(207 days)
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No
The device description and intended use describe a mechanical clamp system and associated instruments, with no mention of software, data processing, or AI/ML terms.
No
The device is used for refixation of cranial bone flaps after craniotomy, which is a structural support function rather than a therapeutic one (e.g., treating a disease or condition).
No
The device is described as an implantable titanium clamp system used for refixation of cranial bone flaps after craniotomy, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of a sterile, titanium implant (CRANIOFIX Clamp) and associated nonpowered neurosurgical 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 "refixation of cranial bone flaps after craniotomy." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "sterile, titanium implant (CRANIOFIX Clamp) and associated nonpowered neurosurgical instruments." These are physical devices used in surgery.
- 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 system does not involve any testing of samples.
Therefore, the CRANIOFIX Titanium Clamp System is a surgical implant and instrument system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Aesculap's CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.
Product codes (comma separated list FDA assigned to the subject device)
GXN
Device Description
The CRANIOFIX Titanium Clamp System consists of a sterile, titanium implant (CRANIOFIX Clamp) and associated nonpowered neurosurgical instruments. The CRANIOFIX Titanium Clamp (FF100T) consists of two 10mm 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. During the craniotomy refixation, the lower disk comes to rest against the inner surface of the cranium and the bone plug. The upper disk comes to rest against the outer portion of the cranium and bone plug.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cranial bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/0 description: The image shows the word "AESCULAP" in bold, capital letters, with a medical symbol to the left of the word. Above the word is the number "K972332" in handwritten font. Below the word is the date "JAN 1 6 1998".
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aesculap CRANIOFIX Titanium Clamp System
October 16, 1997
Submitted by:
Aesculap®, Inc. 100u Gatewav Divu. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (650) 876-7000 x348 FAX: (650) 589-3007
Aesculap CRANIOFIX Titanium Clamp System Product: Burr Hole Cover and Associated Common Names: Nonpowered neurosurgical instruments
Intended Use
Aesculap's CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.
Device Description
The CRANIOFIX Titanium Clamp System consists of a sterile, titanium implant (CRANIOFIX Clamp) and associated nonpowered neurosurgical instruments. The CRANIOFIX Titanium Clamp (FF100T) consists of two 10mm 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. During the craniotomy refixation, the lower disk comes to rest against the inner surface of the cranium and the bone plug. The upper disk comes to rest against the outer portion of the cranium and bone plug.
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Technological Characteristics
The CRANIOFIX Titanium Clamp presses the bone cover and the vault of the cranium between the two disks. The implant is fixed to the cranium by means of special CRANIOFIX nonpowered neurosurgical instrument. It shares similar technological characteristics with titanium mini-plates which are attached to the cranium with bone screws. The main difference between CRANIOFIX and the comparative devices is the means of application.
Performance Standards
No applicable performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. However, the CRANIOFIX Titanium Clamp System will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.
Substantial Equivalence
Aesculap's CRANIOFIX Titanium Clamp System shares similar features and function with corresponding devices distributed by:
- Aesculap ●
- . KLS Martin
- Leibinger .
- Zimmer .
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 16 1998
Ms. Mary Ellen Holden ·Regulatory Compliance Associate Aesculap, Inc. 1000 Gateway Boulevard 94080-7030 South San Francisco, California
K972332 Re: Aesculap CranioFix Titanium Clamp System Regulatory Class: II Product Code: GXN Dated: October 16, 1997 October 20, 1997 Received:
Dear Ms. Holden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with_____ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Mary Ellen Holden
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if known): K972332
Device Name:
Aesculap CRANIOFIX Titanium Clamp System. *
Indication for Use:
. .
Aesculap's CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.
(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 General Restorative Devices | |
| 510(k) Number | K972332 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
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