(182 days)
Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.
The LogiFlex Laparoscopic Band Positioning Device is a sterile, single-use, laparoscopic, blunt dissection instrument. It comprises a shaft with a distal articulating tip incorporating a slot that forms a hook for capturing suture threads and tubing. The LogiFlex Laparoscopic Band Positioning Device is designed to be connected to and used with the reusable, ratchet handle of the Logic Monopolar Laparoscopic Scissors in order to effect articulation of the distal tip. The LogiFlex Laparoscopic Band Positioning Device is not designed to be used with an electrocautery connection.
The provided text describes nonclinical bench testing for the LogiFlex Laparoscopic Band Positioning Device. There is no information about clinical studies with human participants, thus questions related to expert ratings, MRMC studies, or multi-reader performance cannot be answered.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Tip Pull Testing | A tensile axial load > 2kg when pulling suture. | Achieved a load of 2.96kg (pre-production), 2.6kg (production standard) |
| Product straightens to -5° to 0° for cannula introduction/removal. | Passed (articulating from 0° to 90°) | |
| Product articulates to ≥ 90° to allow positioning around the esophagus. | Passed (articulating from 0° to 90°) | |
| Sideway Force Testing | A sideway force ≥ 0.54kg when pulling suture. | Achieved a sideway force of 0.54kg |
| Product straightens to -5° to 0° for cannula introduction/removal. | Passed (articulating from 0° to 90°) | |
| Product articulates to ≥ 90° to allow positioning around the esophagus. | Passed (articulating from 0° to 90°) | |
| Crimped Nipple Pull Out Testing | Crimped nipple to withstand 5kg amount of force. | Achieved an average force of 5.23kg |
| Tip Deflection Testing | Product straightens to -5° to 0° for cannula introduction/removal. | Passed (articulating from 0° to 90°) |
| Product articulates to ≥ 90° to allow positioning around the esophagus. | Passed (articulating from 0° to 90°) | |
| Lifecycle Testing | All 10 specimens to survive 2 irradiation cycles and 50 actuations (articulating from 0° to 90°) without any mechanical defects. | Passed (survived 2 irradiation cycles and 50 actuations without mechanical defects) |
| Drop Testing | Pass in accordance with pass criteria ASTM D4169-1996. After 100% inspection of product after dropping there should be no visible defects found in the product and the package seal should be intact. | Passed (packaging capable of maintaining device sterility and free from damage during transit) |
| Shelf Life (Accelerated Ageing) | Packaging seals meet ASTM F1886-98(2004), burst strength meets ASTM F1140-07, dye penetration meets ASTM F1929-98(2004) after accelerated aging equivalent to 5 years. | Not explicitly stated as "passed" for all specific tests but the report TN 100312 is provided, implying compliance. |
| Sterilization Validation | Achieve a SAL of 10⁻⁶ at a sterilization dose of 25 kilogray (validated in accordance with ANSI / AAMI / ISO 11137-2:2006, using the VDmax2 method). | Validation confirmed; 25 kilogray applied. |
| Biocompatibility - Cytotoxicity | Non-cytotoxic. | Indicated to be non-cytotoxic (negative control non-cytotoxic, positive control cytotoxic). |
| Biocompatibility - Sensitization | Non-sensitiser (stimulation of less than 3). | Considered to be a non-sensitiser (stimulation less than 3 for polar and non-polar extracts). |
| Biocompatibility - Intracutaneous Reactivity | Non-irritant (average reaction not greater than corresponding control). | Considered to be non-irritant (extracts meet ISO 10993-10:2002 requirements). |
2. Sample Size for the Test Set and Data Provenance
- Distal Tip Pull Testing: "13 samples" for production standard product. The provenance of the data is not specified (e.g., country of origin, retrospective/prospective), but it is implied to be laboratory bench testing.
- Lifecycle Testing: "All 10 specimens". The provenance of the data is not specified.
- Shelf Life (Accelerated Ageing): "Thirty test samples at each time point". The provenance of the data is not specified.
- Other tests do not explicitly state sample sizes but generally refer to "the LogiFlex laparoscopic band positioning device," implying testing on representative samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The reported studies are nonclinical bench tests, not involving expert review for diagnostic purposes.
4. Adjudication method for the test set
- Not applicable. The reported studies are nonclinical bench tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. The provided text describes nonclinical bench tests.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical laparoscopic instrument, not an AI algorithm.
7. The type of ground truth used
- Ground truth was based on pre-defined engineering and safety specifications, as documented in technical notes and industry standards (e.g., ASTM, ISO). For example:
- Mechanical strength (tensile load, sideway force, pull out force).
- Articulation angles (-5° to 0°, ≥ 90°).
- Absence of mechanical defects.
- Maintenance of sterility and package integrity.
- Biocompatibility based on established biological response criteria (cytotoxicity, sensitization, irritation).
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning model.
§ 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.