(80 days)
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
AngioJet Ultra AVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console.
The provided text describes a 510(k) submission for the AngioJet® Ultra AVX® Thrombectomy Set, which is a medical device and not an AI/ML software device. Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment are not applicable.
However, I can extract the relevant acceptance criteria and study information available for this medical device from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | o Cytotoxicity (ISO 10993-5) | Testing performed, results provide assurance of conformity. |
| O Sensitization (ISO 10993-10) | Testing performed, results provide assurance of conformity. | |
| o Intracutaneous Reactivity (ISO 10993-10) | Testing performed, results provide assurance of conformity. | |
| o Acute Systemic Toxicity (ISO 10993-11) | Testing performed, results provide assurance of conformity. | |
| o ASTM Hemolysis (ISO 10993-4) | Testing performed, results provide assurance of conformity. | |
| o Material Mediated Pyrogen (ISO 10993-11) | Testing performed, results provide assurance of conformity. | |
| o Physiochemical (ISO 10993-18) | Testing performed, results provide assurance of conformity. | |
| Design Verification | o Operation Pressure | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. |
| o Net Evacuation | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Infusion rate | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Extended Use | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Dimensional testing | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o System leak testing | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Contrast Injection | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Guide Wire Passage | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| o Mechanical Integrity testing | Testing performed at zero time and 2 years accelerated aging, results provide assurance of conformity. | |
| Overall Equivalence | Substantially equivalent to predicate device (K082382 AngioJet Ultra AVX Thrombectomy Set) | Based on similarities in functional design, materials, indications for use, and principles of operation. |
2. Sample size used for the test set and the data provenance
The document states that "Bench and laboratory testing was performed" for biocompatibility and design verification. It does not specify a "test set" in the context of patient data or a specific sample size for a test set. This device is a physical medical device, not an AI/ML algorithm that processes data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert labels on medical images) is not relevant for this device's non-clinical testing. The "ground truth" for the device's performance is established by meeting predefined engineering and biocompatibility specifications through bench and lab testing.
4. Adjudication method for the test set
Not applicable. This concept is typically relevant for human review of AI outputs or image interpretation, which is not the nature of this submission.
5. 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
Not applicable. This device is a thrombectomy set, a physical medical instrument, not an AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used
For biocompatibility, the ground truth is established by the specifications defined in the ISO 10993 standards. For design verification, the ground truth is established by engineering specifications for operational pressure, evacuation, infusion rate, dimensions, leak thresholds, etc.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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K133629 p. 1 of 2
.
Section 5 – 510(k) Summary
| Submitter: | MEDRAD, INC.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA | FEB 14 2014 |
|---|---|---|
| Contact Person: | George LucasSr. Regulatory Affairs AssociatePhone: (763) 450-8060Fax: (763) 780-2227Email: george.lucas@bayer.com | |
| Date Prepared: | November 25, 2013 | |
| Trade Name: | AngioJet® Ultra AVX® Thrombectomy Set | |
| Classification: | 870.5150 | |
| Product Code: | DXE | |
| Predicate Device(s): | The subject device is equivalent to the following device:• K082382 AngioJet Ultra AVX Thrombectomy Set | |
| Device Description: | AngioJet Ultra AVX Thrombectomy Set is a sterile, single use,disposable set that includes a Thrombectomy Catheter and Pump inone combined unit. The AngioJet Ultra AVX Thrombectomy Set isused with the AngioJet Ultra Console. | |
| Intended Use: | AngioJet Ultra AVX Thrombectomy Set is intended for use with theAngioJet Ultra System in breaking apart and removing thrombus fromA-V Access conduits ≥ 3 mm in diameter. | |
| Comparison to predicate: | Change to the color of the manifold from yellow to smoke grey. Inaddition, design changes were made to the predicate device thatincluded: change in waste bag tubing, change in bubble trap, changein glue for manifold bonds, change in manifold strain relief, andchange in waste bag to tube connection. |
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K133629 p. 2 of 2
Performance Data Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
- Biocompatibility Testing .
- o Cytotoxicity (ISO 10993-5)
- O Sensitization (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-10) o
- Acute Systemic Toxicity (ISO 10993-11) o
- o ASTM Hemolysis (ISO 10993-4)
- Material Mediated Pyrogen (ISO 10993-11) o
- o Physiochemical (ISO 10993-18)
- . Design Verification Testing at zero time and at 2 years of accelerated aging.
- O Operation Pressure
- O Net Evacuation
- O Infusion rate
- Extended Use o
- Dimensional testing o
- System leak testing o
- o Contrast Injection
- Guide Wire Passage o
- O Mechanical Integrity testing
- Conclusion: MEDRAD considers the AngioJet Ultra AVX Thrombectomy Set to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2014
MEDRAD, Inc. Mr. George Lucas Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.W. Minneapolis, MN 55433-8003
K133629 Re:
Trade/Device Name: AngioJet Ultra AVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: January 14, 2014 Received: January 15, 2014
Dear Mr. Lucas,
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Mr. George Lucas
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AngioJet® Ultra AVX® Thrombectomy Set
Indications for Use:
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth J. Cavanaugh -S
§ 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).