TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM by CORDIS NEUROVASCULAR, INC.

The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

very high-risk for management by traditional operative techniques
inoperable

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Device Description

Not Found

AI/ML Overview

Here's a breakdown of the requested information, assuming the provided text relates to a medical device approval and not an AI-driven diagnostic or treatment tool. The document is an FDA 510(k) clearance letter for a TRUFILL DCS ORBIT™ Detachable Coil System. Therefore, the acceptance criteria and study described will pertain to the safety and effectiveness of this physical device, not an AI's performance.

Based on the provided text, there is no information related to an AI/Machine Learning device or its performance criteria, studies, or ground truth establishment. The document is a standard FDA 510(k) clearance letter for a physical medical device (detachable coil system) and its indications for use.

Therefore, many of the specific questions regarding AI performance criteria, test sets, ground truth, experts, and MRMC studies are not applicable to this document. The information that can be extracted relates to the device itself and the regulatory process.

Re-interpretation of "Acceptance Criteria" for a Physical Medical Device 510(k):

For a 510(k) clearance, the "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm's accuracy would be. Instead, acceptance criteria are generally met by demonstrating substantial equivalence to a previously legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. This demonstration typically relies on bench testing, biocompatibility testing, sterilization validation, and potentially limited clinical data, all compared against established standards and the predicate's performance.

Based on the provided document, here's what can be inferred and what aspects are not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for 510(k) Submission):
- Demonstrate substantial equivalence in intended use, technological characteristics, and performance to a predicate device.
- Safety and effectiveness comparable to the predicate.
- Compliance with relevant performance standards and regulations (e.g., biocompatibility, sterility, mechanical integrity).
Reported Device Performance:
- The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "reported performance" from a regulatory standpoint—it meets the criteria for market clearance.
- Specific quantitative performance metrics (e.g., rates of successful embolization, complication rates) are NOT detailed in this letter. These would typically be found in the actual 510(k) submission, including summaries of non-clinical and, if applicable, clinical testing.

2. Sample size used for the test set and the data provenance

Not explicitly stated in this document. For a 510(k), test sets would likely include:
- Bench Testing: Often involves hundreds or thousands of cycles for mechanical durability, often dozens of samples for burst pressure, tensile strength, etc. The sample size depends on the specific test and statistical justification.
- Biocompatibility Testing: Typically uses a small number of samples, following ISO 10993 guidelines.
- Limited Clinical Data (if any): While not always required for 510(k), if clinical data were submitted, the sample size would vary.
Data Provenance: Not stated. For a 510(k), data provenance would typically be from the manufacturer's internal testing labs, contract research organizations (CROs), or possibly clinical sites (if clinical data was part of the submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A (Not Applicable to this type of device and document). Ground truth, in the context of an AI device, implies an independent, verified determination that the AI is trying to predict. For a medical device like an embolization coil, the "ground truth" for its safety and effectiveness is established through validated scientific and engineering tests, and potentially clinical outcomes, rather than expert consensus on an interpretation task like with AI.
Experts involved would be those conducting the bench tests (engineers, materials scientists) and potentially clinicians for any clinical studies (neurointerventionalists, neurosurgeons). Their qualifications would be expertise in their respective fields, but they wouldn't be "establishing ground truth" for an AI.

4. Adjudication method for the test set

N/A (Not Applicable). Adjudication methods (like 2+1, 3+1) are common in clinical trials or for establishing ground truth from expert readings (e.g., for AI training/testing data). This document does not describe such a process for the coil system's testing. Testing for a physical device typically follows pre-defined protocols and acceptance limits without "adjudication" in this sense.

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

N/A (Not Applicable). This document refers to a physical embolization device, not an AI system that assists human readers. Therefore, an MRMC study and effects of AI assistance are irrelevant to this FDA clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A (Not Applicable). This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A (Not Applicable in the AI sense). For a physical device, "ground truth" for safety and effectiveness is established by:
- Bench Testing Standards: e.g., device integrity under stress, embolization effectiveness in a simulated vessel model.
- Biocompatibility Data: Demonstrating non-toxicity, non-immunogenicity.
- Sterilization Validation: Proving the device is sterile.
- Clinical Outcomes Data (if applicable for 510(k), or more extensively for PMA): Patient outcomes (e.g., aneurysm occlusion rates, complication rates, long-term stability) would be the ultimate "ground truth" for effectiveness and safety. However, the 510(k) pathway often relies heavily on non-clinical data and comparison to a predicate, not always requiring extensive new clinical trials.

8. The sample size for the training set

N/A (Not Applicable). This device is not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established

N/A (Not Applicable). As there's no AI, there's no training set or ground truth in this context.

In summary: The provided document is an FDA 510(k) clearance letter for a physical medical device, the TRUFILL DCS ORBIT™ Detachable Coil System. It confirms the device's substantial equivalence to a predicate, allowing it to be marketed. The concepts of AI acceptance criteria, training/test sets, ground truth, experts for AI evaluation, and MRMC studies are not relevant to this document.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of a bird or eagle with its wings spread.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Amarilys Machado Senior Regulatory Affairs Specialist Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes. Florida 33014

Re: K032553

Trade/Device Name: TRUFILL DCS ORBIT™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 18, 2003 Received: August 25, 2003

Dear Ms. Machado:

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 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.

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Page 2 - Ms. Amarilys Machado

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) 594-4659. 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/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

, Mark N Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K032\$\$3

Cordis Franchise Form - ( Intended Use Statement

Effective Date 11/15/00

Page 1 of 1

510(k) Number (if known):

Device Name: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe, also known as the TRUFILL DCS ORBIT™ Detachable Coil System.

Indications for Use Statement

very high-risk for management by traditional operative techniques 1)

inoperable 2)

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-The-Counter Use

Mark N Millam

estorative

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Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).