(363 days)
No
The summary describes a mechanical implant made of Nitinol for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to provide active compression and maintain stability across a fusion site as part of an anterior cervical fusion procedure, which is a therapeutic intervention for disc degeneration and associated nerve compression.
No
The device, the UNiTi ACDF Implant System, is an implantable medical device used for anterior cervical intervertebral body fixation to provide compression and stability for spinal fusion, not a diagnostic tool.
No
The device description clearly states it is an "Implant System" consisting of "plate-like staple implants" made of Nitinol, which are physical hardware components intended for surgical implantation.
Based on the provided information, the UNiTi ACDF Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior cervical intervertebral body fixation" as part of a "anterior cervical fusion procedure." This describes a surgical implant used in vivo (within the body) to provide structural support and promote bone fusion.
- Device Description: The description details a "plate-like staple implant" made of Nitinol, designed to provide "active compression and maintain stability across the fusion site." This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The UNiTi ACDF Implant System does not perform any such analysis of bodily specimens.
Therefore, the UNiTi ACDF Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UNiTi ACDF Implant System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The UNiTi ACDF Implant System is limited to one level fusion. A single UNiTi Implant must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
Warning: This device is not approved for attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
PHQ
Device Description
The UNiTi ACDF Implant System consists of plate-like staple implants offered in various sizes to match the various patient anatomies. To accommodate different patient anatomies, the implant sizes are offered in bridge length from 14mm to 20mm and with a leg lengths of 12mm and 14mm. The UNiTi ACDF Implant is manufactured from pseudo-elastic (super-elastic) Nitinol with superelastic properties at room temperature and at in vivo temperatures. The implant is retained in an active open position with its legs held parallel by the insertion device. Upon release from the insertion device, the active compression from the implant is transferred to the bones at the fusion site. In its implant position, the UNiTi ACDF Implant is intended to provide active compression and maintain stability across the fusion site at the desired cervical level (C3-C7).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C3 to C7
Indicated Patient Age Range
Not Found
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
The UNiTi™ ACDF Implant System has been tested in the following test modes:
- Static compression bending per modified ASTM F1717-18
- Static torsion per modified ASTM F1717-18
- Dynamic compression bending per modified ASTM F1717-18
- Corrosion per ASTM F2129-17b
- Cadaveric implantation and range of motion
- Pullout
The results of this non-clinical testing show that the strength of the UNiTi ACDF Implant System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
February 3, 2021
Image /page/0/Picture/1 description: The image contains 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.
Pressio, Inc. % Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K200301
Trade/Device Name: UNiTi ACDF Implant System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PHQ Dated: December 30, 2020 Received: December 30, 2020
Dear Mr. Wright:
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 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
1
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,
Colin O'Neill, M.B.E. 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
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) K200301 Device Name
UNiTi ACDF Implant System
Indications for Use (Describe)
The UNiTi ACDF Implant System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The UNiTi ACDF Implant System is limited to one level fusion. A single UNiTi Implant must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
Warning: This device is not approved for attachment to the posterior elements (pedicles) of the cervical, thoracic, or 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) |
| 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 |
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| "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." |
FORM FDA 3881 (7/17)
3
| Submitter's Name: | Pressio, Inc. |
|---|---|
| Submitter's Address: | 14785 Omicron Drive, Suite 100 |
| San Antonio, TX 78245 | |
| Submitter's Telephone: | 512-695-2971 |
| Contact Person: | Nathan Wright MS |
| Empirical Consulting | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | 03-Feb-2020 |
| Trade or Proprietary Name: | UNiTi ACDF Implant System |
| Common or Usual Name: | Spinal intervertebral body fixation orthosis. |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | PHQ |
| Classification Panel: | Division of Orthopedic Devices |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The UNiTi ACDF Implant System consists of plate-like staple implants offered in various sizes to match the various patient anatomies. To accommodate different patient anatomies, the implant sizes are offered in bridge length from 14mm to 20mm and with a leg lengths of 12mm and 14mm. The UNiTi ACDF Implant is manufactured from pseudo-elastic (super-elastic) Nitinol with superelastic properties at room temperature and at in vivo temperatures. The implant is retained in an active open position with its legs held parallel by the insertion device. Upon release from the insertion device, the active compression from the implant is transferred to the bones at the fusion site. In its implant position, the UNiTi ACDF Implant is intended to provide active compression and maintain stability across the fusion site at the desired cervical level (C3-C7).
INDICATIONS FOR USE
The UNiTi ACDF Implant System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
4
The UNiTi ACDF Implant System is limited to one level fusion. A single UNiTi Implant must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
Warning: This device is not approved for attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
TECHNOLOGICAL CHARACTERISTICS
UNiTi ACDF Implant System is made from Nitinol that conforms to ASTM F2063. The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:
- Indications for Use
- Materials of manufacture ●
- Technological characteristics ●
- Mechanical Performance Data
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate Type |
|-------------|------------------------------------------|---------------------------------|----------------|
| K133906 | C-JAWS Cervical
Compressive Staple | Medicrea
International | Primary |
| K141332 | SmartLOX Cervical Plate
System | Captiva Spine | Additional |
| K142041 | PorOsteon Phusion Metal
Cervical Cage | PorOsteon,
Incorporated | Reference |
| K150125 | Elite™ Nitinol Fixation
System | Biomedical
Enterprises, Inc. | Reference |
PERFORMANCE DATA
The UNiTi™ ACDF Implant System has been tested in the following test modes:
- Static compression bending per modified ASTM F1717-18 ●
- Static torsion per modified ASTM F1717-18
- Dynamic compression bending per modified ASTM F1717-18 ●
- Corrosion per ASTM F2129-17b ●
- Cadaveric implantation and range of motion ●
- Pullout ●
5
The results of this non-clinical testing show that the strength of the UNiTi ACDF Implant System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the UNiTi ACDF Implant System is substantially equivalent to the predicate device.