(96 days)
Not Found
No
The summary describes a mechanical device for retrieving foreign bodies and does not mention any AI or ML components or functionalities.
No
The device is used to retrieve foreign bodies, not to treat a disease or condition.
No
Explanation: The device is indicated for the retrieval of foreign bodies, which is a therapeutic rather than a diagnostic function. While it facilitates fluoroscopic visualization, this is for guidance during retrieval, not for diagnosing a condition.
No
The device description explicitly states it consists of a Nitinol wire and a radiopaque coil, which are physical hardware components.
Based on the provided information, the Concentric Retriever is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems." This describes a procedure performed within the patient's body, not on samples taken from the body.
- Device Description: The description details a physical device designed for insertion into blood vessels.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device during the procedure, not to analyze samples.
- Anatomical Site: The device is used within the patient's vascular system.
IVD devices are designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. The Concentric Retriever is an interventional device used in vivo (within the body).
N/A
Intended Use / Indications for 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.
Product codes
DQY
Device Description
The Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A radiopaque distal coil facilitates fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro, peripheral and coronary vascular systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Way | |
| Mountain View, CA 94043 | |
| 650-938-2100 | |
| Contact | Kevin F. MacDonald |
| Vice 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.
1
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
2
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
3
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