The PASS LP Spinal System includes a pedicle system intended 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: 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 is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having, implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks 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, kyphosis, and/or lordosis), tumor, 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 allograft 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, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum 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. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of new components: "Monoaxial Pedicle Screws' and 'Rod Connectors'.

AI/ML Overview

The provided text is a 510(k) summary for the PASS LP Spinal System, which is a premarket notification to the FDA for a medical device. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The document states that no clinical studies, animal studies, or performance data in the context of acceptance criteria demonstrating device performance were conducted or provided in support of substantial equivalence beyond biocompatibility and mechanical testing. The submission relies on the substantial equivalence principle, meaning the device is similar enough to an already approved device that it does not raise new questions of safety and effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document because a traditional comparative effectiveness study or controlled clinical trial, as implied by your request, was not performed for this 510(k) submission.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document as no specific acceptance criteria for a clinical or performance study are detailed, nor is there reported device performance against such criteria. The document states "no clinical studies were performed."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable. No test set (in the context of clinical or performance data against specific criteria) was used for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No ground truth was established for a test set as no clinical or performance study was conducted.

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

Not applicable. No test set required adjudication.

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. No MRMC study was conducted. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

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

Not applicable. No ground truth for a clinical study was required or established.

8. The sample size for the training set:

Not applicable. This is a spinal implant, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of available "Performance Data" and "Acceptance Criteria" type information from the document:

The "Performance Data" section (Page 7) describes the types of testing that were performed to support the substantial equivalence:

Biocompatibility Testing:
- Tests Performed: Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogen Testing.
- Standards Followed: FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
- Device Classification for Biocompatibility: Defined as an implantable device in contact with tissue and bone, with permanent contact.
- Material Conformance: Ti-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3 for chemical composition.
- Acceptance Criteria (Implied): Conformance to the cited standards and demonstration of biocompatibility (i.e., no adverse findings in the specified tests).
Mechanical Testing:
- Tests Performed: Dynamic axial compression according to ASTM F1717 (when applicable to the new components).
- Acceptance Criteria (Implied/Stated Performance): The products are "as mechanically sound as other devices commercially available." This is a comparative statement rather than a specific numeric acceptance criterion.

This 510(k) submission primarily establishes substantial equivalence based on the device's similarity in design, materials, intended use, and mechanical/biocompatibility performance to a previously cleared predicate device, rather than through new clinical performance studies with specific acceptance criteria that would typically be seen in a de novo or PMA submission for a novel device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 25, 2015

Medicrea International S.A. Ms. Audrev Vion Regulatory Affairs Manager 14 Porte Du Grand Lyon 01700 Neyron France

Re: K142798

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: MNH, KWP, MNI, OSH Dated: March 5, 2015 Received: March 9, 2015

Dear Ms. Vion:

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 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

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Page 2 - Ms. Audrey Vion

forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.

Lori A. Wiggins -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142798

Device Name

PASS LP Spinal System

Indications for Use (Describe)

The PASS LP Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis

(Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having, implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Page 1 of 2

PSC Publishing Sarvices (301) 443-6740 ESF

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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510(K) SUMMARY l.

DEVICE SUBMITTER MEDICREA® INTERNATIONAL S.A. 14 Porte Du Grand Lyon 01700 NEYRON- France

Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88

Contact Person: Audrey VION Regulatory Affairs Manager avion@medicrea.com

Date Prepared: 03/05/2015

2. DEVICE

Name of Device: PASS LP Spinal System

Common or Usual Name: Spinal Lumbar Fixation System

Classification Name:

orthosis, spinal pedicle fixation per MNI 888.3070
orthosis, spondylolisthesis spinal fixation per MNH 888.3070
V appliance, fixation, spinal interlaminal per KWP 888.3050
v pedicle screw spinal system, Adolescent Idiopathic Scoliosis per OSH 888.3070

Regulatory Class: II

Product Code: MNI, MNH, KWP and OSH

3. PREDICATE DEVICE

PASS LP Spinal System, K123138.

This predicate has not been subject to a design-related recall. No reference device was used in this submission.

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4. DEVICE DESCRIPTION

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

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of new components: "Monoaxial Pedicle Screws' and 'Rod Connectors'.

5. INDICATIONS FOR USE

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 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 fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks and 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 Indications For Use statement for the PASS LP Spinal System is identical to the predicate device. Both the subject and predicate device have the same intended use for the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.

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6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the features and characteristics of the PASS LP Spinal System to its predicate device.

Device	PASS LP Spinal System -New Components	PASS LP Spinal System
510(k) number	NA	K123138
Intended use
Thoracic, Lumbarspine	Yes	Yes
PosteriorApproach	Yes	Yes
Design
Rod Connectors
Rod diameters	Ø5.5 or Ø6mm	Ø5.5 or Ø6mm
Bone anchorageconnection	Polyaxial	Polyaxial
ConnectorAngulation	45° in the frontal plane	50° in the frontal plane
Color Coded	Yes	Yes
Shape	Rodpartpre-bent ( radius135.50mm)	Pre-bent rod (radius 135.50mm)
Monoaxial Pedicle Screws
Screw Diameters	Ø4.5mm to Ø7.5mm	Ø4.5mm to Ø7.5mm
Screw Lengths	From 25mm to 60mm with 5mmincrement	From 25mm to 60mmwith5mmincrement
Color Coded	Yes	Yes
Shape	Conical threadSpherical head for connectionwithotherPASSLPcomponentsBreakable threaded part for Nuttightening	Conical threadSpherical head for connection withother PASS LP componentsBreakable threaded part for Nuttightening
ThreadedExtension	Longthreadedshortorextension	Long threaded extension
Materials
PASSLPAdditionalComponents	Titanium alloy (Ti-6AI-4V ELI,following standards ASTMF136 and ISO 5832-3)	Titanium alloy (Ti-6AI-4V ELI,following standards ASTM F136and ISO 5832-3)

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

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7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the PASS LP system was conducted in accordance with the FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

V Cytotoxicity
Sensitization
Irritation
Systemic toxicity
Pyrogen Testing

According to the standard ISO 10993-1, the PASS LP Spinal System is defined as implantable

device in contact with tissue and bone and as a permanent contact with the patient.

For chemical composition, the material conform toTi-6AI-4V ELI, following standards ASTM F136 and ISO 5832-3.

Mechanical testing

When applicable, the tests performed on the additional components (dynamic axial compression according to ASTM F1717) indicate that the products are as mechanically sound as other devices commercially available.

Clinical study

No clinical studies were performed.

Animal study

No animal studies were performed.

8. CONCLUSION

MEDICREA® INTERNATIONAL S.A. PASS LP Spinal System is substantially equivalent to its predicate device in terms of indications for use, design, material and function.

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.