(22 days)
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used to provide immobilization and stabilization of spinal segments, which treats various medical conditions.
No
The device is a spinal system providing immobilization and stabilization, not a tool for diagnosing medical conditions.
No
The device description explicitly states that the PASS Spinal System consists of physical components made of titanium alloy (pedicle screws, rod-plates, nuts, and crosslink members). There is no mention of software as a component of this system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide immobilization and stabilization of spinal segments. This is a therapeutic device, not a diagnostic one.
- Device Description: The device components are physical implants (pedicle screws, rods, nuts, crosslinks) made of titanium alloy. These are used in surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PASS Spinal System does not fit this description.
N/A
Intended Use / Indications for Use
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 turnor, 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 syste, the PASS Spinal System is intended for hook fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondification 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 and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
Product codes
MNH, MNI, KWP
Device Description
The PASS Spinal System consists of pedicle screws, rod-plates, 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 components that are the subject of this Special 510(k) submission are 04.5mm polyaxial pedicle screws and crosslinks (Exhibit I). The pedicle screws are the same design as the polyaxial screws cleared in K001024. The crosslinks are nut, rod and clamp assemblies that hook onto the rods of the assembled PASS Spinal System (K001024) to provide torsional stability to the construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems.
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 of Safety and Effectiveness
-
(1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Orthopedics, Inc. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Joanna Droege February 7, 2002 -
Trade or proprietary device name: PASS Spinal System (2) Pedicle screw spinal system Common or usual name: Class II Classification name:
-
(3) Legally marketed predicate device: PASS Splnal System (K001024)
(4) Subject device description:
The PASS Spinal System consists of pedicle screws, rod-plates, 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 components that are the subject of this Special 510(k) submission are 04.5mm polyaxial pedicle screws and crosslinks (Exhibit I). The pedicle screws are the same design as the polyaxial screws cleared in K001024. The crosslinks are nut, rod and clamp assemblies that hook onto the rods of the assembled PASS Spinal System (K001024) to provide torsional stability to the construct.
(5) Sublect device intended use:
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 fysion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological Impairment, fracture, dislocation, scollosis, splnal turnor, 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 syste, the PASS Spinal System is intended for hook fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformitles (scoliosis, kyphosis and lordosis), turnor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
(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 4.5 mm Screws and Crosslinks is similar in design, materials and indications to the PASS Spinal System (K001024).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2002
Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
K020236 Re: Trade Name: PASS Spinal System Regulatory Number: 21 CFR 888.3070 and 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: January 21, 2002 Received: January 23, 2002
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.
2
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers Assistance at 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.
Miriam C. Provost
for 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
510(k) Number (if known): _ KO20236
PASS Spinal System 4.5 mm Screws and Crosslinks Device Name:
Indications For Use:
PASS Spinal System 4.5 mm Screws and Crosslinks Indications For Use
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 turnor, 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 syste, the PASS Spinal System is intended for hook fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondification 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 and lordosis), tumor, pseudoarthrosis, 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 | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | ----------------------------------------- | ---- | ---------------------- | -- |
(per 21 CFR 801.109)
(Optional Format 1-2-96)
| Miriam C. Provost |
|---|
| (Division Sign-Off) |
| Division of General, Restorative |
| and Neurological Devices |
| 510(k) Number | K020236 |
|---|---|
| --------------- | --------- |