(189 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the dilators, with no mention of AI or ML.
Yes
The device is described as "used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures" and to "perform various manoeuvres of dilation." These actions directly treat or modify the body, indicating it is a therapeutic device.
No
Explanation: The device is described as a surgical instrument used to enlarge, calibrate, locate, trace, dilate, and measure vessels. These actions are interventional or intra-operative manipulations rather than diagnostic assessments. While it can "locate orifices" and "trace the course of abnormal vessels," these functions are for procedural guidance and manipulation, not for generating a diagnosis. It is an instrument for performing procedures, not for identifying a disease or condition.
No
The device description explicitly states that the device is a reusable surgical instrument made of stainless steel, which is a physical material, not software. The performance studies also detail testing of physical characteristics like dimensions, mechanical strength, and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Instrumed Vessel Dilators are described as reusable surgical instruments used to physically enlarge or calibrate vessels during surgical procedures. They are used directly on the patient's anatomy.
- Lack of Biological Sample Analysis: There is no mention of this device being used to analyze biological samples or perform any tests outside of the body.
Therefore, the function and intended use of the Instrumed Vessel Dilators clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 manoeuvres of dilation and measurement of annulus and lumen diameters
Product codes
DWP
Device Description
Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators
Dilators are used
- to check patency of vessel in coronary artery bypass procedures
- to check patency of other vessels in pheripheral vascular procedures
- olive shaped tips (Garrett)
The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure.
Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, coronary artery, pheripheral vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
The results of non-clinical and bench testing indicate that the new devices are completely comparable to the predicate devices.
Results of clinical evaluation based on literature research and market surveillance information from
- . database evaluation
- Information from scientific literature .
- data from market experience of the same or similar devices
has proven that the design is safe and effective.
Instrumed International has provided hundreds of dilators in the last 5 years to customers supporting other than US markets, without any reported customer complaint or potentially reportable event.
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).
0
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
| 510(k) Summary as required by section 807.92(c) | K100518 | AUG 31 2010 |
|---|---|---|
| ------------------------------------------------- | --------- | ------------- |
| date prepared | 8/16/2010 |
|---|---|
| Submission Applicant: | INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173 |
| Establishment Registration Number: | 1421101 |
| Official Correspondent: | Mr. Berndt Fetzer INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173 |
| Phone: | 847-908-0292 |
| Trade name: | Instrumed Vessel Dilators |
| Common name: | Various Vessel Dilators: Cooley Coronary Vessel Dilators, Garrett Vascular Dilators, DeBakey Vascular Dilators |
| Classification name: |
| 21 CFR PART 870 -- Subpart E -- | MEDICAL DEVICES CARDIOVASCULAR DEVICES - Cardiovascular Surgical Devices |
|---|---|
| Sec. 870.4475 | Surgical vessel dilator. Code DWP |
| Regulation Description | A surgical vessel dilator is a device used to enlarge or calibrate a vessel. |
Substantial Equivalence Claims:
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, K030788 AND DEBAKEY VESSEL DILATORS
GEISTER MEDIZINTECHNIK GMBH Applicant
1
Description of the Device:
Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators
Dilators are used
- to check patency of vessel in coronary artery bypass procedures
- to check patency of other vessels in pheripheral vascular procedures
- olive shaped tips (Garrett)
The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure.
Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
Indications for Use:
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 manoeuvres of dilation and measurement of annulus and lumen diameters
Comparison with Predicate Device:
Performance characteristics that have been evaluated for the Instrumed Vessel Dilators through testing performed on the proposed device and testing leveraged from previously cleared devices; including the following technological characteristics:
- Design
- Simulated Use
- Clinical evaluation .
- market surveillance data .
- Dimensional Verification
- Dilator tip diameter .
- Dilator length .
- Tip lenath .
- Wire diameter
- visual inspection
- Dilator surface free from defects .
- Wire surface free from defects .
- mechanical testing
- Test of distal tip retention .
- Wire to handle joint strength .
- · Material
- material certificates
- material analysis �
- mechanical strength .
- corrosion testing
- Test of corrosion resistance .
- biocompatibility
- cytotoxicity effects .
- material certificates
2
510(k) Summary
The results of non-clinical and bench testing indicate that the new devices are completely comparable to the predicate devices.
Results of clinical evaluation based on literature research and market surveillance information from
- . database evaluation
- Information from scientific literature .
- data from market experience of the same or similar devices
has proven that the design is safe and effective.
Instrumed International has provided hundreds of dilators in the last 5 years to customers supporting other than US markets, without any reported customer complaint or potentially reportable event.
The Instrumed Vessel Dilators are substantially equivalent to the predicate devices in terms of
- technical characteristics .
- design .
- . Indications for Use
- . Target population
- . where it is used
- performance .
- biocompatibility .
- . sterilization method
- mechanical safety characteristics .
- as well as sizes and configurations. .
Conclusion:
The presented data that was conducted on the Instrumed Vessel Dilators shows in its results and in comparison to the predicate devices that the products are substantially equivalent to the predicate devices.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Instrumed International, Inc. c/o Mr. Michael Massong QA/RA Director 626 Cooper Court Schaumburg, IL 60173
AUG 31 2010
Re: K100518
Trade/Device Name: Instrumed Vessel Dilators Common Name: Dilator, Vessel, Surgical Regulation Number: 21 CFR 870.4475 Regulatory Class: II Product Code: DWP Dated: August 19, 2010 Received: August 25, 2010
Dear Mr. Massong:
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.
4
Page 2 - Mr. Michael Massong
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ashley B. Swain
Bram D. Zuckerman, M.D. 401 Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K | 00578
Device Name:
Instrumed Vessel Dilators
Indications For Use:
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 manoeuvres of dilation and measurement of annulus and lumen diameters.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anlulu Bour fuiboz
of Cardiovascular Devices
510(k) Number K100518