(70 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Spineology PEEK Lumbar Interbody Fusion Device. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, primarily through pre-clinical testing. However, it does not contain information about studies involving acceptance criteria related to AI/ML device performance, human reader studies, or the establishment of ground truth for such studies.
The "Testing" section explicitly states: "The Spineology PEEK Lumbar Interbody Fusion Device was tested in compliance with FDA's guidance document titled 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'. Preclinical testing according to ASTM F2077 and ASTM F2267. including static compression, static compression shear, dynamic axial and shear compression, and subsidence. Expulsion was also conducted. This testing demonstrated substantially equivalent performance characteristics to the identified predicate devices."
This indicates that the acceptance criteria and study described are for a physical medical device (an intervertebral fusion device), focusing on biomechanical performance and material properties. It is not an AI/ML device.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, as the provided document does not pertain to such a device.
{0}------------------------------------------------
上110933
:
JUN 1 3 2011
| Appendix C | 510(k) Summary |
|---|---|
| Applicant: | Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128651-256-8500 |
| Contact Person: | Bryan Becker |
| Date Prepared: | April 1, 2011 |
| Trade Name: | Spineology PEEK Lumbar Interbody Fusion Device |
| ProductClassification andCode: | Class II Medical Device, Product Code MAX |
| Predicate Device(s): | Pivotec Lumbar Interbody Fusion Device, Captiva Spine, Inc.Capstone Spinal System, Medtronic Sofamor Danek |
| 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: | 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. |
| Summary ofTechnologicalCharacteristics: | The device is shown to be substantially equivalent to the intended use,materials, configuration, and performance characteristics of the predicateproducts. |
| Testing | The Spineology PEEK Lumbar Interbody Fusion Device was tested incompliance with FDA's guidance document titled "Class II SpecialControls Guidance Document: Intervertebral Body Fusion Device".Preclinical testing according to ASTM F2077 and ASTM F2267.including static compression, static compression shear, dynamic axialand shear compression, and subsidence. Expulsion was also conducted.This testing demonstrated substantially equivalent performancecharacteristics to the identified predicate 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. |
.
{1}------------------------------------------------
・・・
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 3 2011
Spineology, Inc. % Mr. Bryan Becker Clinical and Regulatory Affairs Manager . 7800 Third Street N., Suite 600 St. Paul, Minnesota 55128
Re: K110933
Trade/Device Name: Spineology PEEK Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 25, 2011 Received: May 26, 2011
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 10 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
{3}------------------------------------------------
Page 2 - Mr. Bryan Becker
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); 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/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 vours.
Erina Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Form Appendix D
Device Name: The Spineology PEEK Lumbar Interbody Fusion Device
Indications for Use:
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.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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
Division of Surgical, Orthopedic, /and Restorative Devices
K110933 510(k) Number
§ 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.