(100 days)
No
The summary describes a physical interbody fusion cage and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not evaluations of algorithmic performance.
Yes
The device is indicated for spinal fusion procedures to treat degenerative disc disease and instability in the lumbar spine, which are medical conditions, and promotes the restoration of stability and function, thereby serving a therapeutic purpose.
No
Explanation: The device is an interbody fusion cage designed for spinal fusion procedures, which is a therapeutic treatment. It does not perform any diagnostic functions.
No
The device description explicitly states it is comprised of a threaded titanium alloy interbody fusion cage and optional fixation screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, a procedure performed in vivo (within the body). IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The device is a physical implant (threaded titanium alloy interbody fusion cage and screws) designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
The device described is a medical device intended for surgical implantation.
N/A
Intended Use / Indications for Use
The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD
Device Description
The Fixated Asfora BULLET CAGE® (FABC) System is comprised of a threaded titanium alloy interbody fusion cage and two optional fixation screws. The implants are available in an assortment of diameter and length combinations to accommodate a variety of anatomic requirements. The instrumentation for implantation is manufactured from medical grades of stainless steel per ASTM F899 with some having silicone handles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of worst case FABC System devices included static and dynamic compression, static and dynamic compression shear and static torsion according to ASTM F2077. In addition, the subsidence properties were evaluated according to ASTM F2267 and expulsion according to the ASTM draft standard. The mechanical test results demonstrate that FABC System performance is substantially equivalent to the 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.
K140106, K153495, K090048, K112648, K101301, K043479, K024364, P960025, K143163, K113561
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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September 26, 2018
Image /page/0/Picture/1 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 text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
Medical Designs, LLC Kristi Vondra VP of Operations 6709 S. Minnesota Ave. Suite 204 Sioux Falls. South Dakota 57108
Re: K181591
Trade/Device Name: Fixated Asfora BULLET CAGE® (FABC) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: August 15, 2018 Received: August 17, 2018
Dear Kristi Vondra:
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.
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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Brent Showalter -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) K181591
Device Name Fixated Asfora BULLET CAGE® (FABC)
Indications for Use (Describe)
The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared 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) |
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510(k) Summary
| Date: | 5 Sept 2018 |
|---|---|
| Sponsor: | Medical Designs, LLC |
| 6709 South Minnesota Avenue, Suite 204 | |
| Sioux Falls, SD 57108 | |
| Office: 888.276.7271 | |
| Fax: 605.335.3734 | |
| Sponsor Contact: | Kristi Vondra, VP of Operations |
| Proposed Trade Name: | Fixated Asfora BULLET CAGE® (FABC) |
| Common Name: | Lumbar interbody fusion system with and without fixation |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Codes: | Intervertebral body fusion device, 888.3080, MAX & OVD |
| Device Description: | The Fixated Asfora BULLET CAGE® (FABC) System is comprised of a |
| threaded titanium alloy interbody fusion cage and two optional fixation | |
| screws. The implants are available in an assortment of diameter and length | |
| combinations to accommodate a variety of anatomic requirements. The | |
| instrumentation for implantation is manufactured from medical grades of | |
| stainless steel per ASTM F899 with some having silicone handles. | |
| Indications for Use: | The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion |
| procedures in skeletally mature patients for the treatment of degenerative | |
| disc disease (DDD) and instability in the lumbar spine at one or two | |
| contiguous levels from L2 to S1. DDD for lumbar systems is defined as | |
| back pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies. The DDD patients may also have up to | |
| Grade I spondylolisthesis at the involved level(s). Patients should be | |
| skeletally mature and have had at least six (6) months of non-operative | |
| treatment. The FABC devices are used with autograft and/or allograft | |
| comprised of cancellous and/or corticocancellous bone graft. | |
| When used with the two fixation screws, the FABC System is a stand-alone | |
| system and requires no additional supplemental fixation. When used without | |
| the fixation screws, the FABC System should be used with supplemental | |
| fixation cleared for use in the lumbar spine. When only one device is | |
| implanted, the FABC System must be used with supplemental fixation | |
| cleared for use in the lumbar spine. | |
| Materials: | FABC System implants are manufactured from Ti-6AI-4V ELI titanium alloy |
| (ASTM F136). | |
| Primary Predicate: | Primary: S128 Anterior Lumbar Interbody Fusion (ALIF) System (Renovis |
| Surgical Technologies, Inc. - K140106) | |
| Additional Predicates: | Avenue® L Lateral Lumbar Cage and Avenue® T Posterior Lumbar Cage |
| (LDR Holding [now Zimmer Biomet] - K153495), Asfora BULLET CAGE® | |
| ABC (Medical Designs - K090048, K112648), STALIF (Centinel Spine, Inc. |
- K101301), MC+ (LDR Holding - K043479), SynCage-C (Synthes Spine -
K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc. - P960025) and AVS®
ARIA PEEK Spacers (Stryker Corporation - K143163), TM Ardis®
Interbody System (Zimmer Trabecular Metal Technology, Inc. – K113561). |
| Reference Devices: | ASFORA ANTERIOR CERVICAL PLATE SYSTEM (Medical Designs -
K143699) |
| Performance Data: | Mechanical testing of worst case FABC System devices included static and
dynamic compression, static and dynamic compression shear and static
torsion according to ASTM F2077. In addition, the subsidence properties
were evaluated according to ASTM F2267 and expulsion according to the
ASTM draft standard.
The mechanical test results demonstrate that FABC System performance is
substantially equivalent to the predicate devices. |
| Technological
Characteristics: | The FABC System possesses the same technological characteristics as
one or more of the predicate devices. These include:
● intended use (as described above)
● basic design (cage with integrated fixation),
● material (titanium alloy) and
● sizes (dimensions are comparable to those offered by the predicate
systems).
While the FABC System is not identical to the predicate devices, the
differences were shown not to raise new questions of safety and
effectiveness. Therefore the fundamental scientific technology of the FABC
System is similar to previously cleared devices. |
| Conclusion: | The FABC System possesses the same intended use and technological
characteristics as the predicate devices. Therefore the FABC System is
substantially equivalent for its intended use. |
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