(530 days)
200458
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an intervertebral body fusion system for treating degenerative disc disease, which is a therapeutic intervention.
No
The device is an intervertebral body fusion device (an implant) used for treatment, not for diagnosis.
No
The device description clearly states it is a physical implant (hollow rectangular shaped block) made of additively manufactured material, 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 medical devices used to perform tests 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 Eminent Spine 3D Cervical Interbody Fusion System is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. Its purpose is structural support and to promote the growth of bone, not to analyze biological samples.
The description clearly indicates a surgical implant for a structural and biological purpose within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Eminent Spine 3D Cervical Interbody Fusion is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP
Device Description
The Eminent Spine 3D Cervical Interbody Fusion System is comprised of various sizes and configuration to accommodate individual patient anatomy. The device is a hollow rectangular shaped block, which is available in a parallel or lordotic configurations. The device is hollow to allow for placement of bone graft. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device.
This submission is to introduce additively manufactured versions of the implants to the existing Eminent Spine Copperhead Interbody Fusion System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc
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)
Substantial equivalence is supported by the results of mechanical testing, including:
- Static and dynamic compression bending per ASTM 2077
- Static and dynamic torsion per ASTM 2077
- Expulsion
- Subsidence per ASTM F2267
Results support that the subject device performs as well as or better than the chosen acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Eminent Spine Copperhead Interbody Fusion System (K090064)
Reference Device(s)
Tailored-C Cervical Interbody Fusion System (200458)
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 shows 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.
February 6, 2023
Eminent Spine % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K212701
Trade/Device Name: Eminent Spine 3D Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 25, 2023 Received: January 25, 2023
Dear Jennifer Palinchik:
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.
1
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 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.
Katherine D. Kavlock -S
for
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K212701 Page 1 of 1
Device Name
Eminent Spine 3D Cervical Interbody Fusion System
Indications for Use (Describe)
The Eminent Spine 3D Cervical Interbody Fusion is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks 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 3 |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------- |
|| | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a caduceus wrapped around it, set against a golden oval. The word "EMINENT" is written in a dark green font above the word "SPINE", which is in a lighter color.
510(k) Summary
| Submitted By: | Eminent Spine
2004 Ventura Dr. Suite #100
Plano, TX 75093 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date: | 01/25/2023 |
| Contact Person: | Jennifer Palinchik, President |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Eminent Spine 3D Cervical Interbody Fusion System |
| Common Name: | Intervertebral Body Fusion Device |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Cervical |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | ODP |
| Primary Predicate Device: | Eminent Spine Copperhead Interbody Fusion System (K090064)
The primary predicate device has never been subject to a recall. |
| Reference Predicate Device: | Tailored-C Cervical Interbody Fusion System (200458)
The reference predicate devices have never been subject to a recall. |
Device Description:
The Eminent Spine 3D Cervical Interbody Fusion System is comprised of various sizes and configuration to accommodate individual patient anatomy. The device is a hollow rectangular shaped block, which is available in a parallel or lordotic configurations. The device is hollow to allow for placement of bone graft. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device.
This submission is to introduce additively manufactured versions of the implants to the existing Eminent Spine Copperhead Interbody Fusion System.
Indications for Use:
The Eminent Spine 3D Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Summary of Technological Characteristics:
The Eminent Spine 3D Cervical Interbody Fusion System and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features
4
Image /page/4/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a snake wrapped around it, set against a circular backdrop with green accents. The word "EMINENT" is prominently displayed above the word "SPINE" in a smaller font size.
- Intended use .
- Materials
- Dimensions
- . Function
| Table 1: Dimensions and Technological Characteristics Comparison | |
|---|---|
| ------------------------------------------------------------------ | -- |
| Item | Eminent Spine 3D
Cervical Interbody
Fusion System
(Subject Device) | Eminent Spine
Interbody Fusion
System (K090064) | Tailored-C Cervical
Interbody Fusion System
(200458) | Comparison |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification Name | Intervertebral Body
Fusion Device | Intervertebral Body
Fusion Device | Intervertebral Body Fusion
Device | Equivalent |
| Regulation | 888.3080 | 888.3080 | 888.3080 | Equivalent |
| Product Code | ODP | ODP | ODP | Equivalent |
| Indications for Use | The Eminent Spine
3D Cervical
Interbody Fusion
System is indicated
for intervertebral
body fusion in
skeletally mature
patients with
degenerative disc
disease (DDD) of
the cervical spine at
one disc level from
the C2-C3 disc to
the C7-T1 disc.
DDD is defined as
discogenic pain with
degeneration of the
disc confirmed by
history and
radiographic
studies. The device
system is designed
for use with
supplemental
fixation and
autograft to
facilitate fusion.
Patients should have
at least six (6)
weeks of non-
operative treatment
prior to treatment | The Eminent Spine
Interbody Fusion System
(Copperhead) is indicated
for intervertebral body
fusion in skeletally
mature patients with
degenerative disc disease
(DDD) of the cervical
spine at one disc level
from the C2-C3 disc to
the C7-T1 disc. DDD is
defined as discogenic
pain with degeneration of
the disc confirmed by
history and radiographic
studies. The device
system is designed for
use with supplemental
fixation and autograft to
facilitate fusion. Patients
should have at least six
(6) weeks of non-
operative treatment prior
to treatment with an
intervertebral cage. | The Tailored-C Cervical
Interbody Fusion Devices are
indicated for use in skeletally
mature
patients with degenerative
disc disease (DDD) of the
cervical spine with
accompanying radicular
symptoms at one disc level.
DDD is defined as
discogenic pain with
degeneration of the disc
confirmed by patient history
and radiographic studies.
Tailored-C Cervical implants
are used to
facilitate intervertebral body
fusion in the cervical spine
and are placed via an anterior
approach
at one disc level (C2-T1)
using autograft bone.
Tailored-C Cervical implants
are to be used with
supplemental fixation.
Patients should have at least
six (6) weeks of non-
operative treatment
prior to treatment with an
intervertebral cage. | Equivalent |
| Item | Eminent Spine 3D
Cervical Interbody
Fusion System
(Subject Device) | Eminent Spine
Interbody Fusion
System (K090064) | Tailored-C Cervical
Interbody Fusion System
(200458) | Comparison |
| | with an
intervertebral cage. | | | |
| Description | The Eminent Spine
3D Cervical
Interbody Fusion
System is comprised
of various sizes and
configuration to
accommodate
individual patient
anatomy. The
device is a hollow
rectangular shaped
block, which is
available in a
parallel or lordotic
configurations.
Copperhead is
hollow to allow for
placement of bone
graft. There are
teeth on the superior
and inferior surfaces
of the device to
inhibit movement of
the device. | The Eminent Spine
Interbody Fusion System
is comprised of various
sizes and configuration to
accommodate individual
patient anatomy. The
configurations are
designed to provide the
surgeon with different
surgical approach
options. | The Tailored-C Cervical
Interbody Fusion System is
an intervertebral spinal
fixation system
comprised of additively
manufactured cervical
interbody spacers. They are
designed to provide
mechanical support to the
cervical spine while
arthrodesis occurs. The
implant has a partially
porous construction and an
open architecture with a large
variety of footprints and
lordosis
angles to optimize patient fit.
The footprints are offered at
11x13mm, 12x14mm,
14x16mm,
16x18mm, and 17x19mm.
The lordosis is offered at 0°,
4°, and 7°. The height ranges
from 5mm
to 12mm in 1mm increments. | Equivalent |
| Footprints | 14x12 mm, 15x13
mm,
17x12 mm,
17x14 mm, 19x16
mm | 14x12 mm, 15x13 mm,
17x12 mm,
17x14 mm, 19x16 mm | 11x13mm,12x14mm,
14x16mm,
16x18mm, 17x19mm | Equivalent |
| Heights | 5-12 mm | 5-12 mm | 5-12 mm | Equivalent |
| Lordotic angle | 0°, 6° | 0°, 6° | 0°, 4°, 7° | Equivalent |
| Material | Ti-6Al-4V ELI per
ASTM F3001 | PEEK Optima LT1 | Ti-6Al-4V per ASTM F3001 | Equivalent |
5
Image /page/5/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a snake wrapped around it, set against a golden circle. The text "EMINENT" is in a larger, bold, green font, while "SPINE" is in a smaller, lighter green font below it.
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing, including:
- Static and dynamic compression bending per ASTM 2077 ●
- Static and dynamic torsion per ASTM 2077 ●
- . Expulsion
6
Image /page/6/Picture/0 description: The image is a logo for Eminent Spine. The logo features a golden sword with a caduceus wrapped around it, set against a golden circle with green accents. Below the emblem, the word "EMINENT" is written in a bold, teal font, with the word "SPINE" in a smaller font underneath.
- Subsidence per ASTM F2267
Results support that the subject device performs as well as or better than the chosen acceptance criteria.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.