(90 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 spines: 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.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the PASS Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis), tumor, pseudarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The polyaxial crosslink components are manufactured from titanium alloy per ASTM F136.
The hooks can be used for single or multiple level fixation. The polyaxial hooks have the same attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.
The laminar hooks are inserted inferior and superior around the pedicles. The hooks are available in standard and double lamination with a superior offset. The double lamination hooks can be inserted inferior and superior around the pedicles with a pedicle screw assembly without any problem of superimposition.
The laminar hooks are inserted under the lamina and the polyaxial hooks are inserted under the pedicle. The polyaxial hooks are available from 0 to 30 degrees and the double lamination hooks can be inserted under the lamina with a pedicle screw assembly without any problem of superimposition.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Encore Orthopedics PASS Spinal System, formatted to answer your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., minimum tensile strength, fatigue life cycles) or their corresponding reported device performance values. Instead, it indicates that the device's performance was evaluated against a standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ASTM F1717-96 Standards | The performance claims of the PASS Spinal System was performed according to ASTM F1717-96. |
Note: ASTM F1717-96 is a standard specification for spinal implant constructs in vitro static and fatigue testing. This implies that the device's performance was found to be within the acceptable parameters defined by this standard, though the specific numerical results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "The performance claims of the PASS Spinal System was performed according to ASTM F1717-96." This standard outlines methods for in vitro testing of spinal implant constructs, which typically involves a specified number of samples for static and fatigue tests, but the exact number used in this specific study is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data for human or retrospective/prospective studies. The testing was in vitro (laboratory-based) according to an ASTM standard, not derived from human patients or clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to an in vitro mechanical performance study. "Ground truth" in this context would refer to the physical and mechanical properties of the device, established through standardized testing procedures, not through expert consensus or clinical evaluation.
4. Adjudication Method for the Test Set
This question is not applicable, as the study described is an in vitro mechanical performance test, not a clinical study requiring human adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The provided document describes the mechanical performance testing of an orthopedic implant (PASS Spinal System), not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The product is a physical spinal implant system, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for this mechanical study is the physical properties and mechanical integrity of the spinal system components, as determined by standardized in vitro testing methods outlined in ASTM F1717-96. The "truth" is whether the device meets the mechanical performance requirements specified by that standard (e.g., in terms of bending stiffness, torsional stiffness, fatigue life).
8. The Sample Size for the Training Set
This question is not applicable. There is no mention of a "training set" as this is a mechanical performance study of a physical device, not a machine learning or AI model development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as no training set was used.
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510(k) Summary of Safety and Effectiveness
| (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: | October 16, 2001 |
Class II
K01342
page lotl
- PASS Spinal System Trade or proprietary device name: (2) Pedicle screw spinal system Common or usual name: Spinal interlaminal fixation orthosis
JAN 1 5 2002
Classification name:
(3)
- PASS Spinal System (K001024) Legally marketed predicate device:
Subject device description: (4)
The subjects of this submission of polyaxial crossink components for the PASS Spinal System The subjects of this submission are the adultor of poyaxial orosinisher from the morney to ASTM F136.
The hooks can be used for single or multiple level fixation. The polyaxial hooks have the same attachment The nooks can be used for Single of multiple forer maniforners of any and K012175.
mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.
The laminar hooks are inserted inferior and superior around the looks are available hooks are available in standard and The laminar nooks are inseried the superior and superior the same of a superior with a mandard and inserted interior and superior around the pedicies. "The dodble lamination with a pedicle screw assembly without any problem of superimposition.
The laminar hooks are inserted under the lamina and the polyaxial pooks are inserted under the pedicle The laminar hooks are inserted under the lamina and the poyable from and the world and problem of superimposition.
Subject device intended use: (5)
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide Ine PA55 Spinal System Consists of pedice Sorows, Foatsite as an adjunct to husion in the immobilization and stablication of spirant in thoreculty in thorean , lumbar, and sacral spines treatment of the following acule and circuities of doloriment, 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 spondyloilshesian by arth As a pedicies screw system, the PASS Spiral Oystering fusion by autogenous bone graft (Grade 3 and 4) of the LS-ST vellebrae in skeletaly multile resormly with removal of the implants after the attainment of a solid fusion.
When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for When used as a posterior, nor-bediole sorew indications are spondylolistiness, degeneratived by nation hook fixation from 11 to the inun/sacrum. The north heleants on of the disc confirmed by patient disc disease (as uelined by back pan of usoogene onlyn mat asgeneralisms (seudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
Performance data: (6)
The Food and Drug Administration have established no performance standards applicable to performal The Food and Drug Administration have established to performance claims of the PASS Spinal System was performed according to ASTM F1717-96.
Basis for substantial equivalence: '7)
The PASS Spinal System Hooks are equivalent to the other spinal systems commercially available that incorporate pedicle screws, rods, and crosslinking members.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2002
Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
Re: K013442
Trade Name: PASS Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP
Dated: October 16, 2001 Received: October 17, 2001
Dear Ms. Droege:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 accordance 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 affecting 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 Manufacturing 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.
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Page 2 - Ms. Joanna Droege
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 nontication. The I Driving of Castion 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 CFF Part 801 and If you desire specific active for your astic devices), please contact the Office of Compliance at additionally 607.10 for mi == for questions on the promotion and advertising of your device, (201) 594-1639. Fraunicance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respont its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L. Mark N. Milliken
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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510(k) Number (if known): ____________________
Qevice Name: ____Additional Components to PASS Spinal System
Indications For Use:
KC013442
page 1 of 1
Additional Components to PASS Spinal System
Indications For Use
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to r r so opinal cyclern continue 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, to hastor in the troutine of the volumity pondy olisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, 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 Spondylollethous 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.
When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intented for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with Spond from of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, degonoration of the dise common of atthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| OR | |
| (per 21 CFR 801.109) | |
| (Optional Format 1-2-96) | |
| (Division | n-Off) |
| Division | General, Restorative |
| and medical Devices | |
| 510(k) Number | K013442 |
§ 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.