(72 days)
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps members utilized to provide immobilization 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 tumor, and failed previous fusion (pseudoarthrosis).
As a pedicle screw system, the PASS 2 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.
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The provided text is a 510(k) summary for the PASS 2 Spinal System, which is a pedicle screw spinal system. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical testing, rather than a clinical study involving human patients. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanically sound as other commercially available devices | "Testing performed according to ASTM F1717 indicate that the PASS 2 Spinal System is as mechanically sound as other devices commercially available." |
2. Sample size used for the test set and the data provenance
Sample Size: Not specified for the mechanical testing. The testing was likely conducted on a sufficient number of device components to meet ASTM F1717 requirements.
Data Provenance: The data is from mechanical testing, not clinical data from patients. The specific lab or country where the testing was performed is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a mechanical testing study, not a study requiring expert clinical assessment for ground truth. The "ground truth" was established by the specified ASTM F1717 standard for mechanical integrity.
4. Adjudication method for the test set
Not applicable. This was a mechanical testing study, not a study requiring expert adjudication of clinical findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a pedicle screw spinal system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study 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 medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating the device's performance was compliance with the ASTM F1717 standard, which outlines mechanical testing procedures for spinal implant constructs.
8. The sample size for the training set
Not applicable. This device is a pedicle screw spinal system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a pedicle screw spinal system, not a machine learning model.
{0}------------------------------------------------
510(k) SUMMARY of Safety and Effectiveness
1. GENERAL INFORMATION
| Trade Name | PASS 2 Spinal System |
|---|---|
| Common Name | Pedicle Screw Spinal System |
| Classification Name | Orthosis, spinal pedicle fixation |
| Class | II |
| Product Code | MNI, MNH |
| 21 CFR section | 888.3070 |
| Device panel | Orthopedic |
| Legally marketed predicatedevices | USS (Synthes)= K982987MOSS MIAMI (Depuy Spine)= K964024PASSMed (MEDICREA)= K032094 |
| 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. DEVICE DESCRIPTION
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
3. INTENDED USE
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps 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, spinal turnor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS 2 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.
4. PERFORMANCE DATA
Testing performed according to ASTM F1717 indicate that the PASS 2 Spinal System is as mechanically sound as other devices commercially available.
5. SUBSTANTIAL EQUIVALENCE
The PASS 2 Spinal System is similar to the USS (K892987), the MOSS MIAMI (K964024) and PASSMed (K032094) distributed by Synthes, Depuy and Medicrea respectively
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDICREA Technologies % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
OCT - 6 2006
Re: K062136
Trade/Device Name: PASS2 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Orthosis, spinal pedicle fixation Regulatory Class: Class II Product Code: MNI, MNH Dated: July 24, 2006 Received: July 26, 2006
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510 (k) Premarket Notification
PASS 2 Spinal System
Image /page/3/Picture/3 description: The image shows the logo for Medicrea Technologies. The logo is in a rectangular box with a dark background. The word "MEDICREA" is in large, bold, white letters at the top of the box. Below that, the word "TECHNOLOGIES" is in smaller, white letters.
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: PASS2 Spinal System
Indications for Use:
The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps members utilized to provide immobilization 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 tumor, and failed previous fusion (pseudoarthrosis).
As a pedicle screw system, the PASS 2 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.
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)
barbare Ancom
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K062136
§ 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.