(221 days)
The EkoSonic Endovascular System is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- Infusion of solutions into the pulmonary arteries.
- Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-3B and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
The provided document is a 510(k) premarket notification letter and summary for the Boston Scientific EkoSonic Endovascular Device. This document does not describe an AI/ML-based medical device study. Instead, it's a notification for a medical device (a catheter) with modifications to a previously cleared predicate device.
Therefore, the information requested about acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML performance (e.g., sample size, ground truth, experts, MRMC studies) is not applicable to this document.
The document discusses non-clinical performance data which focuses on physical and biological safety testing for the catheter.
Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:
- Device Type: The EkoSonic Endovascular Device is described as a single-use, disposable infusion catheter with a removable ultrasound core, used for infusing fluids into the vasculature. Its function is mechanical and ultrasound-based, not AI/ML-driven.
- Modifications: The changes from the predicate device are listed as: an updated luer design (ISO 80369-7 compliant), a luer material change (Cyrolite® Polymer), and updated packaging and labeling. These are physical modifications, not AI/ML algorithm changes.
- Performance Data: The "Non-Clinical Performance Data" section explicitly states that "Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing, including bench-top performance evaluations and biological safety." It further details "Bench Testing" (physical integrity, functionality, burst pressure) and "Biological Safety Testing" (biocompatibility, bioburden, endotoxin, pyrogenicity, sterility).
- Clinical Testing: The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of EkoSonic Endovascular Device." This confirms that the approval is not based on a clinical efficacy study often associated with AI/ML device performance.
In summary, there is no AI/ML component described in this FDA submission for the EkoSonic Endovascular Device. Therefore, I cannot provide information on acceptance criteria, test sets, ground truth establishment, MRMC studies, or training sets in the context of AI/ML for this particular device.
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November 19, 2021
Boston Scientific Mr. Daniel Root Senior Regulatory Affairs Specialist Two Scimed Place Maple Grove, Minnesota 55311
Re: K211080
Trade/Device Name: EkoSonic Endovascular Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: October 18, 2021 Received: October 20, 2021
Dear Mr. Root:
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
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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 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 (OS) 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,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211080
Device Name EkoSonic Endovascular Device
The EkoSonic Endovascular System is indicated for the:
- · Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- · Infusion of solutions into the pulmonary arteries.
· Controlled and selective infusion of physician-specified fluids, including thrombolytics, into 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) |
||X| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000
| Sponsor | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA |
|---|---|
| Contact Name andInformation | Daniel RootThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 425-395-5820Email: Daniel.Root@bsci.com |
| Proprietary Name | EkoSonic™ Endovascular Device |
| Common Name | Continuous Flush Catheter |
| Product Code(Primary/Secondary) | QEY, KRA |
| Classification(Primary/Secondary) | Mechanical Thrombolysis Catheter (21 CFR §870.5150)Catheter, Continuous Flush (21 CFR §870.1210) |
| Predicate Device | The EkoSonic Endovascular Device is substantially equivalent toanother legally marketed device. This predicate device is the EkoSonicEndovascular Device (K191119). |
| Device Description | The EkoSonic Endovascular System consists of an EkoSonicEndovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-3B and Connector Interface Cables). The EkoSonic EndovascularDevice consists of a single-use, disposable infusion catheter withremovable ultrasound core. The infusion catheter contains multiple sideholes distributed over the length of the treatment zone. The ultrasoundcore contains up to 30 ultrasound elements, evenly spaced over thetreatment zone. Thermal sensors in the treatment zone monitorcatheter temperature. The Control System generates and controls thedelivery of radiofrequency energy to the ultrasound core whilemonitoring and controlling the temperature of the treatment zone. |
| Indications for Use/Intended Use | The EkoSonic Endovascular System is indicated for the:Ultrasound facilitated, controlled and selective infusion ofphysician-specified fluids, including thrombolytics, into thevasculature for the treatment of pulmonary embolism. Infusion of solutions into the pulmonary arteries. Controlled and selective infusion of physician-specified fluids,including thrombolytics, into the peripheral vasculature. |
| Device TechnologyCharacteristics andComparison toPredicate Device | The EkoSonic Endovascular Device incorporates the following changesfrom the predicate EkoSonic Endovascular Device (K191119): anupdated luer design that is ISO 80369-7 compliant; luer materialchange to a Cyrolite® Polymer; and updated packaging and labelingappropriate to be consistent with legal manufacturer branding. |
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| Characteristic | EkoSonic Endovascular Device(Subject Device) | EkoSonic Endovascular Device(Predicate Device) |
|---|---|---|
| 510(k) Number | K211080 | K191119 |
| Product Code | QEY, KRA | QEY, KRA |
| Indications forUse | The EkoSonic Endovascular System[with Control Unit] is indicated for the:• Ultrasound facilitated, controlledand selective infusion of physician-specified fluids, includingthrombolytics, into the vasculaturefor the treatment of pulmonaryembolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selective infusion ofphysician-specified fluids, includingthrombolytics, into the peripheralvasculature. | The EkoSonic Endovascular System[with Control Unit] is indicated for the:· Ultrasound facilitated, controlledand selective infusion of physician-specified fluids, includingthrombolytics, into the vasculaturefor the treatment of pulmonaryembolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selective infusion ofphysician-specified fluids, includingthrombolytics, into the peripheralvasculature. |
| Principle ofOperation | The EkoSonic Endovascular System[EkoSonic Endovascular Device withControl Unit] employs ultrasound tofacilitate the delivery of thrombolyticagents into vascular blood clots. | The EkoSonic Endovascular System[EkoSonic Endovascular Device withControl Unit] employs ultrasound tofacilitate the delivery of thrombolyticagents into vascular blood clots. |
| Infusion HolePattern | Multiple side-holes | Multiple side-holes |
| Catheter WorkingLength | 106 cm or 135 cm | 106 cm or 135 cm |
| Treatment ZoneLength | 6 cm - 50 cm | 6 cm - 50 cm |
| CompatibleGuide Wire | 0.035" | 0.035" |
| Outer Diameter | 5.4 Fr | 5.4 Fr |
| Placement Mode | Percutaneous/endovascular | Percutaneous/endovascular |
| Packaged Sterile | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| Single-UseDisposable | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| MaterialsBiocompatible | Yes - EkoSonic Endovascular Device | Yes - EkoSonic Endovascular Device |
| EkoSonic Endovascular Device | EkoSonic Endovascular Device | |
| Characteristic | (Subject Device) | (Predicate Device) |
| RadiopaqueMarkers | Markerbands on the Infusion Catheter(IC) are radiopaqueThe Ultrasonic Core (USCO ultrasoundelements are also radiopaque | Markerbands on the IC are radiopaqueThe USC ultrasound elements are alsoradiopaque |
| Mechanism ofAction | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU converted toultrasound | R/F electrical from CU converted toultrasound |
| UltrasoundTransducer(s) inCatheter | 6 to 30 | 6 to 30 |
| AcousticCharacteristics | Frequency = 2.05 - 2.35 MHz | Frequency = 2.05 - 2.35 MHz |
| Maximum OutputPower Limit | Power is available for ~100W Pulses.The power output is limited bysoftware to ~50W. | Power is available for ~100W Pulses.The power output is limited bysoftware to ~50W. |
| MaximumEkoSonic DeviceTemperature | Temperature monitoring, feedbackand control system limits the surfacetemperature of the IC to 43°C duringoperation. | Temperature monitoring, feedbackand control system limits the surfacetemperature of the IC to 43°C duringoperation. |
| Luer Design | ISO 80369-7 Compliant | ISO 594 Compliant |
| Luer Material | Cyrolite® Polymer (acrylic copolymer) | Polycarbonate |
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| Non-ClinicalPerformanceData | Determination of substantial equivalence is based on an assessmentof non-clinical performance bench testing, including bench-topperformance evaluations and biological safety. |
|---|---|
| Bench Testing:Bench testing was performed to evaluate physical integrity,functionality, and performance of the catheter. Performance criteriaincludes: catheter tensile strengths, freedom from leak, and burstpressure. | |
| Biological Safety Testing:Biocompatibility testing in accordance with ISO 10993-1, microbialassessments including bioburden and endotoxin, and pyrogenicity andsterility assurance testing show the device has acceptable biologicalsafety for its intended use. | |
| Clinical Testing | Performance testing from clinical studies is not required todemonstrate substantial equivalence of EkoSonic EndovascularDevice. |
| Conclusion | Based on the indications for use, technological characteristics, andperformance testing, EkoSonic Endovascular Device has been shownto be appropriate for its intended use and is considered to besubstantially equivalent to EkoSonic Endovascular Device. K191119. |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).