(28 days)
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No
The 510(k) summary describes a mechanical spinal fixation system made of titanium alloy. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies focus on mechanical soundness according to ASTM standards.
No.
The device is a spinal fixation system, indicated as an adjunct to fusion for immobilization and stabilization of spinal segments, which is not a therapeutic function by itself but rather a supportive mechanical function.
No
Explanation: The device, the Medicrea PASS LP Spinal System, is described as consisting of pedicle screws, hooks, rods, and other components used for immobilization and stabilization of spinal segments as an adjunct to fusion. This indicates it is a surgical implant designed to treat instabilities or deformities, rather than to diagnose them.
No
The device description explicitly lists hardware components (pedicle screws, hooks, sacral plates, etc.) made of titanium alloy, indicating it is a physical implant system, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The PASS LP Spinal System is a collection of implants (screws, rods, etc.) made of titanium alloy. These are surgically implanted into the spine.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical procedure performed directly on the patient's body, not on specimens taken from the body.
The device is a surgical implant used for musculoskeletal support and stabilization, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The PASS LP Spinal System includes a pedicle 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 thoracic, lumbar, and sacral spine:
- Fractures
- Dislocation ・
- । Failed previous fusion (Pseudoarthrosis)
- Degenerative spondylolisthesis with objective evidence of neurological impairment ।
- -Spinal deformations such as scoliosis or kyphosis.
- ၊ Loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5—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.
Product codes
MNH, MNI
Device Description
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AJ-4V ELI) that conforms to ASTM F136.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 to sacrum
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
When applicable, the tests performed on the additional components according to ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K082577". The characters are written in a cursive style, with some connections between the letters and numbers. The writing is in black ink on a white background.
Image /page/0/Picture/1 description: The image shows the text "OCT 3 - 2008" at the top. Below this text is the word "MEDICREA" in a bold, sans-serif font. The word is enclosed in a rectangular box.
SPECIAL 510(K) SUMMARY
1. GENERAL INFORMATION
| Trade Name | PASS LP Spinal System |
|---|---|
| Common Name | ✓ Posterior pedicle screw system |
| ✓ Hooks | |
| ✓ Sacral plate | |
| Classification Name | ✓ orthosis, spinal pedicle fixation per MNI 888.3070 |
| ✓ orthosis, spondylolisthesis spinal fixation per MNH 888.3070 | |
| Class | Class II |
| Product Code | MNI / MNH |
| CFR section | 888.3070 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | The PASS LP Spinal System is substantially equivalent to similar previously cleared lumbar intervertebral body fusion devices. |
| Reason for Special 510(k) | Product range extension and additional components |
| Submitter | MEDICREA® Technologies |
| Z.I. Chef de Baie | |
| 17000 La Rochelle, France | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 | |
| E-Mail: ortho.medix@sbcglobal.net |
2. PREDICATE DEVICE DESCRIPTION
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AJ-4V ELI) that conforms to ASTM F136.
3. DESCRIPTION OF DEVICE MODIFICATION
The purpose of this submission is to make modifications to the PASS LP Spinal System.
4. INTENDED USE
The PASS LP Spinal System includes a pedicle 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 thoracic, lumbar, and sacral spine:
- Fractures
- Dislocation ・
- । Failed previous fusion (Pseudoarthrosis)
- Degenerative spondylolisthesis with objective evidence of neurological impairment ।
- -Spinal deformations such as scoliosis or kyphosis.
- ၊ Loss of stability due to tumors.
Page ii page 1 of 2
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Image /page/1/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K082577". The characters are written in a dark ink on a white background. The handwriting is somewhat messy, but the characters are still legible.
Image /page/1/Picture/1 description: The image shows the word "MEDICREA" in bold, black letters. The letters are large and fill most of the frame. The background behind the letters appears to be a textured pattern, possibly a gray or light-colored design. The overall impression is a clear and legible presentation of the company name.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5—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.
5. PERFORMANCE DATA
When applicable, the tests performed on the additional components according to ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available.
page 2 of
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 03 2008
Medicrea Technologies C/o Mr. J.D. Webb Official Correspondent 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K082577
Trade/Devicc Name: PASS LP Spinal System Regulation Number: 880.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNH, MNI Dated: August 28, 2008 Received: September 5, 2008
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.
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Page 2- Mr. Webb
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Milliman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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MEDIOREA
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: PASS LP Spinal System
PASS LP Spinal System
Indications for Use
The PASS LP Spinal System includes a pedicle 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal deformations such as scoliosis or kyphosis, loss of stability due to tumors, and failed previous fusion (pseudoarthrosis).
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-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.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rola
Division of General, Restorative and Neurological Devices
510(k) Number C082577