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.

Device Description

The PASS 2 components consist of pedicle screws, 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

This 510(k) premarket notification for the PASS 2 Spinal System is for a Class II medical device, specifically a posterior pedicle screw system and sacral plate. The submission describes modifications and an extension of the product range. The "acceptance criteria" here refers to the performance standards the device must meet to be considered substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Standard)	Reported Device Performance
Mechanical soundness according to ASTM F1717	"The tests performed on the additional components according to ASTM F1717... indicate that the products are as mechanically sound as other devices commercially available."
Mechanical soundness according to ASTM F1798	"The tests performed on the additional components according to... 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

This is a submission for a spinal implant system (hardware), not a diagnostic or AI-driven device that would involve a "test set" of patient data in the typical sense. The testing is mechanical engineering testing of the components. Therefore, the concept of sample size for a test set of data and its provenance is not applicable here. The "sample" would refer to the physical components tested for mechanical strength. The document does not specify the number of components tested.

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

This information is not applicable. The "ground truth" for a mechanical device is established by standardized material and mechanical testing procedures, not by human expert assessment of clinical data.

4. Adjudication Method for the Test Set

This is not applicable as the testing is mechanical and follows defined ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance. This submission concerns mechanical performance of a surgical implant.

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

This is not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device is based on mechanical testing standards, specifically ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Guide for Evaluating the Static and Fatigue Performance of Posterior Spinal Systems). The "ground truth" is that the device components perform within acceptable mechanical limits defined by these standards.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical mechanical implant, not an AI model that requires a training set of data.

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

This is not applicable. The ground truth for mechanical testing is established by the specified ASTM standards and laboratory protocols, not by a "training set."

Summary

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Ko 80099

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510(K) SUMMARY

1. GENERAL INFORMATION

Trade Name	PASS 2 Spinal System
Common Name	✓ Posterior pedicle screw system✓ 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	MNH / MNI
CFR section	888.3070
Device panel	Orthopedic
Legally marketed predicate devices	The PASS 2 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

3. DESCRIPTION OF DEVICE MODIFICATION

The purpose of this submission is to make modifications to the PASS2 Spinal System.

4. INTENDED USE

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

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

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black. The seal is simple and iconic, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2008

MEDICREA Technologies % Mr. J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681

Re: K080099

Trade/Device Name: PASS 2 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: March 7, 2008 Received: March 10, 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 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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure

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Indications for Use

510(k) Number (if known): _K080099

Device Name: PASS 2 Spinal System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Oglan for mkm

and Neurological Devices

510(k) Number K080099

Regulation Number and Section

N/A