Search Results
Found 1 results
510(k) Data Aggregation
(209 days)
The SiteSeal™ Femoral Compression Device is indicated for use in the compression of the femoral artery or vein after vessel cannulation.
The Site Seal System consists of a Coated Vicryl™ Suture, a hemostatic powder, a spring-loaded polypropylene SiteSeal™ device, tincture of benzoin and four adhesive dressings in a non-sterile kit. Each component in the kit is individually packaged in the original sterile package. The suture is used to approximate soft tissue on either side of and just above a femoral vessel. The hemostatic powder is poured onto the access site and suture entry/exit sites to control minor external bleeding and exudate from sutures and/or endovascular procedures. The free ends of the suture (after approximating the soft tissue on either side and above the CFA with a first half-knot) are tied tightly around the polypropylene SiteSeal™ device with a second full knot to anchor the device to the skin and provide counter pressure. The internal coil springs apply invariant mechanical pressure against the 3-dimensional, asymmetric SiteSeal™ skin contact surface to induce hemostasis. The asymmetric contact surface is designed so that the physical pressure is greatest towards the heart. A polypropylene roof is placed. Tincture of benzoin and three adhesive dressings stabilize and secure the device to the skin.
Prior to the patient being ambulated, the transparent adhesive dressing, device, loose powder, and suture are removed.
Mechanism of action –
A suture is placed in the soft tissue on both sides and above the access site. The "Zstitch" anchors the SiteSeal to the skin surface creating an inverted skin "channel" aligned with the vessel.
Hemostatic powder covers the access site and suture penetrations to absorb exudate and control minor external bleeding.
The SiteSeal™ device has a three-dimensional skin contact surface that is aligned with the inverted skin channel. The device is pressed tightly against the access site while the sheath is removed.
After sheath removal the SiteSeal™ device is anchored to the access site by tying the device to the skin using the loose ends of the suture. Compressed internal springs apply pressure to the skin external to the vessel such that higher pressure is towards the heart. A polypropylene roof is placed securely over the device. Adhesive strips adhere to the roof and stabilize the SiteSeal™ device.
The springs help modulate heartbeat pressure variation without stopping blood flow through the vessel. The pressure allows continuous blood flow past the access site for a time sufficient to achieve hemostasis. Hemostasis occurs during the time that the SiteSeal™ device is deployed.
The adhesive strip is removed, the sutures are cut and removed, the device is disposed of, any excess powder is brushed off. The patient ambulates immediately.
Nothing is left in the body.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
Acceptance Criteria and Device Performance for SiteSeal™ Femoral Compression Device
Note: The provided text does not explicitly state predetermined quantitative acceptance criteria for the clinical study endpoints in a separate table or section. Instead, it reports the observed safety outcomes and implicitly suggests that the absence of certain events or low incidence rates demonstrate safety and effectiveness. I have interpreted the primary and secondary safety endpoints as the de facto acceptance criteria that the device's performance was measured against.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Primary and Secondary Safety Endpoints) | Reported Device Performance (SiteSeal™ Femoral Compression Device) |
|---|---|
| Primary Safety Endpoints: | |
| Common femoral artery laceration (or needle puncture) | 0% (0/91 access sites), 30 days) access site-related nerve injury |
| Access site-related infection requiring intravenous antibiotics and/or extended hospitalization | 0% (0/91) |
| Total Major Access Site-Related Complications: | 1.1% (1/91) |
| Minor Complications: | |
| Non-treated pseudoaneurysm documented by ultrasound | 0% (0/91) |
| Non-treated arteriovenous fistula documented by ultrasound | 1.1% (1/91) |
| Pseudoaneurysm treated with ultrasound guided thrombin injection, or ultrasound-guided fibrin adhesive | 0% (0/91) |
| Access site hematoma ≥ 6 cm | 1.1% (1/91) |
| Access site-related bleeding requiring > 30 minutes to achieve hemostasis | 7.7% (7/91) |
| Late (following hospital discharge) access site-related bleeding | 2.2% (2/91) |
| Ipsilateral lower extremity arterial emboli | 0% (0/91) |
| Transient loss of ipsilateral lower extremity pulse | 0% (0/91) |
| Ipsilateral deep vein thrombosis | 1.1% (1/91) |
| Access site-related vessel laceration | 0% (0/91) |
| Transient access site related nerve injury | 0% (0/91) |
| Access site wound dehiscence | 0% (0/91) |
| Localized access site infection treated with intramuscular or oral antibiotics | 0% (0/91) |
| Total Minor Access Site-Related Complications: | 13.2% (12/91) |
| Patient Discomfort (0-10 scale): | |
| Mean discomfort score at discharge | 0.45 ± 1.63 (95% CI: 0.11 – 0.79) |
| Mean discomfort score after 24 hours (phone interview) | 1.02 ± 2.17 (95% CI: 0.56 – 1.48) |
| % of cases with no discomfort at discharge | 90.1% (82/91) |
| % of cases with no discomfort after 24 hours | 76.1% (67/88) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size (Pivotal Study): 89 pivotal patients, which resulted in 91 access sites evaluated (2 patients had 2 access sites each). An additional 2 roll-in patients were used for training.
- Data Provenance: Prospective, single-arm, nonrandomized study conducted at 2 medical centers in the United States.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Clinical events were observed and recorded by the study investigators at the medical centers. The ultrasound sub-study involved post-procedure ultrasounds done at the office of one of the two principal investigators.
4. Adjudication Method for the Test Set
The document does not explicitly state an independent adjudication method (e.g., 2+1, 3+1). Clinical events were reported by the study sites.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study was a single-arm evaluation of the SiteSeal device's safety. It does not compare human readers with and without AI assistance, as the device is a mechanical compression device, not an AI diagnostic tool.
6. Standalone Performance Study
Yes, a standalone study was done. This was a standalone clinical study evaluating the safety of the SiteSeal™ Femoral Compression Device and its associated "Z-stitch" procedure in human subjects, without comparison to a control group or human-in-the-loop performance. Its primary goal was to establish the safety of the blind Z-stitch procedure. The bench testing also evaluated the device independently regarding blood flow, spring consistency, suture strength, and pressure analysis.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on:
- Clinical observation and assessment: Incidence of primary and major/minor complications, patient discomfort scores, and clinical events observed during follow-up.
- Imaging data: Ultrasound sub-study for detecting common femoral artery/vein laceration, pseudoaneurysm, arteriovenous fistula, and hematomas.
- Patient medical history and laboratory results: As shown by the identification of Factor 8 deficiency in some patients.
8. Sample Size for the Training Set
- Clinical Training Set: Prior to the pivotal study, there were 2 "roll-in" SiteSeal device patients. These patients were used for investigator training and familiarization with the device.
- The document does not explicitly mention a separate "training set" for the device's internal algorithm development as this is a mechanical device, not an AI or software device.
9. How the Ground Truth for the Training Set Was Established
For the 2 "roll-in" patients, the ground truth was established through direct clinical observation and patient follow-up, similar to the pivotal study patients. The purpose of these patients was for investigator training, so the observation of patient outcomes served to ensure familiarity with the device and procedure.
Ask a specific question about this device
Page 1 of 1