(58 days)
No
The description focuses on the material, design, and mechanical testing of a spinal implant, with no mention of AI or ML capabilities.
Yes
The device is a lumbar cage system intended for spinal fusion procedures to treat degenerative disc disease, which is a therapeutic intervention.
No.
The device is an implant for spinal fusion procedures, not a diagnostic tool. Its intended use is to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states it is a physical implant made from PEEK or Ti 6Al-4V ELI Alloy, with integrated screws and locking mechanisms. It is a hardware device intended for surgical implantation.
Based on the provided information, the Oculus-SA Lumbar Cage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Oculus-SA Lumbar Cage System is a spinal intervertebral fusion device intended for surgical implantation in the lumbar spine to facilitate fusion. It is a physical implant used within the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes related to the device's function.
Therefore, the Oculus-SA Lumbar Cage System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Oculus-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. 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. The Oculus-SA Lumbar Cage System implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Oculus-SA Lumbar Cage System is a stand-alone spinal intervertebral fusion device made from medical grade PEEK (polyetheretherketone) as per ASTM F2026 or Ti 6Al-4V ELI Alloy as per ASTM F136. It is provided in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The PEEK cages have one radiographic marker pin made from tantalum, per ASTM F560. The implants incorporate integrated anterior screw holes to allow for placement of titanium alloy (per ASTM F136) screws. The Oculus-SA Lumbar Cage System is offered in either a three screw or four screw configuration for anterior lumbar interbody fusion procedures. Titanium alloy locking mechanisms secure the screws in place. The Oculus-SA Lumbar Cage System implants and instruments are provided non-sterile and will require sterilization prior to each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spinal fusion procedures, one level (L2 to S1) of the non-cervical spine.
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 Oculus™-SA Lumbar Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077-18
- Static compressive shear per ASTM F2077-18
- Dynamic axial compression per ASTM F2077-18
- Dynamic compressive shear per ASTM F2077-18
- Static subsidence per ASTM F2267-04 (2018)
The results of this non-clinical testing show that the strength of the Oculus™-SA Lumbar Cage 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.
K182195, K173082, K180814, K161129, K130445
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.
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Image /page/0/Picture/0 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
October 2, 2020
Neurostructures, Inc. % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K202190
Trade/Device Name: Oculus™-SA Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: August 4. 2020 Received: August 5, 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.
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.
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 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) |
|---|
| K202190 |
| Device Name |
| Oculus™-SA Lumbar Cage System |
Indications for Use (Describe)
The Oculus-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. 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. The Oculus-SA Lumbar Caqe System implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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| Submitter's Name: | Neurostructures, Inc. |
|---|---|
| Submitter's Address: | 199 Technology Drive, Suite 110 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800-352-6103 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | August 3, 2020 |
| Trade or Proprietary Name: | Oculus™-SA Lumbar Cage 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: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Oculus-SA Lumbar Cage System is a stand-alone spinal intervertebral fusion device made from medical grade PEEK (polyetheretherketone) as per ASTM F2026 or Ti 6Al-4V ELI Alloy as per ASTM F136. It is provided in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The PEEK cages have one radiographic marker pin made from tantalum, per ASTM F560. The implants incorporate integrated anterior screw holes to allow for placement of titanium alloy (per ASTM F136) screws. The Oculus-SA Lumbar Cage System is offered in either a three screw or four screw configuration for anterior lumbar interbody fusion procedures. Titanium alloy locking mechanisms secure the screws in place. The Oculus-SA Lumbar Cage System implants and instruments are provided non-sterile and will require sterilization prior to each use.
INDICATIONS FOR USE
The Oculus-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. 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. The Oculus-SA Lumbar
4
Cage System implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
The indications for use for the Oculus™-SA Lumbar Cage System is similar to that of the predicates listed in Table 5-1.
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:
- Principles of Operation
- . Indications for Use
- Implant Materials ●
- Implant Sizes ●
- Surgical Approach ●
- o Manufacturing
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K182195 | Arco™-SA Lumbar Cage System | NeuroStructures, Inc. | Primary |
| K173082 | Arco™-SA Lumbar Cage System | NeuroStructures, Inc. | Additional |
| K180814 | M3 Stand-Alone ALIF | CoreLink, LLC | Additional |
| K161129 | PILLAR® SA PTC | Orthofix Inc. | Additional |
| K130445 | Vault ALIF System | Spinal USA | Additional |
| K142060 | Transom Anterior Cervical Plate | NeuroStructures, Inc. | Reference |
PERFORMANCE DATA
The Oculus™-SA Lumbar Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077-18 ●
- Static compressive shear per ASTM F2077-18 ●
- Dynamic axial compression per ASTM F2077-18 ●
- Dynamic compressive shear per ASTM F2077-18 ●
- Static subsidence per ASTM F2267-04 (2018) ●
The results of this non-clinical testing show that the strength of the Oculus™-SA Lumbar Cage 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 Oculus™-SA Lumbar Cage System is substantially equivalent to the predicate device.