(27 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an implant system designed to hold an allograft in place after a laminoplasty, preventing expulsion or spinal cord impingement, rather than directly treating a disease or condition.
No
The device is an implant system designed to hold or buttress an allograft in place after a laminoplasty. Its function is structural and mechanical, not diagnostic.
No
The device description clearly states it is an implant system comprised of physical plates and screws made of Titanium/Titanium Alloy, 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 clearly states the device is for use in the lower cervical and upper thoracic spine after a laminoplasty. It is an implant used to hold or buttress an allograft in place. This is a surgical implant used directly on the patient's anatomy.
- Device Description: The description details a system of plates and screws made from Titanium/Titanium Alloy, designed to be implanted into the spine.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body.
N/A
Intended Use / Indications for Use
The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
Product codes
NQW
Device Description
The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile and or sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
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)
Testing of the Laminoplasty Plating System was performed in accordance with ASTM F2193 and F543 (static and dynamic bending and screw pull-out testing). Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
510(k) SUMMARY (as required by 21 CFR 807.92) B.
Aesculap Implant Systems Laminoplasty Plating System October 1, 2010
DEC - 2 2010
| COMPANY: | Aesculap® Implant Systems (AIS), Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle
800-258-1946 (phone)
610-791-6882 (fax) |
| TRADE NAME: | AIS Laminoplasty Plating System |
| COMMON NAME: | Appliance, Fixation, Interlaminal |
| CLASSIFICATION NAME:
REGULATION NUMBER:
PRODUCT CODE: | Orthosis, Spine, Plate, Laminoplasty, Metal
21 CFR 888.3050
NQW |
INDICATIONS FOR USE
The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
DEVICE DESCRIPTION
The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile and or sterile.
PERFORMANCE DATA
Testing of the Laminoplasty Plating System was performed in accordance with ASTM F2193 and F543 (static and dynamic bending and screw pull-out testing). Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market. No clinical testing was performed.
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems (AIS) believes that the Laminoplasty Plating System is Alooolap "In plaint to the AIS Laminoplasty Plating System (K090354) and the Synthes AFS (K032534).
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
I LoriNoLOGio in this submission, the components of the AIS Laminoplasty Plating System is shown to be substantially equivalent and has the same technological characteristics to its shown to be oubotantially comparison in design, intended use, material, function and range of sizes.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
DEC - 2 2010
:
Re: K103284
Trade/Device Name: AIS Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: November 04, 2010 Received: November 05, 2010
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
2
Page 2 - Ms. Lisa M. Boyle
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
DEC - 2 2010
K10 3284 510(k) Number:__
Device Name: Aesculap Implant Systems Laminoplasty Plating System
Indications for Use:
The Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| and/or Over-the-Counter Use | |
| (21 CFR 801 Subpart C) |
(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 Surgical, Orthopedic, and Restorative Devices
KID3284 510(k) Number_