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, Ring handle retractors, MIS Port retractor.

AI/ML Overview

The document describes the submission for a medical device called "Fetzer Medical Self-Retaining Retractors" for 510(k) clearance. The device is a self-retaining retractor for neurosurgery.

Here's an analysis of the acceptance criteria and the study used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Test (Acceptance Criteria Category)	Test Method Summary	Reported Device Performance (Results)
Reprocessing Validation	Verification that devices can be cleaned with provided cleaning steps as per IFU. Contamination of accessible, interior, and exterior surfaces (worst-case) with visible contamination (red blood cells), residual protein, and organisms. Effectiveness evaluated by comparing contamination between control and test instruments. (Acc. ANSI/AAMI ST81 and AAMI TIR 30).	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	Verification that devices can be sterilized with the provided sterilization procedure described in the IFU. Test specimens contaminated with bioindicators or challenge suspension and tested for sterility after the sterilization process. Part-cycle sterilization performed to assure a SAL of 10^-6.	A reduction of test bacteria was observed and assured showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization.
Biocompatibility Testing	Verification of biocompatibility of all patient-contacting materials according to ISO 10993-1. Devices considered "tissue/bone contacting" with contact duration < 24 hours. Cytotoxic tests (ISO 10993-5) and sensitization/irritation tests (ISO 10993-10) performed for 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	Testing for typical forces to hold a wound open during spinal surgery. Testing load was double to triple the maximum load assumed during surgery.	All devices were able to withstand the required test load without deformation or failure.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the "test set" in the context of device performance testing. Instead, it refers to "representative worst-case instruments" for reprocessing validation and "test specimens" for sterilization. It also performs tests on "all patient contacting materials" for biocompatibility and "all devices" (implied across the product line for mechanical tests).

The data provenance is not specified. It is implied to be internal testing conducted by Fetzer Medical GmbH & Co. KG. No country of origin for the data is explicitly mentioned, nor is it stated whether the data is retrospective or prospective, though it's likely prospective laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and study. The ground truth for performance of a mechanical surgical retractor is established through objective engineering and biological testing (e.g., measuring forces, observing bacterial reduction, assessing cytotoxicity), not through expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective human interpretation is involved. For the engineering and biological tests described, the 'results' are objective measurements or observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The Fetzer Medical Self-Retaining Retractors are mechanical surgical instruments.

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

No, a standalone (algorithm only) performance study was not done. This concept is relevant for AI/ML-driven software as a medical device (SaMD) or diagnostic algorithms. The Fetzer Medical device is a conventional, mechanical surgical tool.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established scientific and engineering principles, and regulatory standards:

For reprocessing and sterilization: Reduction of microbial contamination to acceptable, defined levels (e.g., SAL of 10^-6), and removal of visual and chemical contaminants.
For biocompatibility: Absence of cytotoxic effects, sensitization, or irritation as defined by ISO 10993 standards.
For mechanical tests: Ability to withstand (without deformation or failure) loads at multiples of assumed surgical forces, meeting predetermined engineering specifications.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Fetzer Medical device is a mechanical instrument, not an AI/ML device, and therefore does not have a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for this mechanical device.

Summary

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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

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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 (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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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. KGUnter Buchsteig 5D-78532 TuttlingenGERMANY
Contact Person:	Harald Jung, Manager Quality & RegulatoryPhone: +49 7462 94799-182Fax: +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 CourtSchaumburg, IL 60173	I V. Mueller Neuro/Spine871 Industrial Rd.San Carlos, CA 94070, USA
	new device	predicate 1Instrumed K071771	predicate 2V. Mueller K964402
Trade name	Fetzer Medical Self-Retaining Retractors	Instrumed Retractors	Versatrac™ Lumbar Retractor System
Indicationsfor use	Fetzer Medical Self-Retaining Retractors areintended to hold the edges of a wound openduring spinal surgery.	INSTRUMED retractors aredevices intended to provideminimally invasive access tothe spine by ensuring theplacement, positioning of theretractor down to the lamina,with its attachment to a flexiblearm to provide a self-lockingmethod of access to the spinalsite through which tubes,microscopes and surgicalinstruments can be manipulat-ed.	Spinal retractors are intend-ed to hold the edges of awound open during spinalsurgery.
targetpopulation	For patients having a spinal surgery	not defined	same
Designframe type	1 Frame type retractors:The McCulloch type retractors consist of atitanium retractor frame with rigid or with hingedarms and several titanium blades (MuscleBlades / Hook Blades).M-Style Retractors consist of a stainless steelframe with hinged arms, extension bars anddifferent colored aluminum blades.Blades are exchangeable and available in differ-ent length and width configurations to adapt it toa wide range of patient anatomy.	same as Instrumed TitaniumMicrodiscectomy System	same as SHADOW-LINE®McCULLOCH Lumbar Re-tractor
Designframe typeand longitu-dinal with"snap in"	2 Retractor systems with exchangable snap-in bladesThese Systems consist of an expandable frame-type retractor with different exchangable snap-inblades.The shanks are hinged and the blades can belocked 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 aflexible titanium retractor arm to eliminate anyretractor frame "drift".As well there is a longitudinal ringhandle typeretractor frame. It is available with the samehinged shanks and the same auto-locking bladegrasper.The retractor frame can be black coated toreduce the glare.Blades are made from Aluminum or titanium indifferent length and width configurations.	same	same as SHADOW-LINE®Transverse Retractorsame as SHADOW-LINE®Longitudinal Retractor
DesignDistractor	3 Vertebral DistractorThe vertical distractor is a frame type retractorconsisting of a toothed frame with one fixedshank and one movable shank. The shank endsin a tube which can be pulled over a single usedistraction screw.	same	same
	new device	predicate 1Instrumed K071771	predicate 2V. Mueller K964402
DesignSpreader	4 Vertebral SpreaderVertebral spreaders consist of two conjoinedshanks. The working end has a flat design withteeth or serrations at the outer side.The handle is formed with rings or with curvedshank handles. It has a ratchet mechanism tohold the devices in any expanded position. Aswell there are frame type designs with toothedframe and pinion action mecha-nism. Thedevices are manufactured from stainless steel.	N/A	same
DesignScoville	5 Scoville Hemilaminectomy RetractorsThe Scoville Hemilaminectomy Retractorsconsist as well on a toothed frame with onefixed shank and one moveable shank. Theshanks are hinged and the exchangeableretractor blades can be fixed to the shanks witha wing screw.Frame, shank and the different blades weremade from stainless steel material.	N/A	same
DesignRetractorswith fixedblades	6 Self-Retaining Ringhandle Retractors withfixed bladesThere are several types of stainless steel self-retaining retractors with fixed blades.They consist of two conjoined shanks withpermanent fixed blades / hooks.Some variations have curved or hinged shanksto maximize visibility of the operation site.	N/A	same
Designtubularretractors	7 Tubular RetractorThis is a set of different modular tubularretractors of various length and diameter madefrom titanium. The tube can be positioned by antable mounted adjustable flexible arm or an rigidstainless steel arm.Available diameters: 14, 16, 18, 20, 22, 24, 26mmAvailable length: 3 – 16 cm	sameDiameter 14, 16, 18, 20, 22,24, 26 mmLength: 3 - 16 cm	N/A
Materials	Stainless Steel (420, 304, 316)Aluminium AL6082T6Titanium, B265 Grade 2/5	same	same
Biocompati-bility	External communicating device with limitedcontact to tissue / bone / dentin	same	same
Cleaning	Instruments can be processed in a combinedmanual pre cleaning and automated cleaningwith a validated washer-disinfector prior to steri-lization.	manual cleaning with softsponge / soft brush	similarshadow line, neuro retrac-tors, general instrumentsmanual cleaning
Sterilization	non-sterileSterilization prior to use, using steam steriliza-tion.temperature: 132 °C / 270 °Fexposure time:4 minutesdry time:20 minutes	non-sterileto sterilize in steam Autoclav270 °F, 15 min	non-sterileto sterilize with PrevacuumSteam Sterilizationmin 132 °Cmin 3 Min. exposure30 min dry

3. Device Description:

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-cessing Validationacc. ANSI/AAMIST81	The test was performed to verify that the devices could becleaned with the provided cleaning steps in the IFU.This test method is performed by contamination of accessi-ble, interior, and exterior surfaces of representative worstcase instruments intending to reach the sites identified asthe least accessible or most difficult to reach sites (worstcase).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 oforganisms recovered from the control instruments and thetest instruments.	This validation provides evidencethat viable microbiological contami-nation as well as a soil contamina-tion of the "Self-retaining retractors"are removed by the given cleaningand disinfection instructions
Sterilization testing	The test is to verify that the devices could be sterilized withthe provided sterilization procedure described in the IFU.The test specimens were contaminated with bioindicatorsor with a challenge suspension and were tested for sterilityafter 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 wasobserved and assured showing thatcontaminated test specimens arefree of viable/augmentable bacteriaafter sterilization.
Biocompatibilitytesting	To verify the biocompatibility of all patient contacting mate-rials, we evaluated them according ISO 10993-1. FetzerMedical Self-Retaining Retractors were considered "tissue /bone contacting" devices with a contact duration of lessthan 24 hours.We performed several cytotoxic tests according ISO10993-5 and sensitization / irritation tests according ISO10993-10 for the different materials and manufacturinglines.	All tested devices were considerednon cytotoxic and they did notcause any skin irritation reaction forthe indicated contact duration.
Mechanical tests	Devices were tested for typical forces to hold a woundopen during spinal surgery. Testing load was double totribble the maximum load assumed during surgery.	All devices were able to withstandthe 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.

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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.

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).