(29 days)
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 (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.
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.
The provided document is a 510(k) summary for the Sapphire II PRO Balloon Dilatation Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device.
However, the document does not contain the specific type of acceptance criteria and study detailed in the request, which typically pertains to the performance evaluation of a diagnostic or AI-driven medical device (e.g., accuracy, sensitivity, specificity, human reader study data). This document describes performance testing for a physical medical device (balloon catheter), focusing on mechanical properties, sterilization, and biocompatibility.
Therefore, I cannot extract the information to fill out the requested table and answer questions 2-9 from the provided text. The document does not describe a study that proves a diagnostic algorithm meets acceptance criteria.
Based on the provided text, here's what can be inferred about the "acceptance criteria" and "study" for this device, though it doesn't align with the template for diagnostic or AI device evaluation:
-
Acceptance Criteria (Implied): The acceptance criteria are related to the physical and functional performance of the balloon dilatation catheter. The statement "The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device" implies that the device had to pass certain predefined thresholds for parameters such as:
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance
- Catheter Bond Strength
- Tip Pull Strength
- Radiopacity
- Coating Integrity
- Dimensional Verification
- Shaft Burst
- Balloon Inflation and Deflation Time
- Flexibility and Kinking
- Torque Strength
- Particulate Evaluation
- Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
- Sterilization
- Visual Inspection
- Balloon Preparation, Deployment, and Retraction
-
Study That Proves the Device Meets Acceptance Criteria: The study described is a series of bench tests and laboratory evaluations to demonstrate the physical, mechanical, and biological compatibility of the Sapphire II PRO Balloon Dilatation Catheter. The primary objective was to show that the new over-the-wire design meets the same performance standards as its predicate device (OrbusNeich Sapphire II PRO, K180921) and other reference devices, and that it is safe and effective for its intended use.
Therefore, the requested table and answers to questions 2-9 cannot be fully provided as the information is not present in the supplied text.
Here is what can be extracted or stated based on the provided document in the context of the user's request, acknowledging the mismatch in the type of device and study:
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Implied) | Specific Test/Parameter (Examples) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Balloon Rated Burst Pressure | "met all acceptance criteria and were similar to the predicate device" |
| Balloon Fatigue | "met all acceptance criteria and were similar to the predicate device" | |
| Balloon Compliance | "met all acceptance criteria and were similar to the predicate device" | |
| Catheter Bond Strength | "met all acceptance criteria and were similar to the predicate device" | |
| Tip Pull Strength | "met all acceptance criteria and were similar to the predicate device" | |
| Shaft Burst | "met all acceptance criteria and were similar to the predicate device" | |
| Flexibility and Kinking | "met all acceptance criteria and were similar to the predicate device" | |
| Torque Strength | "met all acceptance criteria and were similar to the predicate device" | |
| Dimensional/Visual | Dimensional Verification | "met all acceptance criteria and were similar to the predicate device" |
| Visual Inspection | "met all acceptance criteria and were similar to the predicate device" | |
| Material/Biological | Radiopacity | "met all acceptance criteria and were similar to the predicate device" |
| Coating Integrity | "met all acceptance criteria and were similar to the predicate device" | |
| Particulate Evaluation | "met all acceptance criteria and were similar to the predicate device" | |
| Biocompatibility (Cytotoxicity, Sensitization, Hemocompatibility, etc.) | "met all acceptance criteria and were similar to the predicate device" | |
| Functional (use-related) | Balloon Preparation, Deployment, and Retraction | "met all acceptance criteria and were similar to the predicate device" |
| Balloon Inflation and Deflation Time | "met all acceptance criteria and were similar to the predicate device" | |
| Other | Sterilization | "met all acceptance criteria and were similar to the predicate device" |
| Shelf-Life (Partial) | "met all acceptance criteria and were similar to the predicate device" |
(Note: The table above reiterates that all listed tests for the subject device "met all acceptance criteria and were similar to the predicate device." Specific numerical performance values are not provided in this summary.)
Answers to Specific Questions (based on the provided text's context of a physical device, not a diagnostic/AI device):
-
Sample sizes used for the test set and the data provenance:
- Sample sizes: Not specified in the provided text. The text only lists the types of tests performed.
- Data provenance: Not explicitly stated (e.g., country of origin) but implied to be from laboratory testing performed by or for OrbusNeich Medical Trading Inc. The text mentions "Testing was leveraged from the predicate device (K180921) when applicable" and "Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design," indicating these are laboratory/bench studies, not clinical (retrospective or prospective) patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A) in this context. This question refers to human assessment for ground truth in diagnostic studies. For a physical device, ground truth established by standard testing methods (e.g., measuring dimensions, burst pressure, biocompatibility assays) does not involve human expert consensus in the same way.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This refers to adjudication in human reader studies for diagnostic accuracy.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a physical balloon catheter, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical device, "ground truth" is established by objective, quantitative measurements and standardized laboratory test results based on engineering specifications and regulatory standards (e.g., ISO, ASTM). For example, the "ground truth" for balloon burst pressure is the measured pressure at which the balloon ruptures, compared against a specified acceptance limit. For biocompatibility, it's the results of verified biological assays.
-
The sample size for the training set:
- N/A. This device is not an AI model requiring a training set.
-
How the ground truth for the training set was established:
- N/A. No training set is used for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
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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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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 AvenueFort Lauderdale, FL 33309Phone: 954.730.0711Fax: 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, percutaneous21 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 availableas 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 14atmospheres. The catheter consists of proximal section with a Y-typehub and distal section with a balloon near the distal tip. The straightport of the hub is the guidewire entrance and the side port is used toinflate and deflate the balloon. The external lumen provides forinflation of the balloon with dilute contrast media solution.Theinternal lumen permits the use of a standard 0.014 inch guidewire tofacilitate advancement of the catheter to and through the stenosis to bedilated. Hydrophilic lubricious coatings are applied to the distalsection. One radiopaque platinum marker band is located within theballoon segment. The catheter is compatible with 5F or larger guidingcatheters and 4F or larger guiding sheaths. Two marked sections(3mm in length) are located on the proximal shaft to indicate catheterposition relative to the tip of either guiding catheter or guiding sheath.The design of this dilatation catheter does not incorporate a lumen fordistal dye injections or distal pressure measurements. |
| Intended Use: | The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.0-1.25mmconfigurations) is indicated for:• balloon pre-dilatation of a stenotic portion of a coronary artery orbypass graft stenosis (≥70% stenosis) for the purpose of improvingmyocardial perfusionThe Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mmconfigurations) is indicated for:• balloon dilatation of the stenotic portion of a coronary artery orbypass graft stenosis in patients evidencing coronary ischemia forthe purpose of improving myocardial perfusion• balloon dilatation of a coronary artery occlusion for the treatmentof acute myocardial infarctionThe Sapphire® II PRO Balloon Dilatation Catheter is also indicatedfor:• percutaneous transluminal angioplasty in the peripheralvasculature, 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 sametechnological 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 sterilizationThe following technological differences exist between the subject and |
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- predicate device: over-the-wire catheter shaft design ●
- specific materials selected for proximal shaft
- . exact dimensions of proximal shaft components and catheter
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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.
§ 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.