(14 days)
The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
This is a premarket notification (510(k)) for a medical device, the AngioJet Ultra Spiroflex VG Thrombectomy Set, not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device evaluations (such as acceptance criteria for AI performance metrics, sample size for AI test sets, expert ground truth, MRMC studies, or training set details) is not applicable or present in this document.
The document describes the device, its intended use, and states that it underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, and comparative testing to demonstrate appropriate functional and performance characteristics.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Design | Similar to predicate devices |
| Materials | Similar to predicate devices |
| Indications for Use | Similar to predicate devices |
| Principles of Operation | Similar to predicate devices |
| Mechanical Testing | Passed (demonstrated appropriate functional and performance characteristics) |
| Biocompatibility | Passed |
| Sterility | Passed |
| Comparative Testing | Passed (demonstrated appropriate functional and performance characteristics) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "Representative samples of the devices underwent bench testing."
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The testing was laboratory/bench-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. Testing involved engineering and analytical methods.
4. Adjudication method for the test set:
- Not applicable. Testing was based on engineering and performance standards, not expert adjudication of diagnostic outcomes.
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:
- No. This is not an AI/ML device; an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a thrombectomy set, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's evaluation would be defined by established engineering specifications, material standards, sterility standards, and functional performance benchmarks consistent with the predicate devices. It is not an "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable; this is not an AI/ML device.
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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 USA logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 20, 2021
Possis Medical, Inc. Mike Burnside Sr Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K080806
Trade/Device Name: Angiojet Ultra Spiroflex VG Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
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 April 4, 2008. Specifically, FDA is updating this SE Letter 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 regarding 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 -S O'connell -S Date: 2021.05.20 10:11:13 -04'00'
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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Public Health Service
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
Possis Medical, Inc. c/o Mr. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K080806
AngioJet Ultra Spiroflex VG Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: March 20, 2008 Received: March 21, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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. This letter will allow you to begin marketing your device as described in your Section 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 our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. Lachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
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Indications for Use
510(k) Number (if known): K080806
Device Name: AngioJet® Ultra Spiroflex® VG Thrombectomy Set
Indications for Use:
The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
17
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
MAN OConcurrenes & RODRE Office of Device Evaluation (ODE) Division Sign-Off) ision of Cardiovascular Devices
مكان Number K680866
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.
Section 5 – 510(k) Summary
| Submitter: | Possis Medical, Inc.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA | APR - 4 2008 |
|---|---|---|
| Contact Person: | Mike BurnsideSr. Regulatory Affairs AssociatePhone: (763) 780-4555Fax:(763) 780-2227Email: mike.burnside@possis.com | |
| Date Prepared: | March 20, 2008 | |
| Trade Name: | AngioJet® Ultra Spiroflex® VG Thrombectomy Set | |
| Classification: | 870.5150 | |
| Product Code: | DXE | |
| Predicate Device(s): | The subject devices are equivalent to the following devices:K960970 AngioJet Rapid Thrombectomy System -- Pump Set K972610 AngioJet LF140 Catheter K042874 AngioJet XMI-RX Thrombectomy Catheter K071342 AngioJet XPEEDIOR® Thrombectomy Set (reference device-design only) K072269 AngioJet DVX® Thrombectomy Set (reference device-design only) K072769 AngioJet XMI®, XVG®, & Spiroflex® Thrombectomy Sets (reference device-design only) K073441 AngioJet AVX® Thrombectomy Set (reference device-design only) | |
| Device Description: | Each AngioJet Ultra Thrombectomy Set is a sterile, single use,disposable set that includes the Thrombectomy Catheter and Pump inone combined unit. The AngioJet Ultra Thrombectomy Set is used withthe AngioJet Ultra Console. | |
| Intended Use: | The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for usewith the AngioJet Ultra Console to break apart and remove thrombusfrom infra-inguinal peripheral arteries ≥ 3 mm in diameter. | |
| Functional andSafety Testing: | Representative samples of the devices underwent bench testing,including but not limited to mechanical testing, biocompatibility,sterility, comparative testing to demonstrate appropriate functional andperformance characteristics. | |
| Conclusion: | Possis Medical, Inc. considers the AngioJet Ultra Spiroflex VGThrombectomy Set to be substantially equivalent to the predicatedevices listed above. This conclusion is based upon the devices'similarities in functional design, materials, indications for use, andprinciples of operation. |
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§ 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).