(19 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, the Synthes Low Profile Neuro System, is described as a system for use in various surgical procedures on the midface and craniofacial skeleton, maxilla, and chin. Its components include burr hole covers and screws, which are used to stabilize bones or cover defects after surgical intervention or trauma. It is not intended to treat or cure a disease or condition, but rather to aid in surgical repair and reconstruction.
No
Explanation: The device is described as a surgical system (implants like burr hole covers and screws) used for reconstruction and repair of the craniofacial skeleton, not for diagnosing conditions.
No
The device description clearly describes physical components (burr hole covers, plates, screws) and their intended use in surgical procedures, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures involving the midface and craniofacial skeleton. This is a direct surgical intervention on the body.
- Device Description: The device is described as burr hole covers and screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to be implanted or used directly in surgical procedures on the body.
N/A
Intended Use / Indications for Use
The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes Cranial Plates are intended for use in selective trauma of the midface and The Synthes Cranial Plates are intended for use in sersen of selective orthognathic surgery of the maxilla and chin.
Product codes
GXR, HRS
Device Description
The Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping & self-drilling screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface and craniofacial skeleton; maxilla and chin
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 Low Profile Neuro 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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A long, thin black line runs underneath the word and logo, stretching across the majority of the image.
510(k) Summary
3.0
:
NOV 17 2004
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Low Profile Neuro System |
| Classification: | 21 CFR 882.5250: Cover, Burr Hole |
| Predicate Devices: | Synthes Low Profile Neuro System |
| Device Description: | The Synthes 1.6 mm burr hole covers come in various sizes to
accommodate various fracture and osteotomy sites, have a low
plate/screw head profile and use existing (previously cleared) 1.6
mm or 1.9 mm emergency self-tapping & self-drilling screws. |
| Intended Use: | The Synthes Low Profile Neuro System is intended for use in
selective trauma of the midface and craniofacial skeleton;
craniofacial surgery; reconstructive procedures; and selective
orthognathic surgery of the maxilla and chin. |
| Substantial
Equivalence: | Comparative information presented supports substantial
equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2004
Ms. Lisa Boyle Regulatory Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042986
Trade/Device Name: Synthes (USA) Low Profile Neuro System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: II Product Code: GXR, HRS Dated: October 28, 2004 Received: October 29, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn o re(s) presses is substantially equivalent (for the indications relerenced above and nave decembers and a marketed predicate devices marketed in interstate for use stated in the encrosure) to regard to the Medical Device Amendments, or 10 commerce provision to May 20, 1976, the enaounce with the provisions of the Federal Food, Drug. devices that have been recidisention in acceraapproval of a premarket approval application (PMA). allo Cosmetic Act (1101) that do novice, subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (see above) and existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the over concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I DTT of ibstantes over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it call 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 CI IC Far 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Lisa Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yours over finding of substantial equivalence of your device to a legally promative headler 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 ir you usen of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoraliding of Yelerenes to pur responsibilities under the Act from the Division of Small other general informational 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,
Mark A. Milkeum
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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2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Low Profile Neuro System
Indications for Use:
The Synthes Cranial Plates are intended for use in selective trauma of the midface and The Synthes Cranial Plates are intended for use in sersen of selective orthognathic surgery of the maxilla and chin.
Prescription Use_ X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mullens
Same Division of General, Restorative, and Neurological Devices
510(k) Number K04298
0004