(74 days)
Not Found
No
The summary describes a physical implant (a cage) 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 intended to facilitate fusion and treat degenerative disc disease, which involves addressing and alleviating a medical condition, fitting the definition of a therapeutic device.
No
This device is an intervertebral body fusion cage intended for the treatment of degenerative disc disease, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a "spacer for implantation" and describes physical components like a "cage and a pre-assembled expansion element," indicating it is a physical implant, not software. The performance studies also focus on mechanical and material properties of a physical device.
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 testing is done outside of the body (in vitro).
- Device Description: The VERTACONNECT TLIF cage is an implantable device designed to be placed inside the body (in vivo) to facilitate spinal fusion. It is a physical structure, not a tool for analyzing biological samples.
- Intended Use: The intended use is for inter-vertebral body fusion, which is a surgical procedure performed directly on the patient's spine.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The VERTACONNECT TLIF cage is indicated for inter-vertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in a prepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
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 Test Summary: The following analyses were conducted: Axial compression, shear-compression, and torsion (ASTM F2077) Subsidence (ASTM F2267) Expulsion testing (ASTM F-04.25.0202) Sterility validation (ISO 11737-2) Validation requirements for forming, sealing and assembly processes (EN ISO 11607-2) Seal Strength of Flexible Barrier (ASTM F88/F88M) Detecting Seal Leaks (ASTM F1929) Real-time aging (ASTM F1980) Visual Inspection (ASTM F1886/F1886M-09) Seal Strength (EN ISO 868-5:2009) Peelability (EN ISO 868-5:2009) Atmospheric preconditioning/conditioning - ASTM D4332-14 Compression test - ASTM D642 Vibration test frequency - ASTM F999 Drop test - ASTM D5276 Vibration test noise - ASTM D4728 Tests for cytotoxicity (ISO 10993-5) Endotoxin testing (AAMI ST72) The results of these evaluations indicate that the VERTACONNECT TLIF is as strong or stronger than the predicate devices.
Clinical Test Summary: No clinical studies were performed
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.
Not Found
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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January 25, 2021
SIGNUS Medizintechnik % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K203327
Trade/Device Name: VERTACONNECT TLIF cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 20, 2020 Received: November 12, 2020
Dear J.D. Webb:
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
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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,
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
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Indications for Use
510(k) Number (if known)
Device Name VERTACONNECT TLIF cage
Indications for Use (Describe)
The VERTACONNECT TLIF cage is indicated for inter-vertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.
| 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: VERTACONNECT TLIF
| Date Prepared | October 20, 2020 |
|---|---|
| Submitted By | SIGNUS Medizintechnik |
| Industriestrasse 2 | |
| D - 63755 Alzenau | |
| GERMANY | |
| Primary Contact | J.D. Webb |
| 4313 W. 3800 S | |
| West Haven, UT 84401 | |
| 512-590-5810 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | VERTACONNECT TLIF cage |
| Common Name | Lumbar cage |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Varian Cage, Medyssey Co. (K172756) |
| Additional Predicate | |
| Devices | Forza XP, Orthofix (K172696) |
| AMT WAVE Distractable, AMT (K083626) | |
| Device Description | The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in a |
| prepared intervertebral disc space of the lumbar spine. Its design offers stable contact | |
| surfaces, toothed implant/bone surfaces and large cage windows. The open implant | |
| design supports a bony construction of the intervertebral disc space. The implants consist | |
| of a cage and a pre-assembled expansion element. | |
| Materials | Ti-6Al-4V ELI per ASTM F136 |
| Intended Use | The primary function of the interbody implant is to distract the disc space and restore the |
| natural geometry of the disc space as a place holder, supporting the completion of the | |
| bony fusion. | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The VERTACONNECT TLIF is substantially equivalent to the predicate devices in terms |
| of intended use, design, materials used, mechanical safety and performances. | |
| Indications for Use | The VERTACONNECT TLIF cage is indicated for inter-vertebral body fusion of the lumbar |
| spine, from L2 to S1, in skeletally mature patients who have had six months of non- | |
| operative treatment. The device is intended for use at either one level or two contiguous | |
| levels for the treatment of degenerative disc disease (DDD) with up to Grade I | |
| spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of | |
| the disc confirmed by history and radiographic studies. The device is intended for use with | |
| supplemental fixation and is intended for use with autograft to facilitate fusion. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to | |
| predicate | Intended Use |
| The VERTACONNECT TLIF and the predicate devices are all intended to be used to | |
| maintain adequate disc space until fusion occurs. | |
| Indications for Use | |
| All of the devices comply with the indications for use specified in 21 CFR section 888.3080 | |
| for lumbar interbody fusion devices | |
| Material | |
| The VERTACONNECT TLIF uses the same material as the predicate device. | |
| Design | |
| The VERTACONNECT TLIF and the predicate are equivalent in terms of method of | |
| expansion, shape, and material. | |
| Sizes | |
| The VERTACONNECT TLIF and the predicates are equivalent in their dimensions. | |
| Strength | |
| The VERTACONNECT TLIF has greater or equivalent strength values compared to other | |
| devices cleared for use in the lumbar spine. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Axial compression, shear-compression, and torsion (ASTM F2077) Subsidence (ASTM F2267) Expulsion testing (ASTM F-04.25.0202) Sterility validation (ISO 11737-2) Validation requirements for forming, sealing and assembly processes (EN ISO | |
| 11607-2) Seal Strength of Flexible Barrier (ASTM F88/F88M) Detecting Seal Leaks (ASTM F1929) Real-time aging (ASTM F1980) Visual Inspection (ASTM F1886/F1886M-09) Seal Strength (EN ISO 868-5:2009) Peelability (EN ISO 868-5:2009) Atmospheric preconditioning/conditioning - ASTM D4332-14 Compression test - ASTM D642 Vibration test frequency - ASTM F999 Drop test - ASTM D5276 Vibration test noise - ASTM D4728 Tests for cytotoxicity (ISO 10993-5) Endotoxin testing (AAMI ST72) The results of these evaluations indicate that the VERTACONNECT TLIF is as strong or | |
| stronger than the predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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SIGNUS Medizintechnik considers the VERTACONNECT TLIF to be equivalent to the Conclusions: Nonpredicate devices listed above. This conclusion is based upon the devices' similarities in clinical and Clinical principles of operation, technology, materials and indications for use