(164 days)
Not Found
No
The document describes a physical medical device (cervical fusion cages) and its mechanical testing. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is an interbody fusion cage intended for spinal fusion procedures to treat degenerative disc disease, which is a therapeutic intervention.
No
The device is described as an interbody fusion cage used for spinal fusion procedures. Its intended use is to treat degenerative disc disease by providing structural support and facilitating fusion, not to diagnose a medical condition.
No
The device description clearly states it is a physical implant made of PEEK and Ti-6Al-4V ELI with integrated screws and radiographic markers. It is intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SPICCA Stand-Alone Cervical Fusion Cages are described as implants intended for surgical procedures to fuse vertebrae in the cervical spine. They are physical devices implanted into the body.
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgically implanted device used for structural support and fusion within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The SPICCA Stand-Alone Cervical Fusion Cages are single-use, sterile, PEEK (ASTM F560) anterior cervical interbody fusion cages with integrated Ti-6Al-4V ELI (ASTM F136) screws that are intended to be implanted between two adjacent vertebral bodies as part of single or multilevel Anterior Cervical Discectory and Fusion (ACDF) procedures. The SPICCA Stand-Alone Cervical Fusion Cages which are offered in the SPICCA-SP version and SPICCA-S2 version are offered in a variety of sizes to accommodate various patient anatomies (Note: SPICCA-S2 differ in footprint options and endplate-contacting surface shape). The cages include Tantalum (ASTM F560) radiographic markers and are offered uncoated or coated with titanium plasma spray (ASTM F1580).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from the C2/C3 disc space to the C7/T1 disc space
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SPICCA Stand-Alone Cervical Fusion Cages have been tested in the following test modes:
- Static & Dynamic Axial Compression per ASTM F2077 .
- Static & Dynamic Compression Shear per ASTM F2077 .
- Static & Dynamic Torsion per ASTM F2077 .
- Subsidence per ASTM F2267 ●
The results of this non-clinical testing show that the strength of the SPICCA Stand-Alone Cervical Fusion Cages are sufficient for the intended use and are 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.
K153352, K211111, K212853, K141500
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.
0
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.
August 14, 2023
Southern Medical (Pty) Ltd % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K230608
Trade/Device Name: SPICCA Stand-Alone Cervical Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 19, 2023 Received: July 19, 2023
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 mediation-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 -S
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
Submission Number (if known)
Device Name
SPICCA Stand-Alone Cervical Fusion Cages
Indications for Use (Describe)
The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter's Name: | Southern Medical (Pty) Ltd |
|---|---|
| Submitter's Address: | 55 Regency Drive |
| Route 21 Corporate Park Irene, | |
| Centurion, Gauteng 0178 South | |
| Africa | |
| Submitter's Telephone: | +27 12 667 6243/4 |
| Contact Person: | Nathan Wright MS Empirical |
| Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | March 3, 2023 |
| Trade or Proprietary Name: | SPICCA Stand-Alone Cervical Fusion Cages |
| Device Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| Classification & Regulation #: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SPICCA Stand-Alone Cervical Fusion Cages are single-use, sterile, PEEK (ASTM F560) anterior cervical interbody fusion cages with integrated Ti-6Al-4V ELI (ASTM F136) screws that are intended to be implanted between two adjacent vertebral bodies as part of single or multilevel Anterior Cervical Discectory and Fusion (ACDF) procedures. The SPICCA Stand-Alone Cervical Fusion Cages which are offered in the SPICCA-SP version and SPICCA-S2 version are offered in a variety of sizes to accommodate various patient anatomies (Note: SPICCA-S2 differ in footprint options and endplate-contacting surface shape). The cages include Tantalum (ASTM F560) radiographic markers and are offered uncoated or coated with titanium plasma spray (ASTM F1580).
INDICATIONS FOR USE
The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws should be used to ensure adequate fixation of the implant.
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:
- . Principle of Operation
- Structural Support Mechanism .
- . Materials
- Sizes .
- . Indications for Use
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Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K153352 | Vertu® Ti-Bond Cervical Interbody System | Spinal Elements, Incorporated | OVE, ODP | Primary |
| K211111 | SureMAX-SA™ Cervical Standalone System | Additive Implants, Inc. | OVE | Additional |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | OVE | Additional |
| K141500 | Optio-C™ Anterior Cervical System | Zimmer Spine, Incorporated | KWQ, OVE | Additional |
PERFORMANCE DATA
The SPICCA Stand-Alone Cervical Fusion Cages have been tested in the following test modes:
- Static & Dynamic Axial Compression per ASTM F2077 .
- Static & Dynamic Compression Shear per ASTM F2077 .
- Static & Dynamic Torsion per ASTM F2077 .
- Subsidence per ASTM F2267 ●
The results of this non-clinical testing show that the strength of the SPICCA Stand-Alone Cervical Fusion Cages are sufficient for the intended use and are substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the SPICCA Stand-Alone Cervical Fusion Cages are substantially equivalent to the predicate device.