Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Device Description

Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.

AI/ML Overview

This document is a 510(k) summary for the Geomed Vascular Dilators, a surgical instrument. It is NOT for an AI/ML powered device, therefore most of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Tensile strength testing of the tip-to-wire and handle-to-wire bonds	Bond strength sufficient to withstand forces during clinical use	Bond strength is sufficient to withstand forces experienced during clinical use
Verification of device dimensions	Conformance to specified dimensions	Verified (implied by "Acceptance criteria were met for all tests performed")
Validation testing of recommended end user manual and automated cleaning procedures	Effective cleaning as per FDA guidance	Validated effective cleaning
Validation testing of recommended end user steam sterilization process	Effective sterilization as per FDA guidance	Validated effective steam sterilization
Full-cycle validation testing of drying time after sterilization	Adequate drying time	Validated adequate drying time

Note: The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not detailed in this summary. The summary states that "Acceptance criteria were met for all tests performed," implying that the device successfully passed these tests.

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

The document does not specify the sample sizes for the individual tests (tensile strength, dimensional verification, cleaning, sterilization, drying time). The data provenance is not explicitly mentioned but can be inferred as internal testing performed by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, as part of their 510(k) submission. These are device performance tests, not clinical studies with human data.

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

This information is not applicable as this is not a study involving human interpretation of data or a clinical study. The "ground truth" for these tests would be established by engineering specifications, validated cleaning protocols, and sterilization standards.

4. Adjudication method for the test set

This information is not applicable for device performance testing. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in observations or diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical surgical instrument (vascular dilator), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the device performance tests, the "ground truth" is based on:

Engineering specifications and standards: For tensile strength and device dimensions.
FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (03/17/2015): For cleaning and sterilization validation.
Established industry standards for sterilization and drying: For sterilization and drying time validation.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model being trained.

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

This information is not applicable. There is no "training set" for this type of device submission.

Summary

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September 18, 2019

Geomed Medizin-Technik GmbH & Co. % Angelika Scherp Regulatory Affairs Consultant Business Support International Amstel 320-1 1017 AP Amsterdam The Netherlands

Re: K183438

Trade/Device Name: Geomed Vascular Dilators Regulation Number: 21 CFR 870.4475 Regulation Name: Surgical vessel dilator Regulatory Class: Class II Product Code: DWP Dated: July 26, 2019 Received: July 30, 2019

Dear Angelika Scherp:

This letter corrects our substantially equivalent letter of September 3, 2019.

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brian D. Pullin -S

Brian Pullin, M.S. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183438

Device Name Geomed Vascular Dilators

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K183438

5. 510(k) SUMMARY

Date:	September 1, 2019
Submitter:	Name: Geomed Medizin-Technik GmbH & Co. KGAddress: Ludwigstaler Strasse 27D-78532 TuttlingenGermany
	Contact Person: Hanno HaugTelephone: +49.7461.93550
Product:	Name of Device: Geomed Vascular DilatorsCommon Name: Vascular DilatorClassification Name: Surgical Vessel DilatorCFR Section: 870.4475
Predicate Device:	K100518 – Instrumed Vessel Dilators• This predicate has not been subject to a recall.
Device Description:	Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure.The device is provided non-sterile for steam sterilization by the user.
Indications for Use:	Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Technological Characteristics	The technological and performance characteristics of subject and predicate devices are identical, as shown by the following comparison table:

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Manufacturer	Geomed Medizin-Technik	Instrumed K100518
Indications for Use	Geomed Vascular Dilators aredevices used to enlarge or calibratevessels during coronary arterybypass or angioplasty procedures.They are designed to locateorifices, to trace the course ofabnormal vessels, and to performvarious maneuvers of dilation andmeasurement of annulus and lumendiameters.	INSTRUMED vessel dilators aredevices used to enlarge or calibratevessels during coronary arterybypass or angioplasty procedures.They are designed to locate orifices,to trace the course of abnormalvessels, and to perform variousmaneuvers of dilation andmeasurement of annulus and lumendiameters.
Design	Tapered tip connected to a handleby wire.	Tapered tip connected to handle bywire.
Garrett Vascular Dilator
Tip Diameter	1.0-5.0 mm	1.0-5.0 mm
Length	140 mm / 210 mm	140 mm / 210 mm
DeBakey Vascular Dilator
Tip Diameter	1.0-10.0 mm	1.0-10.0 mm
Length	190 mm	190 mm
Material	ASTM F 899-12b Stainless Steel	ASTM F 899-07 Stainless Steel
Patient Contact	Blood vessels, transient (<15 min.)	Blood vessels, transient (<15 min.)
Sterility	Non-sterile	Non-sterile
Reusable	Yes	Yes

The subject Geomed Vascular Dilators are very similar to the predicate device in terms of intended use and technology. Design verification and validation testing to support determination of substantial equivalence consisted of the following tests:

Tensile strength testing of the tip-to-wire and handle-to-wire bonds, indicating that the bond strength is sufficient to withstand forces experienced during clinical use
人 Verification of device dimensions

Performance Testing:

Σ Validation testing of the recommended end user manual and automated cleaning procedures
Σ Validation testing of the recommended end user steam sterilization process
∑ Full-cycle validation testing of drying time after sterilization

Cleaning and sterilization validation testing was conducted in accordance with the recommendations outlined in FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (03/17/2015).

Acceptance criteria were met for all tests performed.

The subject device Geomed Vascular Dilators has the same technological Conclusion: characteristics and indications for use as the predicate device. The information provided in this 510(k) submission, including results of nonclinical testing. indicates that Geomed Vascular Dilators are substantially equivalent to the predicate device.

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).