MEDICON Spinal Spreading Systems
Device Facts
| Record ID | K161680 |
|---|---|
| Device Name | MEDICON Spinal Spreading Systems |
| Applicant | Medicon EG |
| Product Code | GZT · Neurology |
| Decision Date | Mar 24, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4800 |
| Device Class | Class 2 |
Indications for Use
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 Story
MEDICON Spinal Spreading Systems are reusable manual surgical instruments designed to spread soft tissue and maintain access during spine surgery. The system comprises various spreader models, including expandable frame-type retractors, ring-handle retractors, vertebral spreaders, and tubular retractors. These devices are used in clinical settings (OR) by trained spine surgeons. The instruments function mechanically to hold wound edges open or provide access for minimally invasive procedures. Components include blades, hooks, handles, and depth gauges. The system supports diverse approaches, including cervical, inter-laminar, trans-laminar, extra-foraminal, and dorsolateral. The device provides stable, self-retaining surgical access, which facilitates surgical visualization and procedural efficiency, potentially reducing operative time and improving patient outcomes by maintaining clear access to the surgical site.
Clinical Evidence
No clinical studies were performed. Substantial equivalence is supported by bench testing, including biocompatibility, cleaning validation (AAMI TIR30:2011), steam sterilization validation (ISO 17665-1:2006), and mechanical strength testing of blades and blade supports.
Technological Characteristics
Materials: Stainless steel (ASTM F899), Titanium alloy Ti-6Al-4V (ASTM F136), CP titanium (ASTM F67), Aluminum 6082 (EN 473-3), PEEK CA/CF 30, Polyphenylsulfone (ASTM D6394), Polypropylene (ASTM D4101), and Silicone. Mechanical operation via manual spreading mechanisms (expandable frames, ring handles, vertebral spreaders). Reusable, steam-sterilizable. Radiolucent components included.
Indications for Use
Indicated for use in spine surgery to spread soft tissue and maintain surgical access. For use by surgeons with proper training and experience in spine surgery.
Regulatory Classification
Identification
A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
Predicate Devices
- Fetzer Medical Self-Retaining Retractors (K161004)
- Versatrac™ Lumbar Retractor System (K964402)
- Cervical Self-Retaining Retractor (K935529)
Submission Summary (Full Text)
{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)
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.
| 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 Schmid<br>MEDICON eG<br>Gänsäcker 15<br>78532 Tuttlingen<br>GERMANY<br>(49) 7462 2009-0 Tele<br>email: sales@medicon.de |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-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-Retaining<br>Retractors | Versatrac™ Lumbar Retractor<br>System | 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.<br>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
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.
#### 5. Comparison of technological Characteristics to predicate device
| | New Device | Predicate 1 - Fetzer<br>Medical (K161004) | Predicate 2 - V. Mueller<br>(K964402) | Predicate 3 - T. Koros<br>(K935529) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------|
| Trade name: | Medicon Spinal Spreading<br>Systems | Fetzer Medical Self-Retaining<br>Retractors | Versatrac™ Lumbar Retrac-<br>tor System | Cervical Self-Retaining<br>Retractor |
| Indications for<br>use: | The MEDICON Spinal<br>Spreading Systems are<br>used to spread soft tissue<br>and maintain surgical<br>access in spine surgery<br>and may only be used by<br>surgeons with proper<br>training and adequate<br>experience in spine<br>surgery. | Fetzer Medical Self-<br>Retaining Retractors are<br>intended to hold the edges<br>of a wound open during<br>spinal surgery. | Same | Same |
| Design | | | | |
| Expandable<br>Frame type<br>retractors: | The expandable frame type<br>retractors consist of an<br>expandable toothed rack,<br>two rigid or hinges blade<br>support arm, blade<br>supports and different<br>blade styles and types<br>blades can be attached.<br>Blades are exchangeable<br>and can be snap-loaded<br>from the side or from the<br>top or slide on the arm | Same | Same | Same |
| Expandable<br>Ring handle<br>type retractors: | The expandable ringhandle<br>type retractors consist of two<br>ring handles, a catch, a joint.<br>two shanks and fixed or<br>exchangeable blades/hooks.<br>The exchangeable blades can<br>be snap-loaded from the side<br>or from the top. | Same | Same | Same |
{5}------------------------------------------------
## 510(k) Summary
| Vertebral<br>Spreaders: | Vertebral spreaders consist of<br>two conjoined shanks and<br>have a catch. The working<br>end has a flat design with<br>teeth or serrations at the<br>outer side. These spreaders<br>have ring-handles or shank<br>handles. | Same | Same | N/A |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|------|
| Tubular<br>Retractor: | Tube retractors are used for<br>minimal invasive access and<br>are available in various<br>lengths and diameters. The<br>tube can be fixed to a holding<br>arm or held with manual<br>handles. | Same | Same | N/A |
| Materials: | Stainless steel (ASTM F899) | Same | Same | Same |
| | Titanium alloy, Ti-6Al-4V<br>(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 (ASTM<br>D6394) (only for<br>accessories) | N/A | N/A | N/A |
| | Polypropylene (ASTM D4101)<br>(only for accessories) | N/A | N/A | N/A |
| | Silicone (only for<br>accessories) | 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-clinical<br>Test<br>Summary: | 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 Test<br>Summary: | No clinical studies were performed | |
| Conclusions:<br>Non-clinical<br>and Clinical: | Medicon considers the Spinal Spreading Systems to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices'<br>similarities in principles of operation, technology, materials and indications for<br>use | |
#### 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.
