(111 days)
Not Found
No
The summary describes a physical spinal implant and an optional plate, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical and biological, not related to data analysis or image processing.
Yes
The device is an intervertebral body fusion cage intended for use in treating degenerative disc disease, which explicitly states its purpose in treating a medical condition.
No
This device is an implantable medical device (LLIF Cage, a spinal implant for intervertebral body fusion) used in treatment, not for diagnosing conditions. The indication for use mentions "degeneration of the disc confirmed by patient history and radiographic studies," implying that diagnosis is performed externally, not by the device itself.
No
The device description clearly states it is a physical implant (cage and plate) made of titanium alloy, intended for surgical implantation in the lumbar spine. It also describes mechanical and biological testing, which are relevant to physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a spinal implant (a cage and an optional plate) intended for surgical implantation in the lumbar spine to facilitate intervertebral body fusion. It is a physical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the EIT Cellular Titanium® LLIF Cage and the CONDUIT™ Lateral Switch Plate are medical devices, specifically surgical implants, and not in vitro diagnostics.
N/A
Intended Use / Indications for Use
When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD
Device Description
The CONDUIT™ Lateral Switch Plate ("Plate") is an optional device that connects to the EIT Cellular Titanium® LLIF Cage ("Cage") and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws ("Screws"). The subject device is not considered to be supplemental fixation. Both the Plate and Screws are manufactured from ASTM F136 titanium alloy (Ti-6A1-4V ELI). The Plate is supplied sterile in one- and two-hole configurations in a variety of sizes to attach to one or both adjacent vertebral bodies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, L2-S1
Indicated Patient Age Range
Skeletally mature patients
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)
Mechanical Testing:
- Dynamic Axial Compression (ASTM F2077-18)
- Dynamic Compression Shear (ASTM F2077-18)
- Static Axial Compression analysis (ASTM F2077-18)
- Static Compression Shear analysis (ASTM F2077-18)
- Subsidence analysis (ASTM F2267-04)
- Expulsion analysis
Biological Evaluation:
- Evaluated and tested in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. Results demonstrate compliance with applicable requirements.
MRI Safety Testing:
- Performed per ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2.
Key Results: The subject device is substantially equivalent to legally marketed predicate devices with respect to indications for use, design, function, material composition, and performance testing per testing standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2022
Medos International, SARL % LiJuan He Associate Director, Regulatory Affairs DePuy Spine 325 Paramount Dr. Raynham, Massachusetts 02767
Re: K221325
Trade/Device Name: CONDUIT™ Lateral Switch Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: July 27, 2022 Received: July 28, 2022
Dear LiJuan He:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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).
Sincerely,
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) K221325
Device Name CONDUIT™ Lateral Switch Plate
Indications for Use (Describe)
When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
| 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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Image /page/3/Picture/1 description: The image shows the DePuy Synthes logo. The logo consists of a red figure-eight-like symbol on the left, followed by the words "DePuy Synthes" in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF" in smaller gray font, followed by "Johnson & Johnson" in red script.
510(K) SUMMARY
| A. | Submitter Information | |
|---|---|---|
| Manufacturer: | Medos International SARL | |
| Chemin-Blanc 38 | ||
| 2400 Le Locle, Switzerland | ||
| Submitter: | DePuy Synthes Spine | |
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person: | ||
| Telephone: | ||
| Email: | LiJuan He | |
| 978-406-7629 | ||
| lhe10@its.jnj.com | ||
| B. | Date Prepared | August 19, 2022 |
| C. | Device Name | |
| Trade/Proprietary Name: | CONDUIT™ Lateral Switch Plate | |
| Device Classification | ||
| and Regulation: | Class II per 21 CFR §888.3080 | |
| Product Codes: | MAX, OVD | |
| D. | Predicate Device Names | |
| Primary Predicate: | Nuvasive Modulus XLIF (K192760) | |
| Additional Predicate: | EIT Cellular Titanium® Lumbar Cage LLIF | |
| (K181644); EIT Cellular Titanium® Cervical | ||
| Cage (K201605) | ||
E. Device Description Summary
The CONDUIT™ Lateral Switch Plate ("Plate") is an optional device that connects to the EIT Cellular Titanium® LLIF Cage ("Cage") and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws ("Screws"). The subject device is not considered to be supplemental fixation. Both the Plate and Screws are manufactured from ASTM F136 titanium alloy (Ti-6A1-4V ELI). The Plate is supplied sterile in one- and two-hole configurations in a variety of sizes to attach to one or both adjacent vertebral bodies.
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Image /page/4/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract symbol on the left, followed by the company name in gray, with the words "THE ORTHOPAEDICS COMPANY OF" in smaller gray font underneath. Below that is the Johnson & Johnson logo in red script.
F. Indented Use/Indications for Use
When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
G. Indications for Use Comparison
The subject device (Plate) with the EIT Cellular Titanium® Lumbar LLIF Cage and screws comprise an implant system which has indications for use similar to those of the predicate devices.
F. Non-Clinical Test Summary and Conclusions
-
- Mechanical Testing
The following tests and analyses were performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices:
- Mechanical Testing
-
· Dynamic Axial Compression (ASTM F2077-18)
-
· Dynamic Compression Shear (ASTM F2077-18)
-
· Static Axial Compression analysis (ASTM F2077-18)
-
· Static Compression Shear analysis (ASTM F2077-18)
-
· Subsidence analysis (ASTM F2267-04)
-
Expulsion analysis
-
- The subject devices were evaluated and tested in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. The results demonstrate the subject devices comply with the applicable requirements of ISO 10993-1:2018
-
- MRI Safety Testing per ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2
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Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, The Orthopaedics Company of Johnson & Johnson. The logo features a red symbol resembling a stylized spine or interconnected loops on the left. To the right of the symbol is the company name "DePuy Synthes" in a bold, gray sans-serif font. Below the company name, in a smaller font, is the text "THE ORTHOPAEDICS COMPANY OF" followed by "Johnson & Johnson" in a red, cursive script.
The subject device is substantially equivalent to legally marketed predicate devices with respect to indications for use, design, function, material composition, and performance testing per testing standards.