(232 days)
The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.
The catheter features an outer shaft and is comprised of three: an inflow lumen to supply saline to the catheter tip, an outflow lumen for removal of thrombotic material and a guidewire lumen to accommodate an 0.018 inch guidewire. The catheter is 6F in diameter and is available in soft and braided configurations.
The provided text describes a 510(k) premarket notification for the Oasis Thrombectomy System. This type of submission generally establishes substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria in the same way a PMA or de novo submission might. While a clinical trial is mentioned, the text does not detail specific acceptance criteria or performance metrics in a quantitative manner.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
Acceptance Criteria and Device Performance Study
The document states that a study was conducted to demonstrate substantial equivalence, focusing on safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with quantitative performance metrics for the Oasis Thrombectomy System. Instead, it makes a general statement about safety and effectiveness.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Safe |
| Effectiveness | Effective |
Note: The definition of "safe" and "effective" in this context is implicitly linked to being comparable to the predicate device and the alternative treatment (pulsed spray thrombolytic therapy).
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used in the randomized, prospective clinical trial.
- Data Provenance: The study was a "randomized, prospective clinical trial," indicating that the data was collected specifically for this study, likely in a controlled clinical environment. The country of origin is not explicitly stated, but given the submission to the FDA, it's reasonable to infer a US-based or international study conforming to FDA guidelines.
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the use of experts to establish a ground truth for a test set in the context of image analysis or similar diagnostic device evaluation. The study was a clinical trial comparing the device's performance directly against an alternative treatment. Therefore, the "ground truth" would be the observed clinical outcomes in patients.
4. Adjudication Method for the Test Set:
Given that this was a clinical trial evaluating a thrombectomy device's performance rather than an interpretation of data by multiple readers, there is no mention of an adjudication method (e.g., 2+1, 3+1) for a test set in the context of image or data interpretation. Adjudication in a clinical trial would typically refer to independent review committees for adverse events or specific endpoints, but this information is not provided here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the performance of diagnostic aids, often involving human readers interpreting medical images with and without AI assistance. The Oasis Thrombectomy System is a mechanical device for thrombus removal, not a diagnostic imaging aid.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This device is a physical, mechanical thrombectomy device, and its performance is inherently tied to its use by a clinician in a procedure. There is no "algorithm only" component to evaluate in this context.
7. Type of Ground Truth Used:
The ground truth for the clinical trial would be based on outcomes data related to the removal of thrombus from hemodialysis access grafts and patient safety. This would include direct clinical observations (e.g., successful removal of thrombus, restoration of blood flow), adverse events, and potentially objective measures of graft patency, though these specific details are not provided. The study compared these outcomes against a recognized alternative treatment.
8. Sample Size for the Training Set:
The document does not mention a training set or its sample size. Training sets are relevant for machine learning algorithms or similar data-driven models. This submission focuses on a mechanical device evaluated through a clinical trial.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set is described.
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2/23/99
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
| Owner Operator Submitting Boston Scientific Corporation | |
|---|---|
| this Premarket Notification: One Boston Scientific Place | |
| Natick, MA 01757 | |
| (508) 650.9174 | |
| Contact Person: | Wanda M. Carpinella |
| Regulatory Affairs Department | |
| Device Generic Name: | Thrombectomy Catheter |
| Device Classification: | 74 DXE, Catheter Embolectomy |
B. INDICATIONS FOR USE
The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.
C. DESCRIPTIVE CHARACTERISTICS
The catheter features an outer shaft and is comprised of three: an inflow lumen to supply saline to the catheter tip, an outflow lumen for removal of thrombotic material and a guidewire lumen to accommodate an 0.018 inch guidewire. The catheter is 6F in diameter and is available in soft and braided configurations.
D. SUBSTANTIAL EQUIVALENCE
The subject thrombectomy catheter has been shown to be substantially equivalent to the Fogarty Embolectomy Balloon Catheter and Microvena's 8F Clot Buster Amplatz Thrombectomy Catheter. Results from a randomized, prospective clinical trial established that the proposed thrombectomy catheter is safe and effective for treatment of thrombosed hemodialysis grafts when compared to pulsed spray thrombolytic therapy.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
The catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Boston Scientific monitors bacterial endotoxins on product on a monthly basis.
F. CONCLUSION
Based on the information presented, Boston Scientific Corporation believes that the thrombectomy catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently thrombectomy catheters.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird, with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1999
Ms. Laura Mondano Manager Requlatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K982363
Oasis™ Thrombectomy Catheter System Trade Name: Regulatory Class: II Product Code: MCW Dated: November 23, 1998 Received: November 25, 1998
Dear Ms. Mondano:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listinq of devices, qood manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such
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Page 2 - Ms. Laura Mondano
Existing major requlations affecting your device additional controls. can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, " Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
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510(k) Number (if known): New Application
Oasis™ Thrombectomy System Device Name:
Indications for Use: The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher for TJC
Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).