(196 days)
Not Found
No
The device description and performance studies indicate a purely mechanical, manual surgical instrument with no mention of software, algorithms, or data processing.
No
The device is used to physically enlarge or calibrate a vessel during surgery, which is a surgical tool function, not an active therapeutic intervention like drug delivery or energy-based therapy.
No
Explanation: The device description clearly states that these are "devices used to enlarge or calibrate a vessel during cardiovascular surgery." This describes a therapeutic or surgical function, not a diagnostic one. Diagnostic devices are used to identify or characterize a disease or condition.
No
The device is described as reusable manual surgical instruments made from stainless steel or aluminum, which are physical hardware components. There is no mention of software being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enlarge or calibrate a vessel during cardiovascular surgery." This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a "reusable manual surgical instrument" used for physical manipulation of vessels.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not interact with specimens in this way.
The device is a surgical tool used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
Product codes (comma separated list FDA assigned to the subject device)
DWP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel during cardiovascular surgery.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Automatic Reprocessing Validation according to ANSI/AAMI ST81
Worst case devices were tested to verify that the instruments could be cleaned with the provided cleaning steps in the IFU.
This test is performed by contamination of accessible, interior, and exterior surfaces of representative worst case instruments intending to reach the sites identified as the least accessible or most difficult to reach sites (worst case).
According AAMI TIR 30, the effectiveness of the reprocessing cycle is evaluated by comparing visible contamination (red blood cells), residual protein, the number of organisms and the total organic carbon concentration recovered from the control instruments and the test instruments.
Results: 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
The test is to verify that the devices could be sterilized with the provided sterilization procedure described in the IFU.
The test specimens were contaminated with bio indicators or with a challenge suspension and were tested for sterility after the sterilization process.
To assure a SAL of 10^-6 only a part cycle of the recommended sterilization process was performed in validation.
Results: A reduction of test bacteria was observed and provided assurance that the device will be adequately sterilized under the validated sterilization parameters.
Biocompatibility testing
We conducted cytotoxicity testing according ISO 10993-5 for different materials and manufacturing lines.
Results: 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
Pulling forces were applied to test the mechanical integrity of the devices.
Results: All devices were able to withstand the required pulling force without deformation or failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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
1
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
2
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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3
1. Submitter Information
| Submitter: | Fetzer Medical GmbH & Co. KG
Unter Buchsteig 5
D-78532 Tuttlingen
GERMANY |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Harald Jung, Manager Quality & Regulatory
Phone: +49 7462 94799-182
Fax: +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 Vessel |
| Dilators | ||
| 510(k) No. | K100518 | K030788 |
| 510(k) submitter / | ||
| holder | INSTRUMED INTERNATIONAL, INC. | |
| 626 Cooper Court | ||
| Schaumburg, IL 60173, USA | Geister Medizintechnik GmbH | |
| Föhrenstr. 2 | ||
| 78532 Tuttlingen / Germany |
3. Device Description:
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.
4
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.
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.
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 Debakey |
| Vessel Dilator | |||
| Indication for use | Fetzer Medical vessel dilators are | ||
| devices used to enlarge or calibrate a | |||
| vessel during cardiovascular surgery. | INSTRUMED vessel dilators are | ||
| devices used to enlarge or | |||
| calibrate vessels during coro- | |||
| nary artery bypass or angioplas- | |||
| ty procedures. They are de- | |||
| signed to locate orifices, to trace | |||
| the course of abnormal vessels, | |||
| and to perform various maneu- | |||
| vers of dilation and measure- | |||
| ment of annulus and lumen | |||
| diameters. | Geister vessel dilators are de- | ||
| vices used to enlarge or cali- | |||
| brate 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. |
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 Device
Configurations | Comparison to Predicate Devices |
|---|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ● | Cooley Coronary Dilators
Cooley Vessel Dilators
Garrett Vascular Dilators
DeBakey Vascular Dilators | The Fetzer Medical Vessel Dilators were compared against the predicate devices in the
following 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. The
Hiebert Vascular Dilators are the same as Garrett Vascular Dilator except they are
double-ended. |
| ● | Sarns-Style Dilators
Myocardial Dilators | The Sarns-Style Dilators and Myocardial Dilators differ from the predicate devices in tip
and handle geometry to accommodate larger vessels. |
5
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, and |
| Debakey Vessel Dilator | |||
| Cleaning | Instruments can be processed after | ||
| disassembling in a combined manual | |||
| pre cleaning and automated cleaning | |||
| with a validated washer-disinfector | |||
| prior to sterilization. | manual cleaning with soft | ||
| sponge / soft brush | |||
| no details in IFU | Instruments can be processed | ||
| after disassembling in a com- | |||
| bined manual pre cleaning and | |||
| automated cleaning with a vali- | |||
| dated washer-disinfector prior to | |||
| sterilization. | |||
| Sterilization | non-sterile | ||
| Sterilization prior to use, using steam | |||
| sterilization. | |||
| temperature: | |||
| 132 °C / 270 °F | |||
| exposure time: | |||
| 4 minutes | |||
| dry time: | |||
| 20 minutes | non-sterile | ||
| to sterilize in steam Autoclave | |||
| 270 °F, 15 min | non-sterile | ||
| to sterilize with Prevacuum | |||
| Steam Sterilization | |||
| temperature: | |||
| min 132 °C | |||
| exposure time: | |||
| minimum 3 min | |||
| dry 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 Validation | ||
| according to ANSI/ | ||
| AAMI ST81 | Worst case devices were tested to verify that the | |
| instruments could be cleaned with the provided | ||
| cleaning steps in the IFU. | ||
| This test is performed by contamination of ac- | ||
| cessible, interior, and exterior surfaces of repre- | ||
| sentative worst case instruments intending to | ||
| reach the sites identified as the least accessible | ||
| or most difficult to reach sites (worst case). | ||
| According AAMI TIR 30, the effectiveness of the | ||
| reprocessing cycle is evaluated by comparing | ||
| visible contamination (red blood cells), residual | ||
| protein, the number of organisms and the total | ||
| organic carbon concentration recovered from the | ||
| control instruments and the test instruments. | This validation provides evidence that | |
| contamination of the "Vessel Dilators" | ||
| could be removed in health care facilities | ||
| by the given cleaning and disinfection in- | ||
| structions. | ||
| Sterilization testing | The test is to verify that the devices could be | |
| sterilized with the provided sterilization proce- | ||
| dure described in the IFU. | ||
| The test specimens were contaminated with bio | ||
| indicators or with a challenge suspension and | ||
| were tested for sterility after the sterilization | ||
| process. | ||
| To assure a SAL of 10^-6 only a part cycle of the | ||
| recommended sterilization process was per- | ||
| formed in validation. | A reduction of test bacteria was observed | |
| and provided assurance that the device will | ||
| be adequately sterilized under the validat- | ||
| ed sterilization parameters. | ||
| Biocompatibility | ||
| testing | We conducted cytotoxicity testing according ISO | |
| 10993-5 for different materials and manufactur- | ||
| ing lines. | All patient contacting materials were from | |
| the same material as the equivalent predi- | ||
| cate devices. They were considered non | ||
| cytotoxic for the indicated contact duration. |
6
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 the | |
| required pulling force without deformation | ||
| or 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.