for:
• balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (>=70% stenosis) for the purpose of improving myocardial perfusion.
The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) 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.
The Sapphire® II PRO Balloon Dilatation Catheter is also indicated
for:
• percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.
Product codes (comma separated list FDA assigned to the subject device)
LOX, LIT
Device Description
The Sapphire II PRO Balloon Dilatation Catheter is now also available as an over-the-wire balloon catheter with a working length of 150cm.
The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. 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, bypass graft, renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.
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)
Performance Data:
Testing was leveraged from the predicate device (K180921) when applicable:
- Shelf-Life (Partial)
- Performance Testing (Partial)
- Dimensional Verification (Partial)
- Balloon Rated Burst Pressure (Partial)
- Balloon Fatigue
- Balloon Compliance
- Catheter Bond Strength (Partial)
- Tip Pull Strength
- Radiopacity
- Coating Integrity
Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design:
- Sterilization
- Performance Testing
- Visual Inspection
- Dimensional Verification
- Balloon Preparation, Deployment, and Retraction
- Balloon Rated Burst Pressure
- Shaft Burst
- Balloon Inflation and Deflation Time
- Catheter Bond Strength
- Flexibility and Kinking
- Torque Strength
- Particulate Evaluation
- Biocompatibility
- Cytotoxicity
- Intracutaneous Reactivity
- Sensitization
- Acute Systemic Toxicity
- Pyrogenicity
- Hemocompatibility
- Hemolysis
- Complement Activation
- Partial Thromboplastin Time
- Platelet and Leukocyte Counts
- Genotoxicity
The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device.
Conclusion:
This information supports a determination of substantial equivalence between the Sapphire II PRO balloon dilatation catheter and the predicate device described above.
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.
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.
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
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March 04, 2020
OrbusNeich Medical Trading Inc. John Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, Florida 33309
Re: K200269
Trade/Device Name: Sapphire II PRO Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (Ptca) Catheter Regulatory Class: Class II Product Code: LOX, LIT Dated: January 31, 2020 Received: February 4, 2020
Dear Mr. 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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
2
Indications for Use
510(k) Number (if known) K200269
Device Name Sapphire II PRO Balloon Dilatation Catheter
Indications for Use (Describe)
The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for:
· balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (270% stenosis) for the purpose of improving myocardial perfusion.
The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) 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.
The Sapphire® II PRO balloon dilatation catheter is also indicated for:
· percutaneous transluminal angioplasty in the peripheral vasculature, including renal, fomoral, popliteal, tibial, and peroneal arteries.
| 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 Trading, Inc.
5363 NW 35th Avenue
Fort Lauderdale, FL 33309
Phone: 954.730.0711
Fax: 954.730.7601 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Pazienza |
| Date Prepared: | January 31, 2020 |
| Trade Name: | Sapphire II PRO Balloon 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 (primary)
LIT (secondary |
| Device Class: | Class II |
| Predicate Device: | OrbusNeich Sapphire II PRO (K180921; LOX, LIT; cleared 28-Jun-
2018) |
| Reference Devices: | Abbott Vascular Mini Trek OTW (K110617; LOX; cleared 02-Jun-
2011)
Boston Scientific Emerge OTW (K130391; LOX; cleared 10-Jul-2013)
Medtronic Sprinter Legend OTW (K103095; LOX; cleared 22-Oct-
2010) |
| Device Description: | The Sapphire II PRO Balloon Dilatation Catheter is now also available
as an over-the-wire balloon catheter with a working length of 150cm.
The semi-compliant balloons are available in diameters from 1.0-
1.25mm and lengths from 5-15mm with a rated burst pressure of 14
atmospheres. The catheter consists of proximal section with a Y-type
hub and distal section with a balloon near the distal tip. The straight
port of the hub is the guidewire entrance and the side port is used to
inflate and deflate the balloon. The external lumen provides for
inflation of the balloon with dilute contrast media solution.
The
internal lumen permits the use of a standard 0.014 inch guidewire to
facilitate advancement of the catheter to and through the stenosis to be
dilated. Hydrophilic lubricious coatings are applied to the distal
section. One radiopaque platinum marker band is located within the
balloon segment. The catheter is compatible with 5F or larger guiding
catheters and 4F or larger guiding sheaths. Two marked sections
(3mm in length) are located on the proximal shaft to indicate catheter
position relative to the tip of either guiding catheter or guiding sheath.
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 Balloon Dilatation Catheter (Ø1.0-1.25mm
configurations) is indicated for:
• balloon pre-dilatation of a stenotic portion of a coronary artery or
bypass graft stenosis (≥70% stenosis) for the purpose of improving
myocardial perfusion
The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm
configurations) 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
The Sapphire® II PRO Balloon Dilatation Catheter is also indicated
for:
• percutaneous transluminal angioplasty in the peripheral
vasculature, including renal, femoral, popliteal, infra-popliteal,
tibial, and peroneal arteries. |
| Technological Characteristics: | At a high level, the subject and predicate devices are based on the same
technological elements:
• the same indications for use
• identical semi-compliant balloon
• nominal pressure of 6 atm
• rated burst pressure of 14 atm
• identical distal shaft
• hydrophilic coating
• 0.014" guidewire compatibility
• EO sterilization
The following technological differences exist between the subject and |
4
- predicate device: over-the-wire catheter shaft design ●
- specific materials selected for proximal shaft
- . exact dimensions of proximal shaft components and catheter
5
Performance Data:
Testing was leveraged from the predicate device (K180921) when applicable:
- Shelf-Life (Partial) ●
- Performance Testing (Partial) ●
- Dimensional Verification (Partial) O
- o Balloon Rated Burst Pressure (Partial)
- Balloon Fatigue O
- Balloon Compliance O
- Catheter Bond Strength (Partial) O
- Tip Pull Strength O
- Radiopacity o
- Coating Integrity o
Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design:
- Sterilization ●
- . Performance Testing
- o Visual Inspection
- o Dimensional Verification
- Balloon Preparation, Deployment, and Retraction O
- o Balloon Rated Burst Pressure
- o Shaft Burst
- Balloon Inflation and Deflation Time O
- o Catheter Bond Strength
- Flexibility and Kinking O
- Torque Strength O
- Particulate Evaluation O
- Biocompatibility
- Cytotoxicity O
- Intracutaneous Reactivity O
- Sensitization O
- Acute Systemic Toxicity o
- Pyrogenicity o
- O Hemocompatibility
- · Hemolysis
- Complement Activation
- Partial Thromboplastin Time .
- Platelet and Leukocyte Counts .
- · Hemolysis
- o Genotoxicity
The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device.
Conclusion:
This information supports a determination of substantial equivalence between the Sapphire II PRO balloon dilatation catheter and the predicate device described above.