(30 days)
The Retracta" Detachable Embolization Coil is intended for arterial and venous embolization in the peripheral vasculature.
The Retracta." Detachable Embolization: Coil consists of a fibered embolization coil constructed of platinum and a detachable delivery system. The implant consists of coiled wire and synthetic fibers which increase thrombogenesis. Embolization fibers are spaced along the coil until nearly the proximal tip. The fibers extend perpendicular to the long axis of the coil. Once deployed, the coil forms a curl, which varies in curl diameter and spacing. The embolization coil is delivered to the vasculature by means of a coll delivery wire.
The provided text describes a 510(k) submission for the Retracta" Detachable Embolization Coil. This submission focuses on demonstrating substantial equivalence to predicate devices through technical and performance testing, not on clinical effectiveness studies involving human readers or sophisticated AI algorithms. Therefore, much of the requested information regarding AI performance, human expert evaluation, and MRMC studies is not applicable to this document.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Tensile Testing | Met all predetermined acceptance criteria (delivery system tensile strength during proper clinical use). |
| Device Migration Testing | Met predetermined acceptance criteria (devices should not migrate or perforate vessels during proper clinical use). |
| Load to Retract Testing | Met predetermined acceptance criteria (load to retract coil into delivery system after deployment was less than 4 Newtons under normal clinical use). |
| Corrosion Testing | Demonstrated sufficient resistance to corrosion. |
| MRI Testing | Verified for MR conditional compatibility with applicable parameters listed in Instructions for Use. |
| Radiopacity Comparison Testing | Platinum coils (device material) have the highest visibility compared to other metallic coils. |
| Biocompatibility Testing | Met the predetermined acceptance criteria in conformance with applicable sections of ISO 10993-1. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of units tested) for each of the performance tests. The data provenance is not explicitly mentioned, but as this is a device submitted to the FDA, it is presumed to be laboratory testing conducted by the manufacturer (Cook Incorporated, based in Bloomington, IN, USA) to U.S. regulatory standards. These are retrospective engineering/bench tests, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. The tests performed are engineering and material science tests (tensile strength, biocompatibility, corrosion, etc.) and do not require expert human interpretation of medical images or conditions to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. The tests are objective, quantifiable measurements against predetermined engineering specifications, not evaluations requiring adjudication by multiple human experts.
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
This information is not applicable. This submission is for a physical medical device (embolization coil), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests was defined by predetermined acceptance criteria based on regulatory guidance (FDA Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (2004)) and industry standards (e.g., ISO 10993-1 for biocompatibility). These criteria are objective, measurable thresholds for physical properties and performance characteristics.
8. The sample size for the training set
This information is not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" for such a device would be the design and manufacturing process iterative improvements.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set in the context of AI, there's no ground truth established for one. The "ground truth" for the device design would be established through engineering principles, material science, and adherence to performance specifications derived from regulatory and clinical needs.
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510(k) SUMMARY
Submitted By:
Jennifer Richardson, MA Cook Incorporated 750 Daniels Way Bloomington. IN 47404
Device:
Trade Name: Proposed Classification:
Retracta" Detachable Embolization Coil Device. Vascular, For Promoting Embolization KRD (21 CFR §870.3300)
Indications for Use:
Retracta Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
Predicate Device:
The Retracta Detachable Embolization Coil is identical in terms of intended use, and similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate devices. The device, subject of this submission, is substantially equivalent to the MReye Flipper® Detachable Embolization Coils and the Detach 11 and Detach 18" Embolization Coils cleared under 510(k) numbers K063619 and K992121. respectively.
Comparison to Predicate Device:
It has been demonstrated that the Retracta" Detachable Embolization Coil is comparable to the predicate devices. The predicate devices and the device subject of this submission are all intended for arterial and venous embolization in the peripheral vasculature. The predicate and proposed devices consist of a fibered metallic implant that causes embolization by mechanically obstructing the vessel and causing thrombogenesis. The predicate devices and proposed devices have delivery wires that detach from the embolization coils via a screw-like mechanism.
Device Description:
The Retracta." Detachable Embolization: Coil consists of a fibered embolization coil constructed of platinum and a detachable delivery system. The implant consists of coiled wire and synthetic fibers which increase thrombogenesis. Embolization fibers are spaced along the coil until nearly the proximal tip. The fibers extend perpendicular to the long axis of the coil. Once deployed, the coil forms a curl, which varies in curl diameter and
JAN 0 3 2013
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spacing. The embolization coil is delivered to the vasculature by means of a coll delivery wire.
Test Data:
The following tests were performed to satisfy the FDA Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (2004) and to demonstrate that the Retracta" Detachable Embolization Coil meets applicable design and performance requirements and supports a determination of substantial equivalence.
- · Tensile Testing Testing shows the tensile strength during proper clinical use should not fracture the delivery system. Testing demonstrated that the delivery system met all predetermined acceptance criteria.
- 트 Device Migration Testing - Testing shows that during proper clinical use devices should not migrate or perforate vessels. Testing demonstrated that the device met' the predetermined acceptance criteria.
- . # : Load to Retract Testing - Testing shows that under normal clinical use of the device the load to retract the coil into the delivery system after deployment was less than 4 Newtons. The device met the predetermined acceptance criteria.
- Corrosion Testing - The device demonstrated sufficient resistance to corrosion.
- 트, MRI Testing - MRI testing verifies that the implant will be marked as MR conditional with the applicable parameters listed in the Instructions for Use.
- 트 Radiopacity Comparison Testing - Platinum coils have the highest visibility in radiopacity testing when compared with other metallic coils.
- Biocompatibility Testing Testing shows the device is biocompatible. In : M conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated c/o Ms. Jennifer Richardson, MA Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
JAN 0 3 2013
Re: K123712
Trade/Device Name: RetractaTM Detachable Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: December 03, 2012 Received: December 04, 2012
Dear Ms. Richardson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Jennifer Richardson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K123712 · 510(k) Number (if known):
Device Name: Retracta™ Detachable Embolization Coil
Indications for Use for the Retracta™ Detachable Embolization Coil:
The Retracta" Detachable Embolization Coil is intended for arterial and venous embolization in the peripheral vasculature.
Prescription Use XX (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
123712
CMA Killebrew
510(k) Number
(Division Sign-Off) Division of Cardiovascular Devices
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).