The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

Device Description

The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.

MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).

Function: The LigaPASS spinal system was developed as an implant:

• To provide temporary stabilization as bone anchor during the development of solid bony fusion.

• To aid the repair of bone fracture.

AI/ML Overview

This document is a 510(k) summary for the Medica International's LigaPASS additional components (LigaPASS 2.0 Band - B08110005 and LigaPASS 2.0 Dual Band - B08110010). It focuses on establishing substantial equivalence to previously cleared LigaPASS devices (K172021). The information provided primarily pertains to the design and material comparisons, and non-clinical testing. It does not include data from a study that typically measures specific performance metrics against pre-defined acceptance criteria in the context of medical device AI or diagnostic accuracy, nor does it involve human readers, ground truth establishment by experts, or training/test sets for an algorithm.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and AI-related studies are not applicable to the content of this 510(k) summary.

However, I can extract the relevant information from the provided text regarding the non-clinical testing and the basis for substantial equivalence.

Here's an interpretation based on the provided document, acknowledging the limitations:

This document is a 510(k) Summary, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. In such cases, the "acceptance criteria" are generally that the new device performs at least as well as, or is technologically similar to, the predicate device in terms of safety and effectiveness, supported by non-clinical (and sometimes clinical) data. There isn't a table of numerical "acceptance criteria" against which a new device's performance is explicitly measured in the way one might expect for a diagnostic or AI-driven device's sensitivity/specificity.

The "study" undertaken here is a comparative analysis and non-clinical testing to demonstrate substantial equivalence.

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

As this is a 510(k) for device modifications (additional components to an existing system) and not a novel diagnostic AI product, there aren't explicit numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly regarding material properties and mechanical performance.

Acceptance Criteria Category	Specific Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Biocompatibility	Same as predicate device (materials, manufacturing)	Met (same materials and similar manufacturing processes as predicates)
Mechanical Performance	Mechanically equivalent to predicate device (e.g., static traction)	Met (LigaPASS 2.0 Dual Band – B08110010 showed mechanical equivalence to predicates in static traction testing)
Intended Use	Same as predicate device	Met (intended uses are identical to predicate devices)
Material Composition	Same as predicate device	Met (PET & Pure titanium (T40) conforming to ASTM F67 for both new components and predicates)
Technological Characteristics	Similar to predicate device (number of braids, braid shape, tips)	Met (as detailed in the comparison table on page 5)

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

For the mechanical testing:

Sample Size: Not explicitly stated in terms of number of units tested, but the document refers to "the LigaPASS 2.0 Dual Band – B08110010" being tested. Typically, mechanical tests would involve a statistically relevant number of samples, but this specific number is not provided in the summary.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is non-clinical laboratory testing, not human data.

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

Not applicable. This device is a mechanical implant, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no "test set" requiring adjudication by experts in this context.

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. This is not an AI-assisted diagnostic or imaging device.

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

Not applicable. This device is a mechanical implant.

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

Not applicable. For mechanical non-clinical testing, the "ground truth" is typically the physical and material properties measured against established engineering standards (e.g., ASTM F67 for titanium, NF EN ISO 13934-1 for static traction) and comparison to the predicate device's known performance.

8. The sample size for the training set

Not applicable. This is a mechanical implant, not an AI-driven device requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

April 3, 2018

Medicrea International S.A. Mr. David Ryan Chief Operating Officer 5389 route de Strasbourg - Vancia Rillieux-la-Pape 69140 FRANCE

Re: K173506

Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: March 5, 2018 Received: March 12, 2018

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 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 (QS) regulation (21 CFR Part 820);

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Page 2 - Mr. David Ryan

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -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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Indications for Use

510(k) Number (if known) K173506

Device Name LigaPASS

Indications for Use (Describe)

-Spinal trauma, used in sublaminar, or facet wiring techniques

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

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)

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510(k) SUMMARY MEDICREA INTERNATIONAL's LigaPASS additional components

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

Date Prepared: November 9th 2017

1. Submitter:

MEDICREA INTERNATIONAL S.A. 5389 route de Strasbourg -Vancia RILLIEUX-LA-PAPE 69140 FR

Contact Person: David RYAN MEDICREA INTERNATIONAL S.A. 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR

1. Trade name: LigaPASS

Regulatory Identification/ Classification

Bone fixation cerclage Regulation Number : 21 CFR 888.3010 Product Code: OWI Class II

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

Primary predicate device:

. LigaPASS, (MEDICREA INTERNATIONAL, K172021)

4. Description of the device:

The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.

MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).

Function: The LigaPASS spinal system was developed as an implant:

• To provide temporary stabilization as bone anchor during the development of solid bony fusion.

• To aid the repair of bone fracture.

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5. Indication for Use

Spinal trauma surgery, used in sublaminar, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis;
Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implant grade implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

6. Substantial equivalence claimed to predicate devices

The LigaPASS 2.0 Band – B08110005 components are technologically similar to the already cleared LigaPASS 2.0 Band – B08100005 in terms of intended use, material used, mechanical safety and performances.

LigaPASS 2.0 Band B08100005 (MEDICREA INTERNATIONAL, K172021) ı
The LigaPASS 2.0 Dual Band – B08110010 components are technologically similar to the already cleared LigaPASS 2.0 Band - B08100010 in terms of intended use, material used, mechanical safety and performances.
LigaPASS 2.0 Dual Band B08100010 (MEDICREA INTERNATIONAL, K172021) ।
The table below compares the features and characteristics of the submitted LigaPASS 2.0 Bands components to their predicate devices.

Device	MEDICREAINTERNATIONALLigaPASS 2.0 Band -B08110005	MEDICREAINTERNATIONALLigaPASS 2.0 DualBand- B08110010	MEDICREAINTERNATIONALLigaPASS 2.0 Band	MEDICREAINTERNATIONALLigaPASS 2.0 DualBand
510(k) number	To bedetermined	To bedetermined	K172021	K172021
Intended use
Thoracic	Yes	Yes	Yes	Yes
Lumbar	Yes	Yes	Yes	Yes
Components
Number of braids	One	Two	One	Two
Braid shape	Flat tubular	Flat tubular	Flat tubular	Flat tubular
Tips	Pure titaniummalleable tips	Pure titaniummalleable tips	Pure titaniummalleable tips	Pure titaniummalleable tips
Material
	PET &	PET &	PET &	PET &
	Pure titanium	Pure titanium	Pure titanium	Pure titanium
	(T40) conforming	(T40) conforming	(T40) conforming	(T40) conforming
	to ASTM F67.	to ASTM F67.	to ASTM F67.	to ASTM F67.

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7. Non-clinical Test Summary:

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

Biocompatibility Testing

The LigaPASS 2.0 Band – B08110005 and the LigaPASS 2.0 Dual Band – B08110010 are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.

Mechanical testing

The tests performed on the LigaPASS 2.0 Dual Band – B08110010 (static traction according to standard NF EN ISO 13934-1) indicate that the product is mechanically equivalent to its predicates.

8. Conclusions

The LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010 are substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.