(175 days)
The Cranial LOOP Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.
The Cranial LOOP Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use.
The provided text describes a 510(k) premarket notification for the "Cranial LOOP Cranial Bone Fixation System". It outlines the device's intended use, technological comparison to predicate devices, and a general statement about performance testing. However, it does not contain the specific details required to complete your request, particularly regarding acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The document states: "Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices." This is a summary statement, not the detailed study information you're asking for.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth determination based solely on the provided text.
The closest I can get to addressing your points, based on the limited information, is:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document broadly implies that the device must "perform as intended" and be "substantially equivalent to the predicate devices."
- Reported Device Performance: Not explicitly quantified in the provided text. The document states that "Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices."
The remaining points (2-9) require detailed study information that is not present in the provided 510(k) summary document. This document focuses on the regulatory submission, intended use, and substantial equivalence claim, rather than the raw data or detailed methodology of the performance studies.
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Section 5: 510(k) Summary
OCT 2 5 2010
The following information is provided as required by 21 CFR § 807.87 for the Cranial LOOP Cranial Bone Fixation System (Cranial LOOP) 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
Sponsor: Neos Surgery S.L. Parc Tecnològic del Vallès C/Ceramistes, 2 (08290) Cerdanyola del Vallès Barcelona, Spain
Contact: Marcos Velez-Duran M Squared Associates, Inc. 901 King Street, Suite 200 Alexandria, VA 22314 Ph: 703-562-9800 Ext 206 Fax: 703-562-9797 Email: mvelez-duran@msquaredassociates.com
Date of Submission: April 30, 2010
| Proprietary Name: | Cranial LOOP Cranial Bone Fixation System |
|---|---|
| Common Name: | cranial fixation device |
| Regulatory Class: | 882.5250 Burr hole cover, 882.5330 Preformed. nonalterablecranioplasty plate |
| Product Codes: | GXR, GXN |
Predicate Device(s): INVISx-K010361, CranioFix- K040080, CranioFix Titanium-K972332
Device Description: The Cranial LOOP Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use.
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Intended Use: The Cranial Loop Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.
Discussion of performance testing: Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices.
Technological comparison: The claim of substantial equivalence of the Cranial Loop to the predicate devices is based on the comparison of the intended use, product technical characteristics, performance characteristics and product handling.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Neos Surgery, S.L. % Mr. Marcos Velez-Duran President M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, VA 22314
· OCT 2 5 2010
Re: K101235
Trade/Device Name: Cranial LOOP Cranial Bone Fixation System . Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: September 29, 2010 Received: October 1, 2010
Dear Mr. Velez-Duran:
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.
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Page 2 - Mr. Velez-Duran
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 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 vou 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,
Keora Alexander
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Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OCT 2 5 2010
Section 4: Indications for Use Statement
510(k) Number: . To be assigned K / 0 / 2 35
Cranial LOOP Cranial Bone Fixation System Device Name:
Indications for Use: The Cranial LOOP Cranial Bone Fixation System is a long-
term implantable device indicated for post-craniotomy bone flap fixation.
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)
Ruanal
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101235
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§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).