(257 days)
The Scoreflex PTA Scoring Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of instent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.
The Scoreflex PTA Scoring Balloon Catheter is designed for easy guidewire exchange and available with balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, and 6.0mm, balloon lengths of 15, 20 and 40mm and a catheter working length of 40, 90, or 150cm. There are two catheter designs within the Scoreflex family: the no-coil design has a smaller shaft profile than the corresponding coil design catheter of the same balloon configuration which will allow for access to more distal lesions while the coil design minimizes balloon curvature during inflation. The balloon is made of a semi-complaint material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon jacketed stainless steel hypotube and the scoring wire is laser welded to the distal end of the hypotube. The proximal shaft joins with a smooth transition to the distal shaft (composed of an outer nylon tube with the balloon/tip tube and scoring wire welded at the distal tip). The cutting section of the scoring wire is outside of the balloon. Two radiopaque platinum/iridium marker bands are located on the scoring wire and aligned with the balloon shoulders to ensure accurate positioning of the balloon. The tip lumen is compatible with either a standard 0.014 inch (0.36mm) or 0.018 inch (0.46mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. The catheter is lubricated with hydrophilic coating on the tip and the distal outer body surface; the tip lumen and the balloon are lubricated with silicone coating.
The provided text is a 510(k) Summary for a medical device (Scoreflex PTA Scoring Balloon Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific clinical acceptance criteria for an AI/ML product.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance in the context of an AI/ML device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/ML system.
- Sample size details for a test set, data provenance, number of experts, adjudication methods, or ground truth establishment for an AI/ML system's evaluation.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm-only performance.
- Details about training set sample size or how ground truth was established for a training set in an AI/ML context.
The "Performance Data" section lists various engineering and biocompatibility tests performed on the physical catheter device, such as "Balloon Rated Burst Pressure," "Shaft Burst," "Balloon Fatigue," and "Biocompatibility." These tests are typical for physical medical devices to ensure their safety and mechanical integrity, but are not related to the performance evaluation of an AI/ML algorithm.
The conclusion states that "The Scoreflex PTA Scoring Balloon Catheter test results met all acceptance criteria and were similar to the predicate and reference devices." However, these "acceptance criteria" refer to the engineering and biocompatibility specifications for the physical catheter, not the performance metrics of an AI/ML system.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OrbusNeich Medical Trading, Inc. John Pazienza General Manager and Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, FL 33309
Re: K182713
Trade/Device Name: Scoreflex PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: May 6, 2019 Received: May 7, 2019
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. 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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Plaque Modification Devices Team 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)
K182713
Device Name Scoreflex PTA Scoring Balloon Catheter
Indications for Use (Describe)
The Scoreflex PTA Scoring Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of instent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.
| 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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 AvenueFort Lauderdale, FL 33309Phone: 954.730.0711Fax: 954.730.7601 |
|---|---|
| Contact Person: | John D. Pazienza |
| Date Prepared: | November 15, 2018 |
| Trade Name: | Scoreflex PTA Scoring Balloon Catheter |
| Common Name: | Scoring Balloon Catheter |
| Classification Name: | Catheter, Percutaneous, Cutting/Scoring21 CFR 870.1250 |
| Product Code: | PNO |
| Device Class: | Class II |
| Predicate Device: | Bard Vascutrak (K103459; PNO; cleared December 13, 2010) |
| Reference Devices: | Angioscore, Inc. Angiosculpt (K142983; cleared March 4, 2015)OrbusNeich Jade (K173894; cleared February 9, 2018) |
| Device Description: | The Scoreflex PTA Scoring Balloon Catheter is designed for easy guidewireexchange and available with balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5,5.0, 5.5, and 6.0mm, balloon lengths of 15, 20 and 40mm and a catheterworking length of 40, 90, or 150cm. There are two catheter designs withinthe Scoreflex family: the no-coil design has a smaller shaft profile than thecorresponding coil design catheter of the same balloon configuration whichwill allow for access to more distal lesions while the coil design minimizesballoon curvature during inflation. The balloon is made of a semi-complaintmaterial with a rated burst pressure of 14 atmospheres. The proximal shaftof the catheter is composed of a female luer connector bonded to a nylonjacketed stainless steel hypotube and the scoring wire is laser welded to thedistal end of the hypotube. The proximal shaft joins with a smoothtransition to the distal shaft (composed of an outer nylon tube with theballoon/tip tube and scoring wire welded at the distal tip). The cuttingsection of the scoring wire is outside of the balloon. Two radiopaqueplatinum/iridium marker bands are located on the scoring wire and alignedwith the balloon shoulders to ensure accurate positioning of the balloon.The tip lumen is compatible with either a standard 0.014 inch (0.36mm) or0.018 inch (0.46mm) guidewire. The guidewire enters the catheter tip andadvances coaxially out the Rx port, thereby allowing both coaxial guidanceand rapid exchange of catheter with a single standard length guidewire. Thedesign of this dilatation catheter does not incorporate a lumen for distal dyeinjections or distal pressure measurements. The catheter is lubricated withhydrophilic coating on the tip and the distal outer body surface; the tiplumen and the balloon are lubricated with silicone coating. |
| Intended Use: | The Scoreflex PTA Scoring Balloon Catheter is indicated for PercutaneousTransluminal Angioplasty in the peripheral vasculature, including iliac,femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for thetreatment of obstructive lesions of native or synthetic arteriovenous dialysisfistulae. This device is also indicated for treatment of in-stent restenosis ofballoon expandable and self-expanding stents in the peripheral vasculature. |
| TechnologicalCharacteristics: | At a high level, the subject and predicate devices are based on the sametechnological elements:similar indications for userapid exchange catheter designsemi-compliant balloonscoring wire designhydrophilic coating0.014" and 0.018" guidewire compatibilityEO sterilizationThe following technological differences exist between the subject andpredicate device:specific materials selectedexact dimensions of components and cathetercatheter working lengthballoon diameter and length rangenominal and rated burst pressure |
| Performance Data: | Testing was performed to support the use of the Scoreflex PTA ScoringBalloon Catheter:SterilizationShelf-LifePerformance TestingVisual InspectionDimension InspectionBalloon Preparation, Deployment, and RetractionBalloon Rated Burst PressureShaft BurstBalloon FatigueBalloon ComplianceBalloon Inflation and Deflation TimeCatheter Bond StrengthTip Pull StrengthFlexibility and KinkingTorque StrengthRadiopacityCoating IntegrityParticulate EvaluationBalloon Rated Burst Pressure (within stent)Balloon Fatigue (within stent)BiocompatibilityCytotoxicitySensitizationIntracutaneous ReactivityAcute Systemic Toxicity |
{4}------------------------------------------------
- Hemocompatibility
Hemolysis - . Partial Thromboplastin Time
{5}------------------------------------------------
- " Platelet and Leukocyte Counts
- . Complement Activation
- . In vivo Thromboresistance
- Pyrogenicity O
- Genotoxicity O
The Scoreflex PTA Scoring Balloon Catheter test results met all acceptance criteria and were similar to the predicate and reference devices.
This information supports a determination of substantial equivalence Conclusion: between the Scoreflex PTA Scoring Balloon Catheter and the predicate device described above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).