The PASS LP Spinal System is a pedicle screw fixation system intended for 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondy lolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or 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. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. 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, 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.

The purpose of this submission is to add components to the PASS LP implant range to treat Pars interarticularis fracture.

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 hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a new device's performance characteristics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can extract information regarding the performance data provided to support the substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table for device performance in the way one might expect for a new diagnostic or AI intervention. Instead, it relies on demonstrating substantial equivalence to existing predicate devices through mechanical testing. The implicit acceptance criterion is that the new components perform comparably to the predicates in standard mechanical tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantially equivalent mechanical performance to predicate devices	Demonstrated substantially equivalent performance in Dynamic Compression Bending Tests (following ASTM F1717) to predicates (K123138 and K140449).

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

The document mentions "Dynamic Compression Bending Tests, following the ASTM F1717 'Standard Test Methods for Spinal Implants Constructs in a Vertebrectomy Model' were carried out."

Sample Size: The specific number of devices tested in the Dynamic Compression Bending Tests (n for each test group) is not provided in this document.
Data Provenance: The tests were "carried out" as part of the submission process, implying these were prospective bench tests conducted specifically for this regulatory submission. The country of origin for the data is implicitly France, where Medicrea® International S.A. is based.

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

This section is not applicable. The "ground truth" for the mechanical performance of a spinal implant is determined by established engineering standards (ASTM F1717) and the physical properties observed in the bench tests, not by expert consensus in a clinical setting.

4. Adjudication method for the test set

This section is not applicable. Mechanical tests against a standard do not typically involve human adjudication in the same way clinical or image-based studies do. The results are quantitative measurements against predetermined pass/fail criteria (often, remaining within a certain deviation of predicate performance).

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

This section is not applicable. This document concerns a spinal implant system, not a diagnostic device or AI system that assists human readers.

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

This section is not applicable. This document concerns a spinal implant system, not an AI algorithm.

7. The type of ground truth used

The ground truth used for evaluating the device's performance was:

Mechanical performance metrics as defined by the ASTM F1717 standard for "Spinal Implants Constructs in a Vertebrectomy Model." This involves quantitative measurements of force, displacement, and cycles to failure under defined loading conditions.
Performance of legally marketed predicate devices (CD Horizon Spinal System - K140449, and PASS LP Spinal System - K123138) against the same standard, effectively setting the "ground truth" for acceptable performance.

8. The sample size for the training set

This section is not applicable. This document concerns a spinal implant system, not a device that utilizes a "training set" in the context of machine learning or AI.

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

This section is not applicable. There is no "training set" in the context of this device and evaluation.

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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three interconnected profiles facing to the right.

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

January 9, 2015

Medicrea® International S.A. Mr. David Ryan Marketing and Product Development Director 14 Porte du Grand Lyon Neyron 01700 France

Re: K141398

Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP Dated: December 5, 2014 Received: December 8, 2014

Dear Mr. Ryan:

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

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Page 2 – Mr. David Ryan

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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 yours,

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) K141398

Device Name PASS LP SPINAL SYSTEM

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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510(k) SUMMARY

MEDICREA INTERNATIONAL S.A.'s PASS LP - Additional Components

1. 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: David RYAN Marketing and Product Development Director dryan@medicrea.com

Date Prepared: 12/05/2014

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
appliance, fixation, spinal interlaminal per KWP 888.3050
pedicle screw spinal system, Adolescent Idiopathic Scoliosis per OSH 888.3070
orthosis, spinal pedicle fixation, For Degenerative Disc Disease per NKB 888.3070

Regulatory Class: III

Product Code: NKB, OSH, MNI, MNH, KWP

3. PREDICATE DEVICES

CD Horizon Spinal System (MEDTRONIC, K140449) [Primary Predicate] PASS LP Spinal System (MEDICREA INTERNATIONAL, K123138)

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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 add components to the PASS LP implant range to treat Pars interarticularis fracture.

5. INDICATIONS FOR USE

The PASS LP Spinal System is a pedicle screw fixation system intended for 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or failed previous fusion.

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6. COMPARISON OF TECHNOLOGICAL CHARAGTERISTICS WITH THE PREDICATE DEVICE

The table below compares the features and characteristics of MEDICREA® INTERNATIONAL S.A. PASS LP Spinal System – Additional components to their predicate devices.

Device	PASS LP -Additional components	CD HorizonSpinal System(MEDTRONIC)	PASS LPSpinal System(MEDICREAINTERNATIONAL)	PASS LPSpinal System(MEDICREAINTERNATIONAL)
510(k) number	K141398	K140449	K123138	K123138
Intended use
Thoracic	Yes	Yes	Yes	Yes
Lumbar	Yes	Yes	Yes	Yes
Posterior Approach	Yes	Yes	Yes	Yes
Design
Rod Diameters	Ø4mm	Ø3,5mm toØ6,35mm	Ø5.5 and Ø6 mm	Ø5.5 and Ø6 mm
Hooks	YesOne size availableLeft and Rightversion	YesSeveral Options	YesSeveral Options	YesSeveral Options
Crosslink	Yes	Yes	Yes	Yes
Materials
	Ti-6Al-4V (ASTMF136 & ISO5832-3)	Titanium Alloy orStainless Steel	Ti-6Al-4V (ASTMF136 & ISO5832-3)Or Co-Cr28Mo6 alloy 1(following theASTMF1537and ISO 5832-3)	Ti-6Al-4V (ASTMF136 & ISO5832-3)Or Co-Cr28Mo6 alloy 1(following theASTMF1537and ISO 5832-3)

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7. PERFORMANCE DATA

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

To determine substantial equivalence of the PASS LP components to its predicate, Dynamic Compression Bending Tests, following the ASTM F1717 "Standard Test Methods for Spinal Implants Constructs in a Vertebrectomy Model" were carried out. Those tests demonstrated substantially equivalent performance of the components to its predicate.

8. CONCLUSION

MEDICREA® INTERNATIONAL S.A. PASS LP Spinal System - additional components are substantially equivalent to the already cleared PASS LP components (MEDICREA INTERNATIONAL, K123138) and the CD Horizon Spinal System (MEDTRONIC, K140449) in terms of intended use, materials used, sterilization, mechanical safety and performances.

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.