(149 days)
Not Found
No
The summary describes a physical implantable device (a spinal cage) and its mechanical properties and intended use. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is described as an "anterior interbody fusion device" and is intended to "treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion." This directly indicates a therapeutic purpose.
No
Explanation: The device is an interbody fusion device designed to treat pain and functional disorders by supporting, stabilizing, and immobilizing the lumbar spine and facilitating fusion. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states the device is a physical cage manufactured from PEEK and titanium, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, 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.
- Device Description and Intended Use: The description clearly states that the Southern Anterior Screw Fixated Cage is an implantable device used in the lumbar spine for fusion. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided describes a surgical implant, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.
The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.
Product codes
OVD
Device Description
The Southern Anterior Screw Fixated Cage (SASCA) is intended to treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion. The SASCA devices are stand-alone devices offered in a variety of sizes to accommodate individual patient anatomy. The SASCA cages are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The fixation screws are manufactured from Ti-6Al-4V per ASTM F136. Note: The subject SASCA device is also labeled in markets outside the United States as the Sasca 2 Anterior Lumbar Standalone Fusion Cage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L1 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 SASCA 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 o
The results of this non-clinical testing show that the strength of the SASCA 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)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 10, 2023
Southern Medical (Pty) Ltd % Nathan Wright Engineer and Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K221447
Trade/Device Name: Southern Anterior Screw Fixated Cage (SASCA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD
Dear Nathan Wright:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 14, 2022. Specifically, FDA is updating the associated 510(k) Summary to correct the device description. See the attached 510(k) Summary document for the corrected version.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
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
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 14, 2022
Southern Medical (Pty) Ltd % Nathan Wright Engineer and Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K221447
Trade/Device Name: Southern Anterior Screw Fixated Cage (SASCA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 14, 2022 Received: September 15, 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.
2
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.
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K221447
Device Name
Southern Anterior Screw Fixated Cage (SASCA)
Indications for Use (Describe)
Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.
The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.
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 PRAStaff@fda.hhs.gov
"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."
4
| Submitter's Name: | Southern Medical (Pty) Ltd |
|---|---|
| Submitter's Address: | Building 10, Southern Implants Office Park |
| 1 Albert Road | |
| Irene, Gauteng 0062 | |
| 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: | May 17, 2022 |
| Trade or Proprietary Name: | Southern Anterior Screw Fixated Cage (SASCA) |
| 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 - Spinal Devices (DHT6B) |
K221447 - 510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Southern Anterior Screw Fixated Cage (SASCA) is intended to treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion. The SASCA devices are stand-alone devices offered in a variety of sizes to accommodate individual patient anatomy. The SASCA cages are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The fixation screws are manufactured from Ti-6A1-4V per ASTM F136. Note: The subject SASCA device is also labeled in markets outside the United States as the Sasca 2 Anterior Lumbar Standalone Fusion Cage.
INDICATIONS FOR USE
The Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.
The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.
TECHNOLOGICAL CHARACTERISTICS
5
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 similar 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 |
|-------------|-----------------------------------------|--------------------------|-----------------|-------------------|
| K173347 | STALIF M FLX™ | Centinel Spine, Inc. | OVD | Primary |
| K183426 | MectaLIF Anterior
Stand Alone System | Medacta International SA | OVD | Additional |
PERFORMANCE DATA
The SASCA 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 o
The results of this non-clinical testing show that the strength of the SASCA 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 SASCA is substantially equivalent to the predicate device.