(280 days)
Not Found
No
The device description and performance studies indicate a manual, mechanical surgical tool with no mention of AI/ML capabilities.
No
The device is described as a surgical spreading system used to spread soft tissue and maintain surgical access in spine surgery, not to treat or prevent a disease or condition.
No
This device is described as a surgical spreading system used to maintain surgical access during spine surgery. It is a tool for a surgical procedure, not a device that diagnoses a condition.
No
The device description explicitly states it is made up of multiple reusable manual spreader systems with components made from various materials (radiolucent material, titanium, stainless steel, anodized aluminum), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "spread soft tissue and maintain surgical access in spine surgery." This is a surgical tool used directly on the patient during a procedure.
- Device Description: The description details reusable manual spreader systems made of various materials. These are physical instruments for surgical manipulation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The device is a surgical instrument, not a diagnostic tool.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GZT
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
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)
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons with proper training and adequate experience in spine surgery.
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)
Non-clinical Test Summary: Biocompatibility testing, Cleaning validation of worst case components (AAMI TIR30:2011), Steam Sterilization Validation of worst case components (ISO 17665-1: 2006), Test to determine the strength of blade supports, Test to determine the strength of blades, Engineering analysis to determine strength testing worst case.
Results: Acceptable results for biocompatibility. No visible soil was seen on the test articles for cleaning validation. Each component met the acceptance criteria for steam sterilization. Blade supports met acceptance criteria. Blades met acceptance criteria. Worst case was determined for engineering analysis.
Clinical Test Summary: No clinical studies were performed.
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.
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
§ 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).
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)
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3
1. Submitter Information
| Submitter: | Joachim Schmid
MEDICON eG
Gänsäcker 15
78532 Tuttlingen
GERMANY
(49) 7462 2009-0 Tele
email: sales@medicon.de |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | J.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
512-388-0199 Tele
512-692-3699 Fax
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
Retractors | Versatrac™ Lumbar Retractor
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.
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
Medical (K161004) | Predicate 2 - V. Mueller
(K964402) | Predicate 3 - T. Koros
(K935529) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------|
| Trade name: | Medicon Spinal Spreading
Systems | Fetzer Medical Self-Retaining
Retractors | Versatrac™ Lumbar Retrac-
tor System | Cervical Self-Retaining
Retractor |
| 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. | Fetzer Medical Self-
Retaining Retractors are
intended to hold the edges
of a wound open during
spinal surgery. | Same | Same |
| Design | | | | |
| Expandable
Frame type
retractors: | The expandable frame type
retractors consist of an
expandable toothed rack,
two rigid or hinges blade
support arm, blade
supports and different
blade styles and types
blades can be attached.
Blades are exchangeable
and can be snap-loaded
from the side or from the
top or slide on the arm | Same | Same | Same |
| Expandable
Ring handle
type retractors: | The expandable ringhandle
type retractors consist of two
ring handles, a catch, a joint.
two shanks and fixed or
exchangeable blades/hooks.
The exchangeable blades can
be snap-loaded from the side
or from the top. | Same | Same | Same |
5
510(k) Summary
| Vertebral
Spreaders: | Vertebral spreaders consist of
two conjoined shanks and
have a catch. The working
end has a flat design with
teeth or serrations at the
outer side. These spreaders
have ring-handles or shank
handles. | Same | Same | N/A |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|------|
| Tubular
Retractor: | Tube retractors are used for
minimal invasive access and
are available in various
lengths and diameters. The
tube can be fixed to a holding
arm or held with manual
handles. | 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 (ASTM
D6394) (only for
accessories) | N/A | N/A | N/A |
| | Polypropylene (ASTM D4101)
(only for accessories) | N/A | N/A | N/A |
| | Silicone (only for
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 | ||
| Test | ||
| 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 | ||
| Summary: | No clinical studies were performed | |
| Conclusions: | ||
| Non-clinical | ||
| and Clinical: | Medicon considers the Spinal Spreading Systems to be equivalent to the | |
| predicate devices listed above. This conclusion is based upon the devices' | ||
| similarities in principles of operation, technology, materials and indications for | ||
| 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.