K Number
K111880
Device Name
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
Manufacturer
Date Cleared
2011-09-26

(87 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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.
More Information

Not found

Not Found

No
The device description and performance studies focus on the material properties, mechanical testing, and intended use as an intervertebral body fusion device. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.

Yes
Explanation: The device is indicated for intervertebral body fusion to treat degenerative disc disease, which is a medical condition. This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.

No

The device is an intervertebral body fusion device used for treatment, not diagnosis. It is intended to facilitate fusion in patients with degenerative disc disease, not to identify or characterize a medical condition.

No

The device description explicitly states it is made of PEEK-OPTIMA LT1 with Titanium markers and is available in a range of lengths and heights, indicating it is a physical implantable device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The provided text describes a physical implantable device made of PEEK and Titanium markers, designed to be surgically placed in the lumbar spine for fusion.
  • Intended Use: The intended use is for intervertebral body fusion in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a specimen.

The device is a surgical implant used in a therapeutic procedure, not a diagnostic test.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MAX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine from L2 to S1

Indicated Patient Age Range

skeletally mature

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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, including static compression, static compression shear, dynamic axial compression, and subsidence. Expulsion was also conducted. This testing demonstrated substantially equivalent performance characteristics to the identified predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

4CIS® PEEK PLIF Cage System from Solco, USA, Inc., Capstone Spinal System, Medtronic Sofamor Danek

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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 600
Saint Paul, MN 55128
651-256-8500 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bryan Becker |
| Date Prepared: | August 25, 2011 |
| Trade Name: | Spineology PEEK Bullet Lumbar Interbody Fusion Device |
| Regulatory
Classification: | Class II Medical Device, Product Code MAX, 21 CFR 888.3080
Intervertebral 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 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. |
| 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. |
| Summary of
Technological
Characteristics: | The device is shown to be substantially equivalent to the intended use,
materials, configuration, and performance characteristics of the predicate
products. |
| 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 and ASTM |
| | F2267, including static compression, static compression shear, dynamic
axial compression, and subsidence. Expulsion was also conducted. This
testing demonstrated substantially equivalent performance
characteristics to the identified predicate devices. |
| Conclusion: | The information submitted in this premarket notification supports a
determination that the Spineology PEEK Lumbar Interbody Fusion
Device is substantially equivalent in technological characteristics and
intended 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

3

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

4

. 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_