(68 days)
INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
The Instrumed Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:
- . Some have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
- Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross – action mechanism to apply tension to the vessel for occlusion.
- The choice of jaw style depends on the surgeon's preference, based on the type and delicacy of ↓ the vessel to be occluded.
The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
Instrumed vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy,
The instruments are offered in non-sterile condition.
This is a 510(k) premarket notification for the Instrumed Vascular Clamp, a reusable surgical instrument. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or quantitative performance metrics are provided in the document for the Instrumed Vascular Clamps. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The reported device performance is qualitative, asserting that the new device is "completely comparable" to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics, sizes and configurations) | "The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices." |
| "Biocompatibility and sterilization studies were successfully completed." | |
| "The Instrumed product is similar to the predicate device in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics as well as sizes and configurations." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "non-clinical and bench testing" was conducted. However, it does not specify the sample size used for the test set.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a surgical instrument, the non-clinical and bench testing would generally be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a physical device like a vascular clamp, "ground truth" would likely be established through standardized engineering tests and material analyses, not through expert consensus in the typical sense of image-based or diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation appears to be based on direct testing and comparison to predicate devices' specifications, not on expert adjudication of ambiguous cases.
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 where human interpretation is a key component, not for surgical instruments like vascular clamps.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of the vascular clamps would be based on:
- Engineering Specifications/Standards: Performance criteria related to material strength, clamping force, corrosion resistance, sterilization effectiveness, and biocompatibility, as defined by relevant industry standards (e.g., ASTM F 899-07 for Stainless Steel).
- Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not provided and is generally not relevant for this type of device submission. There is no "training set" in the context of a physical surgical instrument; it's not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).