(168 days)
The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.
The SoftFix™ Balloon Trocar is a series of sterile and single-use Trocar intended to be included as an extension to the previously cleared Unimax Trocar Series.
In general, the Trocars from Unimax Trocar Series consist of an Obturator and a Cannula containing a seal system. The Obturator is used to place the cannula through the incision site into the patient's body cavity where the Cannula remains anchored at a desired position. For that anchoring purpose, previously cleared Trocars belonging to the Unimax Trocar Series are equipped with threaded Cannulas or Cannulas with a movable bolster. As a series extension, the Cannulas belonging to the SoftFix™ Balloon Trocars are now available with an inflatable balloon and a manually movable bolster to provide stabilization and minimize the fascial trauma during an endoscopic procedure. Whereas these Cannulas are also designed to be compatible with the Obturators belonging to the previously cleared Trocars from the Unimax Trocar Series. The balloon and movable bolster combination on the cannula come with two options;
- a) "SoftFix™ Balloon Fixation Ring" combination
- b) "SoftFix™ Balloon Fixation Cone" combination
Similar to Cannulas of the Trocars from the Unimax Trocar Series, each Cannula of the SoftFix™ Balloon Trocars is a combination of a sleeve and a housing, fitted with a pair of seal and valve to maintain pneumoperitoneum when the Obturator or other laparoscopic devices are inserted or withdrawn through it during the surgical procedures. The Cannula also contains a stopcock with rotation valve at its proximal end in order to allow or prevent passage of any insufflation gas (e.g. CO2), when needed. Near the stopcock, the Cannula contains an inflation port to inflate/deflate the balloon using a standard syringe. While the movable "fixation ring" can be slid down the Cannula sleeve to adjust its height as well as fixing the Cannula at a desired position, the height of the "fixation cone" can be adjusted by pressing the thumb notch present on it and the Cannula can be anchored at the desired position by affixing fascial sutures on the struts present near the thumb notch.
The provided text is a 510(k) Summary for the SoftFix™ Balloon Trocar. It describes non-clinical performance testing but does not contain information about acceptance criteria or studies related to AI/algorithm performance, human reader studies, ground truth establishment, or training set details. Therefore, many of the requested items cannot be answered from the provided document.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Test Method | Acceptance Criteria | Result (PASS/FAIL) |
|---|---|---|---|
| Biocompatibility | In vitro Cytotoxicity test as per ISO 10993-5 | Test article shall be non-cytotoxic | PASS |
| Irritation test per ISO 10993-10 | Test article shall not induce any significant irritation. | PASS | |
| Skin sensitization test per ISO 10993-10 | Test article shall not induce any significant sensitization | PASS | |
| Sterility | Sterilization Validation per ISO 11135 | The sterilization method shall be validated | PASS |
| Sterile Packaging per ISO 11607-1 | The device packaging shall remain sterile during its shelf life period | PASS | |
| Bench Performance Testing | Obturator Insertion Test | Obturators of the devices shall have an insertion force lower than the predefined threshold value when inserted through the cannula. | PASS |
| Obturator Removal Test | Obturators of the devices shall have a removal force lower than the predefined threshold value when removed from the cannula. | PASS | |
| Trocar Penetration Test | The Trocars shall have an insertion force lower than the predefined threshold value when inserted through layers of skin with varying thickness. | PASS | |
| Cannula Stabilization Test | The Cannulas shall remain stable at its original position after maneuver of instruments with varying sizes. | PASS | |
| Air-Leakage Test | The Trocars shall not have any leakage and shall be able to maintain a constant value during real use simulation. | PASS | |
| Balloon Volume Test | The balloons on the Trocars shall be inflated to the recommended volume and shall maintain the predefined threshold diameter. | PASS | |
| Balloon Rigidity Test | The balloons on the Trocars shall withstand the predefined threshold value when mechanically pulled with a constant force. | PASS | |
| Fixation Device Retention Test | The fixation device shall withstand the predefined threshold value when mechanically pushed with a constant force. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any of the individual non-clinical tests. It only states that "non-clinical testing were conducted."
- There is no information on data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This document describes non-clinical performance testing for a medical device (trocar), not an AI/imaging diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation (e.g., radiologists) is not applicable. The ground truth for these physical and functional tests would be based on engineering specifications and direct measurements against those specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/imaging diagnostic device requiring human adjudication of interpretations.
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 is a physical medical device (trocar), not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the ground truth is based on predefined engineering specifications, industry standards (ISO), and mechanical measurements/simulations.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.