(27 days)
Not Found
No
The description focuses on mechanical components and their function for cranial fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an implantable system for fixation of cranioplasty plates, burr holes, and cranial fractures, which are structural repair functions, not directly involved in treating a disease or improving a bodily function beyond structural support.
No
The device, Aesculap's CranioFix 2 System, is described as titanium implants used for fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures. This is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly states it consists of sterile, titanium implants (Clamps) and associated manual instruments, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "sterile, titanium implants (Clamps) and associated manual instruments." These are physical devices used for surgical fixation.
- Anatomical Site: The anatomical site is the "cranium," which is a part of the human body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens. It is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
Product codes (comma separated list FDA assigned to the subject device)
GXN
Device Description
The CranioFix 2 Clamp System consists of sterile, titanium implants (Clamps) and associated manual instruments. The Clamps are available in three sizes: 11mm, 16mm, and 20mm. The clamp consists of two concave disks which are connected with a pin through the center. The pin is securely attached to the lower disk; the upper disk is loosely mounted onto the pin. Each disk has rows of teeth extending along the edge of the concave side. The disks are mounted onto the pin with the teeth of each one facing the teeth of the other. The CranioFix 2 Titanium Clamps have a sleeve securely attached on the end of the pin. During the fixation, the lower disk comes to rest against the inner surface of the cranium and the upper disk comes to rest against the outer surface of the cranium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
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 testing was performed to ensure that the modified device demonstrated equivalent tensile strength to the predicate CranioFix 2 device.
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.
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
K122353
Page 1 of 2
AUG 30 2012
D. SPECIAL 510(k) SUMMARY CRANIOFIX 2 TITANIUM CLAMP SYSTEM
August 3, 2012
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Denise R. Adams, Regulatory Affairs Specialist
610-984-9076(phone)
610-231-3713 (fax)
denise.adams@aesculap.com (email) |
| TRADE NAME: | CranioFix 2 Titanium Clamp System |
| COMMON NAME: | Plate, Cranioplasty, Preformed, Non-alterable |
| REGULATION: | Preformed non-alterable cranioplasty plate |
| PRODUCT CODE: | GXN |
| REGULATION: | 882.5330 |
| REVIEW PANEL: | Neurology |
INTENDED USE
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
DEVICE DESCRIPTION
The CranioFix 2 Clamp System consists of sterile, titanium implants (Clamps) and associated manual instruments. The Clamps are available in three sizes: 11mm, 16mm, and 20mm. The clamp consists of two concave disks which are connected with a pin through the center. The pin is securely attached to the lower disk; the upper disk is loosely mounted onto the pin. Each disk has rows of teeth extending along the edge of the concave side. The disks are mounted onto the pin with the teeth of each one facing the teeth of the other. The CranioFix 2 Titanium Clamps have a sleeve securely attached on the end of the pin. During the fixation, the lower disk comes to rest against the inner surface of the cranium and the upper disk comes to rest against the outer surface of the cranium.
TECHNOLOGICAL CHARACTERISTICS (Compared to Predicate)
The CranioFix 2 Clamp System has the same form, function, and material composition as the predicate CranioFix 2 Clamp System. Several minor modifications were made to the design of the device in order to enhance securement of the top disc and for manufacturability purposes.
1
PURPOSE FOR SUBMISSION
The purpose for this special 510(k) submission is to gain marketing clearance for minor modifications to Aesculap's CranioFix 2 Clamp System.
PERFORMANCE DATA
Mechanical testing was performed to ensure that the modified device demonstrated equivalent tensile strength to the predicate CranioFix 2 device.
SUBSTANTIAL EQUIVALENCE
Risk analysis and performance testing demonstrate that the device modifications described in this premarket notification do not raise new questions of safety or effectiveness and therefore are substantially equivalent to the predicate device:
Aesculap CranioFix and CranioFix 2 Titanium Clamp System cleared via K040864.
2
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 depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap, Inc. c/o Ms. Denise R. Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
AUG 300 2012
Re: K122353
Trade/Device Name: CranioFix 2 Titanium Clamp System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: August 3, 2012 Received: August 3, 2012
Dear Ms. Adams:
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. 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
3
Page 2 - Ms. Denise Adams
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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.
http://www.fda.gov/MedicalDevices/ResourcestorYourIndustry/default.htm.
Sincerely vours.
Kesia Alexander
Malvina B. Eydelman, 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
A. INDICATIONS FOR USE STATEMENT
K122353 510(k) Number (if known):
Device Name: CranioFix 2 Titanium Clamp System
Indication for Use:
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
. Or
Prescription Use X
Over-the-Counter Use
(Per 21 CFR 801.109)
(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 Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K122353