(74 days)
The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.
This looks like a 510(k) summary for a medical device called the "Fetch® Aspiration Catheter." This type of document is generally for regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial would for a new drug or novel medical device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as typically seen in clinical performance evaluations.
Here's why and what information is present:
- 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, that information submitted to FDA does not raise new questions of safety and effectiveness.
- Lack of Performance Metrics/Acceptance Criteria: The document mentions "mechanical testing, biocompatibility testing, and sterility assessment" were performed, but it does not provide specific acceptance criteria (e.g., "device must achieve X% successful thrombus removal") or the quantitative results of these tests against such criteria.
- No Clinical Study Details: There is no description of a clinical study (like a standalone or MRMC study) with human subjects, sample sizes for test/training sets, expert adjudication, or ground truth establishment relevant to clinical performance (e.g., efficacy in thrombus removal in patients).
Based on the provided text, I cannot complete the requested tables and information because the document describes a regulatory submission for substantial equivalence, not a clinical study proving performance against specific acceptance criteria.
The available information is limited to:
- Device Name: Fetch® Aspiration Catheter
- Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
- Predicate Devices: The Fetch Aspiration Catheter - K062172 and K070363 (meaning this submission is likely for a modification or new size of an existing device).
- Testing Mentioned (without results or criteria): Mechanical testing, biocompatibility testing, and sterility assessment.
To answer your specific questions, the document would need to be a clinical study report, a performance study report, or similar, which it is not.
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May 20, 2021
Possis Medical, Inc. Mike Burnside 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K081989
Trade/Device Name: Fetch Aspiration Catheter 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 September 26, 2008. 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 regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.
Sincerely.
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.05.20
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Possis Medical Inc. c/o Mr. Mike Burnside Regulatory Affairs Manager 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433-8003
Re: K081989
Trade/Device Name: Fetch® Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: Class II Product Code: DXE Dated: August 29, 2008 Received: September 2, 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.
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 agencics. 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
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Page 2 - Mr. Mike Burnside
systems (OS) 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 Biometrics' (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 yours.
R. Vochner
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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Indication for Use
510(k) Number (if known): K Ø 8 | 989
Device Name: The Fetch® Aspiration Catheter
Indications for Use:
The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna D. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_上08|989
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SEP 2 6 2008
:
Section 5 - 510k Summary Information
:
| Applicant: | Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003Tel: (612) 780-4555Fax: (612) 780-2227 ERN: 2183460 |
|---|---|
| Contact Person: | Mike BurnsideRegulatory Affairs ManagerPhone: (763) 780-4555Fax:(763) 780-2227Email:mike.burnside@possis.com |
| Date Prepared: | July 11, 2008 |
| Trade Name: | Fetch® Aspiration Catheter |
| Common Name ofDevice/ Classificationand Code: | Catheter,EmbolectomyProduct Code: DXEClass II/21 CFR 870.5150 Cardiovascular |
| Predicate Device: | The Fetch Aspiration Catheter - K062172 and K070363Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003 |
| Device Description: | The FETCH Aspiration Catheter is a rapid exchange, low-profile tip,dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track tothe target site. It is used for aspiration of fresh, soft emboli and thrombiIts outer diameter 0.052" (1.33 mm) or 4F allows advancement to thetarget site through a 6F (0.070" I.D.) guiding catheter. A radiopaquemarker is located about 2 mm from the distal tip. FETCH is providedwith an extension line, 30 cc syringe, one-way stopcock and a 40micron collection basket. This basket can be used to filter aspiratedblood for laboratory analysis of collected thrombus. |
| Intended Use: | The Fetch® Aspiration Catheter is indicated for the removal of fresh,soft emboli and thrombi from vessels in the arterial system andcoronary vasculature. |
| Summary ofTechnologicalCharacteristics: | Representative samples of the device underwent testing including butnot limited to mechanical testing, biocompatibility testing, andsterility assessment. |
| Conclusion: | Possis Medical, Inc. considers the Fetch Aspiration Catheter to besubstantially equivalent to the predicate device listed above.Thisconclusion is based upon the devices' similarities in functional design,materials, indications for use, and principles of operation. |
§ 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).