(141 days)
Not Found
No
The description focuses on the mechanical design and materials of the device, with no mention of AI/ML terms or image processing capabilities that would typically indicate AI/ML involvement in this context.
No.
The device is used to retrieve misplaced foreign bodies, which is a restorative or diagnostic action, not a therapeutic one as it does not treat a disease or condition.
No
The device is indicated for the retrieval of foreign bodies, which is an interventional therapeutic procedure, not a diagnostic one.
No
The device description clearly describes a physical medical device made of Nitinol wire with a helical tip and filaments, and a radiopaque coil. It is not software.
Based on the provided information, this device 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." This is a therapeutic or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device (wire with a tip) designed for mechanical retrieval, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like reagents, assays, or sample preparation).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The Modified 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 Modified Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip with filaments. 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 (K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Modified Concentric Restrieves was designed under the Concentric Quality System which is in compliance with 21CFR§820.30.
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
AUG 1 1 2004
510(k) Summary
General Information
| Classification | Class II, Percutaneous Catheter per 21 CFR § 870.1250 |
|---|---|
| Trade Name | Modified 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 Modified Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced The Mounted Concentional radiological procedures in the neuro, peripheral and coronary vascular systems.
Predicate Devices
Concentric Retriever Manufactured by Concentric Medical, Inc.
Device Description
Device Dossinglion
The Modified Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip with filaments. 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 The Mouried Concerners 203076). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Modified Concentric Restrieves 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 The Modified Convention for use, function, methods of manufacturing, and materials used are substantially equivalent. Concentric Medical, Inc. believes the Modified Concentric Retriever is substantially equivalent to existing legally marketed devices.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2004
Mr. Kevin F. MacDonald Vice President, Clinical and Regulatory Concentric Medical, Inc. 1380 Shorebird Way Mountain View, CA 94043
Re: K040745
Trade/Device Name: Modified Concentric Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: July 29, 2004 Received: July 30, 2004
Dear Mr. MacDonald:
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 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
2
Page 2 -- Mr. Kevin F. MacDonald
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21) CFR (2000) (2006) (2006) (2006) and Sal. 542 of the Act): 21 CFR 1000 forth in the quality systems (QS) regulation (2 ~21 cm 4 ch); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Action S product radiation control provisions (Sections 35 device as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your de This letter will allow you to begin marketing sour alevice of your device of your device to a legally
premarket notification. The FDA innify of substantial equir device and premarket notification. The FDA finding 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 device on our coalified by the specifically, for questions on the contact the Office of Compliance at (301) 594-40-1. Tracket file of Compliance at (301) 594promotion and advertising of your device, please contact the office of Compliance promotion and advertising of your device, preducting by reference to premarket
4639. Also, please note the regulation entitled, "Misbranding on vour 4639. Also, please note the regulation entires, "thereas are "
notification" (21CFR Part 807.97) you may obtain. Other general information of notification" (ZICFR Part 807.97) your hay obtained from the Division of Small Manufacturess,
responsibilities under the Act may be obtained from the Division of Small 44 responsibilities under the Act may be ood inst toll)-free minber (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-free music html International and Consumer Assistantes and Constantes and mamain.html
Sincerely yours,
Dmna 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): | This application |
|---|---|
| Device Name: | Modified Concentric Retriever |
| Indications for Use: | The Modified 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. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ._____________________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dma R. Vachner
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K040745