(87 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 and is made of PEEK-OPTIMA LT1 with Titanium markers. The device and associated instruments are provided non-sterile.
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 and ASTM F2267 standards was performed.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | (Implied) Substantial equivalence to predicate devices under specified test conditions. | Demonstrated substantially equivalent performance characteristics to the identified predicate devices in all tests. |
| Static Compression | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Static Compression Shear | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Dynamic Axial Compression | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Subsidence | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Expulsion | (Not explicitly stated, but implied to meet or exceed predicate device performance) | Testing performed. Results deemed substantially equivalent. |
| Biocompatibility/Material Integrity | (Implied) The device material (PEEK-OPTIMA LT1 with Titanium markers) is suitable for implant and its integrity is maintained. | (No specific performance values reported in the summary, but the device is cleared, implying satisfactory material performance.) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes preclinical testing of the device itself and does not involve patient data or a "test set" in the context of clinical trials or AI/algorithm performance. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable to the information provided. The tests mentioned (ASTM F2077, ASTM F2267) would involve a specified number of physical device samples for mechanical testing, as per the respective standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as this document describes the preclinical mechanical testing of a medical device, not a study involving human-in-the-loop performance or diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size:
Not applicable. This is a 510(k) summary for a physical interbody fusion device, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the mechanical tests conducted (static compression, static compression shear, dynamic axial compression, and subsidence, expulsion), the "ground truth" would be established by the physical properties and performance characteristics of the predicate devices and the relevant ASTM standards. The goal was to demonstrate "substantially equivalent performance characteristics to the identified predicate devices."
8. The Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" in the context of preclinical mechanical testing of an interbody fusion device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
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SEP 2 6 2011
·
510(k) Summary
ﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ
| Applicant: | Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128651-256-8500 |
|---|---|
| Contact Person: | Bryan Becker |
| Date Prepared: | August 25, 2011 |
| Trade Name: | Spineology PEEK Bullet Lumbar Interbody Fusion Device |
| RegulatoryClassification: | Class II Medical Device, Product Code MAX, 21 CFR 888.3080Intervertebral body fusion device |
| Predicate Device(s): | 4CIS® PEEK PLIF Cage System from Solco, USA, Inc.Capstone Spinal System, Medtronic Sofamor Danek |
| 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 and is made ofPEEK-OPTIMA LT1 with Titanium markers. The device and associatedinstruments are provided non-sterile. |
| Indications for 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 and ASTM |
| F2267, including static compression, static compression shear, dynamicaxial compression, and subsidence. Expulsion was also conducted. Thistesting 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. |
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Image /page/2/Picture/1 description: The image shows a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized caduceus, a symbol of medicine and health. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The image is in black and white.
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20995-0002
Spineology Inc. % Mr. Bryan Becker Clinical and Regulatory Affairs Manager 7800 3rd Street North, Suite 600 St. Paul. Minnesota 55128
SEP 26 2011
Re: K111880
Trade/Device Name: Spineology PEEK Bullet Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: August 26, 2011 Received: August 29, 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 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 - Mr. Bryan Becker
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.lda.gov/Aboutf DA/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.
for. Noter
per Cin
Mark N. Melkerso Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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.
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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KIII880 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.