(179 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests of the device itself.
Yes.
The device is used to facilitate fusion in patients with degenerative disc disease, which is a therapeutic treatment.
No
This device is an intervertebral body fusion device used for treatment, not diagnosis. It is implanted to facilitate fusion based on pre-existing diagnoses confirmed by history and radiographic studies.
No
The device description clearly states it is comprised of physical components (cages, markers, instruments) made of materials like PEEK, titanium, tantalum, and stainless steel. It also describes non-clinical testing of these physical components.
No, 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 Function: The Integrity Spine Core System is a physical implant (a cervical intervertebral body fusion device) designed to be surgically placed in the spine to facilitate fusion. It is a therapeutic device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion" in patients with degenerative disc disease. This is a treatment, not a diagnostic process.
- Device Description: The description details the materials and components of the implant itself, not reagents or equipment for analyzing biological samples.
- Performance Studies: The performance studies listed are mechanical tests (compression, torsion, subsidence, expulsion) related to the physical properties and function of the implant, not studies evaluating the accuracy of a diagnostic test.
The device is used in conjunction with "radiographic studies" to confirm the diagnosis of degenerative disc disease, but the device itself does not perform the diagnostic function. The radiographic studies are the diagnostic tools in this scenario.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms 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 with 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 Integrity Spine Core System is a cervical interbody fusion system comprised of lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.
The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray coated with titanium that conforms to ASTM F1580. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the surgeon with proper placement of the device.
The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel that conforms to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, 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)
Non-clinical Testing:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-11
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11
- Subsidence testing, conducted in accordance with ASTM F2267-04
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2023
Integrity Spine % Jennifer Palinchik President JALEX Medical 27865 Clemens Rd. Suite 3 Westlake, Ohio 44145
Re: K223043
Trade/Device Name: The Integrity Spine Core System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 22, 2023 Received: February 23, 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 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)
Device Name The Integrity Spine Core System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms 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 with 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 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Integrity Spine. The logo features the letters "I" and "S" in a stylized font, with the word "Integrity" in red above the word "Spine" in black. To the left of the letters is a spine graphic. The logo is clean and professional, and it conveys a sense of trust and expertise.
510(k) Summary
| Submitted By: | Integrity Spine
414 W Sunset Rd Ste 205
Dallas, TX 75206 |
|-----------------------------|------------------------------------------------------------------------------|
| Date: | 03/16/2023 |
| Contact Person: | Jennifer Palinchik, President
JALEX Medical |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Integrity Spine Core System |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Cervical |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | ODP |
| Predicate Device: | K132718 Integrity Spine Core System |
| Additional Predicate: | K133967 Aurora Spine Interbody Fusion System |
| | The predicate devices have not been subject to any design related
recalls |
Device Description:
The Integrity Spine Core System is a cervical interbody fusion system comprised of lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.
The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray coated with titanium that conforms to ASTM F1580. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the surgeon with proper placement of the device.
The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel that conforms to ASTM F899.
Intended Use:
When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms 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 with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
4
Image /page/4/Picture/0 description: The image is a logo for Integrity Spine. The logo features the letters "I" and "S" in a stylized font, with a spine graphic incorporated into the "I". The word "Integrity" is written in red above the word "Spine", which is written in black. The logo is clean and professional, and it effectively communicates the company's focus on spinal health.
Summary of Technological Characteristics:
The Integrity Spine Core System and the primary predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features
- Intended use ●
- Materials
- Dimensions .
- . Function
| Feature | Integrity Spine Core System (Subject) | Integrity Spine Core System (K132718) | Aurora Spine Interbody Fusion System (K133967) | Comparison |
|---|---|---|---|---|
| Classification Name | Intervertebral Body Fusion Device with Integrated Fixation, Cervical | Intervertebral Body Fusion Device with Integrated Fixation, Cervical | Intervertebral Body Fusion Device with Integrated Fixation, Cervical | Equivalent |
| Regulation | 888.3080 | 888.3080 | 888.3080 | Equivalent |
| Product Code | ODP | ODP | ODP | Equivalent |
| Device Description | The Integrity Spine Core System is a cervical interbody fusion system comprised of lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach. |
The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray | The Integrity Spine Core System is a cervical interbody fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.
The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the | The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed | Equivalent |
| Feature | Integrity Spine
Core System
(Subject) | Integrity Spine Core
System (K132718) | Aurora Spine
Interbody Fusion
System (K133967) | Comparison |
| | coated with
titanium that
conforms to ASTM
F1580.
Additionally, the
devices contain
tantalum markers
that conform to
ASTM F560 to
assist the surgeon
with proper
placement of the
device. | surgeon with proper
placement of the
device.
The Integrity Spine
Core System is
implanted using a
combination of device
specific and universal
class I instruments
manufactured from
stainless steel that
conforms to ASTM
F899. | commercially pure
titanium coating on
the superior and
inferior surfaces. | |
| Intended Use | When used as a
cervical
intervertebral body
fusion device, the
Integrity Spine
Core System is
indicated for
intervertebral body
fusion in skeletally
mature patients
with degenerative
disc disease (DDD)
of the cervical
spine with
accompanying
radicular symptoms
at one disc level
from the C2-C3
disc to the C7-T1
disc. DDD is
defined as | When used as a
cervical intervertebral
body fusion device,
the Integrity Spine
Core System is
indicated for
intervertebral body
fusion in skeletally
mature patients with
degenerative disc
disease (DDD) of the
cervical spine with
accompanying
radicular symptoms 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 | The Aurora Spine
Interbody Fusion
System is indicated
for use as an
intervertebral body
fusion device in
skeletally mature
patients with
degenerative disc
disease (defined as
discogenic back pain
with degeneration of
the disc confirmed
by patient history
and radiographic
studies) at one level
of the cervical spine
with accompanying
radicular symptoms.
Patients should have
six weeks of non- | Equivalent |
| Feature | Integrity Spine Core System (Subject) | Integrity Spine Core System (K132718) | Aurora Spine Interbody Fusion System (K133967) | Comparison |
| | discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. | radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. | operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used. | |
| Interbody Heights | 5-11 mm | 5-11 mm | 5-12 mm | Equivalent |
| Interbody Footprints | 14x11 mm, 17x13 mm | 14x11 mm, 17x13 mm | 14x12 mm, 16x14 mm | Equivalent |
| Lordosis | 6° | 0° and 6° | 5° | Equivalent |
| Implant Materials | PEEK Zeniva ZA-500 Per ASTM F2026, Titanium coating Per ASTM F1580, Tantalum markers Per ASTM F560 | PEEK Zeniva ZA-500 Per ASTM F2026, Tantalum markers Per ASTM F560 | PEEK Optima Per ASTM F2026, Titanium coating per ASTM F67, Tantalum markers Per ASTM F560 | Equivalent |
Table 1, Technological Characteristics Comparison
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Image /page/5/Picture/0 description: The image is a logo for Integrity Spine. The logo features a stylized spine graphic integrated into the letters "I" and "S". The word "Integrity" is in red above the word "Spine" which is in black.
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Image /page/6/Picture/0 description: The image contains a logo for "Integrity Spine". The logo features a stylized spine graphic integrated into the letters "I" and "S". The word "Integrity" is in red, and the word "Spine" is in black.
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Image /page/7/Picture/0 description: The image is a logo for Integrity Spine. The logo features the words "Integrity Spine" in a bold, sans-serif font. The word "Integrity" is in red, while the word "Spine" is in black. To the left of the words is a stylized image of a spine in black and white, with a red square behind it. The logo is simple and professional, and it conveys the message that Integrity Spine is a reliable and trustworthy provider of spinal care.
Non-clinical Testing:
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-11 ●
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11 ●
- Subsidence testing, conducted in accordance with ASTM F2267-04
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 ●
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.