(189 days)
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.
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.
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.
§ 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).