(141 days)
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.
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.
The provided text is for a 510(k) Pre-Market Notification for a medical device called the "Modified Concentric Retriever." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through a full clinical trial with detailed acceptance criteria and performance metrics against such criteria.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement for ground truth, and comparative effectiveness studies are not available or applicable in the provided document. The 510(k) is a regulatory submission for a Class II device, which typically relies on bench testing and comparison to a legally marketed predicate device.
Here's an analysis of what can be gleaned from the document, acknowledging the limitations for your specific questions:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Retrieval of foreign bodies misplaced during interventional radiological procedures in neuro, peripheral, and coronary vascular systems. | "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." (Matches intended use of predicate) |
| Function: Perform similarly to the predicate Concentric Retriever. | "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 is substantially equivalent to the predicate product, the Concentric Retriever, in terms of indications for use, function, methods of manufacturing, and materials used." (Implies functional equivalence) |
| Materials: Made of materials suitable for this use and used in previously cleared products. | "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." (Meets material suitability) |
| Manufacturing Quality: Designed under a quality system in compliance with 21CFR§820.30. | "The Modified Concentric Retriever was designed under the Concentric Quality System which is in compliance with 21CFR§820.30." (Meets quality system compliance) |
Study that proves the device meets the acceptance criteria:
The document describes a "Testing Summary" stating: "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 implies a series of bench tests (e.g., mechanical strength, dimensional accuracy, material compatibility, functional deployment/retrieval in a simulated environment) were conducted to demonstrate that the modified device performs similarly to the predicate and meets its own internal specifications. No clinical study is mentioned.
Regarding the specific questions, much of the information is not provided due to the nature of a 510(k) for this type of device:
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The "Testing Summary" refers to "all components, subassemblies, and/or full devices," implying a certain number of units were tested, but no concrete sample size is given.
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. Given it's bench testing, it would be conducted in a laboratory setting, likely at the manufacturer's facility in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For bench testing of a device like a catheter, "ground truth" as it relates to clinical outcomes or expert consensus on diagnosis/treatment is not established by medical experts for the device's performance. The "ground truth" would be the engineering specifications and performance against industry standards or the predicate device's known performance characteristics.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials to resolve discrepancies in human readings or diagnoses. This device's testing involves engineering and performance metrics, not human interpretation of clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical medical instrument (a retriever catheter) and does not involve AI or human "readers" interpreting images or data. Therefore, an MRMC study and AI-related effectiveness are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- For this 510(k), the "ground truth" for the device's performance is based on engineering specifications, design requirements, and the established performance characteristics of the predicate device. This is demonstrated through bench testing (e.g., mechanical integrity tests, simulated use tests) to ensure the Modified Concentric Retriever meets its intended function and safety profile when compared to its predicate.
8. The sample size for the training set:
- Not applicable. This device does not use an algorithm that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this device.
{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 WayMountain View, CA 94043 |
| 650-938-2100 | |
| Contact | Kevin F. MacDonaldVice 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 usein the retrieval of foreign bodies misplaced duringinterventional 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
§ 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).