(26 days)
No
The device description and performance studies focus on the mechanical properties and retrieval function of the device, with no mention of AI or ML.
No
The device is described as being for "retrieval of foreign bodies misplaced during interventional radiological procedures." This indicates a tool for removing objects, not a device intended to treat a disease, injury, or other condition.
No
The device is indicated for the retrieval of foreign bodies, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components (Nitinol wire, platinum coil, radiopaque distal coil) and its intended use involves physical retrieval within the vascular system, indicating it is a hardware device.
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 performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a physical device designed for mechanical retrieval, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical retrieval within the vascular system.
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 platinum coil is attached over the helical 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
interventional radiological procedures
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 the same manner as the predicate Concentric Retriever (K003410). 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 8820.30.
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
Concentric Medical, Inc.
11030476
510(k) Summary
MAR 1 1 2003
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 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 Concentric Retriever K003410 Manufactured by Concentric Medical, Inc.
Device Description
The Concentric Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A platinum coil is attached over the helical 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 the same manner as the predicate Concentric Retriever (K003410). 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 8820.30.
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/2 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized emblem that resembles an abstract representation of a bird or a symbol of protection and care.
MAR 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin F. MacDonald Vice President, Clinical and Regulatory Affairs Concentric Medical, Inc. 1380 Shorebird Way Mountain View, CA 94043
Re: K030476
Trade/Device Name: Modified Concentric Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 12, 2003 Received: February 13, 2003
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 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsmamain.html
Sincerely yours.
V.R. Delatorre, M.D.
Bram D. Žuckerman, 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
Modified Concentric Retriever
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
X. C. M.
Number KD30474
(Optional Format 1-2-96)