(29 days)
No
The document describes surgical instruments (inserters) and implants (cages) for spinal fusion. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of AI/ML technology. The performance studies focus on mechanical endurance testing of the instruments.
Yes.
The device is used in intervertebral body fusion procedures to treat degenerative disc disease, which involves a therapeutic intervention.
No
Explanation: The device, CONDUIT™ LLIF Straight Inserters, is described as being used with EIT Cellular Titanium® LLIF Cages for intervertebral body fusion procedures. It is an instrument for surgery, not for diagnosing conditions.
No
The device description explicitly states the device is made from "commonly used orthopedic materials" and is a "reusable instrument," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical insertion of spinal implants (LLIF Cages) during intervertebral body fusion procedures. This is a surgical tool used directly on the patient during a procedure.
- Device Description: The device is described as reusable instruments designed to interface with spinal cages during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale 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.
Product codes
MAX
Device Description
The CONDUIT™ LLIF Straight Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from 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
Non-clinical testing was conducted to confirm device performance per intended use including impact endurance test, and thread endurance test. The results of this non-clinical testing show that the performance of the CONDUIT™ LLIF Straight Inserters are sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
January 5, 2023
Enztec Limited % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K223671
Trade/Device Name: CONDUIT™ LLIF Straight Inserters Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 7, 2022 Received: December 7, 2022
Dear Mr. Wright:
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 -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) K223671
Device Name CONDUIT™ LLIF Straight Inserters
Indications for Use (Describe)
The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale 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.
| 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
| Submitter's Name: | Enztec Limited | |
|---|---|---|
| Submitter's Address: | 3/17 Print Place | |
| Middleton, Christchurch 8024 | ||
| Submitter's Telephone: | +64 27 829 2440 | |
| Contact Person: | Nathan Wright MS | |
| Empirical Technologies | ||
| 719-351-0248 | ||
| nwright@empiricaltech.com | Image: Empirical Technologies logo | |
| Date Summary was Prepared: | December 7, 2022 | |
| Trade or Proprietary Name: | CONDUIT™ LLIF Straight Inserters | |
| Device Classification Name: | Implant insertion tool for intervertebral fusion device with bone graft, | |
| lumbar | ||
| Classification & Regulation #: | Class II per 21 CFR §888.3080 | |
| Product Code: | MAX | |
| Classification Panel: | Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CONDUIT™ LLIF Straight Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.
INDICATIONS FOR USE
The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale 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-S 1. 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.
TECHNOLOGICAL CHARACTERISTICS
CONDUIT™ LLIF Straight Inserters are made from Stainless Steel per ASTM F899 and Radel in conformance with USP Class VI. The subject and predicate devices have nearly identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use ●
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- Materials of manufacture ●
- Sterility ●
- Compatibility ●
Primary Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Predicate
Type |
|----------------|------------------------------------|---------------|-------------------|
| K212823 | DePuy CONDUITT™ Angled Inserters | DePuy Synthes | MAX |
PERFORMANCE DATA
Non-clinical testing was conducted to confirm device performance per intended use including impact endurance test, and thread endurance test. The results of this non-clinical testing show that the performance of the CONDUIT™ LLIF Straight Inserters are sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the CONDUIT™ LLIF Straight Inserters is substantially equivalent to the predicate device.