(204 days)
The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
- upper and lower extremity peripheral arteries > 1.5mm in diameter and
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
AngioJet Solent Dista Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Dista Thrombectomy Set is used with the AngioJet Ultra Console.
The provided text describes a 510(k) premarket notification for the AngioJet Solent Dista Thrombectomy Set. While it lists various performance tests conducted, it does not provide specific acceptance criteria or detailed results of those tests. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study with defined acceptance criteria for a novel AI/medical imaging device.
Therefore, the requested information, which is typically associated with the evaluation of AI/medical imaging devices against specific performance metrics and acceptance criteria, cannot be fully extracted from this document.
However, based on the information provided, here's what can be inferred or stated about the testing performed:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document lists "Performance Data" which includes various types of testing, but it does not specify quantitative acceptance criteria or the reported performance metrics against those criteria.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test. The document mentions "GLP Animal acute and chronic safety studies" but does not give the number of animals or the species.
- Data Provenance: Not specified, but given the nature of the tests (biocompatibility, hemocompatibility, operational characteristics, animal studies), the data would likely be from laboratory and animal testing, not human patient data (retrospective or prospective) in the context of clinical efficacy for an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes physical and biological testing of a thrombectomy device, not an AI or imaging device requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable, as there is no mention of expert review or consensus for establishing ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for imaging devices or AI tools that assist human readers in interpretation, which is not the case for this thrombectomy set.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The AngioJet Solent Dista Thrombectomy Set is a physical medical device, not an algorithm.
7. The type of ground truth used:
The concept of "ground truth" as typically applied to AI/imaging devices (e.g., pathology, outcomes data) is not directly relevant here. The "truth" in these tests would be established through objective measurements against design specifications and established biological safety standards. For example:
- Biocompatibility: Conformance to ISO 10993 standards (e.g., no cytotoxicity, no sensitization).
- Hemocompatibility: Conformance to ASTM F2382-04 and ISO 10993-4 (e.g., acceptable hemolysis rates, minimal complement activation).
- Mechanical Integrity: Meeting predetermined tensile strengths, compression limits, etc.
- Clot Removal: Demonstrated effectiveness in removing clots in an in-vitro or animal model.
- Animal Studies: Observation of no adverse events or unacceptable tissue reactions/injury in animal models.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Summary of available information regarding performance data:
The document lists the following types of performance data collected to support substantial equivalence:
- Biocompatibility:
- Cytotoxicity (ISO 10993-5)
- Intracutaneous Reactivity (ISO 10993-10)
- Sensitization (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18)
- Hemocompatibility:
- ASTM Hemolysis (ISO 10993-4)
- Partial Thromboplastin Time Assay (ASTM F2382-04)
- C3a Complement Activation (ISO 10993-4)
- SC5b-9 Complement Activation (ISO 10993-4)
- Thromboresistance (ISO 10993-4)
- Catheter operational characteristics
- Leak testing
- Corrosion
- Dimensional verification
- Guidewire compatibility tests
- Particulate generation
- Tracking/function in tortuosity
- Extended use
- Clot removal
- Hemolysis
- Thermal dose
- Mechanical integrity (tensile strengths, compression/buckling, torque testing)
- GLP Animal acute and chronic safety studies.
The "Conclusion" states that "Testing (bench, biocompatibility testing, and animal testing) verified that the new device is substantially equivalent to the predicate devices." This implies that the results of these tests met the necessary standards for safety and performance required for a 510(k) clearance, demonstrating equivalence to the predicate devices.
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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 seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
February 8, 2021
Medrad. Inc. Mike Burnside Regulatory Affairs Manager 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433-8003
Re: K113363
Trade/Device Name: AngioJet Solent Dista Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Mike Burnside:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 06, 2012. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -5 O'connell -S Date: 2021.02.08 08:08:00 -05'00'
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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUN - 6 2012
MEDRAD, Inc. c/o Mike Burnside Regulatory Affairs Manager 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K113363
Trade/Device Name: AngioJet Solent Dista Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: March 28, 2012 Received: April 11, 2012
Dear Mr. Burnside:
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. 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. However, we remind you 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.
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Page 2 - Mr. Mike Burnside
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.S. Helleber
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K113363
Device Name: AngioJet® Solent™ Dista Thrombectomy Set
Indications for Use:
The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
- upper and lower extremity peripheral arteries > 1.5mm in diameter and
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Cus A. Helle
of CDRH, Office of Device Evaluation (ODE) of Cardiovascular Devices
510(k) Numbe
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|< 113363
6 2012
| Section 5 - 510(k) Summary JUN - | |
|---|---|
| Submitter: | MEDRAD, INC.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA |
| Contact Person: | Mike BurnsideRegulatory Affairs ManagerPhone: (763) 717-1077Fax: (763) 780-2227Email: micahel.burnside@possis.com |
| Date Prepared: | February 16, 2012 |
| Trade Name: | AngioJet® Solent™ Dista Thrombectomy Set |
| Classification: | 870.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate Device(s): | The subject device is equivalent to the following devices:• K111182 AngioJet Ultra Solent Omni Thrombectomy Set• K072769 AngioJet Ultra XMI Thrombectomy Set |
| Device Description: | AngioJet Solent Dista Thrombectomy Set is a sterile, single use,disposable set that includes a Thrombectomy Catheter and Pump inone combined unit. The AngioJet Solent Dista Thrombectomy Set isused with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Solent Dista Thrombectomy Set is intended for use withthe AngioJet Ultra Console to break apart and remove thrombus from:• upper and lower extremity peripheral arteries ≥ 1.5mm in diameter and• for use with the AngioJet Ultra Power Pulse Kit for the controland selective infusion of physician specified fluids, includingthrombolytic agents, into the peripheral vascular system. |
| Comparison to predicate: | Design changes were made to the predicate device which included:change in length of device, changes to the jet body, changes tocatheter shaft, changes to distal section of catheter, and changes todiameter of catheter. |
| Performance Data | Bench and laboratory testing was performed to support adetermination of substantial equivalence to the predicate device.Results from the testing provide assurance that the proposed deviceconforms to the requirements for its intended use. This included thefollowing testing:• Biocompatibilityo Cytotoxicity (ISO 10993-5)o Intracutaneous Reactivity (ISO 10993-10)o Sensitization (ISO 10993-10)o Acute Systemic Toxicity (ISO 10993-11)o Material Mediated Pyrogen (ISO 10993-11) |
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- o Physiochemical (ISO 10993-18)
- Hemocompatibility o
- ASTM Hemolysis (ISO 10993-4)
- · Partial Thromboplastin Time Assay (ASTM F2382-04)
- · C3a Complement Activation (ISO 10993-4)
- · SC5b-9 Complement Activation (ISO 10993-4)
- · Thromboresistance (ISO 10993-4)
- Catheter operational characteristics .
- Leak testing .
- Corrosion .
- Dimensional verification 0
- . Guide wire compatibility tests
- Particulate generation
- Tracking/function in tortuosity .
- . Extended use
- . Clot removal
- Hemolysis .
- Thermal dose .
- Mechanical integrity (tensile strengths, compression / . buckling, torque testing)
- . GLP Animal acute and chronic safety studies.
Conclusion:
MEDRAD considers the AngioJet Solent Dista Thrombectomy Set to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation. Testing (bench, biocompatibility testing, and animal testing) verified that the new device is substantially equivalent to the predicate devices.
§ 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).