(133 days)
No
The summary describes a passive interbody fusion device manufactured using additive manufacturing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is an intervertebral body fusion device used in lumbar spinal fusion procedures for patients with degenerative disc disease, which qualifies it as a therapeutic device.
No
This device is an IB3D™ PL Spinal System, which is an inter-somatic spacer (implant) used in lumbar spinal fusion procedures. It is a therapy device, not a diagnostic one.
No
The device description clearly states that the IB3D™ PL Spinal System implants are physical inter-somatic spacers manufactured from Titanium alloy. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The IB3D™ PL Spinal System is described as an "inter-somatic spacer" intended for surgical implantation between vertebrae in the lumbar spine. It is a physical implant made of titanium alloy.
- Intended Use: The intended use is for lumbar spinal fusion procedures to treat conditions like Degenerative Disc Disease and degenerative scoliosis. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used in the body, not a test performed on a sample from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2 to S1
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
Mechanical Testing: The subject device IB3D™ PL Spinal System worst-case constructs underwent static and dynamic axial compression and compression shear testing in accordance with ASTM E2077 subsidence testing in accordance with ASTM F2267. Impaction testing was also performed as recommended by ISO 23089-2.
Particulate and wear analysis on dynamically loaded specimens was conducted per ASTM F1877.
Clinical tests: No clinical testing was used in order to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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"
1
(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).
2
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
3
Indications for Use
510(k) Number (if known) K241164
Device Name IB3D™ PL Spinal System
Indications for Use (Describe)
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.
| 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 - Vancia | |
| Rillieux-la-Pape, 69140 | |
| France | |
| Phone : 00 33 4 72 01 87 87 | |
| Contact Person | Cécile HUMBERT |
| Sr Regulatory Affairs Specialist | |
| MEDICREA 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 MAX |
| Regulation Number 21 CFR 888.3080 | |
| Regulation Name Intervertebral body fusion device | |
| Class II | |
| III. Predicate devices | |
| Primary predicate device | Device name Capstone Control™ Spinal System |
| 510(k) information K192502, cleared on 01/22/2020 | |
| Common Name Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Product Code MAX, KWQ, MQP, OVD, PLR | |
| Regulation Number 21 CFR 888.3080 | |
| Regulation Name Intervertebral body fusion device | |
| Class II | |
| Additional predicate device | Device name Adaptix Interbody System with Titan nanoLOCK Surface Technology |
| 510(k) information K201267, cleared on 08/26/2020 | |
| Common Name Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Product Code MAX, OLO | |
| Regulation Number 21 CFR 888.3080 | |
| Regulation Name Intervertebral body fusion device | |
| Class II | |
| Additional predicate device | Device name IMPIX 3D Print Cages |
| 510(k) information K163595, cleared on 11/13/2017 | |
| Common Name Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Product Code MAX | |
| Regulation Number 21 CFR 888.3080 | |
| Regulation Name Intervertebral body fusion device | |
| Class II | |
| V. | Indications for use |
| The 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 with 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. | |
| 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 device | |
| and the predicate devices are intended to help provide immobilization and stabilization of spinal | |
| segments of the thoracic, lumbar, and sacral spine. | |
| VII. | Performance data |
| Nonclinical tests | The following non-clinical performance data were provided in support of |
| substantial equivalence: | |
| Mechanical Testing | |
| The subject device IB3D™ PL Spinal System worst-case constructs underwent | |
| static and dynamic axial compression and compression shear testing in | |
| accordance with ASTM E2077 subsidence testing in accordance with ASTM |
5
IV. Subject 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.
V. Intended use and indications for use
F2267. Impaction testing was also performed as recommended by ISO 23089-2.
6
| | Particulate and wear analysis on dynamically loaded specimens was conducted
per 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 predicate
devices: | |
| | – 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) -