(183 days)
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.
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).
The provided text is related to a 510(k) submission for a medical device called the "Asfora Bullet Cage™ System, Intervertebral Body Fusion Device." This submission is a request for substantial equivalence to previously cleared devices.
Key takeaway: This document is a 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on a new, formal study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested points below about specific performance metrics and study design are not applicable to this type of regulatory submission. The document explicitly states: "No significant changes to the design of the device were made. Risk assessment was performed which concluded no additional testing was required."
Here's a breakdown based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Not explicitly stated for new device performance) | Reported Device Performance (Not explicitly stated for new device performance) |
|---|---|---|
| Substantial Equivalence (Primary Goal of 510(k) Submission) | The device should be "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... or to devices that have been reclassified..." This implies that the device's technological characteristics, intended use, and safety and effectiveness profile should be similar to authorized predicate devices, posing no new questions of safety or effectiveness. | The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to the predicate devices outlined in the submission (K090048, Asfora Bullet Cage System and P950019/S9 Ray TFC Threaded Fusion Cage). The conclusion from Medical Designs, LLC was "based upon the devices’ similarities in principles of operation, technology, materials and indications for use." The FDA's clearance letter confirms this determination. |
| Functional and Safety Testing | Implicitly, the device should meet the functional and safety standards expected for such an intervertebral body fusion device. While specific criteria aren't provided for this submission for new testing, the previous predicate devices would have met these. | The document explicitly states: "No significant changes to the design of the device were made. Risk assessment was performed which concluded no additional testing was required." This indicates that the device's performance is assumed to meet existing standards based on its similarity to the predicate devices and the lack of significant design changes. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This 510(k) submission is for substantial equivalence without new performance testing. There is no "test set" of patients or data from a clinical study for this specific submission to demonstrate novel device performance. The clearance is based on comparison to predicate devices, which would have undergone their own testing previously.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: As there was no specific "test set" or clinical study for this submission, there was no ground truth to be established by experts for new performance data. The regulatory decision was made by FDA reviewers (e.g., Mark N. Melkerson, Director Division of Surgical, Orthopedic and Restorative Devices).
4. Adjudication method for the test set
- Not Applicable: No clinical or performance study with a test set requiring adjudication was conducted for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This device is an implantable medical device (intervertebral body fusion device), not an imaging or AI-assisted diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant to its evaluation, and no such study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is an implantable medical device, not an algorithm. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used
- Not Applicable (in the context of new device performance): The "ground truth" for this 510(k) submission is the pre-existing FDA clearance and established safety and effectiveness of the identified predicate devices. The new device demonstrates "substantial equivalence" to these known safe and effective devices.
8. The sample size for the training set
- Not Applicable: This is an implantable medical device. The concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.
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6.0 510(k) Summary_
| 6.0 510(k) Summary | |
|---|---|
| Submitter: | Medical Designs, LLC1210 W. 18th Street, Suite 104Sioux Falls, South Dakota 57104 |
| Contact Person: | Kristi VondraVice President of OperationsTelephone: (605) 275-1032Fax: (605) 335-3734 |
| Date Prepared: | September 8, 2011 |
| Trade Name: | Asfora Bullet Cage™ System, Intervertebral Body Fusion Device |
| Classification: | Class IIIntervertebral Body Fusion Device21 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 fusiondevice (cage) with a threaded titanium end cap.The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, devicedesigned to immobilize adjacent vertebrae and promote arthrodesis (fusion)across the disc space. The Asfora Bullet Cage is available in ten sizes: 5diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mmor 25mm). |
| Intended Use: | The Asfora Bullet Cage® is indicated for spinal fusion procedures inskeletally mature patients with degenerative disc disease (DDD) andinstability 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 withdegeneration of the disc confirmed by history and radiographic studies. TheDDD patients may also have up to Grade I spondylolisthesis at the involvedlevel(s). The ABC cage devices are used with autogenous bone graft.Patients should be skeletally mature and have had at least six (6) months ofnon-operative treatment prior to implant. When implanted via a posterior(PLIF, TLIF) approach, this device should be used with supplementalfixation. |
| Functional andSafety Testing: | No significant changes to the design of the device were made. Riskassessment was performed which concluded no additional testing wasrequired. |
| Conclusion: | Medical Design, LLC considers the device name to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indicationsfor 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
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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
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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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§ 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.