The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods or dominos. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.

Device Description

The PASS OCT Spinal System is a posterior system. which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.

The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.

The purpose of this 510(k) submission is to add offset connectors to the PASS OCT Spinal System.

AI/ML Overview

This FDA 510(k) summary describes a spinal implant system, not an AI/ML powered device. Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance are not applicable.

However, I can extract the relevant information regarding the non-clinical testing performed for this medical device.

Device Name: PASS OCT Spinal System (specifically, additional components including offset connectors)

Device Type: Spinal implant system, specifically a posterior system for immobilizing spinal segments as an adjunct to fusion.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance for the additional components (offset connectors). However, it refers to the standard used for mechanical evaluation.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance meeting requirements of ASTM F1798 (Implied: adequate strength and fatigue resistance for spinal implants)	The subject components (offset connectors) of the PASS OCT spinal system were mechanically evaluated in axial and torsional grip and dynamic flexion-extension per ASTM F1798. (This indicates the tests were performed and presumably met the standard, otherwise it would likely not be cleared.)
Biocompatibility requirements met (Implied: non-pyrogenic)	Pyrogenicity testing was conducted in support of PASS OCT component substantial equivalence. (This indicates the test was performed and presumably met the standard.)

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

Sample Size: Not explicitly stated in terms of number of devices tested. Mechanical testing typically involves a statistically relevant number of samples, but the exact count is not provided here.
Data Provenance: Not applicable in the context of human data. The testing is non-clinical (bench testing), performed on the device components themselves.

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

Not applicable. This is a non-clinical, bench testing study. "Ground truth" does not apply in the context of expert consensus for interpretations as it would for imaging or diagnostic AI. The "ground truth" for mechanical testing is established by the test methods and acceptance limits defined in the ASTM F1798 standard.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are relevant for human interpretation tasks, not for mechanical bench testing.

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

No. This is a non-clinical bench study of a spinal implant, not an AI/ML diagnostic or assistive device for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical mechanical testing, the "ground truth" is defined by the specifications and requirements of the ASTM F1798 standard (Standard Practice for Testing Impact-Resistant Spinal Fracture Reduction Systems components in axial and torsional grip and dynamic flexion-extension). The pyrogenicity testing would adhere to established standards for biocompatibility.

8. The Sample Size for the Training Set:

Not applicable. There is no training set as this is a physical medical device, not an AI/ML algorithm.

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

Not applicable. There is no training set for this type of device.

Summary

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

July 11, 2016

Medicrea International S.A. Mr. David Rvan VP Product Development and Marketing 14 Porte du Grand Lyon Neyron 01700 FRANCE

Re: K161149

Trade/Device Name: PASS OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: June 23, 2016 Received: June 27, 2016

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

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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 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. 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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K161149

Device Name PASS OCT Spinal System

Indications for Use (Describe)

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

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

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510(k) SUMMARY

MEDICREA INTERNATIONAL's PASS OCT additional components

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for the PASS OCT Spinal System- Additional Components:

Date Prepared: 20 June 2016

1. Submitter:

Submitter:	Contact Person:
MEDICREA INTERNATIONAL S.A.	David RYAN
14 Porte du Grand Lyon	MEDICREA INTERNATIONAL S.A.
NEYRON 01700	14 Porte du Grand Lyon
FRANCE	NEYRON 01700
Phone Number : +33 4 72 01 87 87	FRANCE

1. Trade name: PASS OCT Spinal System

Regulatory Identification/ Classification

Orthosis, Cervical pedicle screw spinal fixation Product Code: NKG Unclassified, Pre-Amendment

Spinal Interlaminal Fixation Orthosis Regulation Number: 21CFR 888.3050 Product Code: KWP Class II

1. Predicate or legally marketed devices which are substantially equivalent:

Primary predicate:

PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K150918)

Additional predicate:

Vertex Reconstruction System, (MEDTRONIC SOFAMOR DANEK USA; K143471) ●
No reference devices were used in this submission.

4. Description of the device:

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12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.

Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use any of the PASS OCT Spinal System implant components with components from any other systems or manufacturer unless specifically labeled to do so in this or another MEDICREA® INTERNATIONAL document.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-30; CP Titanium according to the ASTM F67 and ISO 5832-2: PEEK OPTIMA LT1® according to the ASTM F2026-10 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO5832-12 and ASTM F1537.

Function: The PASS OCT spinal system was developed as an implant:

· To provide immobilization and stabilization of posterior spinal segments
to auqment 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

The purpose of this 510(k) submission is to add offset connectors to the PASS OCT Spinal System.

5. Indication for Use

The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Substantial equivalence claimed to predicate devices 6.

The PASS OCT Spinal system components are technologically similar to the already cleared PASS OCT Spinal System Components and Vertex Reconstruction System Components in terms of intended use, materials used, mechanical safety and performances

. PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K150918)
Vertex Reconstruction System, (MEDTRONIC SOFAMOR DANEK USA; K143471) .

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The table below compares the features and characteristics of PASS OCT components to their predicate devices.

Device	MEDICREAINTERNATIONALPASS OCT SpinalSystemNEW COMPONENT	MEDICREAINTERNATIONALPASS OCT SpinalSystem	MEDTRONIC SOFAMORDANEKVertex ReconstructionSystem
510(k) number	Unknown	K150918	K143471
Intended use
Occipital	Yes	Yes	Yes
Cervical	Yes	Yes	Yes
Thoracic	Yes	Yes	Yes
Components
Anchoragemeans	-Polyaxial screws- Polyaxial hooks- Occipital bonescrews	-Polyaxial screws- Polyaxial hooks- Occipital bone screws	- Multi-axial screws- Hooks- Occipital bone screws
Offset Connector	Yes	No	Yes
Materials
	Titanium Alloy (Ti-6Al-4V) according toASTM F136 & ISO5832-3- Grade Titaniumaccording to ASTMF67-13 & ISO 5832-2PEEK OPTIMA LT1conforming to ASTMF2026Co-Cr 28Mo6 alloy 1(following theASTMF1537	Titanium Alloy (Ti-6Al-4V) according to ASTMF136 & ISO 5832-3- Grade Titaniumaccording to ASTM F67-13 & ISO 5832-2PEEK OPTIMA LT1conforming to ASTMF2026Co-Cr 28Mo6 alloy 1(following theASTMF1537	Titanium Alloy (Ti-6Al-4V) according to ASTMF136 & ISO 5832-3- Grade Titaniumaccording to ASTM F67& ISO 5832-2- Shape Memory Alloy(Nitinol-NiTi) accordingto ASTM F2063

Non-clinical Test Summary: 7.

The subject components of the PASS OCT spinal were mechanically evaluated in axial and torsional grip and dynamic flexion-extension per ASTM F1798.

Pyrogenicity testing was conducted in support to PASS OCT component substantial equivalence.

8. Clinical Test Summary

No clinical data was provided.

9. Conclusions Non clinical and Clinical

The PASS OCT Spinal system components are substantially equivalent to legally marketed predicate device.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.