(151 days)
Not Found
No
The device description and performance studies focus on mechanical and reprocessing aspects, with no mention of AI or ML.
No.
The device is a surgical instrument (retractor) used to hold wound edges open; it does not directly treat or prevent a disease or condition.
No
The device is a surgical retractor, an instrument used to hold tissue open during surgery, and does not perform any diagnostic function such as identifying a disease or condition.
No
The device description explicitly states it is a reusable manual instrument made from stainless steel, aluminum, or titanium, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hold the edges of a wound open during spinal surgery." This is a surgical instrument used directly on a patient during a procedure.
- Device Description: The description details a reusable manual instrument made from stainless steel, aluminum, or titanium. This aligns with surgical tools, not devices used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
GZT
Device Description
Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.
Devices are available with the following features:
- frame type retractors consist of a toothed frame with one fixed shank and one moveable shank. . The movable shank can be distracted via a pinion action with a wing screw or a turning knob to adjust it to the opening of the wound. It is self-retaining via a spring loaded ratchet lever and can be released by pressing this ratchet lever.
Blades are exchangeable and available in different length and width configurations to adapt it to a wide range of patient anatomy.
The shanks can be hinged to optimize the adjustment to the surgical site.
-
Ring handle retractors consist of two conjoined shanks held via a spring loaded ratchet. ● Distraction is performed by pressing the ring handles together until the anatomical structures are distracted sufficiently. Ring handle retractors are available in different styles with fixed shanks and fixed blades. As well
there are types with hinged shanks and exchangeable blades in different length and width configurations to adapt it to different patient anatomy. -
. MIS Port retractor is a set of different modular tubular retractors of various length and diameter. They can be inserted over a dilator into the wound and is held by a table mounted adjustable flexible arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following performance data were provided in support of the substantial equivalence determination:
-
Automatic Reprocessing Validation acc. ANSI/AAMI ST81: The test was performed to verify that the devices could be cleaned with the provided cleaning steps in the IFU. This test method is performed by contamination of accessible, interior, and exterior surfaces of representative worst case instruments intending to reach the sites identified as the least accessible or most difficult to reach sites (worst case). According AAMI TIR 30, the effectiveness of the reprocessing cycle is evaluated by comparing visible contamination (red blood cells), residual protein and the number of organisms recovered from the control instruments and the test instruments.
- Results: This validation provides evidence that viable microbiological contamination as well as a soil contamination of the "Self-retaining retractors" are removed by the given cleaning and disinfection instructions.
-
Sterilization testing: The test is to verify that the devices could be sterilized with the provided sterilization procedure described in the IFU. The test specimens were contaminated with bioindicators or with a challenge suspension and were tested for sterility after the sterilization process. To assure a SAL of 10^-6 only a part cycle of the recommended sterilization process was performed in validation.
- Results: A reduction of test bacteria was observed and assured showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization.
-
Biocompatibility testing: To verify the biocompatibility of all patient contacting materials, we evaluated them according ISO 10993-1. Fetzer Medical Self-Retaining Retractors were considered "tissue / bone contacting" devices with a contact duration of less than 24 hours. We performed several cytotoxic tests according ISO 10993-5 and sensitization / irritation tests according ISO 10993-10 for the different materials and manufacturing lines.
- Results: All tested devices were considered non cytotoxic and they did not cause any skin irritation reaction for the indicated contact duration.
-
Mechanical tests: Devices were tested for typical forces to hold a wound open during spinal surgery. Testing load was double to tribble the maximum load assumed during surgery.
- Results: All devices were able to withstand the required test load without deformation or failure.
The nonclinical testing demonstrated, that the Fetzer Medical self-retaining retractors are substantial equivalent to the predicate devices and perform as well as or better than the legally marketed predicate devices.
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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Fetzer Medical GmbH & Co. KG Mr. Harald Jung Manager Quality & Regulatory Affairs Unter Buchsteig 5 D-78532 Tuttlingen Germany
Re: K161004
Trade/Device Name: Fetzer Medical Self-Retaining Retractors Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: August 5, 2016 Received: August 8, 2016
Dear Mr. Jung:
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
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 yours,
Carlos L. Pena -SFD/Δ
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) K161004
Device Name
Fetzer Medical Self-Retaining Retractors
Indications for Use (Describe)
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.
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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3
Image /page/3/Picture/1 description: The image shows the logo for Fetzer Medical. The logo features the word "Fetzer" in a stylized, sans-serif font, with a blue swoosh above the "t". Below the word "Fetzer" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue swoosh adds a touch of color and visual interest.
1. Submitter Information
| Submitter: | Fetzer Medical GmbH & Co. KG
Unter Buchsteig 5
D-78532 Tuttlingen
GERMANY |
|-----------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Harald Jung, Manager Quality & Regulatory
Phone: +49 7462 94799-182
Fax: +49 7462 94799-282 |
| Date Prepared: | 2016-09-09 |
| Device Trade Name: | Fetzer Medical Self-Retaining Retractors |
| 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 | Instrumed Retractors | Versatrac™ Lumbar Retractor System | |
|---|---|---|---|
| 510(k) No. | K071771 | K964402 | |
| 510(k) submitter / holder | INSTRUMED INTERNATIONAL, INC. | ||
| 626 Cooper Court | |||
| Schaumburg, IL 60173 | I V. Mueller Neuro/Spine | ||
| 871 Industrial Rd. | |||
| San Carlos, CA 94070, USA | |||
| new device | predicate 1 | ||
| Instrumed K071771 | predicate 2 | ||
| V. Mueller K964402 | |||
| Trade name | Fetzer Medical Self-Retaining Retractors | Instrumed Retractors | Versatrac™ Lumbar Retractor System |
| Indications | |||
| for use | Fetzer Medical Self-Retaining Retractors are | ||
| intended to hold the edges of a wound open | |||
| during spinal surgery. | INSTRUMED retractors are | ||
| devices intended to provide | |||
| minimally invasive access to | |||
| the spine by ensuring the | |||
| placement, positioning of the | |||
| retractor down to the lamina, | |||
| with its attachment to a flexible | |||
| arm to provide a self-locking | |||
| method of access to the spinal | |||
| site through which tubes, | |||
| microscopes and surgical | |||
| instruments can be manipulat- | |||
| ed. | Spinal retractors are intend- | ||
| ed to hold the edges of a | |||
| wound open during spinal | |||
| surgery. | |||
| target | |||
| population | For patients having a spinal surgery | not defined | same |
| Design | |||
| frame type | 1 Frame type retractors: | ||
| The McCulloch type retractors consist of a | |||
| titanium retractor frame with rigid or with hinged | |||
| arms and several titanium blades (Muscle | |||
| Blades / Hook Blades). | |||
| M-Style Retractors consist of a stainless steel | |||
| frame with hinged arms, extension bars and | |||
| different colored aluminum blades. | |||
| Blades are exchangeable and available in differ- | |||
| ent length and width configurations to adapt it to | |||
| a wide range of patient anatomy. | same as Instrumed Titanium | ||
| Microdiscectomy System | same as SHADOW-LINE® | ||
| McCULLOCH Lumbar Re- | |||
| tractor | |||
| Design | |||
| frame type | |||
| and longitu- | |||
| dinal with | |||
| "snap in" | 2 Retractor systems with exchangable snap- | ||
| in blades | |||
| These Systems consist of an expandable frame- | |||
| type retractor with different exchangable snap-in | |||
| blades. | |||
| The shanks are hinged and the blades can be | |||
| locked to the frame with a blade hub and auto- | |||
| locking blade grasper. | |||
| The transverse fram can be fixed to a table- | |||
| mounted stainless steel retractor arm or a | |||
| flexible titanium retractor arm to eliminate any | |||
| retractor frame "drift". | |||
| As well there is a longitudinal ringhandle type | |||
| retractor frame. It is available with the same | |||
| hinged shanks and the same auto-locking blade | |||
| grasper. | |||
| The retractor frame can be black coated to | |||
| reduce the glare. | |||
| Blades are made from Aluminum or titanium in | |||
| different length and width configurations. | same | same as SHADOW-LINE® | |
| Transverse Retractor |
same as SHADOW-LINE®
Longitudinal Retractor |
| Design
Distractor | 3 Vertebral Distractor
The vertical distractor is a frame type retractor
consisting of a toothed frame with one fixed
shank and one movable shank. The shank ends
in a tube which can be pulled over a single use
distraction screw. | same | same |
| | new device | predicate 1
Instrumed K071771 | predicate 2
V. Mueller K964402 |
| Design
Spreader | 4 Vertebral Spreader
Vertebral spreaders consist of two conjoined
shanks. The working end has a flat design with
teeth or serrations at the outer side.
The handle is formed with rings or with curved
shank handles. It has a ratchet mechanism to
hold the devices in any expanded position. As
well there are frame type designs with toothed
frame and pinion action mecha-nism. The
devices are manufactured from stainless steel. | N/A | same |
| Design
Scoville | 5 Scoville Hemilaminectomy Retractors
The Scoville Hemilaminectomy Retractors
consist as well on a toothed frame with one
fixed shank and one moveable shank. The
shanks are hinged and the exchangeable
retractor blades can be fixed to the shanks with
a wing screw.
Frame, shank and the different blades were
made from stainless steel material. | N/A | same |
| Design
Retractors
with fixed
blades | 6 Self-Retaining Ringhandle Retractors with
fixed blades
There are several types of stainless steel self-
retaining retractors with fixed blades.
They consist of two conjoined shanks with
permanent fixed blades / hooks.
Some variations have curved or hinged shanks
to maximize visibility of the operation site. | N/A | same |
| Design
tubular
retractors | 7 Tubular Retractor
This is a set of different modular tubular
retractors of various length and diameter made
from titanium. The tube can be positioned by an
table mounted adjustable flexible arm or an rigid
stainless steel arm.
Available diameters: 14, 16, 18, 20, 22, 24, 26
mm
Available length: 3 – 16 cm | same
Diameter 14, 16, 18, 20, 22,
24, 26 mm
Length: 3 - 16 cm | N/A |
| Materials | Stainless Steel (420, 304, 316)
Aluminium AL6082T6
Titanium, B265 Grade 2/5 | same | same |
| Biocompati-
bility | External communicating device with limited
contact to tissue / bone / dentin | same | same |
| Cleaning | Instruments can be processed in a combined
manual pre cleaning and automated cleaning
with a validated washer-disinfector prior to steri-
lization. | manual cleaning with soft
sponge / soft brush | similar
shadow line, neuro retrac-
tors, general instruments
manual cleaning |
| Sterilization | non-sterile
Sterilization prior to use, using steam steriliza-
tion.
temperature: 132 °C / 270 °F
exposure time:
4 minutes
dry time:
20 minutes | non-sterile
to sterilize in steam Autoclav
270 °F, 15 min | non-sterile
to sterilize with Prevacuum
Steam Sterilization
min 132 °C
min 3 Min. exposure
30 min dry |
3. Device Description:
Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.
Devices are available with the following features:
- frame type retractors consist of a toothed frame with one fixed shank and one moveable shank. . The movable shank can be distracted via a pinion action with a wing screw or a turning knob to adjust it to the opening of the wound. It is self-retaining via a spring loaded ratchet lever and can be released by pressing this ratchet lever.
Blades are exchangeable and available in different length and width configurations to adapt it to a wide range of patient anatomy.
The shanks can be hinged to optimize the adjustment to the surgical site.
-
Ring handle retractors consist of two conjoined shanks held via a spring loaded ratchet. ● Distraction is performed by pressing the ring handles together until the anatomical structures are distracted sufficiently. Ring handle retractors are available in different styles with fixed shanks and fixed blades. As well
there are types with hinged shanks and exchangeable blades in different length and width configurations to adapt it to different patient anatomy. -
. MIS Port retractor is a set of different modular tubular retractors of various length and diameter. They can be inserted over a dilator into the wound and is held by a table mounted adjustable flexible arm.
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Image /page/4/Picture/1 description: The image is a logo for Fetzer Medical. The word "Fetzer" is written in a large, sans-serif font, with a blue and gray swoosh above the "t". Below "Fetzer" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern, and the colors are professional and calming.
4. Indications for Use
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.
5. Comparison of technological Characteristics to predicate device
5
Image /page/5/Picture/0 description: The image shows the text "510(k) Summary" in a large, bold font. The text is black and is centered on a white background. There is a horizontal line underneath the text.
Image /page/5/Picture/1 description: The image shows the logo for Fetzer Medical. The logo is in gray, with the word "Fetzer" in a stylized font. A blue swoosh appears above the "t" in Fetzer. Below the word "Fetzer" is the word "MEDICAL" in a smaller, sans-serif font.
6
Image /page/6/Picture/1 description: The image shows the logo for Fetzer Medical. The word "Fetzer" is written in a stylized font, with a blue swoosh above the "t". Below "Fetzer" is the word "MEDICAL" in a smaller, sans-serif font. The overall design is clean and modern.
6. Testing
The following performance data were provided in support of the substantial equivalence determination:
| Test | Test Method Summary | Results |
|---|---|---|
| Automatic Repro- | ||
| cessing Validation | ||
| acc. ANSI/AAMI | ||
| ST81 | The test was performed to verify that the devices could be | |
| cleaned with the provided cleaning steps in the IFU. | ||
| This test method is performed by contamination of accessi- | ||
| ble, interior, and exterior surfaces of representative worst | ||
| case instruments intending to reach the sites identified as | ||
| the least accessible or most difficult to reach sites (worst | ||
| case). | ||
| According AAMI TIR 30, the effectiveness of the repro- | ||
| cessing cycle is evaluated by comparing visible contamina- | ||
| tion (red blood cells), residual protein and the number of | ||
| organisms recovered from the control instruments and the | ||
| test instruments. | This validation provides evidence | |
| that viable microbiological contami- | ||
| nation as well as a soil contamina- | ||
| tion of the "Self-retaining retractors" | ||
| are removed by the given cleaning | ||
| and disinfection instructions | ||
| Sterilization testing | The test is to verify that the devices could be sterilized with | |
| the provided sterilization procedure described in the IFU. | ||
| The test specimens were contaminated with bioindicators | ||
| or with a challenge suspension and were tested for sterility | ||
| after the sterilization process. | ||
| To assure a SAL of 10^-6 only a part cycle of the recom- | ||
| mended sterilization process was performed in validation. | A reduction of test bacteria was | |
| observed and assured showing that | ||
| contaminated test specimens are | ||
| free of viable/augmentable bacteria | ||
| after sterilization. | ||
| Biocompatibility | ||
| testing | To verify the biocompatibility of all patient contacting mate- | |
| rials, we evaluated them according ISO 10993-1. Fetzer | ||
| Medical Self-Retaining Retractors were considered "tissue / | ||
| bone contacting" devices with a contact duration of less | ||
| than 24 hours. | ||
| We performed several cytotoxic tests according ISO | ||
| 10993-5 and sensitization / irritation tests according ISO | ||
| 10993-10 for the different materials and manufacturing | ||
| lines. | All tested devices were considered | |
| non cytotoxic and they did not | ||
| cause any skin irritation reaction for | ||
| the indicated contact duration. | ||
| Mechanical tests | Devices were tested for typical forces to hold a wound | |
| open during spinal surgery. Testing load was double to | ||
| tribble the maximum load assumed during surgery. | All devices were able to withstand | |
| the required test load without de- | ||
| formation or failure. |
The nonclinical testing demonstrated, that the Fetzer Medical self-retaining retractors are substantial equivalent to the predicate devices and perform as well as or better than the legally marketed predicate devices.
7. Substantial Equivalence
Substantial equivalence for the Fetzer self-retaining retractors is based on similarities in intended use, design (function, dimensions and operational principles), materials and labeling based on their promotional materials, labeling and clearance letter.
Slight differences in the intended use to the Instrumed device do not result in another indication or use at a different surgical site or with another patient population. Therefore the differences do not raise any new issues relating to the safety or effectiveness of the device.
Design and material of the frame type retractors (McCulloch / M-Style), the frame type and longitudinal retractors with "snap in", the Vertebral Distractor, the Vertebral Spreader, the Scoville retractors and the ringhandle retractors with fixed blades is exactly same as the predicate devices from Instrumed and V.Mueller.
Design and material of the tubular retractors is same as predicate from Instrumed devices.
7
510(k) Summary
Image /page/7/Picture/1 description: The image shows the logo for Fetzer Medical. The word "Fetzer" is written in a stylized, sans-serif font, with a blue swoosh above the "t". Below "Fetzer" is the word "MEDICAL" in a smaller, sans-serif font. The overall design is clean and modern.
Minor differences in the Cleaning and Sterilization procedure result from a more detailed description for the Fetzer Medical self-retaining retractors. Cleaning and Sterilization is verified with several performance tests.
The minor differences between the Fetzer Medical self-retaining retractors and the predicate devices do not raise any new issues of safety or effectiveness.
Performance data demonstrate, that the Fetzer Medical self-retaining retractors do comply to relevant standards and that they are equivalent to the predicate devices.
8. Conclusion
Based on the comparison of technological characteristics and performance testing the subject device is substantially equivalent to the predicate.