(76 days)
Not Found
No
The summary describes a physical implantable device for bone fixation and contains no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as being for "fixation of cranial bone flaps," which is a structural or supportive function, not one intended to treat or ameliorate a disease or condition.
No
The device is described as an "Absorbable CranioFix" intended for "fixation of cranial bone flaps." Its purpose is to physically secure bone, not to identify or diagnose a 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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of cranial bone flaps." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device consists of "absorbable discs connected by a suture loop." This is a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The description of the Absorbable CranioFix does not involve any such testing or analysis of specimens.
Therefore, the Aesculap Absorbable CranioFix is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.
Product codes (comma separated list FDA assigned to the subject device)
HBW, GXR
Device Description
Aesculap's Absorbable 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)
Not Found
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.
Synthes Resorbable Cranial Clamp (modified) (K031654), Synthes Resorbable Cranial Clamp (K021408 and K031654), MacroPore CraniLoc NS (K002334)
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
MAR 3 1 2004
K040080 Paige
Absorbable CranioFix
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull, Regulatory Affairs Manager
800-258-1946 (phone)
610-791-6882 (fax)
matt.hull@aesculap.com (email) |
| TRADE NAME: | Aesculap Absorbable CranioFix |
| COMMON NAME: | Cranioplasty plate fastener |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE:
REGULATION: | HBW
882 5360 |
REVIEW PANEL: Neurology
INTENDED USE
Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.
DEVICE DESCRIPTION
Aesculap's Absorbable CranioFix consists of two absorbable discs connected by a suture loop.
PURPOSE FOR SUBMISSION
The purpose for this submission is to gain marketing clearance for the Aesculap Absorbable CranioFix.
PERFORMANCE STANDARDS
No performance standards have been promulgated under Section 514 of the Food, Druq and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
The Aesculap Absorbable CranioFix as described in this premarket notification is substantially equivalent to these predicate devices:
- Synthes Resorbable Cranial Clamp (modified) (K031654) .
- Synthes Resorbable Cranial Clamp (K021408 and K031654) .
- MacroPore CraniLoc NS (K002334) ◆
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2004
Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K040080
Trade/Device Name: Aesculap Absorbable CranioFix Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: II Product Code: GXR Dated: January 14, 2004 Received: January 15, 2004
Dear Mr. Hull:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
b. Mark N. Mellman
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Absorbable CranioFix
X
Indication for Use:
Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.
or
Prescription Use
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)
Mule N Milken
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
(Optional Format 3-10-98)
510(k) Number K040080
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