Rampar™ L 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 spondyolisthesis 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. Rampart™ L is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Description

RampartTM L devices are designed for use with autograft as an adjunct to fusion and are 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 LT-1 with tantalum markers. The device is provided sterile and associated instruments are provided non-sterile.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (RampartTM-L, an intervertebral body fusion device). 510(k) submissions typically demonstrate substantial equivalence to a predicate device through non-clinical performance data and do not generally involve clinical studies with human participants, expert consensus for ground truth, or multi-reader multi-case studies as would be found for AI/ML-based diagnostic devices.

Therefore, many of the requested categories are not applicable to this type of submission.

Here's an analysis based on the provided text, focusing on the information that is present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Predicate Performance)	Reported Device Performance (RampartTM-L)
Similar static compression performance to predicate devices (Spineology PEEK Lumbar Interbody Fusion Devices/Rampart™-O)	Demonstrated similar static compression performance to identified predicate devices.
Similar static shear compression performance to predicate devices	Demonstrated similar static shear compression performance to identified predicate devices.
Similar subsidence performance to predicate devices	Demonstrated similar subsidence performance to identified 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)

Sample Size: Not applicable. The testing was preclinical (bench testing) and involved devices, not patient data.
Data Provenance: Not applicable. The data is from bench testing, not clinical studies involving patients or human 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)

Number of Experts: Not applicable. Ground truth as typically defined in AI/ML studies is not relevant here, as this is preclinical mechanical testing.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This is preclinical mechanical testing, not a study requiring adjudication of human observations.

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

MRMC Study: No. This is not an AI/ML diagnostic device, and no MRMC study was conducted.
Effect Size: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the mechanical testing, the "ground truth" (or reference) was the established performance characteristics of the predicate devices as measured by standardized ASTM F2077 and ASTM F2267 test methods. The goal was to show similar performance.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. There is no training set for this type of device.

Summary

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510(k) Summary

JAN - 9 2014 ・

Applicant:	Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128Phone: 651-256-8500Fax: 651-256-8505
Contact Person:	Bryan Becker
Date Prepared:	October 30, 2013
Trade Name:	RampartTM-L
Product Classificationand Code:	Class II Medical Device, Product Code MAX, 21 CFR 888.3080
Predicate Device(s):	Spineology PEEK Lumbar Interbody Fusion Devices/Rampart™-O(K111880, K113030, K120293, K123652, K130396, K131216,and K132053)
Device Description:	RampartTM L devices are designed for use with autograft as an adjunct tofusion and are intended for use with supplemental fixation systems clearedfor use in the lumbar spine. The device is available in a range of lengthsand heights and is made of PEEK-OPTIMA LT-1 with tantalum markers.The device is provided sterile and associated instruments are provided non-sterile.
Intended Use:	RampartTM L is an intervertebral body fusion device indicated forintervertebral body fusion at one level or two contiguous levels in thelumbar spine from L2 to S1 in patients with degenerative disc disease(DDD) with up to Grade I spondylolisthesis at the involved level(s). DDDis defined as back pain of discogenic origin with degeneration of the discconfirmed by patient history and radiographic studies. These patientsshould be skeletally mature and have had six months of non-operativetreatment. RampartTM L is designed for use with autograft as an adjunctto fusion and is intended for use with supplemental fixation systems clearedby the FDA for use in the lumbar spine.
Purpose of this 510(k):	The purpose of this 510(k) is to extend the range of sizes of Rampart O tocreate the Rampart-L devices.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intended use,materials, configuration, and performance characteristics of the predicateproducts.
Testing	Preclinical testing according to ASTM F2077 (static compression andstatic sheer compression) and ASTM F2267 (subsidence), was used tojustify substantial equivalence. This testing demonstrated similarperformance characteristics to the identified predicate devices.
Conclusion:	The information submitted in this premarket notification supports adetermination that RampartTM L is substantially equivalent intechnological characteristics and intended use to the predicate device.

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K133371 Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's emblem, which features a stylized caduceus-like symbol with three wavy lines extending from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2014

Spineology, Incorporated Mr. Bryan Becker Regulatory Affairs Manager and Compliance Officer 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K133371

Trade/Device Name: Rampart™-L Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 13, 2013 · Received: December 16, 2013

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

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Page 2 - Mr. Bryan Becker

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wigqins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K133371

Device Name

Rampart-L

Indications for Use (Describe)

radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Rampart™ L is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

... . FOR FDA USE ONLY : 14 : 14

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

STATE PARTY

Division of Orthopedic Devices

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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Regulation Number and Section

§ 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.