(295 days)
No
The device description and performance studies focus on the material properties, mechanical testing, and physical design of the interbody fusion system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for intervertebral body fusion of the spine to address conditions like cervical disc degeneration and/or cervical spinal instability, aiming to alleviate radiculopathy, myelopathy, and/or pain. This directly addresses health conditions for therapeutic benefit.
No
The device is an intervertebral body fusion system, which is an implant used for treatment (fusion) of the spine, not for diagnosing conditions. While its use is confirmed by imaging studies, the device itself does not perform diagnostic functions.
No
The device description clearly states it is an implant made of physical materials (hydroxyapatite impregnated polyetheretherketone polymer and tantalum markers) and describes its physical characteristics and mechanical testing. This indicates it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The INTEGRATE™-C Interbody Fusion System is an implantable medical device made of PEEK and Tantalum. It is surgically placed in the spine to facilitate fusion.
- Intended Use: The intended use is for intervertebral body fusion in the spine, specifically for anterior cervical interbody fusion in patients with certain spinal conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
- Input: The input is imaging studies (radiographs, CT, MRI), which are used to assess the patient's condition and guide the surgical procedure, not to analyze a biological specimen.
The INTEGRATE™-C Interbody Fusion System is a surgical implant used for treatment, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The INTEGRATE™-C Interbody Fusion System implant is made of a single, continuous piece of hydroxyapatite impregnated polyetheretherketone polymer (ASTM F2026 & F1185). The INTEGRATE™-C Interbody Fusion System implant body is monolithic with porous regions derived directly from the implant body, not a sintered or otherwise additive coating, and extended through the device. The device is available in a variety of footprints, lordosis and heights to accommodate variations in the individual pathology and anatomic of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Tantalum (ASTM F560) radiopaque markers are placed in the device to aid in determining the location of the implant intra- and post-operatively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical spine, C2 - T1
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)
The INTEGRATE™-C Interbody Fusion System has been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic compressive shear per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267
- Validation Cadaver Lab
- Static Tension Testing per ASTM F1147
- Dynamic Shear Testing per ASTM F1160
- Static Shear Testing per ASTM F1044
The results of this non-clinical testing show that the strength of the INTEGRATE™-C Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
April 28, 2023
HAPPE Spine % Meredith P. Vanderbilt Director of Consulting Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K222004
Trade/Device Name: INTEGRATE™-C Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 29, 2023 Received: March 29, 2023
Dear Ms. Vanderbilt:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known)
Device Name
INTEGRATE™-C Interbody Fusion System
Indications for Use (Describe)
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.
Type of Use (Select one or both, as applicable) 図 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 respond to, a collection of information
unless it displays a currently valid OMB number.'
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(K) SUMMARY
| Submitter's Name: | HAPPE Spine, LLC |
|---|---|
| Submitter's Address: | 220 Lyon Street, NW, Suite 500 |
| Grand Rapids, MI 49503 | |
| Submitter's Telephone: | +1-616-294-1026 |
| Contact Person: | Meredith Lee May MS, RAC |
| Empirical Testing Corp. | |
| 1-719-337-7579 | |
| MMay@EmpiricalTech.com | |
| Image: Empirical Testing Corp. Logo | |
| Date Summary was Prepared: | July 6, 2022 |
| Trade or Proprietary Name: | INTEGRATE™-C Interbody Fusion System |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The INTEGRATE™-C Interbody Fusion System implant is made of a single, continuous piece of hydroxyapatite impregnated polyetheretherketone polymer (ASTM F2026 & F1185). The INTEGRATE™-C Interbody Fusion System implant body is monolithic with porous regions derived directly from the implant body, not a sintered or otherwise additive coating, and extended through the device. The device is available in a variety of footprints, lordosis and heights to accommodate variations in the individual pathology and anatomic of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Tantalum (ASTM F560) radiopaque markers are placed in the device to aid in determining the location of the implant intra- and post-operatively.
INDICATIONS FOR USE
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.
HAPPE Spine INTEGRATE™-C Interbody Fusion System
4
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have similar technological characteristics and the differences regarding material composition do not raise any new issues of safety and effectiveness; mechanical and biocompatibility testing have mitigated concerns based on differences in material composition. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Product Code ●
- Sterility ●
- Sizes ●
- Graft Material
- Device Material ●
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K173030 | Cohere® | Vertera Spine™ | ODP | Primary |
| K133784 | Vista®-S | Zimmer Trabecular Metal Technology, Inc | ODP | Additional |
| K172484 | A-CIFT™ SoloFuse™ | SpineFrontier (LESpine) | ODP, OVE | Additional |
| K191581 | Endoskeleton® TL | Titan Spine | OVD, MAX | Reference |
PERFORMANCE DATA
The INTEGRATE™-C Interbody Fusion System has been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077 ●
- Static and dynamic compressive shear per ASTM F2077
- Static and dynamic torsion per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Validation Cadaver Lab ●
- Static Tension Testing per ASTM F1147 ●
- Dynamic Shear Testing per ASTM F1160
- Static Shear Testing per ASTM F1044 ●
The results of this non-clinical testing show that the strength of the INTEGRATE™-C Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
5
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the INTEGRATE™-C Interbody Fusion System is substantially equivalent to the predicate device.