(130 days)
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.
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.
This is a 510(k) summary for a spinal fixation device, not a diagnostic or AI-driven device. As such, the information typically found in acceptance criteria and efficacy studies for software-driven medical devices (such as sensitivity, specificity, reader studies, ground truth establishment) is not applicable here.
The provided document describes the PASSmed Spinal System, a hardware device used for spinal immobilization and stabilization. The "study" mentioned in the document is a non-clinical mechanical test to demonstrate the device's physical properties, not a clinical study involving human patients or a software algorithm evaluating medical images.
Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" in the context of a mechanical spinal implant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Soundness | Performance according to ASTM F1717 standard. | "PASSmed system is as mechanically sound as other devices commercially available." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the ASTM F1717 testing. For mechanical tests of components, this would typically involve a statistically significant number of samples of each device configuration or critical component.
- Data Provenance: The testing was "performed according to ASTM F1717," indicating it was likely conducted in a controlled laboratory setting. No country of origin for data is specified, but the submitter (Medicrea) is from FRANCE, and the contact person is in the USA. Given it's a mechanical test, the origin of the data isn't tied to patient demographics or retrospective/prospective collection as it would be for a clinical diagnostic study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For a mechanical device, "ground truth" typically refers to the physical properties of the materials and design, evaluated against established engineering standards (like ASTM F1717). There aren't "experts" in the same way as radiologists for image interpretation; rather, there are engineers and technicians who conduct and analyze the mechanical tests according to predefined protocols.
4. Adjudication Method for the Test Set
- Not Applicable. Mechanical testing against an ASTM standard doesn't involve "adjudication" in the sense of resolving disagreements among human reviewers. The results are quantitative and objective measurements of material properties and structural integrity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human readers interpret data. It is not applicable to a mechanical implant device.
6. If a Standalone Performance (i.e. algorithm only without human-in-the-loop performance) was done
- No. This refers to the standalone performance of a software algorithm. The PASSmed Spinal System is a physical implant, not a software algorithm. The "standalone performance" equivalent would be the mechanical performance of the device itself, which was evaluated via ASTM F1717.
7. The Type of Ground Truth Used
- Engineering Standards and Material Specifications. The "ground truth" for a mechanical device is its ability to withstand specified loads, fatigue, and other physical stresses as defined by relevant engineering standards (in this case, ASTM F1717) and the material properties of its components.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no "training set" for this type of device.
Summary of the "Study" Mentioned:
The "study" referenced in the 510(k) summary is identified as:
- "Testing performed according to ASTM F1717."
ASTM F1717 is a standard test method for "Spinal Implant Constructs in a Vertebrectomy Model (Mechanical Testing of Spinal Implants)." This standard specifies the methodology for mechanical characterization of spinal implant assemblies, including pedicle screw systems, under various loading conditions (e.g., static, fatigue).
The purpose of this testing is to demonstrate the mechanical equivalence and safety of the PASSmed system compared to legally marketed predicate devices. The acceptance criterion is that the device is "as mechanically sound as other devices commercially available," which is demonstrated by meeting or exceeding the mechanical performance benchmarks set by the ASTM F1717 standard and comparing favorably to predicate devices that have also undergone similar testing. This is a common approach for demonstrating substantial equivalence for hardware medical devices in 510(k) submissions.
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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.
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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
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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
Page iii
§ 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.