(29 days)
Crescent: The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These devices may be implanted via an open or a minimally invasive transforaminal approach.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Bullets: The Spineology PEEK Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.
This document describes a 510(k) summary for the Spineology PEEK Lumbar Interbody Fusion Devices, specifically a modification to add tantalum markers. The information provided does not detail a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics in terms of accuracy, sensitivity, specificity, etc., are provided for an AI or algorithm. The document states:
"No testing was required for this change. The results of a risk analysis showed that the device was substantially equivalent to the identified predicate devices."
The "performance" criteria for this submission are based on the device's substantial equivalence to predicate devices in its intended use, materials, configuration, and performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K110933, K111880, K113030) in intended use, materials, configuration, and performance characteristics for PEEK Lumbar Interbody Fusion Devices. | The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products. A risk analysis supported this conclusion. |
| Safety and effectiveness based on established predicate devices. | The FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set involving patient data or images was used for this submission, as "No testing was required for this change." The submission is for a modification (adding tantalum markers) to an already cleared device, relying on substantial equivalence arguments rather than new clinical or performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was performed for this 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 submission is for a physical medical implant modification, not an AI/algorithm-based diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this specific submission, the "ground truth" equivalent would be the established safety and performance of the predicate physical devices. The substantial equivalence argument relies on the existing approval of the predicate devices, not new ground truth generated for an algorithm.
8. The sample size for the training set
Not applicable. There is no algorithm being "trained" in this submission.
9. How the ground truth for the training set was established
Not applicable. There is no algorithm being trained.
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队 120293
page 1 of 2
FEB 2 9 2012
510(k) Summary
| Applicant: | Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128651-256-8500 |
|---|---|
| Contact Person: | Bryan Becker |
| Date Prepared: | January 18, 2012 |
| Trade Name: | Spineology PEEK Lumbar Interbody Fusion Devices |
| Product Classificationand Code: | Class II Medical Device, Product Code MAX |
| Purpose of Application: | The purpose of this special 510(k) modification is to add tantalummarkers. |
| Predicate Device(s): | Spineology PEEK Lumbar Interbody Fusion Devices (K110933,K111880, K113030) |
| Device Description: | The Spineology PEEK Lumbar Interbody Fusion Device is designed foruse with autograft to facilitate fusion and is intended for use withsupplemental fixation systems cleared for use in the lumbar spine. Thedevice is available in a range of lengths and heights. The device andassociated instruments are provided non-sterile. |
| Intended Use: | Crescent: The Spineology PEEK Lumbar Interbody Fusion Device is anintervertebral body fusion device indicated for intervertebral body fusionat one level or two contiguous levels in the lumbar spine from L2 to S1 inpatients with degenerative disc disease (DDD) with up to Grade Ispondylolisthesis at the involved level(s). DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by patienthistory and radiographic studies. These patients should be skeletallymature and have had six months of non-operative treatment.These devices may be implanted via an open or a minimally invasivetransforaminal approach.The Spineology PEEK Lumbar Interbody Fusion Device is designed foruse with autograft to facilitate fusion and is intended for use withsupplemental fixation systems cleared by the FDA for use in the lumbarspine.Bullet: The Spineology PEEK Bullet Lumbar Interbody Fusion Device isan intervertebral body fusion device indicated for intervertebral body |
| to S1 in patients with degenerative disc disease (DDD) with up to Grade Ispondylolisthesis at the involved level(s). DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by patienthistory and radiographic studies. These patients should be skeletallymature and have had six months of non-operative treatment. | |
| These devices may be implanted singly or in pairs via an open or aminimally invasive posterior or transforaminal approach. | |
| The Spineology PEEK Bullet Lumbar Interbody Fusion Device isdesigned for use with autograft to facilitate fusion and is intended for usewith supplemental fixation systems cleared by the FDA for use in thelumbar spine. | |
| Summary ofTechnologicalCharacteristics: | The device is shown to be substantially equivalent to the intended use,materials, configuration, and performance characteristics of the predicateproducts. |
| Testing | No testing was required for this change. The results of a risk analysisshowed that the device was substantially equivalent to the identifiedpredicate devices. |
| Conclusion: | The information submitted in this premarket notification supports adetermination that the Spineology PEEK Lumbar Interbody FusionDevice is substantially equivalent in technological characteristics andintended use to the predicate devices. |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name encircling a symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of an abstract shape, resembling a person embracing or supporting another, with flowing lines suggesting movement or care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spineology Inc. % Mr. Bryan Becker Clinical and Regulatory Affairs Manager 7800 310 Street North, Suite 600 Saint Paul, Minnesota 55128
FEB 2 9 2012
Re: K120293
Trade/Device Name: PEEK Bullet Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 25, 2012 Received: January 31, 2012
Dear Mr. Becker:
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 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.
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Page 2 - Mr. Bryan Becker
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/ucm115809.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,
Mark Haldane
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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Device Name: The Spineology PEEK Bullet Lumbar Interbody Fusion Device
Indications for Use:
Crescent: The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These devices may be implanted via an open or a minimally invasive transforaminal approach.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Bullets: The Spineology PEEK Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Prescription Use X (Part 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
| 510(k) Number | K120293 |
|---|---|
| --------------- | --------- |
§ 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.