Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.

There are several types of dilators made from stainless steel or aluminum:

Cooley Coronary Dilators
Cooley Vessel Dilators
Garrett Vascular Dilators
Hiebert Vascular Dilators
DeBakey Vascular Dilators
Sarns-Style Dilators
Myocardial Dilators

These dilators are available in a range of different length and diameters.

The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.

Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.

The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: Fetzer Medical Vessel Dilators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness from scratch through extensive clinical trials for new medical technologies like AI/ML devices. As such, the information you're asking for, particularly regarding acceptance criteria, study design for proving performance, and expert-driven ground truth establishment (which is typical for AI/ML diagnostic devices), is not present in this document.

The document focuses on non-clinical performance testing (reprocessing, sterilization, biocompatibility, mechanical tests) to demonstrate that the Fetzer Medical Vessel Dilators are as safe and effective as existing, legally marketed predicate devices.

Here's a breakdown of why your specific questions cannot be answered by this document and what is provided:

Why the document does not contain the requested information (related to AI/ML device performance studies):

Device Type: The Fetzer Medical Vessel Dilators are manual surgical instruments, specifically vessel dilators. They are not an AI/ML diagnostic or therapeutic device.
Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This involves comparing indications for use, technological characteristics (design, materials, performance), and demonstrating that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or conducting large-scale clinical studies with human readers, ground truth consensus, or advanced statistical analyses like MRMC studies, which are common for AI/ML-driven diagnostic devices.
Performance Data Scope: The "performance data" mentioned in this document refers to physical testing of the device (e.g., cleanability, sterilizability, mechanical strength), not diagnostic accuracy or clinical outcomes in patients.

What the document does provide regarding "Testing":

The document details performance testing conducted to show the device's characteristics are similar to the predicate devices and that it meets relevant standards for a surgical instrument.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit): For this type of device, the "acceptance criteria" are broad and relate to meeting industry standards and demonstrating comparable performance to the predicate device in specific functional aspects.
- Automatic Reprocessing Validation according to ANSI/AAMI ST81: The implicit acceptance criterion is that "contamination...could be removed...by the given cleaning and disinfection instructions."
- Sterilization testing: The implicit acceptance criterion is that "the device will be adequately sterilized under the validated sterilization parameters" to achieve a SAL (Sterility Assurance Level) of 10^-6.
- Biocompatibility testing (ISO 10993-5): The implicit acceptance criterion is that materials are "non cytotoxic for the indicated contact duration."
- Mechanical tests: The implicit acceptance criterion is that devices "were able to withstand the required pulling force without deformation or failure."
Reported Device Performance:

Test	Reported Device Performance
Automatic Reprocessing Validation	"This validation provides evidence that contamination of the 'Vessel Dilators' could be removed in health care facilities by the given cleaning and disinfection instructions."
Sterilization testing	"A reduction of test bacteria was observed and provided assurance that the device will be adequately sterilized under the validated sterilization parameters."
Biocompatibility testing (Cytotoxicity)	"All patient contacting materials were from the same material as the equivalent predicate devices. They were considered non cytotoxic for the indicated contact duration."
Mechanical tests	"All devices were able to withstand the required pulling force without deformation or failure."

2. Sample size used for the test set and the data provenance:

Test Sets: The document refers to "worst case devices" for reprocessing validation and "test specimens" for sterilization testing. The exact number of units or biological samples tested is not specified.
Data Provenance: This is not applicable in the context of clinical patient data. The tests are laboratory-based. No country of origin for clinical data is mentioned as no clinical studies were performed. The tests are retrospective in the sense they were done before submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications:

Not applicable. The "ground truth" for these tests relates to measurable physical/biological parameters (e.g., residual protein levels, bacterial reduction, material cytotoxicity, mechanical force applied), not expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable. This refers to consensus building among experts for subjective interpretations, which is not relevant for the objective laboratory tests performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. This type of study is for evaluating observer performance, typically in diagnostic imaging. It was not conducted for this surgical instrument.

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

Not applicable. This relates to AI/ML algorithm performance. The device is a manual surgical tool.

7. The type of ground truth used:

Laboratory-based measurements against established standards:
- Reprocessing: Measured contamination levels (red blood cells, residual protein, organisms, total organic carbon) against AAMI TIR 30 guidelines.
- Sterilization: Reduction of bioindicators/challenge suspension to achieve SAL 10^-6.
- Biocompatibility: Cytotoxicity results per ISO 10993-5.
- Mechanical: Resistance to pulling forces.

8. The sample size for the training set:

Not applicable. This is typically for machine learning models. No training set for an algorithm was used.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a minimalist design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 29, 2017

Fetzer Medical Gmbh & Co. Kg Mr. Harald Jung Manager Ouality/ Regulatory Affairs Unter Buchsteig 5 D-78532 Tuttlingen Germany

Re: K163524

Trade/Device Name: Fetzer Medical Vessel Dilator Regulation Number: 21 CFR 870.4475 Regulation Name: Surgical Vessel Dilator Regulatory Class: Class II Product Code: DWP Dated: May 30, 2017 Received: June 1, 2017

Dear Mr. Harald 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

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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 the quality systems (QS) 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.

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163524

Device Name Vessel Dilators

Indications for Use (Describe)

Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular 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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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:	26.06.2017
Device Trade Name:	Fetzer Medical Vessel Dilators
Common / Usual Name:	Vessel Dilators
Classification Name	Dilator, Vessel, Surgical
Regulatory Class:	II
Product Code:	DWP
Regulation	21 CFR 870.4475 Surgical Vessel Dilator

2. Predicate Device:

	Primary Predicate	Secondary Predicate
Trade name	Instrumed Vessel Dilators	Geister Garrett, Cooley and Debakey VesselDilators
510(k) No.	K100518	K030788
510(k) submitter /holder	INSTRUMED INTERNATIONAL, INC.626 Cooper CourtSchaumburg, IL 60173, USA	Geister Medizintechnik GmbHFöhrenstr. 278532 Tuttlingen / Germany

3. Device Description:

There are several types of dilators made from stainless steel or aluminum:

Cooley Coronary Dilators -
-Cooley Vessel Dilators
-Garrett Vascular Dilators
-Hiebert Vascular Dilators
-DeBakey Vascular Dilators
-Sarns-Style Dilators
-Myocardial Dilators

These dilators are available in a range of different length and diameters.

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510(k) Summary

Image /page/4/Picture/1 description: The image shows the logo for Fetzer Medical. The logo features the word "Fetzer" in a stylized font, with a blue swoosh above the "t". Below "Fetzer" is the word "MEDICAL" in smaller, sans-serif font. The overall design is clean and modern.

4. Comparison of Indications for Use

The Fetzer Medical Vessel Dilators have the same intended use as the predicate devices, although there are differences in the indications for use. The indications are further compared below:

	Subject Device	Primary Predicate	Secondary Predicate
Trade name	Fetzer Medical Vessel Dilators	Instrumed Vessel Dilators	Garrett, Cooley, and DebakeyVessel Dilator
Indication for use	Fetzer Medical vessel dilators aredevices used to enlarge or calibrate avessel during cardiovascular surgery.	INSTRUMED vessel dilators aredevices used to enlarge orcalibrate vessels during coro-nary artery bypass or angioplas-ty procedures. They are de-signed to locate orifices, to tracethe course of abnormal vessels,and to perform various maneu-vers of dilation and measure-ment of annulus and lumendiameters.	Geister vessel dilators are de-vices used to enlarge or cali-brate vessels during coronaryartery bypass or angioplastyprocedures. They are designedto locate orifices, to trace thecourse of abnormal vessels, andto perform various maneuvers ofdilation and measurement ofannulus and lumen diameters.

5. Comparison of Device Design to predicate device

The subject and predicate devices are similar in terms of device design, with some additional geometries available in the subject device. The device designs are compared further below:

	Fetzer Medical Vessel Dilators DeviceConfigurations	Comparison to Predicate Devices
●	Cooley Coronary DilatorsCooley Vessel DilatorsGarrett Vascular DilatorsDeBakey Vascular Dilators	The Fetzer Medical Vessel Dilators were compared against the predicate devices in thefollowing properties, and found to fall within the range offered under the predicate devic-es:● Tip geometry and dimensions● Handle and wire dimensions● Materials
●	Hiebert Vascular Dilators	The predicate devices do not include Hiebert Vascular Dilator configurations. TheHiebert Vascular Dilators are the same as Garrett Vascular Dilator except they aredouble-ended.
●	Sarns-Style DilatorsMyocardial Dilators	The Sarns-Style Dilators and Myocardial Dilators differ from the predicate devices in tipand handle geometry to accommodate larger vessels.

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Image /page/5/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 swoosh above the "t". Below "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.

6. Comparison of Cleaning and Sterilization

The Cleaning and Sterilization for the Fetzer Medical Vessel Dilators are similar to the range conditions for the predicate devices:

	Subject Device	Primary Predicate	Secondary Predicate
Trade name	Fetzer Medical Vessel Dilators	Instrumed Vessel Dilators	Geister Garrett, Cooley, andDebakey Vessel Dilator
Cleaning	Instruments can be processed afterdisassembling in a combined manualpre cleaning and automated cleaningwith a validated washer-disinfectorprior to sterilization.	manual cleaning with softsponge / soft brushno details in IFU	Instruments can be processedafter disassembling in a com-bined manual pre cleaning andautomated cleaning with a vali-dated washer-disinfector prior tosterilization.
Sterilization	non-sterileSterilization prior to use, using steamsterilization.temperature:132 °C / 270 °Fexposure time:4 minutesdry time:20 minutes	non-sterileto sterilize in steam Autoclave270 °F, 15 min	non-sterileto sterilize with PrevacuumSteam Sterilizationtemperature:min 132 °Cexposure time:minimum 3 mindry time:30 min

7. Testing

The following performance data were provided in support of the substantial equivalence determination:

Test	Test Method Summary	Results
Automatic Repro-cessing Validationaccording to ANSI/AAMI ST81	Worst case devices were tested to verify that theinstruments could be cleaned with the providedcleaning steps in the IFU.This test is performed by contamination of ac-cessible, interior, and exterior surfaces of repre-sentative worst case instruments intending toreach the sites identified as the least accessibleor most difficult to reach sites (worst case).According AAMI TIR 30, the effectiveness of thereprocessing cycle is evaluated by comparingvisible contamination (red blood cells), residualprotein, the number of organisms and the totalorganic carbon concentration recovered from thecontrol instruments and the test instruments.	This validation provides evidence thatcontamination of the "Vessel Dilators"could be removed in health care facilitiesby the given cleaning and disinfection in-structions.
Sterilization testing	The test is to verify that the devices could besterilized with the provided sterilization proce-dure described in the IFU.The test specimens were contaminated with bioindicators or with a challenge suspension andwere tested for sterility after the sterilizationprocess.To assure a SAL of 10^-6 only a part cycle of therecommended sterilization process was per-formed in validation.	A reduction of test bacteria was observedand provided assurance that the device willbe adequately sterilized under the validat-ed sterilization parameters.
Biocompatibilitytesting	We conducted cytotoxicity testing according ISO10993-5 for different materials and manufactur-ing lines.	All patient contacting materials were fromthe same material as the equivalent predi-cate devices. They were considered noncytotoxic for the indicated contact duration.

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510(k) Summary

Image /page/6/Picture/1 description: The image shows the logo for Fetzer Medical. The logo is gray, with a blue swoosh above the "t" in Fetzer. The word "MEDICAL" is written in smaller, gray letters below the word "Fetzer."

Test	Test Method Summary	Results
Mechanical tests	Pulling forces were applied to test the mechani-cal integrity of the devices.	All devices were able to withstand therequired pulling force without deformationor failure.

The nonclinical testing demonstrated, that the Fetzer Medical Vessel Dilators are substantial equivalent to the predicate devices.

Performance Testing – Clinical / Animal

Clinical and animal testing were not conducted to support the substantial equivalence of this device to the predicates. The testing described above was adequate to address the differences between the subject device and predicate devices.

8. Substantial Equivalence

Substantial equivalence for the Fetzer Medical Vessel Dilators is based on similarities in intended use, design (function and operational principles), materials and labeling.

Although the indications for use are not identical between the subject device and the predicate devices, the intended use is the same.

Design and material of the different Fetzer Medical Vessel Dilators are within the range of those found in predicate devices except for the Myocardial Dilator and the Sarns-Style Dilators which are designed for larger vessels. Biocompatibility equivalence is supported by cytotoxicity testing conducted according to ISO 10993-5. The lager design of the Myocardial and the Sarns-Style Dilators does not raise new concerns reqarding the substantial equivalence of the device to the predicate.

There are minor differences in the Cleaning and Sterilization compared to the predicate devices. Cleaning and Sterilization were verified with several performance tests.

Performance data demonstrate, that the Fetzer Medical Vessel Dilators comply with relevant standards and that they are substantially equivalent to the predicate devices.

9. Conclusion

Based on the comparison of the intended use, technological characteristics and performance testing, the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 870.4475 Surgical vessel dilator.

(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).