(76 days)
Not Found
No
The device description and intended use focus on mechanical fixation using titanium implants and manual instruments, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended for the fixation of cranioplasty plates and cranial fractures, which are medical treatments for an injury or disease, thus classifying it as a therapeutic device.
No
Explanation: The device is described as a system for the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures. Its function is to hold things in place rather than to identify or analyze medical conditions.
No
The device description clearly states it consists of sterile, titanium implants (Clamps) and associated manual instruments, which are physical 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 involving the physical repair and stabilization of the skull.
- Device Description: The device is described as "sterile, titanium implants (Clamps) and associated manual instruments." These are physical devices used for mechanical fixation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the CranioFix and CranioFix2 System does not involve any testing of biological samples.
The device is a surgical implant used for structural support and fixation within the body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
Aesculap's CranioFix and CranioFix2 System are 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)
84HBW, 84GXR, 76JEY, 84GXN
Device Description
The CranioFix and CranioFix2 Clamp System consist 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 disks of the CranioFix Titanium Clamp (11mm) are solid (no drainage holes). The disks of the CranioFix Titanium Clamp (16mm and 20mm) have open areas for drainage. The CranioFix2 Titanium Clamp (11mm, 16mm, and 20mm) 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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these 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.
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
JUN 1 7 2004
Page 1 of 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
craniofix titanium clamp system
April 1, 2004
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|---------------|------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky, Regulatory Affairs Associate
800-258-1946 (phone)
610-231-3713 (fax)
kathy.racosky@aesculap.com (email) |
| TRADE NAME: | CranioFix and CranioFix2 Titanium Clamp System |
| COMMON NAME: | Cranioplasty Plate Fastener (Burr Hole Cover) |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE DEVICE | CLASSIFICATION | REVIEW PANEL | |
|---|---|---|---|
| 84HBW | Fastener, Plate, | ||
| Cranioplasty | 882.5360 | 84 Neurology | |
| 84GXR | Cover, Burr Hole | 882.5250 | 84 Neurology |
| 76JEY | Plate, Bone | 872.4760 | 76 Dental |
| 84GXN | Plate,Cranioplasty, | ||
| Preformed, Non-Altered | 882.5330 | 84 Neurology |
INTENDED USE
Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
DEVICE DESCRIPTION
The CranioFix and CranioFix2 Clamp System consist 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 disks of the CranioFix Titanium Clamp (11mm) are solid (no drainage holes). The disks of the CranioFix Titanium Clamp (16mm and 20mm) have open areas for drainage. The CranioFix2 Titanium Clamp (11mm, 16mm, and 20mm) 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.
1
PURPOSE FOR SUBMISSION
The purpose for this submission is to gain marketing clearance for additions to rne purpose for this Clamp System and the expansion to the indication for use statement for Aesculap's Titanium CranioFix Clamp System.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
The device modifications and expanded indications for use described in this premarket notification are substantially equivalent to these predicate devices:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with a flowing ribbon-like design below them. The image is in black and white.
Public Health Service
JUN 1 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K040864
Trade/Device Name: CranioFix Titanium Clamp System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: April 1, 2004 Received: April 2, 2004
Dear Ms. Racosky:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 75 ttg enactment date of the Medical Device Amendments, or to conninered prior to Milly 20, 178, in accordance with the provisions of the Federal Food, Drug, devices that have been receive approval of a premarket approval application (PMA). and Cosmetic rece (110) that to neview, subject to the general controls provisions of the Act. The r ou may, dierelere, mains of the Act include requirements for annual registration, listing of general controls pro reseries, 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 If your device is easonned (ional controls. Existing major regulations affecting your device can thay be subject to buen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ooncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTT of localites of our device complies with other requirements of the Act that 1 Dr has made a associations administered by other Federal agencies. You must or any I edetal states and states and states and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Far 607); lacemig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordinal are qualisy 351-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisang your and equivalence of your device to a legally premaired 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 If you desire specific acrice 101 ) 594-4659. Also, please note the regulation entitled, Connact the Orification of Company of Cet notification" (21CFR Part 807.97). You may obtain Misorallumg by reference to premainer stibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Marlie M Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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~ Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
040864
Device Name: CranioFix Titanium Clamp System
Indication for Use:
Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of Aesourap 3 - Oraniot xx and fixation of cranial fractures.
Prescription Use_X (per 21 CFR 801.109)
Over-the-Counter Use ________________________________________________________________________________________________________________________________________________________ or
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
l. Mark N. Milkeerson
Division of General, Restorative. and Neurological Devices
(Optional Format 3-10-98)
510(k) Number K040864