(56 days)
The CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages: EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® ALIF Cage, EIT Cellular Titanium® TLIF Cage, EIT Cellular Titanium® LLIF Cage, EIT Cellular Titanium® T/PLIF Cage.
The CONDUIT™ Instruments are non-sterile, reusable instruments that may be used during placement of various EIT Cellular Titanium® Interbody Cages during spinal surgery. The CONDUIT™ Instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national standards specifications. The purpose of this submission is to introduce a new set of instruments to be used with the EIT Cellular Titanium® Cervical and Lumbar Cages and there are no changes to the implant devices.
The provided text is a 510(k) Premarket Notification summary for the CONDUIT™ Instruments, which are non-sterile, reusable instruments used in spinal surgery. This document primarily focuses on demonstrating substantial equivalence to a predicate device (EIT Cellular Titanium® Interbody Cages, K201605) based on intended use, technological characteristics, and performance.
Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance metrics for an AI/algorithm-based medical device aiming to achieve clinical performance goals (e.g., sensitivity, specificity, accuracy).
Instead, the document references "Non-clinical testing conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use." This type of testing typically involves:
- Mechanical/functional testing: Ensuring the instruments function as intended (e.g., proper grip, secure attachment to implants, durability).
- Biocompatibility: Confirmation that materials are safe for patient contact (though these are instruments, not implants, so direct patient contact for prolonged periods is less relevant, but sterilization and handling are).
- Sterilization validation: Ensuring the instruments can be effectively sterilized for reuse.
- Material verification: Confirmation that the materials meet specified ASTM standards.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/algorithm for this specific device from the given text.
The closest I can get to a "study" is the statement in section H:
"Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The results demonstrate that the device performs as well as the predicate devices for the compared design inputs."
This implies a comparison against a predicate, likely in terms of functional equivalence and safety, rather than a clinical performance study with specific AI metrics.
In summary, none of the requested information (acceptance criteria for AI, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, standalone AI performance, training set details) is present in the provided FDA 510(k) documentation for the CONDUIT™ Instruments because it is a submission for surgical instruments, not an AI/algorithm-driven device.
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May 6, 2021
Medos International, SARL % Ms. Christine Cahillane Regulatory Affairs Specialist DePuy Spine 325 Paramount Dr. Raynham, Massachusetts 02767
Re: K210728
Trade/Device Name: CONDUIT™ Instruments Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: March 9, 2021 Received: March 11, 2021
Dear Ms. Cahillane:
We have reviewed vour 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 5 10(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
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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,
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210728
Device Name CONDUITTM Instruments
Indications for Use (Describe)
The CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages:
EIT Cellular Titanium® Cervical Cage
The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.
EIT Cellular Titanium® ALIF Cage
The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.
EIT Cellular Titanium® TLIF Cage
The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are 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 non-operative treatment with an intervertebral cage.
EIT Cellular Titanium® T/PLIF Cage
The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 = S1 whose condition requires the use of interbody
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fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.
| 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
| Manufacturer: | Medos International, SARLChemin-Blanc 382400 Le Locle, Switzerland |
|---|---|
| Contact: | Christine CahillaneDePuy Synthes325 Paramount DriveRaynham, MA 02767 |
| Telephone Number: | 508-828-3064 |
| Email Address: | ccahilla@its.jnj.com |
| A. Date Prepared | April 5, 2021 |
| B. Device Name | |
| Trade/Proprietary Name: | CONDUIT™ Instruments |
| Device Classificationand Regulation: | Class II per 21 CFR §888.3080 |
| Classification Productand Panel Codes: | ODP - Intervertebral Fusion Device with Bone Graft,CervicalMAX - Intervertebral Fusion Device with Bone Graft,Lumbar |
| C. Predicate Device Names | |
| Primary Predicate: | EIT Cellular Titanium® Interbody Cages (K201605) |
D. Device Description
The CONDUIT™ Instruments are non-sterile, reusable instruments that may be used during placement of various EIT Cellular Titanium® Interbody Cages during spinal surgery. The CONDUIT™ Instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national standards specifications. The purpose of this submission is to introduce a new set of instruments to be used with the EIT Cellular Titanium® Cervical and Lumbar Cages and there are no changes to the implant devices.
E. Indications for Use
The CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages:
EIT Cellular Titanium® Cervical Cage
The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior
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cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.
EIT Cellular Titanium® ALIF Cage
The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® TLIF Cage
The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages 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 non-operative treatment prior to treatment with an intervertebral cage.
EIT Cellular Titanium® T/PLIF Cage
The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative
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disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The intended use, technological characteristics, and performance including material, design and performance of the CONDUIT Instruments are consistent with those of the predicate devices.
G. Materials
The CONDUIT Instruments are constructed from Stainless Steel and Radel in conformance with ASTM standards: F899, A276, A693, A564/A564M, and D6934.
H. Performance Testing Summary
Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The results demonstrate that the device performs as well as the predicate devices for the compared design inputs.
I. Conclusion
The indications for use and intended use of the subject device are consistent with those of the predicate devices. Comparison of technological characteristics and results of performance testing demonstrate that the modifications to the design do not introduce any new questions of safety or effectiveness and, are therefore, substantially equivalent to the predicate devices.
§ 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.