Self-retaining Retractor

K161004 · Fetzer Medical GmbH & Co. KG · GZT · Sep 9, 2016 · Neurology

Device Facts

• Record ID: K161004
• Device Name: Self-retaining Retractor
• Applicant: Fetzer Medical GmbH & Co. KG
• Product Code: GZT · Neurology
• Decision Date: Sep 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2

Intended Use

Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.

Device Story

Manual, reusable surgical instruments; stainless steel, aluminum, or titanium construction. Used in spinal surgery to hold wound edges open. Includes frame-type retractors (McCulloch/M-Style), ring-handle retractors, vertebral distractors/spreaders, Scoville hemilaminectomy retractors, and modular tubular retractors. Operated by surgeons in clinical settings. Mechanical operation via ratchets, pinion actions, or wing screws to distract and lock blades in position; tubular versions held by table-mounted flexible arms. Provides stable surgical site access; improves visualization for the surgeon. Non-sterile; requires manual pre-cleaning, automated washer-disinfector processing, and steam sterilization prior to use.

Clinical Evidence

Bench testing only. Validation included automated reprocessing (AAMI TIR 30/ANSI/AAMI ST81) confirming removal of soil/microbiological contamination; sterilization validation (SAL 10^-6); biocompatibility (ISO 10993-1, -5, -10) confirming non-cytotoxicity and lack of irritation; and mechanical load testing demonstrating structural integrity under forces exceeding surgical requirements.

Technological Characteristics

Materials: Stainless steel (420, 304, 316), Aluminum (AL6082T6), Titanium (B265 Grade 2/5). Mechanical actuation: Ratchet, pinion, or wing screw. Form factors: Frame-type, ring-handle, tubular. Sterilization: Steam (132°C/270°F). Biocompatibility: Tissue/bone contacting <24 hours.

Indications for Use

Indicated for patients undergoing spinal surgery requiring wound retraction.

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

• Instrumed Retractors (K071771)
• Versatrac™ Lumbar Retractor System (K964402)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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)

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |

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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<br>Unter Buchsteig 5<br>D-78532 Tuttlingen<br>GERMANY |
|-----------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Harald Jung, Manager Quality & Regulatory<br>Phone: [phone]<br>Fax: [phone] |
| 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.<br>626 Cooper Court<br>Schaumburg, IL 60173 | I V. Mueller Neuro/Spine<br>871 Industrial Rd.<br>San Carlos, CA 94070, USA | |
| | new device | predicate 1<br>Instrumed K071771 | predicate 2<br>V. Mueller K964402 |
| Trade name | Fetzer Medical Self-Retaining Retractors | Instrumed Retractors | Versatrac™ Lumbar Retractor System |
| Indications<br>for use | Fetzer Medical Self-Retaining Retractors are<br>intended to hold the edges of a wound open<br>during spinal surgery. | INSTRUMED retractors are<br>devices intended to provide<br>minimally invasive access to<br>the spine by ensuring the<br>placement, positioning of the<br>retractor down to the lamina,<br>with its attachment to a flexible<br>arm to provide a self-locking<br>method of access to the spinal<br>site through which tubes,<br>microscopes and surgical<br>instruments can be manipulat-<br>ed. | Spinal retractors are intend-<br>ed to hold the edges of a<br>wound open during spinal<br>surgery. |
| target<br>population | For patients having a spinal surgery | not defined | same |
| Design<br>frame type | 1 Frame type retractors:<br>The McCulloch type retractors consist of a<br>titanium retractor frame with rigid or with hinged<br>arms and several titanium blades (Muscle<br>Blades / Hook Blades).<br>M-Style Retractors consist of a stainless steel<br>frame with hinged arms, extension bars and<br>different colored aluminum blades.<br>Blades are exchangeable and available in differ-<br>ent length and width configurations to adapt it to<br>a wide range of patient anatomy. | same as Instrumed Titanium<br>Microdiscectomy System | same as SHADOW-LINE®<br>McCULLOCH Lumbar Re-<br>tractor |
| Design<br>frame type<br>and longitu-<br>dinal with<br>"snap in" | 2 Retractor systems with exchangable snap-<br>in blades<br>These Systems consist of an expandable frame-<br>type retractor with different exchangable snap-in<br>blades.<br>The shanks are hinged and the blades can be<br>locked to the frame with a blade hub and auto-<br>locking blade grasper.<br>The transverse fram can be fixed to a table-<br>mounted stainless steel retractor arm or a<br>flexible titanium retractor arm to eliminate any<br>retractor frame "drift".<br>As well there is a longitudinal ringhandle type<br>retractor frame. It is available with the same<br>hinged shanks and the same auto-locking blade<br>grasper.<br>The retractor frame can be black coated to<br>reduce the glare.<br>Blades are made from Aluminum or titanium in<br>different length and width configurations. | same | same as SHADOW-LINE®<br>Transverse Retractor<br><br>same as SHADOW-LINE®<br>Longitudinal Retractor |
| Design<br>Distractor | 3 Vertebral Distractor<br>The vertical distractor is a frame type retractor<br>consisting of a toothed frame with one fixed<br>shank and one movable shank. The shank ends<br>in a tube which can be pulled over a single use<br>distraction screw. | same | same |
| | new device | predicate 1<br>Instrumed K071771 | predicate 2<br>V. Mueller K964402 |
| Design<br>Spreader | 4 Vertebral Spreader<br>Vertebral spreaders consist of two conjoined<br>shanks. The working end has a flat design with<br>teeth or serrations at the outer side.<br>The handle is formed with rings or with curved<br>shank handles. It has a ratchet mechanism to<br>hold the devices in any expanded position. As<br>well there are frame type designs with toothed<br>frame and pinion action mecha-nism. The<br>devices are manufactured from stainless steel. | N/A | same |
| Design<br>Scoville | 5 Scoville Hemilaminectomy Retractors<br>The Scoville Hemilaminectomy Retractors<br>consist as well on a toothed frame with one<br>fixed shank and one moveable shank. The<br>shanks are hinged and the exchangeable<br>retractor blades can be fixed to the shanks with<br>a wing screw.<br>Frame, shank and the different blades were<br>made from stainless steel material. | N/A | same |
| Design<br>Retractors<br>with fixed<br>blades | 6 Self-Retaining Ringhandle Retractors with<br>fixed blades<br>There are several types of stainless steel self-<br>retaining retractors with fixed blades.<br>They consist of two conjoined shanks with<br>permanent fixed blades / hooks.<br>Some variations have curved or hinged shanks<br>to maximize visibility of the operation site. | N/A | same |
| Design<br>tubular<br>retractors | 7 Tubular Retractor<br>This is a set of different modular tubular<br>retractors of various length and diameter made<br>from titanium. The tube can be positioned by an<br>table mounted adjustable flexible arm or an rigid<br>stainless steel arm.<br>Available diameters: 14, 16, 18, 20, 22, 24, 26<br>mm<br>Available length: 3 – 16 cm | same<br>Diameter 14, 16, 18, 20, 22,<br>24, 26 mm<br>Length: 3 - 16 cm | N/A |
| Materials | Stainless Steel (420, 304, 316)<br>Aluminium AL6082T6<br>Titanium, B265 Grade 2/5 | same | same |
| Biocompati-<br>bility | External communicating device with limited<br>contact to tissue / bone / dentin | same | same |
| Cleaning | Instruments can be processed in a combined<br>manual pre cleaning and automated cleaning<br>with a validated washer-disinfector prior to steri-<br>lization. | manual cleaning with soft<br>sponge / soft brush | similar<br>shadow line, neuro retrac-<br>tors, general instruments<br>manual cleaning |
| Sterilization | non-sterile<br>Sterilization prior to use, using steam steriliza-<br>tion.<br>temperature: 132 °C / 270 °F<br>exposure time:<br>4 minutes<br>dry time:<br>20 minutes | non-sterile<br>to sterilize in steam Autoclav<br>270 °F, 15 min | non-sterile<br>to sterilize with Prevacuum<br>Steam Sterilization<br>min 132 °C<br>min 3 Min. exposure<br>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

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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.

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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-<br>cessing Validation<br>acc. ANSI/AAMI<br>ST81 | The test was performed to verify that the devices could be<br>cleaned with the provided cleaning steps in the IFU.<br>This test method is performed by contamination of accessi-<br>ble, interior, and exterior surfaces of representative worst<br>case instruments intending to reach the sites identified as<br>the least accessible or most difficult to reach sites (worst<br>case).<br>According AAMI TIR 30, the effectiveness of the repro-<br>cessing cycle is evaluated by comparing visible contamina-<br>tion (red blood cells), residual protein and the number of<br>organisms recovered from the control instruments and the<br>test instruments. | This validation provides evidence<br>that viable microbiological contami-<br>nation as well as a soil contamina-<br>tion of the "Self-retaining retractors"<br>are removed by the given cleaning<br>and disinfection instructions |
| Sterilization testing | The test is to verify that the devices could be sterilized with<br>the provided sterilization procedure described in the IFU.<br>The test specimens were contaminated with bioindicators<br>or with a challenge suspension and were tested for sterility<br>after the sterilization process.<br>To assure a SAL of 10^-6 only a part cycle of the recom-<br>mended sterilization process was performed in validation. | A reduction of test bacteria was<br>observed and assured showing that<br>contaminated test specimens are<br>free of viable/augmentable bacteria<br>after sterilization. |
| Biocompatibility<br>testing | To verify the biocompatibility of all patient contacting mate-<br>rials, we evaluated them according ISO 10993-1. Fetzer<br>Medical Self-Retaining Retractors were considered "tissue /<br>bone contacting" devices with a contact duration of less<br>than 24 hours.<br>We performed several cytotoxic tests according ISO<br>10993-5 and sensitization / irritation tests according ISO<br>10993-10 for the different materials and manufacturing<br>lines. | All tested devices were considered<br>non cytotoxic and they did not<br>cause any skin irritation reaction for<br>the indicated contact duration. |
| Mechanical tests | Devices were tested for typical forces to hold a wound<br>open during spinal surgery. Testing load was double to<br>tribble the maximum load assumed during surgery. | All devices were able to withstand<br>the required test load without de-<br>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.

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# 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.