(183 days)
K090048, P950019/S9
K090048, P950019/S9
No
The summary describes a physical implant (a spinal fusion cage) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for spinal fusion procedures to treat degenerative disc disease, which falls under therapeutic intervention.
No
The device is an interbody fusion device designed to promote spinal fusion, not to diagnose medical conditions.
No
The device description clearly states it is a threaded titanium alloy interbody fusion device (cage) with a threaded titanium end cap, indicating it is a physical implant, not software.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Asfora Bullet Cage is a physical implant designed to be surgically placed in the lumbar spine to promote bone fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Asfora Bullet Cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with 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). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
Product codes
MAX
Device Description
The Asfora Bullet Cage (ABC) is a threaded titanium alloy interbody fusion device (cage) with a threaded titanium end cap. The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, device designed to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space. The Asfora Bullet Cage is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm).
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)
No significant changes to the design of the device were made. Risk assessment was performed which concluded no additional testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090048, P950019/S9
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
6.0 510(k) Summary_
| 6.0 510(k) Summary | |
|---|---|
| Submitter: | Medical Designs, LLC |
| 1210 W. 18th Street, Suite 104 | |
| Sioux Falls, South Dakota 57104 | |
| Contact Person: | Kristi Vondra |
| Vice President of Operations | |
| Telephone: (605) 275-1032 | |
| Fax: (605) 335-3734 | |
| Date Prepared: | September 8, 2011 |
| Trade Name: | Asfora Bullet Cage™ System, Intervertebral Body Fusion Device |
| Classification: | Class II |
| Intervertebral Body Fusion Device | |
| 21 CFR 888.3080 | |
| Product Code: | MAX |
| Predicate Device(s): | The subject device is equivalent to the following devices: |
| • K090048, Asfora Bullet Cage System | |
| • P950019/S9 Ray TFC Threaded Fusion Cage (down-classified to Class II) | |
| Device Description: | The Asfora Bullet Cage (ABC) is a threaded titanium alloy interbody fusion |
| device (cage) with a threaded titanium end cap. | |
| The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, device | |
| designed to immobilize adjacent vertebrae and promote arthrodesis (fusion) | |
| across the disc space. The Asfora Bullet Cage is available in ten sizes: 5 | |
| diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm | |
| or 25mm). | |
| Intended Use: | The Asfora Bullet Cage® is indicated for spinal fusion procedures in |
| skeletally mature patients with 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). The ABC cage devices are used with autogenous bone graft. | |
| Patients should be skeletally mature and have had at least six (6) months of | |
| non-operative treatment prior to implant. When implanted via a posterior | |
| (PLIF, TLIF) approach, this device should be used with supplemental | |
| fixation. | |
| Functional and | |
| Safety Testing: | No significant changes to the design of the device were made. Risk |
| assessment was performed which concluded no additional testing was | |
| required. | |
| Conclusion: | Medical Design, LLC considers the device name to be equivalent to the |
| predicate devices listed above. This conclusion is based upon the devices' | |
| similarities in principles of operation, technology, materials and indications | |
| for use. |
.
.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medical Designs, LLC % Ms. Kristi Vondra VP of Operations 1210 W. 18th Street, Suite 104 Sioux Falls, South Dakota 57104
MAR 1 3 2012
Re: K112648
Trade/Device Name: Asfora Bullet Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 17, 2012 Received: February 21, 2012
Dear Ms. 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. 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
2
Page 2 - Ms. Kristi Vondra
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
fee Dettler
N. Wells
Osceola, Pa.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health · ··
Enclosure
3
5.0 Indications For Use Statement
510(k) Number: K112648
Device Name: Asfora Bullet Cage System
Indications for Use:
The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with 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). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K112648 510(k) Number_
Medical Designs, LLC Special 510(k) Response to Questions K112648
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