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 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.

Device Description

The DePuy CONDUIT™ LLIF SQUID Inserter is designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instrument has been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instrument is provided non-sterile and made from commonly used orthopedic materials. There are no changes to the implants or to other instruments provided with the implants.

AI/ML Overview

The provided document describes a medical device, the "DePuy CONDUIT™ LLIF SQUID Inserter," and its clearance process through the FDA 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/ML device (e.g., AUC, sensitivity, specificity, physician performance with/without AI, expert adjudication, ground truth establishment) are not applicable to this submission. This document describes a surgical instrument and its mechanical and functional performance, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the information provided, explicitly stating where specific requested details are not relevant or available:

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

For this type of device (a surgical instrument), acceptance criteria are typically related to mechanical integrity, functionality, and compatibility, rather than clinical performance metrics like sensitivity or specificity.

Acceptance Criterion	Reported Device Performance
Functionality	Sufficient for intended use (Confirmed via functionality bench test)
Impact Endurance	Passed impact test
Thread Endurance	Passed thread endurance test
Usability	Acceptable (Confirmed via formative usability test)
Compatibility	Confirmed compatible with EIT Cellular Titanium® LLIF Cages and predicate devices
Material Composition	Primarily Stainless Steel per ASTM F899 (for implant- and patient-contacting components). Meets requirements for intended use.
Sterility	Provided non-sterile (Consistent with predicate; implies sterilization by user)

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

Test Set Sample Size: Not explicitly stated as a numerical sample size. The "bench tests" and "formative usability test" would have involved a sufficient number of device units and/or simulated use cases to demonstrate robust performance. However, these are not clinical "test sets" in the sense of patient data.
Data Provenance: The tests are described as "non-clinical testing" and "bench tests," indicating in-house engineering and laboratory testing rather than patient data from a specific country or retrospective/prospective study.

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

Not Applicable. This is a mechanical/functional device, not an AI/ML device requiring expert interpretation of medical images or data for ground truth. Ground truth for these tests would be established by engineering specifications and successful completion of physical actions (e.g., the inserter successfully grips the cage).

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

Not Applicable. As no expert interpretation or diagnostic classification is involved, no adjudication method is relevant.

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

No, an MRMC study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical surgical instrument, not an algorithm.

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

For surgical instruments, "ground truth" relates to successful mechanical function, adherence to material specifications, and safe interaction with other components (e.g., the implant cage) and the surgical environment. It is established by:
- Engineering specifications and standards: The device must meet predefined mechanical strength, endurance, and dimensional tolerances.
- Functional verification: The device must reliably perform its intended action (e.g., grasp, insert, release an implant).
- Material conformity: Verification that materials meet specified ASTM standards.

8. The sample size for the training set

Not Applicable. This is a manufactured physical device, not an AI/ML model that is 'trained' on data.

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

Not Applicable. No training set for an AI/ML model is involved.

Summary

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June 28, 2022

Enztec Limited % Nathan Wright, MS Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K220449

Trade/Device Name: DePuy CONDUIT™ LLIF SQUID Inserter Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 26, 2022 Received: May 27, 2022

Dear Nathan 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

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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 medical devices and radiation-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) K220449

Device Name

DePuy CONDUIT™ LLIF SQUID Inserter

Indications for Use (Describe)

The DePuy CONDUIT™ LLIF SQUID Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

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

Submitter's Name:	Enztec Limited
Submitter's Address:	3/17 Print PlaceMiddleton, Christchurch 8024
Submitter's Telephone:	+64 27 829 2440
Contact Person:	Nathan Wright MSEmpirical Testing Corp.1-719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	February 14, 2022
Trade or Proprietary Name:	DePuy CONDUIT™ LLIF SQUID Inserter
Common or Usual Name:	Implant insertion tool for intervertebral fusion device with bone graft, lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	OR: Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The DePuy CONDUIT™ LLIF SQUID 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 nicro 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-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 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

DePuy CONDUIT™ LLIF SQUID Inserters are made primarily from Stainless Steel per ASTM F899 (note: all implant contacting and patient tissue and bone contacting components are Stainless Steel per ASTM F899) with accessory components of other metal or plastic materials. The subject and predicate devices have nearly identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:

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Indications for Use ●
Materials of manufacture (for implant- and patient-contacting components)
Sterility ●
. Compatibility

Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	ProductCode	PredicateType
K210728	CONDUIT™ Instruments	DePuy Synthes	ODP, MAX	Primary
K201605	EIT Cellular Titanium®Cages	EIT Emerging ImplantTechnologies GmbH (withDePuy Synthes Spine)	ODP, MAX	Additional
K212823	DePuy CONDUIT LLIFAngled Inserters	Enztec Limited	MAX	Additional
K072791	Synthes Oracle Spacer	Synthes Spine	MAX, MQP	Additional

PERFORMANCE DATA

Non-clinical testing was conducted to confirm device performance per intended use including functionality bench test, impact test, thread endurance test, and formative usability test. The results of this non-clinical testing show that the performance of the DePuy CONDUIT™ LLIF SQUID 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 DePuy CONDUIT™ LLIF SQUID Inserter is substantially equivalent to the predicate device.

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.