(51 days)
The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.
The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.
Here's a breakdown of the acceptance criteria and the study details for the VECTEC Disposable Trocars and Laparoscopic Accessories, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VECTEC device were based on demonstrating substantial equivalence to predicate devices, particularly regarding safety and performance. The primary performance criteria centered on the dielectric withstand testing requirements for electrosurgical devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dielectric withstand testing requirements | VECTEC laparoscopic accessories met the dielectric withstand testing |
| of ANSI/AAMI HF-18:2001 | requirements of ANSI/AAMI HF-18:2001. |
| Substantial equivalence in Intended Use | Demonstrated by similarity in Intended Use to predicate devices. |
| Substantial equivalence in characteristics | Devices are similar in characteristics to predicate devices. |
| Biocompatible materials | Composed of biocompatible materials; same as predicate devices. |
| Energy source compatibility | Monopolar electrosurgical energy is the same as used for predicate devices. |
| Sterilization | Sterilized using traditional, validated ethylene oxide procedure per EN |
| 550:1994 to a SAL of 10-6 with acceptable residual EO levels per ISO | |
| 0993-7:1995. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing described is bench electrosurgical device performance testing. Therefore, there is no information on sample sizes related to human or animal subjects, nor on data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the performance testing was adherence to the ANSI/AAMI HF-18:2001 standard for dielectric withstand testing and comparison to the characteristics of predicate devices. This is a technical standard rather than a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable. Since there's no clinical test set requiring human interpretation or consensus, there's no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices and bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is not an algorithm or AI system. It is a physical medical device (trocars and laparoscopic accessories) designed for direct surgical use.
7. The Type of Ground Truth Used
The ground truth used for demonstrating the device's acceptable performance was primarily:
- Engineering Standards: Meeting the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.
- Predicate Device Equivalence: Direct comparison of technological characteristics, intended use, materials, and energy source compatibility with already legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.