(199 days)
The Bookwalter Gordon Adjustable Compression Element is indicated for use to provide hemostasis of the femoral vascular access site, during and following catheterization or cannulation procedures.
The Bookwalter Gordon Adjustable Compression Element is an adjustable metal compression device that provides an alternative to applying direct hand pressure to obtain hemostasis during vascular catheterization procedures. The device is secured to a surgical table by means of a compatible clamp which supports an articulating arm that allows positioning of the "metal hand" over the vascular access site. The hand has "fingers" that can be adjusted separately to apply compressive pressure to particular locations around the vascular access site. Once in place the Adjustable Compression Element remains securely in position thereby providing ongoing compression without intervention by the surgical staff although it can be adjusted at any time if so desired. The device is reusable and can be cleaned and sterilized in the hospital setting. The Adjustable Compression Element is constructed of high strength stainless steel for rigidity and durability during use. The system also has an available sterilization container to ensure effective reprocessing.
This document is a 510(k) Pre-market Notification for a medical device called the "Bookwalter Gordon Adjustable Compression Element." It's a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel research study with acceptance criteria for a new AI or diagnostic device.
Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets does not apply directly to this document. This document describes a mechanical device, not a diagnostic algorithm.
However, I can extract the relevant information from the provided text regarding the device and its testing:
Device Name: Bookwalter Gordon Adjustable Compression Element
Indications for Use: To provide hemostasis of the femoral vascular access site, during and following catheterization or cannulation procedures.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Capable of continuous compression without bending or loosening.
- Able to achieve hemostasis.
- Withstand maximum compression force.
- Expand & contract under full load.
- Withstand 2X force load. (Specific quantitative thresholds for "maximum compression force," "full load," and "2X force load" are not provided in this document, but typically would be defined in the test protocols.) | "The mechanical performance testing for maximum compression force, expanding and contracting under full load, and 2X force load test demonstrate that the subject device is capable of continuous compression without bending, or loosening. This testing demonstrates that the product is capable of performing compression and thereby hemostasis in the same manner as the predicate device." "The device provides sufficient compression to achieve hemostasis and can be mounted, positioned, and adjusted in a manner similar to the predicate." |
| Biocompatibility: - Device materials are safe for patient contact. | Cytotoxicity testing was performed. (Specific results or standards met are not detailed, but the submission implies successful completion.) |
| Cleaning & Sterilization: - Device can be effectively cleaned and sterilized in a hospital setting.
- Sterilization process is efficacious.
- Drying time is appropriate. | "Steam Sterilization Efficacy Validation," "Dry Time Validation" were performed. "Validation testing for sterilization of all re-usable components has been completed successfully and cleaning rationale provided." "Instructions provide user information for use, cleaning, and reuse." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes mechanical and sterilization testing of a physical device. It does not involve patient data or human subjects in the typical sense of a clinical trial.
- The "test set" would refer to the units of the device subjected to the mechanical, biocompatibility, and sterilization tests. The number of devices tested is not specified in the summary but would be detailed in the full test reports.
- Data provenance is not applicable in the context of this device's testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of this device would be established by engineering specifications and validated laboratory testing, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers or interpretation.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document pertains to a mechanical medical device, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document is about a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, material science properties, and validated laboratory testing against predefined criteria (e.g., specific force values, sterilization efficacy standards, biocompatibility standards).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" like an AI algorithm would.
9. How the ground truth for the training set was established:
- Not applicable. There is no concept of a "training set" for this mechanical 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).