(181 days)
No
The summary describes a physical implant (lumbar cage system) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical implant intended to treat degenerative disc disease and facilitate spinal fusion, which are therapeutic interventions.
No.
The device is an implantable lumbar cage system designed to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description explicitly states it is an intervertebral fusion device made from medical grade PEEK, titanium, and tantalum markers, and describes physical dimensions and materials, indicating it is a hardware implant.
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant intended for spinal fusion procedures. It is a physical device placed within the body to facilitate bone growth and stabilize the spine.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Arco™-SA Lumbar Cage System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arco™-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 levels(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 Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
Product codes
OVD
Device Description
The Arco™-SA Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F136, and tantalum markers per ASTM F560. The subject device implant cages are offered in a variety of footprints and sizes to accommodate various patient anatomies. The Arco™-SA Lumbar Cage System is offered in heights of 12-22mm, widths of 28- 38mm, and lengths of 24-29mm. The subject device implant screws are offered in Ø5.0-6.0mm diameters and lengths ranging 20-35mm. The subject device implant is offered with a lordosis of 7- 30°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine, 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 Arco™-SA Lumbar Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077-11
- Static compressive shear per ASTM F2077-11
- Dynamic axial compression per ASTM F2077-11
- Dynamic compressive shear per ASTM F2077-11
- Static subsidence per ASTM F2267-04
- Static expulsion per ASTM DRAFT F-04.25.02.02
The results of this non-clinical testing show that the strength of the Arco™-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)
K161230, K131276, K133967, K132421, K131122, K150643, K120966
Reference Device(s)
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. The words "U.S. Food & Drug Administration" are written in blue to the right of the square.
March 29, 2018
NeuroStructures, Inc. % Ms. Meredith L. May Vice President, Empirical Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K173082
Trade/Device Name: Arco™-SA Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 21, 2018 Received: February 22, 2018
Dear Ms. May:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173082
Device Name Arco™-SA Lumbar Cage System
Indications for Use (Describe)
The Arco™-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 levels(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 Arco™ -SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
| 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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| Submitter's Name | NeuroStructures, Inc. |
|---|---|
| Submitter's Address | 16 Technology Drive, Suite 165 |
| Irvine, CA 92618 | |
| Company Contact Person | Kathleen Wong |
| kw@neurostructures.com | |
| 949.370.4497 | |
| Contact Person | Meredith L. May MS, RAC |
| Empirical Consulting | |
| 719-337-7579 | |
| MMay@EmpiricalConsulting.com | |
| Date Summary was | |
| Prepared | 15 February 2018 |
| Trade or Proprietary Name | Arco™-SA Lumbar Cage System |
| Common or Usual Name | Intervertebral Fusion Device With Integrated Fixation, |
| Lumbar | |
| Classification | Class II per 21 CFR §888.3080 Device Classification |
| Product Code | OVD |
| Classification Panel | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Arco™-SA Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F136, and tantalum markers per ASTM F560. The subject device implant cages are offered in a variety of footprints and sizes to accommodate various patient anatomies. The Arco™-SA Lumbar Cage System is offered in heights of 12-22mm, widths of 28- 38mm, and lengths of 24-29mm. The subject device implant screws are offered in Ø5.0-6.0mm diameters and lengths ranging 20-35mm. The subject device implant is offered with a lordosis of 7- 30°.
INDICATIONS FOR USE
The Arco™-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 levels(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 Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
4
The indications for use for the Arco™-SA Lumbar Cage System is similar to that of the Table 5-1: Predicate Devices.
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 ●
| 510k
Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate Type |
|----------------|---------------------------------------|-----------------|----------------|
| K161230 | Lumbar Interbody Implants | NuVasive® | Primary |
| K131276 | SYNFIX Lateral/SynFix-LR System | Synthes | Additional |
| K133967 | IBFD | Aurora Spine | Additional |
| K132421 | Implant Systems | Aesculap® | Additional |
| K131122 | Stand-Alone ALIF System | Renovis | Additional |
| K150643 | MIDLINE IITM | Centinel Spine | Additional |
| K120966 | Lumbar System | Depuy | Additional |
| K171914 | Cortina™ Lumbar Cage System | NeuroStructures | Reference |
Table 5-1: Predicate Devices
PERFORMANCE DATA
The Arco™-SA Lumbar Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077-11 ●
- Static compressive shear per ASTM F2077-11 ●
- Dynamic axial compression per ASTM F2077-11 ●
- Dynamic compressive shear per ASTM F2077-11 o
- Static subsidence per ASTM F2267-04 o
- Static expulsion per ASTM DRAFT F-04.25.02.02 ●
The results of this non-clinical testing show that the strength of the Arco™-SA Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Arco™-SA Lumbar Cage System is substantially equivalent to the predicate device.