(28 days)
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.
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.
The following information is extracted from the provided text to describe the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on a Special 510(k) submission for modifications to the PASS LP Spinal System, rather than presenting a performance study with specific acceptance criteria in the traditional sense of a clinical trial or algorithm evaluation. Instead, the acceptance is based on demonstrating mechanical equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical soundness as other commercially available devices. (Inferred from "indicates that the products are as mechanically sound as other devices commercially available.") | Tests performed on additional components according to ASTM F1798. |
| Substantial equivalence to similar previously cleared lumbar intervertebral body fusion devices for specified indications for use. | FDA's issuance of a substantial equivalence determination (K082577). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the additional components of the device, not a data set for an algorithm.
- Data Provenance: Not applicable. The tests performed are mechanical in nature, not based on patient data. The submitter is MEDICREA® Technologies, based in La Rochelle, France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. Ground truth for a device's mechanical soundness is established through standardized engineering tests (e.g., ASTM F1798), not through expert consensus on a test set of data.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, not for mechanical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance:
Not applicable. This document describes a medical device (spinal system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is based on engineering standards and specifications, specifically ASTM F1798 for mechanical testing, and the demonstration of substantial equivalence to predicate devices cleared by the FDA.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not an AI/algorithm study.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set. The "ground truth" for the device's design and intended use is established through its adherence to manufacturing standards and its similarity to previously approved devices.
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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® TechnologiesZ.I. Chef de Baie17000 La Rochelle, France |
| Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-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.
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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.
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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
N/A