The PASS LP Spinal Systems include 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 of thoracic, lumbar, and sacral spine:

Fractures
Dislocation
Failed previous fusion (Pseudoarthrosis)
Spinal stenosis
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 Systems are 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 PASS LP also include hooks and rods and sacralitiiac screws 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 deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis), turnor, stenosis. pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allografi and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-SAI-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. Similarly to the PASS LP implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

Function: The PASS LP was developed as an implant:

To provide immobilzation and stabilization of posterior spinal segments
to augment the development of a solid spinal fusion
to provide stability to ease fusion
to be mechanically resistant to allow the fusion of the operated level

AI/ML Overview

The provided text describes a 510(k) summary for the MEDICREA® INTERNATIONAL PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of features, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the non-clinical tests performed to demonstrate mechanical equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Conformance to ASTM F1717 & F1798	Established via comparison to previously cleared devices
(Specific values are not provided as this is a summary of equivalence to predicate devices, not performance against specific clinical metrics.)	(Specific values are not provided in the document.)	(Specific values are not provided in the document.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. The "test set" in this context refers to mechanical testing of components, not a clinical data set. The document states "mechanical testing... was conducted following the ASTM F1717" and "additional components... tested following the ASTM F1798". No specific sample size (number of constructs tested) is provided in the summary.
Data Provenance: Not applicable in the context of clinical data. The mechanical tests were performed on the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in the clinical sense, is not established for mechanical testing.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable for mechanical testing.

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

MRMC Study: No. The document explicitly states: "No clinical studies were performed." This is a regulatory submission for a medical device implant, not an AI diagnostic device.

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

Standalone Performance: No. This device is a spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the mechanical performance, the "ground truth" is adherence to established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the mechanical performance of previously cleared devices. This is a technical/engineering "ground truth," not a clinical one.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. There is no AI component or machine learning model described as part of this device or its evaluation.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable. There is no AI component or machine learning model described.

Summary

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K123138

PAGE 1 OF 5

FEB 0 5 2013 510(k) Summary for the MEDICREA® INTERNATIONAL PASS LP Spinal System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the PASS LP Spinal System.

Date Prepared: September 9, 2012

1. Submitter:
  Contact Person:

Audrey VION

MEDICREA INTERNATIONAL

14 Porte du Grand Lyon

NEYRON 01700

14 Porte du Grand Lyon

PHONE: +33 4 72 01 87 87

MEDICREA INTERNATIONAL

1. Trade name: PASS LP Spinal System
  Common Name: Spinal fixation appliances

Classification Name: Pedicle screw spinal system $888.3070

Classification and Regulation: OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation KWP Appliance, Fixation, Spinal Interlaminal

1. Predicate or legally marketed devices which are substantially equivalent:
- . The PASS LP Spinal System (MEDICREA, K110497)
- The TSRH Spinal System (MEDTRONIC, K111942) .

Description of the device:

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

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Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

Function: The PASS LP was developed as an implant:

To provide immobilzation and stabilization of posterior spinal segments ●
to augment the development of a solid spinal fusion .
to provide stability to ease fusion .
to be mechanically resistant to allow the fusion of the operated level ●

5. 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)
· Spinal stenosis
· 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 fision 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 LP also includes hooks and rods and sacrafiliac screws 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, tracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pediatic patients. the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

6. Substantial equivalence claimed to predicate devices

MEDICREA® INTERNATIONAL PASS LP Spinal System is substantially equivalent to the MEDTRONIC TSRH Spine System, in terms of intended use, materials used, mechanical safety and performances.

● The TSRH Spinal System (MEDTRONIC, K111942)

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K123138

The table below compares the features and characteristics of MEDICREA® INTERNATIONAL PASS LP Spinal System to this predicate device.

Device	TSRH(MEDTRONIC)	PASS LP Spinal System
510(k) number	K111942	In progress
Intended use	The TSRH Spinal System isintended for use as a pediclescrew fixation system of the noncervical posterior spine inskeletally mature patients usingallograft and/or autograft. TheTSRH Spinal System isindicated as an adjunct to fusionfor one or more of the following:degenerative disc disease(defined as back pain ofdiscogenic origin withdegenerative disc confirmed byhistory and radiographicstudies); degenerativespondylolysthesis with objectiveevidence of neurologicalimpairment, fracture, dislocation,scoliosis, kyphosis, spinal tumor,and/or failed previous fusion(pseudarthrosis).	MEDICREA® INTERNATIONALPASS LP Spinal System includesa pedicle system intended toprovide immobilization andstabilization of spina segments inskeletally mature patients as anadjunct to fusion in the treatmentof the following acute and chronicinstabilities or deformities ofthoracic, lumbar and sacral spine:fracture, dislocation, failedprevious fusion (pseudoarthrosis),spinal stenosis, degenerativespondylolisthesis with objectiveevidence of neurologicalimpairment, spinal deformationssuch as scoliosis or kyphosis ansloss of stability due to tumors
Design
Fundamentalscientifictechnology	Posterior rod and screw systemwith medial rods.	Posterior rod and screw systemwith medial rods.
Connection ofcomponents	The pedicle screw is connectedto the rod using a connectorwhich provides an offset thatallows positioning the rodsmedial to the pedicle	The pedicle screw is connected tothe rod using a connector whichprovides an offset that allowspositioning the rods medial to thepedicle
Range	- Rods and pre-bent rods,- Pedicle screws,- Nuts,- Connectors,- Cross connectors,- Hooks,- Dominos,- Sacral connection,- Iliac connection	- Rods and pre-bent rods,- Pedicle screws,- Nuts,- Connectors,- Cross connectors,- Hooks,- Dominos,- Sacral connection,- Iliac connection
Materials
Device	TSRH(MEDTRONIC)	PASS LP Spinal System
All components	Titanium alloy conforming toASTM F136	Titanium alloy conforming toASTM F136
Rods	Cobalt-28-Chromium-6Molybdenum Alloy conformingto ASTM F1537	Cobalt-28-Chromium-6Molybdenum Alloy conforming toASTM F1537

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Material composition is identical to other MEDICREA® INTERNATIONAL products that have been cleared via the 510(k) process.

7. Non-clinical Test Summary:

The PASS LP Spinal System submitted by MEDICREA in this 510k includes only components that have been approved by the FDA in the previous 510Ks (K062136, K080099, K082069, K082577, K083308, K083810, K100297, K110497, K112493) for the following indications:

The PASS LP Spinal 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: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondwlolisthesis (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 LP also includes hooks, rods and sacral/iliac screws 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The purpose of this new submission is to extend the indications for use to adolescent idiopathic scoliosis. No other changes in terms of design characteristics, principles of operation, packaging, sterility, biocompatibility or mechanical performances have undergone.

Mechanical testing of the MEDICREA® INTERNATIONAL PASS LP implants was conducted following the ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectorny Model" to characterize the mechanical properties of the device. MEDICREA® INTERNATIONAL PASS LP additional components cleared in special 510(k) was also tested following the ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants" to characterize their mechanical properties.

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These data was compared to the mechanical performance for other devices cleared for surgical fixation of the skeletal system.

Accordingly, the mechanical performance of INTERNATIONAL PASS LP Spinal System implants has been established via these cleared devices (K062136, K080099, K082069, K082577, K083308, K083810, K100297, and K110497)

Clinical Test Summary

No clinical studies were performed

Conclusions Nonclinical and Clinical

MEDICREA PASS LP Spinal System is substantially equivalent to its predicate devices in terms of indications for use, design, material and function.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2013

Medicrea International % Ms. Audrey Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron - France

Re: K123138

Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, MNI, MNH, KWP Dated: September 20, 2012 Received: November 8, 2012

Dear Ms. Vion:

This letter corrects our substantially equivalent letter of February 5, 2013.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Audrey Vion

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin DKeith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): K123138

Device Name: PASS LP Spinal System

Indications for Use:

· Fractures
· Dislocation
· Failed previous fusion (Pseudoarthrosis)
· Spinal stenosis
· Degenerative spondylolisthesis with objective evidence of neurological impairment
· Spinal deformations such as scoliosis or kyphosis.
· Loss of stability due to tumors.

Over-The-Counter Use Prescription Use > AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronaldi P: Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123138

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.