(428 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data sets for training/testing.
No.
The device's intended use is for fixation of cranial bone flaps, which is a structural and supportive function, not directly therapeutic.
No
Explanation: The device is intended for fixation of cranial bone flaps, which is a therapeutic function, not a diagnostic one. It is a physical implant, not a tool for identifying or characterizing a medical condition.
No
The device description explicitly states it consists of "two absorbable discs connected by a suture loop," which are physical components, not software.
Based on the provided information, the Aesculap PEEK CranioFix is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of cranial bone flaps." This is a surgical procedure performed in vivo (within the body) to secure bone.
- Device Description: The device consists of "two absorbable discs connected by a suture loop." This describes a physical implant used during surgery.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. The description of the PEEK CranioFix does not involve any such testing or analysis of biological samples.
Therefore, the Aesculap PEEK CranioFix is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
Product codes (comma separated list FDA assigned to the subject device)
GXR
Device Description
Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone
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. This device has been evaluated and performs in accordance with ASTM F452/ASTM F2026. The subject device was found to be similar in performance to previously cleared spinal systems with similar indications.
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
§ 882.5250 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
K091692
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
| Aesculap PEEK Craniofix |
|---|
| August 10, 2010 |
AUG 1 2 2010
Aesculap® Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
Lisa M. Bovle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
Aesculap PEEK CranioFix TRADE NAME:
Burr Hole Cover COMMON NAME:
CLASSIFICATION NAME: Cover, Burr, Hole (GXR)
REGULATION NUMBER: 882.5250
SUBSTANTIAL EQUIVALENCE
The Aesculap PEEK CranioFix as described in this premarket notification is substantially equivalent to the following predicate device:
- Aesculap Absorbable Craniofix (K040080)
DEVICE DESCRIPTION
ﺳﯿﺮ
Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop.
INDICATIONS FOR USE
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The Aesculap PEEK Craniofix has similar characteristics in design features (size, shape, function) and is considered substantially equivalent to the previously cleared predicate device on the market (K040080). The only change to the new device when compared to the predicate is a change in material.
All materials used in the manufacturing of the PEEK Craniofix are well recognized in their use as being biocompatible materials for implants and have been used in surgical procedures for many years. These materials have been accepted in previously cleared submissions.
1
091692
PERFORMANCE DATA
. . .
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. This device has been evaluated and performs in accordance with ASTM F452/ASTM F2026. The subject device was found to be similar in performance to previously cleared spinal systems with similar indications.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap®, Inc. c/o Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
AUG 1 2 2010
Re: K091692
Trade/Device Name: Aesculap PEEK CranioFix Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: June 14, 2010 Received: June 15, 2010
Dear Ms. Boyle:
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, Or to 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 misbrandi, ing and adulteration. Please note: CDRH does not evaluate information related to contractly and 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 - Ms. Lisa M. Boyle
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 af 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 elections product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
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/ucm1115800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305 Almin ase 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 tollofire no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Image /page/3/Picture/8 description: The image shows the word "for" written in cursive. The "f" is large and loops around, connecting to the "o" and "r". The writing appears to be handwritten, possibly with a pen or marker. The word is positioned on the left side of the image.
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
K091692 PEEK CranioFix
AUG 1 2 2010
INDICATIONS FOR USE STATEMENT A.
510(k) Number (if known): K091692
Device Name: PEEK CranioFix
Indication for Use:
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
Over-the-Counter Use Prescription Use or
(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
(Optional Format 3-10-98)
510(k) Number K091692
002