(86 days)
Not Found
No
The device description and intended use focus on mechanical fixation components (staples and screws) and do not mention any software, algorithms, or data processing capabilities that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as an "anterior vertebral body staple" and an "anterior spinal staple system" intended for "anterior vertebral body fixation to the T3-L5 spine," which indicates a therapeutic purpose.
No
The device is described as an "Anterior Spinal Staple System" intended for "anterior vertebral body fixation to the T3-L5 spine," which is a treatment or surgical device, not one for diagnosing conditions.
No
The device description explicitly states the staples are manufactured from Titanium alloy, indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Encore Anterior Spinal Staple System is a physical implant designed for surgical fixation of the spine. It is used in the body, not to test samples from the body.
- Intended Use: The intended use is for "anterior vertebral body fixation," which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Encore Anterior Spinal Staple System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Encore Anterior Spinal Staple System is intended for anterior vertebral body fixation to the T3-L5 spine. This system is indicated to be used with an anterior spinal system that consists of screws that are between 6.0 and 6.5mm diameter manufactured out of Ti alloy.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The anterior vertebral body staple is designed to work in conjunction with the any existing spinal fixation systems utilizing 6.0mm to 6.5mm titanium screws. The staples are manufactured from Titanium alloy and are available as a single or double staple. The single staple has one hole for screw fixation with a 6.0mm -6.5mm titanium screws. The double staples are designed in pairs with specific superior and inferior components. Each has two screw holes allowing screws to pass through at a converging angle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T3-L5 spine
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K030667 p'/%
| MAY 28 2003 |
|---|
| ------------- |
510(k) Summary of Safety and Effectiveness
-
Submitter's name: (1) Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Debbie De Los Santos February 19, 2003 -
Encore Anterior Spinal Staple System Trade or proprietary device name: Anterior Spinal Staple System Common or usual name: 888.3060 - Spinal Intervertebral Body Classification name: Fixation Orthosis
-
Predicate devices: (3)
(2)
AcroMed KASS (K974757) Blackstone Medical (K022605)
Subject device description: (4)
The anterior vertebral body staple is designed to work in conjunction with the any existing spinal fixation systems utilizing 6.0mm to 6.5mm titanium screws. The staples are manufactured from Titanium alloy and are available as a single or double staple. The single staple has one hole for screw fixation with a 6.0mm -6.5mm titanium screws. The double staples are designed in pairs with specific superior and inferior components. Each has two screw holes allowing screws to pass through at a converging angle.
(5) Subiect device intended use:
The Encore Anterior Spinal Staple System is intended for anterior vertebral body fixation to the T3-L5 spine. This system is indicated to be used with an anterior spinal system that consists of screws that are between 6.0 and 6.5mm diameter manufactured out of Ti alloy.
(6) Basis for Substantial Equivalence:
The Encore Anterior Spinal Staple System is similar in design, indications and materials to AcroMed's Kaneda Anterior Spinal System (K974757) and Blackstone Spinal Fixation System (K022605).
MAY 28 2003
DR
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service" in bold, black font. The text is horizontally oriented and appears to be a title or heading. The background is plain white, providing a clear contrast for the text.
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
MAY 28 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debbie De Los Santos Supervisor, Regulatory/OA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
Re: K030667
Trade Name: Encore Anterior Spinal Staple System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 28, 2003 Received: March 3, 2003
Dear Ms. De Los Santos:
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. Debbie De Los Santos
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), 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 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,
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
KO306 510(k) Number (if known):
Encore Anterior Spinal Staple System Device Name: _
Indications For Use:
Encore Anterior Spinal Staple System Indications For Use
The Encore Anterior Spinal Staple System is intended for anterior vertebral body fixation to the T3-L5 spine. This system is indicated to be used with an anterior spinal system that consists of screws that are between 6.0 and 6.5mm diameter manufactured out of Ti alloy.
(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 (Optional Format 1-2-96)
for Mark N. Melkerson
Division Sign Off
on of General, Restorative and Neurological Devices
510(k) Number K030667