(96 days)
The Concentric Retriever is indicated for use in the retrieval of foreign bodics misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
The Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A radiopaque distal coil facilitates fluoroscopic visualization.
The provided text describes a 510(k) premarket notification for a medical device called the "Concentric Retriever." However, it does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.
The document's purpose is to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria or conduct a de novo study to prove a device meets specific performance metrics.
Specifically, the document states:
- "The modified Concentric Retriever was tested in a similar manner as the predicate Concentric Retriever (K003410, K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests." This indicates that the testing was primarily to ensure the modified device performed similarly to the predicate and met its existing specifications, not to establish new acceptance criteria or conduct a new clinical or performance study to prove efficacy or safety against such criteria.
- "The modified Concentric Retriever is equivalent to the predicate product, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent." This is the core argument for a 510(k) submission, confirming equivalence rather than proving performance against specific acceptance criteria with a dedicated study.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set) because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device via manufacturing and materials comparisons and limited "similar manner" testing, rather than a detailed performance study with defined acceptance criteria.
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JUN 2 1 2004
Κοψογιου
510(k) Summary
General Information
| Classification | Class II, Percutaneous Catheter per 21 CFR § 870.1250 |
|---|---|
| Trade Name | Concentric Retriever |
| Submitter | Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043 |
| 650-938-2100 | |
| Contact | Kevin F. MacDonaldVice President, Clinical and Regulatory Affairs |
Intended Use
The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
Predicate Devices K003410, K030476 Concentric Retriever Manufactured by Concentric Medical, Inc.
Device Description
The Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A radiopaque distal coil facilitates fluoroscopic visualization.
Materials
All materials used in the manufacture of the modified Concentric Retriever are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The modified Concentric Retriever was tested in a similar manner as the predicate Concentric Retriever (K003410, K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The modified Concentric Retriever was designed under the Concentric Quality System which is in compliance with 21CFR§820.30.
Summary of Substantial Equivalence
The modified Concentric Retriever is equivalent to the predicate product, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Concentric Medical, Inc. believes the Concentric Retriever is substantially equivalent to existing legally marketed devices.
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Image /page/1/Picture/1 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 symbol that resembles an eagle or bird-like figure with three parallel lines extending from its head, creating a sense of movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
Mr. Kevin F. MacDonald Vice President, Clinical and Regulatory Affairs Concentric Medical, Inc. 1380 Shorebird Way Mountain View, CA 94043
- K040700 Re:
Trade/Device Name: Percutaneous Introducer Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: June 11, 2004 Received: June 14, 2004
Dear Mr. MacDonald:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 10(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosure) to regally the Medical Device Amendments, or to commerce prof to May 20, 1910, the exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not requent of the general controls provisions of the Act. The I ou may, merelore, manel of the Act include requirements for annual registration, listing of general controls provisions wastice, 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 If your device is classified ($60 a00 ro) als. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ovavents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dri 3 issualles complies with other requirements of the Act that I DA has made a develations administered by other Federal agencies. You must or any I catal statues and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 – Mr. Kevin F. MacDonald
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (DF OF S42 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 901 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to begin markstuig your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equiralend thus, premarket notification. The PDA inding of substantial equive 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
r the If you desire specific advice for your active at (301) 594-4646. Additionally, for questions of Compliance at 3 contact the Office of Compliance at (301) 591 - 1612 - 12 - 1 Compliance at (301) 594promotion and advertising of your device, please contact the Office of Company of promotion and advertising of your ac-roo, pear ".
4639. Also, please note the regulation entitled, "Misbranding by reference to premation on van 4639. Also, please note the regulation entreal. Other general information on your notification" (21CFK Part 807.77) your hajred from the Division of Small Manufacturers,
responsibilities under the Act may be obtained from the Division of Small Ma responsibilities under the Act may be out its toll-free number (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-free number (800) tour l niternational and Consultip://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dumer 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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Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
This application
Concentric Retriever
The Concentric Retriever is indicated for use in the
retrieval of foreign bodics misplaced during
interventional radiological procedures in the neuro,
peripheral and coronary vascular systems.
Prescription Use
(Per 21 CFR 801 Subpart D)
X
OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
D
Dunner (Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K040700
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).