(19 days)
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The additional component that is the subject of this Special 510(k) submission is the PASS Spinal System Sacral Plate. It has the same polyaxial mechanism as the polyaxial screws cleared in K001024. The difference is that the plate is attached by two additional screws rather than directly to the vertebrae.
The provided text describes a Special 510(k) submission for the PASS Spinal System Sacral Plate, not a study evaluating device performance against acceptance criteria using AI. The document is a regulatory approval letter based on "substantial equivalence" to a predicate device, not on performance data from a clinical or technical study.
Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document as it does not contain such a study.
The relevant sections state:
- "(6) Performance data: The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems."
- "(7) Basis for substantial equivalence: The PASS Spinal System Sacral Plate is similar in design, materials and indications to the PASS Spinal System (K001024)."
This indicates that the approval was granted based on the device's similarity to an existing legally marketed device, not on meeting specific performance criteria through a new study.
{0}------------------------------------------------
JUL 3 1 2001
Class II
16012175
| (1) | Submitter's name: | Encore Orthopedics, Inc. |
|---|---|---|
| Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 | |
| Submitter's telephone number: | (512) 834-6255 | |
| Contact person: | Joanna Droege | |
| Date summary prepared: | July 10, 2001 | |
| (2) | Trade or proprietary device name: | PASS Spinal System |
| Common or usual name: | Pedicle screw spinal system |
- PASS Spinal System (K001024) Legally marketed predicate device: (3)
Subject device description: (4)
Classification name:
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The additional component that is the subject of this Special 510(k) submission is the PASS Spinal System Sacral Plate. It has the same polyaxial mechanism as the polyaxial screws cleared in K001024. The difference is that the plate is attached by two additional screws rather than directly to the vertebrae.
Subject device intended use: (5)
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
(6) Performance data:
The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems.
Basis for substantial equivalence: (7)
The PASS Spinal System Sacral Plate is similar in design, materials and indications to the PASS Spinal System (K001024).
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center is an emblem that resembles a stylized bird or eagle with three wing-like extensions above its head. The emblem is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2001
Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
K012175 Re: Trade Name: PASS Spinal System Sacral Plate Regulatory Class: II Product Code: MNI Dated: July 10, 2001 Received: July 12, 2001
Dear Ms. Droege:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 encededience with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Fecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Marufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
{2}------------------------------------------------
Page 2 - Ms. Joanna Droege
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your de rice of our accessions of compliance at a additionally 809.10 for in Vito diagnostic as on the promotion and advertising of your device, (301) 594-4659. Additionally, for questions on the presence the regulation please contact the Office of Comphanee at (301) 37 - 1 - 1 CFF 807.97). Other general entitled, "Misoranding by releveloc to pearlies Act may be obtained from the Division of Small miormation on your responsionnes ander uner (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
K0/2175
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PASS Spinal System
Indications For Use:
PASS Spinal System
Indications For Use
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members THE PROD Spinal bywenner and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, Spondylonoussis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended for the treatment of ris a pource better byth (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
(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)
OR
//
tuur
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012175
N/A