The PASS 2 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

When used 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 also includes hooks and rods 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.

Device Description

The Medicrea PASS 2 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-6Al-4V ELI) that conforms to ASTM F136.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDICREA PASS 2 Spinal System:

The provided document, K082069, is a 510(k) summary for a Special 510(k) submission, primarily for a product range extension and additional components of the PASS 2 Spinal System. As such, the performance data provided is focused on mechanical testing rather than clinical or AI-driven performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical soundness equivalent to commercially available devices	Tests performed on additional components according to ASTM F1717 or ASTM F1798 indicate that the products are as mechanically sound as other devices commercially available.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the mechanical tests. It mentions "tests performed on the additional components," implying a discreet number of physical units were tested.

Data Provenance: The tests refer to ASTM standards, which are recognized industry-wide standards for mechanical testing of medical devices. The country of origin for the data is not specified beyond being generated for a French company submitting to the FDA. The testing conducted is inherently prospective in nature, as it involves newly manufactured components undergoing specific mechanical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of submission. The "ground truth" for mechanical testing of spinal implants is defined by the physical properties and performance characteristics measured against established ASTM standards, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing results are typically quantitative and objective measurements against predetermined pass/fail criteria from the ASTM standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. The PASS 2 Spinal System is a mechanical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This submission is for a mechanical spinal implant, not an algorithm or AI device.

7. The Type of Ground Truth Used

For the mechanical performance, the "ground truth" is based on the specified mechanical properties and performance requirements outlined in the ASTM F1717 and ASTM F1798 standards. The device's components must withstand certain loads, fatigue cycles, and exhibit specific mechanical behaviors to be deemed acceptable.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical performance testing of a spinal implant. Training sets are typically associated with machine learning or AI algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

K082069
Page 1 of 2

MEDICREA

SPECIAL 510(k) SUMMARY

GENERAL INFORMATION 1.

OCT - 8 2008

Trade Name	PASS 2 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✓ appliance, fixation, spinal interlaminal per KWP 888.3050
Class	Class II
Product Code	MNI / MNH / KWP
CFR section	888.3070 / 888.3050
Device panel	Orthopedic
Legally marketed predicate devices	The PASS 2 Spinal System is substantially equivalent to similarpreviously 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

DESCRIPTION OF DEVICE MODIFICATION 3.

The purpose of this submission is to make modifications to the PASS 2 Spinal System.

4. INTENDED USE

{1}------------------------------------------------

K08 2069
Page 2 of 2

5. PERFORMANCE DATA

When applicable, the tests performed on the additional components according to ASTM F1717 or ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available.

{2}------------------------------------------------

Image /page/2/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 three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2008

Medicrea Technologies % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, TX 78681

Re: K082069

Trade/Device Name: PASS2 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: September 3, 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.

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

{3}------------------------------------------------

Page 2 - Mr. J.D. Webb

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 N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "MEDICREA" in a bold, sans-serif font. The letters are black and stand out against a textured background. The word appears to be part of a logo or heading, possibly related to a medical or healthcare company.

INDICATIONS FOR USE

510(k) Number (if known): K082069

Device Name: PASS 2 Spinal System

PASS 2 Spinal System

Indications for Use

Prescription Use✓
AND/OR
Over-The-Counter Use__
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K082869

Regulation Number and Section

§ 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.