(186 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a lumbar intervertebral fusion device intended to facilitate fusion for patients with degenerative disc disease, which constitutes a therapeutic action.
No
The Dakota ALIF System is designed for intervertebral body fusion of the spine, providing mechanical support to facilitate biological fusion, rather than diagnosing conditions.
No
The device description explicitly states that the Dakota ALIF System consists of physical components such as cages, bone screws, and screw backout prevention plates made of PEEK, tantalum, and titanium alloy. This indicates it is a hardware medical device, not software-only.
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.
- Dakota ALIF System Function: The Dakota ALIF System is a surgical implant designed to provide mechanical support and facilitate fusion in the lumbar spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The device description details the materials and components of a physical implant, not reagents or equipment for laboratory testing.
Therefore, based on the provided information, the Dakota ALIF System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dakota ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Dakota ALIF System is intended for use at either one level or two contiquous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Dakota ALIF System is a stand-alone system intended to be used with the bone screws provided. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA for use in the lumbar spine.
Product codes
OVD
Device Description
The Dakota ALIF System consists of cages in various widths, heights, and lordoses to accommodate individual patient anatomy and graft material size and bone screws. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Dakota ALIF System cages are medical grade PEEK (per ASTM F2026) with tantalum (per ASTM F560) markers and titanium alloy Ti-6Al-4V (per ASTM F136 or ISO 5832-3) integrated fixation screws and screw backout prevention plates. The cages are provided non-sterile.
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
The Dakota ALIF System has been tested in the following test modes:
- . Static and dynamic axial compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Screw-backout testing .
The results of this non-clinical testing show that the strength of the Dakota ALIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K173082, K130445, K103369, K173347
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). 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.
April 1, 2022
Precision Spine, Inc. % Nathan Wright Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K213118
Trade/Device Name: Dakota ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 2, 2022 Received: March 3, 2022
Dear Nathan 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.
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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq 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 Dakota ALIF System
Indications for Use (Describe)
The Dakota ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Dakota ALIF System is intended for use at either one level or two contiquous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Dakota ALIF System is a stand-alone system intended to be used with the bone screws provided. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA 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) |
---|---|
------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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Submitter's Name: | Precision Spine, Inc. |
---|---|
Submitter's Address: | 2050 Executive Drive |
Pearl, Mississippi 39208 | |
Submitter's Telephone: | 601-420-4244 |
Contact Person: | Nathan Wright MS |
Empirical Testing Corp. | |
1-719-351-0248 | |
nwright@empiricaltech.com | |
Image: Empirical Testing Corp. logo | |
Date Summary was Prepared: | March 28, 2022 |
Trade or Proprietary Name: | Dakota ALIF System |
Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Classification: | Class II per 21 CFR §888.3080 |
Product Code: | OVD |
Classification Panel: | Orthopedic Devices – Spinal Devices (DHT6B) |
K213118 - 510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Dakota ALIF System consists of cages in various widths, heights, and lordoses to accommodate individual patient anatomy and graft material size and bone screws. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Dakota ALIF System cages are medical grade PEEK (per ASTM F2026) with tantalum (per ASTM F560) markers and titanium alloy Ti-6Al-4V (per ASTM F136 or ISO 5832-3) integrated fixation screws and screw backout prevention plates. The cages are provided non-sterile.
INDICATIONS FOR USE
The Dakota ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Dakota ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Dakota ALIF System is a stand-alone system intended to be used with the bone screws provided. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA for use in the lumbar spine.
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K213118 - 510(K) SUMMARY
K213118 Page 2 of 2
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture ●
- Structural support mechanism ●
- . Sizes
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code | Predicate
Type |
|-----------------|---------------------------------------|-----------------------|-----------------|-------------------|
| K173082 | ArcoTM-SA Lumbar Cage System | NeuroStructures, Inc. | OVD | Primary |
| K130445/K103369 | Vault ALIF System | Spinal USA | OVD | Additional |
| K173347 | STALIF M FLXTM | Centinel Spine, Inc. | OVD | Additional |
PERFORMANCE DATA
The Dakota ALIF System has been tested in the following test modes:
- . Static and dynamic axial compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Screw-backout testing .
The results of this non-clinical testing show that the strength of the Dakota ALIF 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 Dakota ALIF System is substantially equivalent to the predicate device.