(56 days)
Not Found
No
The device description focuses on mechanical components and physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is intended to remove foreign bodies, which is a procedural/interventional function, not a therapeutic one. It facilitates a medical procedure rather than treating a disease or condition directly.
No
This device is designed to remove foreign bodies, not to diagnose a condition. It is an interventional tool used during procedures, not for diagnosis.
No
The device description clearly outlines physical components such as a core wire, helical loops, polymer filaments, a radiopaque coil, and an insertion tool, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems." This describes a therapeutic or interventional procedure performed directly on a patient's body.
- Device Description: The description details a physical device designed for mechanical retrieval within blood vessels. It does not describe a test or assay performed on biological samples outside of the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
Therefore, the Modified Concentric Retriever is a medical device used for an interventional procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Modified Concentric Retriever consists of a flexible, tapered core wire with five The Nically-shaped helical loops at the distal end. Polymer filaments are fastened to the helix to aid in the entrapment and retrieval of foreign bodies. A radiopaque coil is attached over the distal end to facilitate fluoroscopic visualization. The device is covered with a hydrophilic coating to reduce friction during use. A visible marker on the Retriever wroximal end aids the physician in determining when the Retriever tip is about to exit the Microcatheter tip. The device is provided with an insertion tool to facilitate introduction into a Microcatheter and a torque device to facilitate manipulation. The Modified Coocentric Retriever is delivered to the treatment site using a compatible Microcatheter as specified in the Instructions for Use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Modified Concentric Retriever has successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Concentric Medical, Inc. Modified Concentric Retriever
SEP - 1 2005
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 | |
| tel: 650-938-2100 | |
| Contact | Jean M. Caillouette, RAC |
| Manager, Regulatory Affairs |
Intended Use
The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
Predicate Device K040745 Concentric Retriever LX Manufactured by Concentric Medical, Inc.
Device Description
The Modified Concentric Retriever consists of a flexible, tapered core wire with five The Nically-shaped helical loops at the distal end. Polymer filaments are fastened to the helix to aid in the entrapment and retrieval of foreign bodies. A radiopaque coil is attached over the distal end to facilitate fluoroscopic visualization. The device is covered with a hydrophilic coating to reduce friction during use. A visible marker on the Retriever wroximal end aids the physician in determining when the Retriever tip is about to exit the Microcatheter tip. The device is provided with an insertion tool to facilitate introduction into a Microcatheter and a torque device to facilitate manipulation. The Modified Coocentric Retriever is delivered to the treatment site using a compatible Microcatheter as specified in the Instructions for Use.
Materials
All materials used in the manufacture of the Modified Concentric Retriever are suitable for the intended use of the device and have been used in numerous previously-cleared products.
Testing Summary
The Modified Concentric Retriever has successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification. The Modified Concentric Retriever has
1
Concentric Medical, Inc. Modified Concentric Retriever
been designed, developed and manufactured in accordance with the Concentric Quality System which complies with the requirements of Title 21, CFR$820.30.
Summary of Substantial Equivalence
Dulminal y of Bubbannal the Modified Concentric Retriever are either identical or substantially equivalent to the existing, legally marketed predicate device identified in this application. As such, Concentric Medical, Inc. believes the Modified Concentric Retriever is substantially equivalent to the legally marketed predicate device.
2
Public Health Service
SEP - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Concentric Medical, Inc. c/o Ms. Jean M. Caillouette Manager, Regulatory Affairs 1380 Shorebird Way Mountain View, CA 94043
Re: K051838
Modified Concentric Retriever, Model 90039 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY · Dated: August 11, 2005 Received: August 12, 2005
Dear Ms. Caillouette:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave uctchined the acrese to actives marketed in interstate for use stated in the encrosule, to regary manological Device Amendments, or to commerce prior to May 28, 1970, the characterial as a securitions of the Federal Food, Drug, devices that nave been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. and Cosmetic Act (Act) that do not require upprovite of the general controls provisions of the Act. The Y ou may, merelore, market the device, saloject to the gentration, listing of
general controls provisions of the Act include requirements for annual registration, includes a general controls provisions of the free here.................................................................................................................................. adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) this effective major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller. Entrological on 898. In addition, FDA may be found in the Code of Peastal Registering your device in the Federal Register.
3
Page 2 - Ms. Jean M. Caillouette
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Durna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Concentric Medical, Inc. Modified Concentric Retriever
Indications for Use
| 510(k) Number (if known): | This application K051838 |
|---|---|
| Device Name: | Modified Concentric Retriever |
| Indications for Use: | The Modified Concentric Retriever is intended to |
| remove foreign bodies misplaced during interventional | |
| radiological procedures in the neuro, peripheral and | |
| coronary vascular systems. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
suma R. Jochner
Division Sign-Off) Tivision of Cardiovascular Devices
: 10(k) Number_k 051838
Confidential
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