(85 days)
Not Found
Not Found
No
The description focuses on mechanical components and their function, with no mention of AI/ML terms or data processing.
No
The device is described as being indicated for covering burr holes and for fixation of cranial bone flaps, which are structural and mechanical functions, not therapeutic. It does not treat a disease or improve a health condition.
No
The device description indicates its use for covering burr holes and fixing bone flaps, which are surgical and reconstructive functions, not diagnostic ones.
No
The device description clearly states it consists of physical components (two disks connected by a tensioned ratcheting shaft), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for covering burr holes and fixing cranial bone flaps. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical clamp designed for mechanical fixation of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
Synthes Rapid Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.
Product codes (comma separated list FDA assigned to the subject device)
GXR, HBW
Device Description
Synthes Rapid Resorbable Cranial Clamp consists of two disks connected by a tensioned ratcheting shaft. The clamps fit a range of burr holes and craniotomy gap sizes.
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
adult and pediatric populations
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. There is a line underneath the word "SYNTHES". The logo is in black and white.
510(k) Summary
3.0
SEP = 8 2004
K 041611
Page _________ of ____
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Class II, §882.5250 - Burr hole cover
Class II, §882.5360 - Cranioplasty plate fastener |
| Classification: | Title 21 CFR 882.5250: Burr Hole Cover and section 882.5360:
Cranioplasty Plate Fastener. |
| Predicate Device: | Synthes Resorbable Cranial Clamp
Biomet Lactosorb RapidFlap |
| Device Description: | Synthes Rapid Resorbable Cranial Clamp consists of two disks
connected by a tensioned ratcheting shaft. The clamps fit a range
of burr holes and craniotomy gap sizes. |
| Intended Use: | Synthes Rapid Resorbable Cranial Clamp is intended for covering
burr holes and for fixation of cranial bone flaps in adult and
pediatric populations. |
| Substantial
Equivalence: | Documentation was provided which demonstrated the Synthes
Rapid Resorbable Cranial Clamp to be substantially equivalent to
other legally marketed devices. |
| | The term "substantial equivalence" as used in this 510(k)
notification is limited to the definition of substantial equivalence
found in the Federal Food, Drug and Cosmetic Act, as amended
and as applied under 21CFR 807, Subpart E under which a device
can be marketed without premarket approval or reclassification. A
determination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matters. No
statements related to, or in support of substantial equivalence
herein shall be construed as an admission against interest under the
US Patent Laws or their application by the courts. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301
Re: K041611
Trade/Device Name: Rapid Resorbable Cranial Clamp Regulation Number: 21 CFR 882.5250, 21 CFR 882.5360 Regulation Name: Burr hole cover, Cranioplasty plate fastener Regulatory Class: II Product Code: GXR, HBW Dated: June 14, 2004 Received: June 15, 2004
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, 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.
2
Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and the FDA finding of substantial equivalence of your device to a legally promated 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) 594-4639. 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 may be obtained 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,
Sincerely yours,
Mark A. Milken
Celia M. Witten, PhD, MD Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized letter inside of a circle. There is a horizontal line underneath the word. The "R" in "SYNTHES" has a registered trademark symbol next to it.
of l Page 1
- .
2.0
Indications for Use
(041611
Rapid Resorbable Cranial Clamp
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.
Prescription Use
(Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
Jse
rt C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mulkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041611