(265 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a reusable surgical instrument, with no mention of AI or ML.
Yes.
The device is used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures, which is a therapeutic intervention.
No
The device description and intended use indicate that the Geomed Vascular Dilators are surgical instruments used to enlarge or calibrate vessels during procedures, not to diagnose medical conditions by providing information about a disease or condition. Its purpose is interventional (to modify vessels) and measurement, not diagnostic.
No
The device description explicitly states it is a reusable stainless-steel surgical instrument, which is a physical hardware device. The performance studies also focus on physical properties like tensile strength and sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to enlarge or calibrate vessels during surgical procedures (coronary artery bypass or angioplasty). This is a direct intervention on the patient's body.
- Device Description: The device is described as a reusable stainless-steel surgical instrument used by surgeons. This aligns with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / 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.
Product codes
DWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
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
- Verification of device dimensions
Performance Testing:
- Validation testing of the recommended end user manual and automated cleaning procedures
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
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.
| 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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K183438
5. 510(k) SUMMARY
| Date: | September 1, 2019 |
|---|---|
| Submitter: | Name: Geomed Medizin-Technik GmbH & Co. KG |
| Address: Ludwigstaler Strasse 27 | |
| D-78532 Tuttlingen | |
| Germany | |
| Contact Person: Hanno Haug | |
| Telephone: +49.7461.93550 | |
| Product: | Name of Device: Geomed Vascular Dilators |
| Common Name: Vascular Dilator | |
| Classification Name: Surgical Vessel Dilator | |
| CFR 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 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. | INSTRUMED vessel 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. | ||
| Design | Tapered tip connected to a handle | |
| by wire. | Tapered tip connected to handle by | |
| wire. | ||
| 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 ( 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.