(106 days)
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 Bullet 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 document describes a 510(k) summary for the Spineology PEEK Bullet Lumbar Interbody Fusion Device. It outlines the device's intended use, technological characteristics, and testing conducted, but it does not contain the specific information requested about acceptance criteria for a study proving the device meets those criteria.
The document states:
- Testing: "The Spineology PEEK Bullet 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, including static compression and static compression shear. This testing demonstrated improved performance characteristics to the identified predicate devices."
This indicates that the device underwent preclinical mechanical testing according to an ASTM standard, rather than a clinical study evaluating human readers or AI performance. The purpose of this testing was to show "improved performance characteristics" compared to predicate devices, focusing on physical properties like static compression and static compression shear.
Therefore, for the requested information:
1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not explicitly stated as numerical values in the document. The general criterion was "compliance with FDA's guidance document titled 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'" and "preclinical testing according to ASTM F2077."
* Reported Device Performance: "demonstrated improved performance characteristics to the identified predicate devices" in terms of static compression and static compression shear. Specific quantitative results are not provided.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" | Achieved |
| Preclinical testing according to ASTM F2077 (static compression, static compression shear) | Demonstrated improved performance characteristics compared to 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):
* This was preclinical mechanical testing of a physical device, not a clinical study with a test set of data. Thus, these concepts do not apply in the typical sense of AI/reader studies. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by ASTM F2077.
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. This was mechanical testing, not a study requiring expert readers or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. This was mechanical testing.
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:
* No MRMC study was conducted or mentioned. This document pertains to a physical interbody fusion device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not applicable. Ground truth in this context would be the measured physical properties of the device as per ASTM standards.
8. The sample size for the training set:
* Not applicable. This was mechanical testing, not a machine learning study with a training set.
9. How the ground truth for the training set was established:
* Not applicable.
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JAN 2 6 2012
|-113030 page 1 of 2
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: | October 10, 2011 |
| Trade Name: | Spineology PEEK Bullet Lumbar Interbody Fusion Device |
| Product Classificationand Code: | Class II Medical Device, Product Code MAX |
| Predicate Device(s): | Spineology PEEK Bullet Lumbar Interbody Fusion Device (K111880) |
| Device Description: | 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 for use in the lumbar spine.The device is available in a range of lengths and heights. The device andassociated instruments are provided non-sterile. |
| Intended Use: | The Spineology PEEK Bullet 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 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 | The Spineology PEEK Bullet Lumbar Interbody Fusion Device wastested in compliance with FDA's guidance document titled "Class IISpecial Controls Guidance Document: Intervertebral Body FusionDevice". Preclinical testing according to ASTM F2077, including staticcompression and static compression shear. This testing demonstrated. |
| improved performance characteristics to the identified predicatedevices. | |
| 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle symbol, represented by three curved lines that suggest the bird's wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
Spineology, Inc. % Mr. Bryan Becker 7800 Third Street North Suite 600 Saint Paul. Minnesota 55128
Re: K113030
Trade/Device Name: The Spineology 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: December 15, 2011 Received: January 13, 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
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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 (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/Reportal.roblem/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 N. Melkerson
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
DSPC
Enclosure
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Appendix D
Indications for Use Form
Device Name: The Spineology PEEK Bullet Lumbar Interbody Fusion Device
Indications for Use:
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.
AND/OR Prescription Use X (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. Inthopedic, and Restorative Devices
KI13030 510(k) Number_
Special 510(k) for the Spineology PEEK Bullet Lumbar Interbody Fusion Device
§ 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.