IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

Device Description

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136.

The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only.

The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.

AI/ML Overview

This is a medical device submission, not an AI/ML device submission. Therefore, it does not contain information about acceptance criteria, test sets, ground truth, or training sets typical for AI/ML performance evaluation.

The provided document describes the IB3D™ PL Spinal System, an intervertebral body fusion device. The acceptance criteria and supporting studies for this type of device focus on mechanical performance, biocompatibility, and manufacturing quality, not diagnostic accuracy or AI algorithm performance.

Here's a breakdown of the relevant information from the document:

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

The document mentions several non-clinical tests performed to support substantial equivalence. These tests serve as the basis for demonstrating the device meets certain performance criteria. However, explicit "acceptance criteria" presented in a table format with corresponding "reported device performance" values are not detailed in this summary.

Non-clinical tests performed in support of substantial equivalence:

Test Name	Standard/Method
Mechanical Testing
Static and Dynamic Axial Compression	ASTM E2077
Compression Shear Testing	ASTM E2077
Subsidence Testing	ASTM F2267
Impaction Testing	ISO 23089-2 (recommended)
Particulate and wear analysis	ASTM F1877

The summary states that these tests were performed on "worst-case constructs" of the IB3D™ PL Spinal System. The implication is that the device met the performance requirements of these standards, demonstrating substantial equivalence to its predicates.

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

For mechanical and material tests of this nature, "sample size" typically refers to the number of test articles (implants) subjected to testing. This information is not specified in the provided 510(k) summary. The document does not describe patient data (e.g., country of origin, retrospective/prospective) because no clinical testing was used to support the submission.

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

This information is not applicable as the submission is for a medical device (intervertebral body fusion device) and does not involve diagnostic interpretation or AI algorithm evaluation requiring human experts to establish ground truth from medical images or clinical data.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable as this is not an AI-assisted device. The submission explicitly states: "No clinical testing was used in order to support this submission."

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

This information is not applicable as this is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the specified test standards (ASTM, ISO). Meeting the criteria outlined in these standards for mechanical strength, fatigue, wear, and biocompatibility constitutes the "ground truth" for proving the device's performance characteristics and safety.

8. The sample size for the training set:

This information is not applicable as this is a medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as this is not an AI/ML product.

Summary

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September 6, 2024

Medicrea International S.A.S. (Medtronic) Cecile Humbert Sr. Regulatory Affairs Specialist 5389 Route de Strasbourg - Vancia Rillieux-la-Pape, 69140 France

Re: K241164

Trade/Device Name: IB3D™ PL Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 25, 2024 Received: April 26, 2024

Dear Cecile Humbert:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241164

Device Name IB3D™ PL Spinal System

Indications for Use (Describe)

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

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 IB3D™ PL Spinal System

Date prepared: April 26, 2024

I. Submitter information
Submitter	MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)5389 Route de Strasbourg - VanciaRillieux-la-Pape, 69140FrancePhone : 00 33 4 72 01 87 87
Contact Person	Cécile HUMBERTSr Regulatory Affairs SpecialistMEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
II. Device identification
Trade name	IB3D™ PL Spinal System
Classification	Common Name Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation	Product Code MAXRegulation Number 21 CFR 888.3080Regulation Name Intervertebral body fusion deviceClass II
III. Predicate devices
Primary predicate device	Device name Capstone Control™ Spinal System510(k) information K192502, cleared on 01/22/2020Common Name Intervertebral Fusion Device With Bone Graft, LumbarProduct Code MAX, KWQ, MQP, OVD, PLRRegulation Number 21 CFR 888.3080Regulation Name Intervertebral body fusion deviceClass II
Additional predicate device	Device name Adaptix Interbody System with Titan nanoLOCK Surface Technology510(k) information K201267, cleared on 08/26/2020Common Name Intervertebral Fusion Device With Bone Graft, LumbarProduct Code MAX, OLORegulation Number 21 CFR 888.3080Regulation Name Intervertebral body fusion deviceClass II
Additional predicate device	Device name IMPIX 3D Print Cages510(k) information K163595, cleared on 11/13/2017Common Name Intervertebral Fusion Device With Bone Graft, LumbarProduct Code MAXRegulation Number 21 CFR 888.3080Regulation Name Intervertebral body fusion deviceClass II
V.	Indications for use
	The IB3D™ PL Spinal System is indicated for use in lumbar spinal fusionprocedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies. DDDpatients may also have up to Grade 1 spondylolisthesis or retrolisthesis at theinvolved levels. When used for these indications, the IB3D™ PL Spinal System isintended for use with supplemental fixation systems cleared for use in the lumbarspine.
	Additionally, the IB3D™ PL Spinal System can be used to provide anterior columnsupport in patients diagnosed with degenerative scoliosis as an adjunct to pediclescrew fixation.
	All patients should be skeletally mature and have had at least 6 months ofnonoperative treatment. The IB3D™ PL Spinal System is intended to be used withautogenous bone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate when the subject device is used as an adjunct to fusion. Theseimplants may be implanted via an open or a minimally invasive posterior ortransforaminal approach. When implanting via posterior approach (PLIF), aminimum of two implants is required per spinal level.
VI.	Comparison of technological characteristics
	The subject devices have similar fundamental scientific technology, material, overall design, dimensions,operative principle intended use, indications and sterilization as the predicate devices. The subject deviceand the predicate devices are intended to help provide immobilization and stabilization of spinalsegments of the thoracic, lumbar, and sacral spine.
VII.	Performance data
Nonclinical tests	The following non-clinical performance data were provided in support ofsubstantial equivalence:
	Mechanical Testing
	The subject device IB3D™ PL Spinal System worst-case constructs underwentstatic and dynamic axial compression and compression shear testing inaccordance with ASTM E2077 subsidence testing in accordance with ASTM

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IV. Subject device description

The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only.

V. Intended use and indications for use

F2267. Impaction testing was also performed as recommended by ISO 23089-2.

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	Particulate and wear analysis on dynamically loaded specimens was conductedper ASTM F1877.
Clinical tests	No clinical testing was used in order to support this submission.
VIII.	Conclusion
Based on the information contained in this submission, MEDICREA INTERNATIONAL (MEDTRONIC)believes that the subject IB3D™ PL Spinal System is substantially equivalent to the following predicatedevices:
	– Predicate 1 (Primary Predicate): CAPSTONE CONTROL (K192502, S.E. 01/22/2020)
	– Predicate 2 (Additional Predicate): ADAPTIX (K201267, S.E. 08/26/2020)

Predicate 3 (Additional Predicate): IMPIX 3D PRINT (K163595, S.E. 11/13/2017) -

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.