(175 days)
Not Found
No
The summary describes a mechanical bone fixation system and does not mention any AI or ML components or functionalities.
No
Explanation: The device is a bone fixation system for post-craniotomy bone flaps, which is a supportive and structural device rather than one that treats or cures a disease or condition. It is intended to fix a bone flap, not to provide therapy.
No
The device is a fixation system used post-craniotomy to secure bone flaps, not to diagnose medical conditions. Its function is purely mechanical.
No
The device description clearly states it is a "long-term implantable device" and a "biocompatible, postoperative cranial bone fixation system," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "post-craniotomy bone flap fixation." This describes a surgical procedure to fix a bone flap to the skull, which is a direct treatment or repair of a physical structure within the body.
- Device Description: The device is described as a "long-term implantable device" and a "cranial bone fixation system." This further reinforces its role as a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens for diagnostic purposes.
Therefore, the Cranial LOOP Cranial Bone Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cranial Loop Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.
Product codes (comma separated list FDA assigned to the subject device)
GXR, GXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone/skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
INVISx-K010361, CranioFix- K040080, CranioFix Titanium-K972332
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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. nonalterable |
| cranioplasty 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.
Page 10 of 46
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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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized representation of human figures, symbolizing the department's focus on health and human well-being.
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.
3
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
Image /page/3/Picture/7 description: The image shows the word "for" written in cursive. The word is written in black ink on a white background. The letter "f" is tall and slender, and the letters "o" and "r" are smaller and rounder. The word is slightly tilted to the right.
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
4
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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