(132 days)
No
The summary describes a surgical instrument (inserter) and an implant (cage) for spinal fusion. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities. The performance studies are bench tests and usability tests, not studies evaluating algorithmic performance.
Yes
The EIT Cellular Titanium® LLIF Cage, which the inserter is designed to be used with, is indicated for intervertebral body fusion procedures for degenerative disc disease, which is a therapeutic intervention.
No
This device is an inserter for intervertebral body fusion cages and is used to implant the cages during surgery. It is a surgical instrument, not a device that diagnoses a condition.
No
The device description explicitly states it is a "reusable instrument" made from "commonly used orthopedic materials," indicating it is a physical hardware device, not software.
Based on the provided text, 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: The description clearly states that the DePuy CONDUIT™ LLIF SQUID Inserter is a reusable instrument designed for use during surgical procedures (Lumbar Interbody Fusion). It is used to insert a spinal implant (the EIT Cellular Titanium® LLIF Cage) into the body.
- Intended Use: The intended use is to facilitate the insertion of a spinal implant for intervertebral body fusion. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure, not in vitro (in glass, or outside the body) for diagnostic purposes.
N/A
Intended Use / 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 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.
Product codes
MAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar and sacral spine)
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 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.
Key Metrics
Not Found
Predicate Device(s)
K210728, K201605, K212823, K072791
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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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
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 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
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.
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 Place |
| Middleton, Christchurch 8024 | |
| Submitter's Telephone: | +64 27 829 2440 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 1-719-351-0248 | |
| nwright@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:
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.
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 or
Model Name | Manufacturer | Product
Code | Predicate
Type |
|-------------|----------------------------------------|-------------------------------------------------------------------------|-----------------|-------------------|
| K210728 | CONDUIT™ Instruments | DePuy Synthes | ODP, MAX | Primary |
| K201605 | EIT Cellular Titanium®
Cages | EIT Emerging Implant
Technologies GmbH (with
DePuy Synthes Spine) | ODP, MAX | Additional |
| K212823 | DePuy CONDUIT LLIF
Angled 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.