Rampart™-O: Rampart™-O 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. Rampart™-O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Rampart™-T: Rampart™-T 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. Rampart™-T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Device Description

Rampart™-O and Rampart™-T 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 devices are available in a range of lengths and heights. The devices are provided sterile and non-sterile. The associated instruments are provided non-sterile.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no specific acceptance criteria or performance metrics reported for the device, as no testing was performed. The 510(k) relies on substantial equivalence to predicate devices.

Acceptance Criterion	Reported Device Performance
No specific acceptance criteria were defined or reported in the document.	No performance data was reported as "no testing was performed."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No testing was performed on a test set.
Data Provenance: Not applicable. No new data was generated or used from a test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No test set was used, and thus no ground truth was established by experts for a test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "No testing was performed."
Effect Size of Human Reader Improvement with AI vs. Without AI: Not applicable, as no MRMC study or AI component is mentioned.

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

Standalone Performance: No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. No new empirical data requiring a ground truth was generated as "no testing was performed." The submission relies on substantial equivalence to previously cleared devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The device is a physical medical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. The device is a physical medical implant, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary of the K132053 510(k) Submission:

This 510(k) application for the Rampart™-O and Rampart™-T intervertebral body fusion devices is a submission to update the indications for use and the ability to provide the products as sterile. Crucially, the application states: "No testing was performed."

Therefore, the submission establishes substantial equivalence based on the intended use, materials, configuration, and performance characteristics of the predicate products (Rampart™ O (K131216) and Rampart™ T (K121129)), rather than through new performance studies or data collection. This means that all questions related to acceptance criteria, device performance studies, test sets, training sets, ground truth establishment, and expert involvement are not applicable to the information provided in this specific 510(k) summary.

Summary

{0}------------------------------------------------

: ·

510(k) Summary

Applicant:	Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128Phone: 651-256-8500Fax: 651-256-8505
Contact Person:	Bryan Becker
Date Prepared:	July 1, 2013
Trade Name:	Rampart™-O and Rampart™-T
Product Classificationand Code:	Class II Medical Device, Product Code MAX, 21 CRF 888.3080
Predicate Device(s):	Rampart™ O (K131216) and Rampart™ T (K121129)
Device Description:	Rampart™-O and Rampart™-T devices are designed for use withautograft as an adjunct to fusion and are intended for use with supplementalfixation systems cleared for use in the lumbar spine. The devices areavailable in a range of lengths and heights. The devices are provided sterileand non-sterile. The associated instruments are provided non-sterile.
Intended Use:	Rampart™-O: Rampart™-O is an intervertebral body fusion deviceindicated for intervertebral body fusion at one level or two contiguouslevels in the lumbar spine from L2 to S1 in patients with degenerative discdisease (DDD) with up to Grade I spondylolisthesis at the involvedlevel(s). DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies. These patients should be skeletally mature and have had sixmonths of non-operative treatment. Rampart™-O is designed for use withautograft as an adjunct to fusion and is intended for use with supplementalfixation systems (e.g. pedicle screws) cleared by the FDA for use in thelumbar spine.Rampart™-T:Rampart™-T is an intervertebral body fusion deviceindicated for intervertebral body fusion at one level or two contiguouslevels in the lumbar spine from L2 to S1 in patients with degenerative discdisease (DDD) with up to Grade I spondylolisthesis at the involvedlevel(s). DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies. These patients should be skeletally mature and have had sixmonths of non-operative treatment. Rampart™-T is designed for use withautograft as an adjunct to fusion and is intended for use with supplementalfixation systems (e.g. pedicle screws) cleared by the FDA for use in thelumbar spine.
Purpose of this 510(k):	The purpose of this 510(k) is to update the indications statements and theability to provide the products as sterile.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products.
Testing	No testing was performed.
Conclusion:	The information submitted in this premarket notification supports a determination that the devices subject to this submission are substantially equivalent in technological characteristics and intended use to the predicate devices.

SEP 1 6 2013

{1}------------------------------------------------

K132053; Page 2 of 2

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

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

September 16, 2013

Spineology, Incorporated Mr. Bryan Becker Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K132053

Trade/Device Name: Rampart™-O, Rampart™-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 18, 2013 Received: July 19, 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

{3}------------------------------------------------

Page 2 - Mr. Bryan Becker

forth in the quality systems (OS) 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K132053

Device Name: Rampart™ O and Rampart™ T

Indications for Use:

Rampart™ O: Rampart™ O 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. Rampart™ O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Rampart™ T: Rampart™ T 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. Rampan™ T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.