Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

Device Description

The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.

AI/ML Overview

This document describes the 510(k) premarket notification for the TRUPUSH® Coil Pusher, a component of the TRUFILL® Vascular Occlusion System. The submission aims to demonstrate substantial equivalence to a predicate device, focusing on process changes, packaging changes, and manufacturing site transfer.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed with quantitative targets in the provided document. Instead, the "Design Verification Testing" and "Design Validation Testing" sections list the types of tests performed. The implication is that the device met the inherent acceptance criteria for each test to support substantial equivalence. Without specific numerical thresholds, we can only infer that the performance was deemed acceptable for regulatory clearance.

Test Category	Specific Test (Acceptance Criteria Implicitly Met)	Reported Device Performance/Outcome
Design Verification	Total Product Length	Implied to meet specified dimensional requirements.
	Taper Length	Implied to meet specified dimensional requirements.
	OD of the Proximal Joint	Implied to meet specified dimensional requirements.
	OD of the Distal Joint	Implied to meet specified dimensional requirements.
	OD of the Proximal End of the PTFE Sleeve	Implied to meet specified dimensional requirements.
	Proximal Marker Position	Implied to meet specified positional requirements.
	Distal Placement of the PTFE Sleeve	Implied to meet specified positional requirements.
	PTFE Sleeve Visual Inspection	Implied to pass visual inspection for defects.
	Distal End of PTFE Sleeve Visual Inspection	Implied to pass visual inspection for defects.
	Overall Visual Inspection	Implied to pass overall visual inspection for defects.
	Distance from the Proximal End of the PTFE Sleeve to the Corewire Taper	Implied to meet specified dimensional requirements.
	Distal Solder Joint Length	Implied to meet specified dimensional requirements.
	Distal Solder Joint Visuals	Implied to pass visual inspection for defects and proper formation.
	Turns to Failure	Implied to demonstrate sufficient torsional strength/durability for intended use.
	Distal Joint Strength	Implied to demonstrate sufficient strength at the distal joint for intended use.
	Package Integrity	Implied to pass tests ensuring package integrity (e.g., preventing microbial ingress).
	Package Challenge	Implied to pass tests challenging package robustness or performance.
	Seal Integrity Test (Dye Penetration)	Implied to pass, indicating no dye penetration and thus a sterile barrier.
	Packaging-Seal Strength (Pull Test)	Implied to meet specified pull strength requirements for package seals.
	Product Migration	Implied to demonstrate that the product does not migrate within the package unexpectedly or detrimentally.
Design Validation	3-cavity torque device clip	Implied to perform as intended with a 3-cavity torque device clip, likely related to securement or deployment.
	Pushability	Implied to demonstrate acceptable ease of advancement through a microcatheter.
	Retractability	Implied to demonstrate acceptable ease of withdrawal from a microcatheter.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes used for each of the "Design Verification Testing" or "Design Validation Testing" items. It also does not specify the provenance of the data (e.g., country of origin).

The document mentions "in-vitro and in-vivo testing." In-vitro testing typically refers to tests conducted in a controlled environment, such as a lab bench, using bench models or simulators. In-vivo testing often involves animal models or human subjects. Given the context of a 510(k) for a device like a coil pusher, in-vivo testing likely refers to animal studies to simulate real-world use conditions, as human clinical trials are typically not required for 510(k) unless there are significant performance or safety questions not addressed by bench testing or animal studies. The text does not specify sample sizes or details of these studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable and not provided in the document. The studies conducted are engineering and performance tests (e.g., dimensional measurements, mechanical strength, pushability, retractability, package integrity), not diagnostic or interpretative tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective engineering and performance measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images, and the AI's impact on their performance is assessed. The TRUPUSH® Coil Pusher is a physical medical device, not an AI or diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study (in the context of an algorithm's performance) was not done. The device is a physical medical instrument, not an algorithm. The "standalone" performance here refers to the physical device's function as designed, which is what the design verification and validation tests aim to assess.

7. Type of Ground Truth Used

The "ground truth" for the tests described are engineering specifications, measurement standards, and functional performance requirements for mechanical and material properties, as well as operational characteristics like pushability and retractability. For example, the ground truth for "Total Product Length" would be the engineering drawing's specified length with its permissible tolerance range. The ground truth for "Seal Integrity Test (Dye Penetration)" would be the absence of dye penetration under specified conditions.

8. Sample Size for the Training Set

This information is not applicable. The TRUPUSH® Coil Pusher is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for a machine learning model.

Summary

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Page 1 of 3 CFF 10463867 Revision 02 Only the Native File to be Used

SEP 2 6 2007

510(k) Summary of Safety and Effectiveness

Submitter's Name/Contact Person	Amarilys MachadoManager, Regulatory AffairsCordis Neurovascular, Inc.14000 NW 57th CourtMiami Lakes, Florida 33014Ph. 786 313 6493Fax. 786 313 6480Amachad2@crdus.jnj.com
Trade Name / Common Name	The trade name is :Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher)The common name is:Artificial Embolization Device
Classification	This is a Class II Device, per 21 CFR 882.5950 (84HCG)
Performance Standard	The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this device.
Intended use	The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
Device Description	The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.

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Cordis®
a Johnson & Johnson company

KO 71962

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Predicate Devices The predicate devices are listed in the table below:

Device	Company	Product Code	510(k) Number	Predicate for:(if multiple predicates)
TRUPUSH®Coil Pusher	CordisNeurovascular, Inc.	K983483	HCG	- Intended Use- Design- OperatingPrinciple- Materials- Sterilization- Shelf Life- ManufacturingProcess

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KU71962

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Page 3 of 3 CFF 10463867 Revision 02 Only the Native File to be Used

Summary of Studies

The in-vitro and in-vivo testing was conducted to support substantial equivalence to the predicate device, addressing the process changes, packaging changes and manufacturing site transfer.

Design Verification Testing:

. Total Product Length
� Taper Length
OD of the Proximal Joint
. OD of the Distal Joint
. OD of the Proximal End of the PTFE Sleeve
. Proximal Marker Position
Distal Placement of the PTFE Sleeve
. PTFE Sleeve Visual Inspection
. Distal End of PTFE Sleeve Visual Inspection
. Overall Visual Inspection
. Distance from the Proximal End of the PTFE Sleeve to the Corewire Taper
t Distal Solder Joint Length
. Distal Solder Joint Visuals
. Turns to Failure
. Distal Joint Strength
. Package Integrity
. Package Challenge
Seal Integrity Test (Dye Penetration) .
Packaging-Seal Strength (Pull Test) .
. Product Migration

Design Validation Testing:

3-cavity torque device clip .
Pushability .
Retractability .

Summary of Substantial Equivalence

The proposed TRUPUSH® Coil Pusher is similar in its basic design, construction, indication for use, and performance characteristics to the predicate device the current TRUPUSH® Coil Pusher.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cordis Neurovascular, Inc. % Amarilys Machado Regulatory Affairs Manager 14000 Northwest, 57th Court Miami Lakes, Florida 33014

SEP 26 2007

Re: K071962

Trade/Device Name: Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: August 27, 2007 Received: August 28, 2007

Dear Amarilys 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 -- 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Ftz
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 CFF 20014 Only the Native File to be Used Intended Use Statement

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Indications for Use

510(k) Number (if known):

Device Name: TRUPUSH® Coil Pusher

Indications For Use:

The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Prescription Use X (Part 21 CFR 801 Subpart D)

1071962
AND/0B10(k)Number-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).