(87 days)
Not Found
Not Found
No
The summary describes a mechanical device for cranial fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for mechanical fixation of bone flaps and covering burr holes, which are structural and surgical support functions, not directly involved in treating a disease or condition.
No
The device is described as a clamp intended for covering burr holes and fixation of cranial bone flaps, which is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it consists of physical components (two disks, ratcheting shaft, optional spacer), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Synthes Resorbable Cranial Clamps are intended for "covering burr holes and for fixation of cranial bone flaps." This is a surgical device used directly on the patient's body during a procedure, not for testing samples outside the body.
The information provided about the device's function and application directly contradicts the definition of an IVD.
N/A
Intended Use / Indications for Use
Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.
Product codes (comma separated list FDA assigned to the subject device)
GXR
Device Description
Resorbable Cranial Clamps consist of two disks connected by a ratcheting shaft with an available optional spacer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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.
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).
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Page 1 of 1
'JUL 2 9 2002
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 ext. 7191
Contact: Matthew M. Hull |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Resorbable Cranial Clamps |
| CLASSIFICATION: | Class II, 21 CFR 882.5250: Burr Hole Cover and 882.5360: Cranioplasty
Plate Fastener. |
| PREDICATE DEVICE: | Documentation was provided which demonstrated the Synthes Resorbable
Cranial Clamp to be substantially equivalent to other legally marketed
devices. |
| DEVICE DESCRIPTION: | Resorbable Cranial Clamps consist of two disks connected by a ratcheting
shaft with an available optional spacer. |
| INTENDED USE: | Resorbable Cranial Clamps are intended for covering burr holes and for
fixation of cranial bone flaps. |
| MATERIAL: | Poly(L/DL-lactide) |
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K021408
Trade/Device Name: Synthes Resorbable Cranial Clamps Regulation Number: 882.5250 and 882.5360 Regulation Name: Burr Hole Cover and Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: GXR Dated: May 2, 2002 Received: May 3, 2002
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.
2
Page 2 - Mr. Matthew M. Hull, RAC
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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 vours.
R. Mark N. Millikan
elia 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
3
2.0 Indications for Use Statement
510(k) Number (if known):
Device Name: Resorbable Cranial Clamps
Indications for Use:
Synthes Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use NB
L. Mark N. Millman
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021408
Confidential