The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.

Device Description

The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.

AI/ML Overview

This document describes the MEDICON Spinal Spreading Systems, a set of reusable manual retractor systems used in spine surgery. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics of an AI/ML device. Therefore, many of the requested details concerning AI/ML device acceptance criteria and study designs are not applicable or cannot be extracted from this medical device submission.

Here's an analysis based on the information provided, highlighting the differences due to the nature of the device:

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

Acceptance Criteria (General Safety & Performance)	Reported Device Performance
Biocompatibility	Acceptable results
Cleaning Validation (AAMI TIR30:2011)	No visible soil on test articles
Steam Sterilization Validation (ISO 17665-1: 2006)	Each component met acceptance criteria
Strength of blade supports	Blade supports met acceptance criteria
Strength of blades	Blades met acceptance criteria
Engineering analysis for strength testing worst case	Worst case was determined

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is not an AI/ML device, but a physical medical instrument. The "test set" here refers to the physical devices undergoing non-clinical technical testing. Specific sample sizes for each test (e.g., number of blade supports tested) are not provided, only the qualitative outcome. The data provenance is internal testing performed by the manufacturer, MEDICON eG, which is based in Germany.

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)

This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML devices where interpretation is involved. For a physical surgical instrument, the acceptance criteria are based on objective engineering and sterilization standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert interpretations (e.g., in reading medical images) are resolved to establish a ground truth. For the physical testing of surgical instruments, results are objective and measured against established standards, not subject to expert interpretation discrepancies in the same way.

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

This is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems or AI assistance in a clinical setting with human readers. This device is a surgical instrument, not a diagnostic or AI-assisted system. No clinical studies (including MRMC) were performed.

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

This is not applicable. There is no algorithm or AI component in this medical device.

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

The "ground truth" for this device's performance is established by adherence to recognized engineering standards for mechanical strength, biocompatibility standards, and sterilization validation standards. This is not an expert consensus or pathology-based ground truth typical for AI/ML or diagnostic devices.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/ML system, so there is no training set.

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

This is not applicable. No training set exists for this device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

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

March 24, 2017

MEDICON eG % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K161680

Trade/Device Name: MEDICON Spinal Spreading Systems Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: February 21, 2017 Received: February 24, 2017

Dear Mr. Webb:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

Page 2 - J.D. Webb

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 Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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.

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K161680

Device Name MEDICON Spinal Spreading Systems

Indications for Use (Describe)

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

1. Submitter Information

Submitter:	Joachim SchmidMEDICON eGGänsäcker 1578532 TuttlingenGERMANY(49) 7462 2009-0 Teleemail: sales@medicon.de
Contact Person:	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Date Prepared:	February 17, 2017
Device Trade Name:	Medicon Spinal Spreading Systems
Common / Usual Name:	Self-Retaining Retractors
Classification Name:	Self-Retaining retractor for neurosurgery
Code of Federal Regulations (CFR):	21 CFR 882.4800
Regulatory Class:	II
Product Code:	GZT

2. Predicate Device:

Trade name:	Fetzer Medical Self-RetainingRetractors	Versatrac™ Lumbar RetractorSystem	Cervical Self-Retaining Retractor
510(k) No.:	K161004	K964402	K935529
510(k) submitter:	Fetzer Medical GmbH & Co. KG	I V. Mueller	Koros Surgical Instruments, Corp

3. Device Description:

Device Description:	The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.The spreader models (accessories) include:
	Spreader	Accessories
	Spread-iT Retractor Set I & Set II	titanium hooks, blades & depth gauge
	retraCT system set	PEEK blades, wrench & screwdriver
	Cervicalino System	Bay blades, handle
	Piccolino counter retractor	spreading sleeves, trocar sleeves, dilator set & handles
	Caspar laminectomy spreader	blades & hooks
	Hauser French retractor	blades & speculums

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

Spinal retractor	blades
Scoville laminectomy retractor	blades
Haverfield Scoville lamin retractor	blades & handle
Haverfield Scoville
Inge lamina spreader	hooks & blades
Williams retractor
Cervical tissue retractor
Cloward lamina spreader
Cloward cervical spreader
Markham Meyerding retractor

4. Indications for Use

5. Comparison of technological Characteristics to predicate device

	New Device	Predicate 1 - FetzerMedical (K161004)	Predicate 2 - V. Mueller(K964402)	Predicate 3 - T. Koros(K935529)
Trade name:	Medicon Spinal SpreadingSystems	Fetzer Medical Self-RetainingRetractors	Versatrac™ Lumbar Retrac-tor System	Cervical Self-RetainingRetractor
Indications foruse:	The MEDICON SpinalSpreading Systems areused to spread soft tissueand maintain surgicalaccess in spine surgeryand may only be used bysurgeons with propertraining and adequateexperience in spinesurgery.	Fetzer Medical Self-Retaining Retractors areintended to hold the edgesof a wound open duringspinal surgery.	Same	Same
Design
ExpandableFrame typeretractors:	The expandable frame typeretractors consist of anexpandable toothed rack,two rigid or hinges bladesupport arm, bladesupports and differentblade styles and typesblades can be attached.Blades are exchangeableand can be snap-loadedfrom the side or from thetop or slide on the arm	Same	Same	Same
ExpandableRing handletype retractors:	The expandable ringhandletype retractors consist of tworing handles, a catch, a joint.two shanks and fixed orexchangeable blades/hooks.The exchangeable blades canbe snap-loaded from the sideor from the top.	Same	Same	Same

{5}------------------------------------------------

510(k) Summary

VertebralSpreaders:	Vertebral spreaders consist oftwo conjoined shanks andhave a catch. The workingend has a flat design withteeth or serrations at theouter side. These spreadershave ring-handles or shankhandles.	Same	Same	N/A
TubularRetractor:	Tube retractors are used forminimal invasive access andare available in variouslengths and diameters. Thetube can be fixed to a holdingarm or held with manualhandles.	Same	Same	N/A
Materials:	Stainless steel (ASTM F899)	Same	Same	Same
	Titanium alloy, Ti-6Al-4V(ASTM F136)	Same	Same	Same
	CP titanium (ASTM F67)	Same	Same	Same
	Aluminum 6082 (EN 473-3)	Same	Same	Same
	PEEK CA/CF 30	N/A	N/A	N/A
	Polyphenylsulfone (ASTMD6394) (only foraccessories)	N/A	N/A	N/A
	Polypropylene (ASTM D4101)(only for accessories)	N/A	N/A	N/A
	Silicone (only foraccessories)	N/A	N/A	N/A

6. Testing

The following performance data were provided in support of the substantial equivalence determination:

	Test Method Summary	Results
Non-clinicalTestSummary:	Biocompatibility testing	Acceptable results
	Cleaning validation of worst case components (AAMI TIR30:2011)	No visible soil was seen on the test articles.
	Steam Sterilization Validation of worst case components (ISO 17665-1: 2006)	Each component met the acceptance criteria.
	Test to determine the strength of blade supports	Blade supports met acceptance criteria
	Test to determine the strength of blades	Blades met acceptance criteria
	Engineering analysis to determine strength testing worst case	Worst case was determined
Clinical TestSummary:	No clinical studies were performed
Conclusions:Non-clinicaland Clinical:	Medicon considers the Spinal Spreading Systems to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications foruse

7. Substantial Equivalence

Substantial equivalence for the Medicon self-retaining retractors is based on similarities in intended use, design (function, dimensions and operational principles), materials, labeling and clearance letter.

8. Conclusion

The minor differences between the Medicon Spinal Spreading Systems and the predicate devices of safety and effectiveness. Non-clinical testing demonstrates that the Medicon Systems do comply to relevant standards and they are equivalent to the predicate devices. Based on the comparison of technological characteristics and nonclinical testing the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).