(41 days)
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils.
The provided document describes the TRUFILL® DCS Syringe II, an artificial embolization device, and its substantial equivalence to a predicate device. The information details the performance and safety testing, as well as design validation, conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Performance and Safety Testing" and "Design Validation Testing" conducted. The reported device performance is that these tests were conducted and the device performed as intended and met specifications.
| Acceptance Criteria (Implied from Test Titles) | Reported Device Performance |
|---|---|
| Gauge Accuracy and Pressure Cycling Accuracy | Testing conducted; device performs as intended |
| Luer Lock Connector Dimensional Verification adherence | Testing conducted; device performs as intended |
| Chemical Compatibility | Testing conducted; device performs as intended |
| Joint Pull Strength | Testing conducted; device performs as intended |
| Device Integrity | Testing conducted; device performs as intended |
| Torque Functionality | Testing conducted; device performs as intended |
| Device Flush Particulate Levels | Testing conducted; device performs as intended |
| Biocompatibility | Testing conducted; device performs as intended |
| Syringe Packaging Integrity | Testing conducted; device specifications conform to user needs |
| Purge and Detachment of TRUFILL® DCS Detachable Coils Functionality | Testing conducted; device specifications conform to user needs |
| Purge and Detachment of TRUFILL DCS ORBIT™ Detachable Coils Functionality | Testing conducted; device specifications conform to user needs |
| Syringe Integrity | Testing conducted; device specifications conform to user needs |
| Ability to Pressurize Syringe | Testing conducted; device specifications conform to user needs |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each specific test or the data provenance (e.g., country of origin of the data, retrospective or prospective). It generally states that "in-vitro laboratory performance testing" and "in-vitro testing" were conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are in-vitro laboratory tests, which typically rely on measurement instruments and adherence to technical specifications rather than human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided. Given the nature of in-vitro engineering and performance testing, there's no mention of human adjudication methods like 2+1 or 3+1.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are in-vitro performance and design validation tests of the device itself, not studies comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical instrument (a syringe) used to manipulate medical coils. It does not involve an "algorithm" or "AI" in the context of image analysis or diagnostic support. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The tests performed are standalone in the sense that they assess the device's technical specifications and functionality independent of a human operator, but it's not an AI or algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the in-vitro tests would have been established by engineering specifications, validated measurement techniques, and established industry standards for device performance, material compatibility, and sterile processing. For example, gauge accuracy would be compared against a known standard, and dimensional verification against engineering drawings.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical medical device like the TRUFILL® DCS Syringe II.
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Page 1 of 2 CFF 10463867 Revision 02 Only the Native File to be Used
510(k) Summary of Safety and Effectiveness
| Submitter'sName/ContactPerson | Amarilys MachadoRegulatory Affairs Manager |
|---|---|
| Cordis Neurovascular, Inc.14000 N.W. 57th CourtMiami Lakes, Florida 33014786-313-6493786-313-6480 (Fax)amachad2@crdus.jnj.com | |
| October 26, 2006DEC - 7 2006 | |
| Trade Name /Common Name | The trade name is:The TRUFILL® DCS Detachable Coil System, comprised of the TRUFILL® DCSDetachable Coil and the TRUFILL® DCS Syringe or the TRUFILL® DCS Syringe IIThe TRUFILL DCS ORBIT™ Detachable Coil System, comprised of the TRUFILLDCS ORBIT™ Detachable Coil and the TRUFILL® DCS Syringe or the TRUFILL®DCS Syringe II |
| The common name for the TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable CoilSystems is: Artificial Embolization Device. | |
| Classification | These devices have been classified as Class II, per 21 CFR 882.5950 (84HCG), which havebeen classified within the Division of Cardiovascular, Respiratory, and Neurological Devices. |
| PerformanceStandard | There are no performance standards applicable under Section 514 of the Food, Drug andCosmetic Act for Artificial Embolization Devices. |
| Intended use | The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family ofDetachable Coils. |
| DeviceDescription | The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threadedplunger assembly with a locking mechanism, and a flexible high-pressure extension tube witha male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCSORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL®family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllablepressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils. |
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Page 2 of 2 CFF 10463867 Revision 02 Only the Native File to be Used
510(k) Summary of Safety and Effectiveness
Predicate Devices The predicate device is listed in the table below:
| Device | Company | ProductCode | 510(k)Number | Predicate for:(if multiplepredicates) |
|---|---|---|---|---|
| TRUFILL® DCSSyringe | Cordis Neurovascular, Inc. | HCG | K030963 | Intended Use Design Detachment Mechanism Sterilization |
Summary of Studies
The following table summarizes the in-vitro laboratory performance testing that was conducted to demonstrate the safety and effectiveness of the TRUFILL® DCS Syringe.11 and to demonstrate that the device performs as it is intended.
| Performance and Safety Testing |
|---|
| Gauge Accuracy and Pressure Cycling |
| Luer Lock Connector Dimensional Verification |
| Chemical Compatibility Testing |
| Joint Pull Test |
| Device Integrity Test |
| Torque Test |
| Device Flush Particulate Test |
| Biocompatibility Testing |
The following table summarizes the in-vitro testing that was conducted to validate the design of the TRUFILL® DCS Syringe II and to ensure that the device specifications conform to the user needs and intended use.
| Design Validation Testing |
|---|
| Syringe Packaging |
| Purge and Detachment of TRUFILL® DCS Detachable Coils |
| Purge and Detachment of TRUFILL DCS ORBIT™ Detachable Coils |
| Syringe Integrity |
| Ability to Pressurize Syringe |
Summary of Substantial Equivalence
The TRUFILL® DCS Syringe II is similar in its basic design, construction, indication for use, and performance characteristics to the predicate device, the TRUFILL® DCS Syringe.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, rendered in black. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion around the bird. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cordis Neurovascular, Inc. % Amarilys Machado Manager, Regulatory Affairs 14000 N.W. 57th Court Miami Lakes, Florida 33014
DEC - 7 2006
Re: K063254
Trade/Device Name: TRUFILL® DCS Syringe II Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: October 26, 2006 Received: October 27, 2006
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. Iisting 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 (OS) 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,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K063i2S4
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Page 1 of 1 CFF 20014 Only the Native File to be Used Intended Use Statement
Page 1 of 1
Indications for Use
510(k) Number (if known): KOG 3 2S 4
Device Name: TRUFILL® DCS Syringe II
Indications For Use:
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-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)
| (Division Sign-Off) | |
|---|---|
| -- | -------------------------------------- |
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K063254 |
|---|---|
| --------------- | --------- |
§ 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).