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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for Instrumed Vessel Dilators. This is a traditional medical device, not an AI/ML powered device, therefore the typical AI/ML-related study criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context. The acceptance criteria and supporting "studies" are focused on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, material analysis, and existing market data, rather than clinical trials with human subjects or AI model performance metrics.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a 510(k) for a physical medical device:

Acceptance Criteria and Device Performance for Instrumed Vessel Dilators

The "acceptance criteria" for the Instrumed Vessel Dilators are primarily based on demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device meets specific performance characteristics and safety requirements, similar to the predicate. The "reported device performance" reflects how the Instrumed Dilators met these equivalence criteria through various non-clinical tests and evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Design Equivalence	- Similar overall design to predicate.	- Design is comparable to predicate devices.
Simulated Use Performance	- Safe and effective simulated clinical use.	- Clinical evaluation (literature & market surveillance) confirms safety and effectiveness.
Dimensional Verification	- Dilator tip diameter within specified range.	- Measured and verified.
	- Dilator length within specified range.	- Measured and verified.
	- Tip Length within specified range.	- Measured and verified.
	- Wire diameter within specified range (if applicable).	- Measured and verified.
Visual Inspection	- Dilator surface free from defects.	- Visually inspected and deemed free from defects.
	- Wire surface free from defects (if applicable).	- Visually inspected and deemed free from defects.
Mechanical Testing	- Distal tip retention strength.	- Tested and confirmed.
	- Wire to handle joint strength.	- Tested and confirmed.
Material Properties	- Material analysis of ASTM F 899-07 Stainless Steel.	- Material certificates provide analysis and mechanical strength data.
Corrosion Resistance	- Resistance to corrosion as per standards.	- Tested and confirmed.
Biocompatibility	- Absence of cytotoxicity effects.	- Tested and confirmed (cytotoxicity evaluation).
Clinical Safety & Effectiveness (Indirect)	- No adverse events or complaints from market use.	- Hundreds of dilators provided outside US over 5 years with no reported customer complaints or reportable events.
Sterilization Method	- Compatible with specified sterilization methods.	- Comparable to predicate (though stated as "non-sterile condition" for shipment, implying appropriate sterilization before use).
Technical Characteristics Equivalence	- Similar technical characteristics to predicate.	- Technical characteristics are comparable to predicate.
Indications for Use Equivalence	- Same intended use as predicate.	- Indications for Use are comparable to predicate.
Target Population Equivalence	- Same patient population as predicate.	- Target population is comparable to predicate.
Usage Environment Equivalence	- Same environment where used as predicate.	- Usage environment is comparable to predicate.
Performance Equivalence	- Equivalent performance to predicate.	- Performance is comparable to predicate.
Mechanical Safety Characteristics Equivalence	- Equivalent mechanical safety to predicate.	- Mechanical safety characteristics are comparable to predicate.
Sizes and Configurations Equivalence	- Similar sizes and configurations to predicate.	- Sizes and configurations are comparable to predicate.

2. Sample Size Used for the Test Set and Data Provenance

Given this is a physical device and not an AI/ML model, the concept of a "test set" for performance evaluation is different.

Sample Size: The document does not specify exact sample sizes for each type of bench test (e.g., how many dilators were tested for tip retention, corrosion, etc.). It generally refers to "the proposed device" or "the new devices" in plural, implying a representative number were subjected to the specified tests.
Data Provenance:
- Bench Testing: Performed on the proposed Instrumed Vessel Dilators. The country of origin for this testing is not explicitly stated but assumed to be under the applicant's (INSTRUMED INTERNATIONAL, INC. in Schaumburg, IL) oversight. This is prospective testing performed specifically for the 510(k) submission.
- Clinical Evaluation: Based on "literature research" and "market surveillance information." This includes "database evaluation," "scientific literature," and "data from market experience of the same or similar devices."
- Market Experience: Data from Instrumed International's own sales (hundreds of dilators over 5 years to non-US markets) with "no reported customer complaint or potentially reportable event." This data is retrospective from global markets (markets other than US).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable to this type of device. The "ground truth" for a physical device like a dilator is established through engineering standards, mechanical tests, material specifications, and clinical consensus on safe and effective surgical practice. There is no concept of "experts establishing ground truth for a test set" in the way it applies to diagnostic AI systems. Expert surgeons would use these devices, but their role in a 510(k) for this product is primarily related to the general acceptance and understanding of dilator function and safety, not as ground truth adjudicators for a specific performance evaluation dataset.

4. Adjudication Method (for the test set)

This question is not applicable. The "test set" here refers to the physical devices undergoing bench testing. The outcomes of these tests (e.g., measured diameter, material composition, breakage force) are objective measurements against defined specifications or standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (especially imaging-based ones) to assess how human reader performance changes with or without an AI aid. Instrumed Vessel Dilators are surgical instruments, not diagnostic tools, so an MRMC study is not relevant.

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

No, a standalone study was not done. This concept applies specifically to AI algorithms. The Instrumed Vessel Dilators are physical devices that are inherently used "with human-in-the-loop" (i.e., by a surgeon).

7. The Type of Ground Truth Used

The "ground truth" for the Instrumed Vessel Dilators is based on a combination of:

Engineering Specifications and Standards: For dimensional accuracy, material properties (ASTM F 899-07), mechanical strength, and corrosion resistance.
Predicate Device Performance and Safety Profile: The established safety and effectiveness of the legally marketed predicate devices (KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, K030788 AND DEBAKEY VESSEL DILATORS) serve as a de facto "ground truth" for what constitutes acceptable device performance and safety for this class of device.
Clinical Literature and Market Surveillance: General medical understanding of appropriate indications for use and safe practices for vessel dilation.
Biocompatibility Standards: To ensure the material is non-cytotoxic and safe for contact with human tissue.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model involved; therefore, no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. There is no AI model involved; therefore, no "training set" ground truth to establish.

Summary

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	510(k) Summary
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510(k) Summary as required by section 807.92(c)	K100518	AUG 31 2010
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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

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Description of the Device:

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 .

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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.

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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.

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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

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Indications for Use

510(k) Number (if known): K | 00578

Device Name:

Instrumed Vessel Dilators

Indications For Use:

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

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).