(90 days)
No
The description focuses on the mechanical design and function of an expandable interbody fusion device and does not mention any AI or ML components.
Yes.
The device is intended for spinal intervertebral body fusion to treat degenerative disc disease and facilitate intervertebral body fusion, which are therapeutic actions.
No
The device is an interbody fusion system designed for spinal fusion, not for diagnosing medical conditions. It provides structural support and stability to facilitate fusion after discectomy.
No
The device description clearly states it is an expandable lumbar intervertebral body fusion device consisting of a shell and shim component, which are physical implants. It also mentions manual surgical instruments. This is a hardware device, not software only.
Based on the provided text, the FlareHawk Interbody Fusion System 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.
- FlareHawk's Function: The FlareHawk Interbody Fusion System is a surgical implant designed to be placed within the spine to facilitate bone fusion. It is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The description details the physical components and function of the implant, not a diagnostic assay or test kit.
Therefore, the FlareHawk Interbody Fusion System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Integrity Implants' FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine from L2 to S1
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Prescription Use
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)
Integrity Implants has conducted bench performance testing in support of this premarket notification submission as follows:
- Coating Characterization and Coating Integrity Testing
- Stereological Assessment in accordance with ASTM F1854 (as appropriate)
- Static Shear Strength in accordance with ASTM F1044
- Static Tensile Strength in accordance with ASTM F1147
- Abrasion Resistance in accordance with ASTM F1978
- Wear Debris and Particle Characterization in accordance with ASTM F1877
- Finished Device Mechanical Testing
- Static Axial Compression in accordance with ASTM F2077
- Dynamic Axial Compression in accordance with ASTM F2077
- Static Compression Shear in accordance with ASTM F2077
- Dynamic Compression Shear in accordance with ASTM F2077
Integrity Implants has conducted a biocompatibility assessment in accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.
Based on the bench performance testing, biocompatibility assessment/testing, and other supporting documentation provided in this premarket notification, the subject FlareHawk Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices, and any differences between the subject device and the predicate devices do not impact the safety and effectiveness of FlareHawk Interbody Fusion System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K142504, K130573, K143740, K150152, K201367
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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November 3, 2020
Integrity Implants Inc. Ms. Lauren Kamer Senior Director of Regulatory and Clinical Affairs 354 Hiatt Drive Palm Beach Gardens, Florida 33418
Re: K202198
Trade/Device Name: FlareHawk Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 4, 2020 Received: August 5, 2020
Dear Ms. Kamer:
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.
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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.
Brent L. 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) K202198
Device Name FlareHawk Interbody Fusion System
Indications for Use (Describe)
The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectorny. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
| 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 - K202198
FlareHawk Interbody Fusion System
October 1, 2020
| I. | Company: | Integrity Implants Inc.
354 Hiatt Drive
Palm Beach Gardens, FL 33418
Telephone: 561-529-3861 |
|------|-------------------------|-------------------------------------------------------------------------------------------------------|
| II. | Contact: | Lauren Kamer
Senior Director of Regulatory and Clinical Affairs |
| III. | Proprietary Trade Name: | FlareHawk® Interbody Fusion System |
| IV. | Common Name: | Intervertebral Body Fusion Device
with Bone Graft, Lumbar |
| V. | Classification Name: | Intervertebral Body Fusion Device (21 CFR 888.3080) |
| | Class: | II |
| | Product Code: | MAX |
VI. Product Description
Integrity Implants' FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk
4
interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.
Indications for Use VII.
FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
VIII. Summary of Technological Characteristics
The subject FlareHawk Interbody Fusion System has substantially similar fundamental scientific technology as the predicate FlareHawk Interbody Fusion System. Like the predicate FlareHawk Interbody Fusion System, the shell component of the subject FlareHawk Interbody Fusion System implants is a rectangular frame that is inserted into the disc space in a non-expanded form, with subsequent in-situ expansion resulting from the insertion of the shim component. The shim locks to both the shell core and the posterior of the shell when the implant is deployed.
Like the predicate FlareHawk Interbody Fusion System, the subject shell component is manufactured from PEEK per ASTM F2026, and incorporates an integrated core manufactured from titanium alloy per ASTM F136, and tantalum markers per ASTM F560 for imaging purposes. The subject shell components are offered in both non-coated and coated with CP titanium (Grade 2 commercially pure titanium that meets the chemical composition requirements of ASTM F67) versions. The shell component features a
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bulleted nose designed to facilitate ease of insertion, as well as directional teeth on its superior and inferior surfaces to resist expulsion.
The subject shells are offered in both CP Ti coated and uncoated versions.
Like the predicate FlareHawk Interbody Fusion System, the shim component of the subject FlareHawk Interbody Fusion System implants has a tapered front end that inserts into and expands the shell component to the desired height and lordosis. The shim is manufactured from titanium alloy per ASTM F136 and are color anodized for differentiation.
The subject shells and shims are offered in both non-sterile (and intended to be steam sterilized by the user) and gamma sterilized versions.
IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence
To demonstrate the substantial equivalence of the subject FlareHawk Interbody Fusion System to legally marketed predicate devices, FlareHawk Interbody Fusion System, K183184 (SE 04/03/2019), is used as the primary predicate device. Integrity Implants' FlareHawk Interbody Fusion System, K182114 (SE 01/07/2019), is also used as a predicate for this submission.
The following devices are being used as reference devices for this submission to demonstrate that commercially pure titanium coatings are not new and currently exist on other legally marketed lumbar interbody fusion devices:
- . SpineFrontier Lumbar Interbody Fusion Device System (K142504, SE 05/13/2015)
- . Tyber Medical Intervertebral Body Fusion Device (K130573, SE 09/30/2013)
- Alphatec Spine Battalion Universal Spacer System (K143740, SE 05/22/2015)
- Octane Straight Intervertebral Fusion Device, Ti Coated (K150152, SE 05/11/2015)
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Additionally, FlareHawk TiHawk9 Interbody Fusion System, K201367 (SE 09/23/2020), is used as a reference device for this submission. The following characteristics of FlareHawk TiHawk9 Interbody Fusion System are identical to the subject device:
- . Materials and means of manufacture
- . Coating and coating application
- . Biocompatibility
- . Non-sterile processing processes and recommendations
X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted
Integrity Implants has conducted bench performance testing in support of this premarket notification submission as follows:
- . Coating Characterization and Coating Integrity Testing
- Stereological Assessment in accordance with ASTM F1854 (as appropriate) o
- Static Shear Strength in accordance with ASTM F1044 o
- Static Tensile Strength in accordance with ASTM F1147 o
- Abrasion Resistance in accordance with ASTM F1978 o
- o Wear Debris and Particle Characterization in accordance with ASTM F1877
- . Finished Device Mechanical Testing
- Static Axial Compression in accordance with ASTM F2077 o
- Dynamic Axial Compression in accordance with ASTM F2077 o
- Static Compression Shear in accordance with ASTM F2077 O
- Dynamic Compression Shear in accordance with ASTM F2077 o
Integrity Implants has conducted a biocompatibility assessment in accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.
XI. Conclusions Drawn for the Non-Clinical and Clinical Tests
Based on the bench performance testing, biocompatibility assessment/testing, and other supporting documentation provided in this premarket notification, the subject FlareHawk Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices, and any differences between the subject device and the predicate devices do not impact the safety and effectiveness of FlareHawk Interbody Fusion System.