(72 days)
Synthes Resorbable Cranial Clamp, Medtronic INVISx Lock System
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device is described as a clamp intended for covering burr holes and fixation of cranial bone flaps, which are structural and reparative functions rather than therapeutic ones aimed at treating a disease or disorder.
No
The device description states its purpose is for "covering burr holes and for fixation of cranial bone flaps," which are structural and mechanical functions, not diagnostic.
No
The device description clearly indicates it is a physical clamp consisting of disks and a shaft, 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 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 used for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
Synthes Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps.
Product codes
GXR, HBW
Device Description
Synthes 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
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)
Synthes Resorbable Cranial Clamp, Medtronic INVISx Lock System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG - 8 2003
page 1 of 1
3. 510(k) Summary
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name: | Synthes Resorbable Cranial Clamp, (modified) |
| Classification: | Class II, §882.5250 ">– Burr hole cover
Class II, §882.5360 – Cranioplasty plate fastener |
| Intended use: | Synthes Resorbable Cranial Clamp is intended for covering burr
holes and for fixation of cranial bone flaps. |
| Predicate device: | Synthes Resorbable Cranial Clamp
Medtronic INVISx Lock System |
| Device description: | Synthes 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. |
| Material: | Poly (L/DL-lactide) |
10005
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal 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
AUG - 8 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K031654
Trade/Device Name: Synthes Resorbable Cranial Clamp (Modified) Regulation Number: 21 CFR 882.5250 and 882.5360 Regulation Name: Burr hole cover and Cranioplasty plate fastener Regulatory Class: II Product Code: GXR and HBW Dated: May 23, 2003 Received: May 28, 2003
Dear Ms. Smith:
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. Bonnie J. Smith
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 yours.
Miriam C. Provost
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
3
Inclications for Use Statement 2.
Page __ 1_____________________________________________________________________________________________________________________________________________________________________
51(k) Number (if known):
Device Name:
Synthes Resorbable Cranial Clamp, (modified)
Indications for Use:
Synthes Resorbable Cranial Clamp is intended for covering burr holes and for fixation of cranial bone flaps.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031654
(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 No
00004
Pre market Notification 510(k) Synthes Resorbable Cranial Clamp (modified)