(130 days)
No
The device description and intended use clearly describe a mechanical pedicle screw system with associated components. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections explicitly state "Not Found".
Yes.
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various instabilities or deformities, which directly addresses medical conditions.
No
This device is a pedicle screw system, described as an implant used for immobilization and stabilization of spinal segments, and is not designed to diagnose medical conditions.
No
The device description clearly outlines physical components such as screws, clamps, rods, and plates, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide mechanical support and stabilization to the spine. It is used in the body during surgery.
- Device Description: The description details physical components like screws, rods, clamps, and plates, which are all hardware intended for implantation.
- 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 screening.
IVD devices are used outside the body to analyze biological samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The PASSmed is a pedicle screw system intended 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 the 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 PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra 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.
It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Product codes
KWP, MNH, MNI
Device Description
The PASSmed system includes pedicies include polyasial screws in a various lengths and diameters. Standard and offist height seres are available, with the offset used in cases of severe spondylolisticsis. Standard and realignment clamps are used to connect the screw and rods. Rods are Ø6mm in lengths ranging from 50mm. It also includes sacral plates and serens. The sacral plate takes the place of pedicle screw in connecting the rod to the sacrum. The place is attached to the sarum with two serews. The polyasial attachment mechanism to the same as the pedicle screws. The plates come in right and left configuration. The rod-plates are similar to the consist of a short rod segment that has enarged portions at the ends with holes to attach directly to screw with hemispherical nuts rather than connecting to the rod was a clamp. The rods attach to the hooks and can be used for single or multiple level lisations. They have the same rod attachment mechanism as the polyasial serews. The laminar hooks are inserted inferior around the lamina, pediele hooks are inserted inferior and superior around the pedicles.
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)
Testing performed according to ASTM F1717 indicate that the PASSmed system is as mechanically sound as other devices commercially available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001024, K012175, K013191, K013431, K013442, K020236
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
Date November 11, 2003
NOV 1 4 2003
Submitter
Medicrea Z.I. Chef de Baic 17000 LaRochelle, FRANCE
Contact person
J.I). Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Posterior pedicle screw system Hooks Sacral plate
Classification name
Spondylolisthesis Spinal Fixation Device System per MNH 888.3070 Pedicle Screw Spinal System per MNI 888.3070 Spinal Interlaminal Fixation Orthosis per KWP 888.3050
Equivalent Device
The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. These devices were all submitted by Encore Orthopedics. All of the cleared devices were designed, manufactured and packaged by Medicrea.
Device Description
The PASSmed system includes pedicies include polyasial screws in a various lengths and diameters. Standard and offist height seres are available, with the offset used in cases of severe spondylolisticsis. Standard and realignment clamps are used to connect the screw and rods. Rods are Ø6mm in lengths ranging from 50mm. It also includes sacral plates and serens. The sacral plate takes the place of pedicle screw in connecting the rod to the sacrum. The place is attached to the sarum with two serews. The polyasial attachment mechanism to the same as the pedicle screws. The plates come in right and left configuration. The rod-plates are similar to the consist of a short rod segment that has enarged portions at the ends with holes to attach directly to screw with hemispherical nuts rather than connecting to the rod was a clamp. The rods attach to the hooks and can be used for single or multiple level lisations. They have the same rod attachment mechanism as the polyasial serews. The laminar hooks are inserted inferior around the lamina, pediele hooks are inserted inferior and superior around the pedicles.
Intended Use
The PASSmed is a pediele serew system intended to provide immobilization of spinal segments in skelctally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degencive spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system PASSmed is indicated for the treament of severe spondylolisthesis (Grades 3 and 4) of the L2-51 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacra spine (L 3 to sacrum) with removal of the implants after the attainment of a solid fusion.
I also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies, trauma (i.e., fracture or dislocation), spinal stenosis, deformities (i.e., scolosis, kyphosis, and/or lordosis), tumor, pseudoat(trosis and failed previous fusion.
Summary Nonclinical Tests
Testing performed according to ASTM F1717 indicate that the PASSmed system is as mechanically sound as other devices commercially available.
K032094
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
NOV 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicrea C/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032094 Trade/Device Name: PASSmed Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: October 10, 2003 Received: October 14, 2003
Dear Mr. Webb:
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 - Mr. J.D. Webb
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) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
to Mark A. Millers
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
510(k) number (if known): K032094
Device Name: PASSmed Spinal System
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Indications for Use:
PASSmed Spinal System Indications for Use
The PASSmed is a pedicle screw system intended 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 the 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 PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra 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.
It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous 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)
)
Mark N Mulkerson
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number K032049
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