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510(k) Data Aggregation
(357 days)
Use in gastric and bariatric surgical procedures for the application of suction, stomach decompression and drainage of gastric fluids and irrigation.
The GLG (Gastric Light Guide) is a multi-channel bougie which allows all functions to be performed with one device and one insertion. The GLG is a single use device that is provided sterile (sterilized using Ethylene Oxide). A light channel runs the full length of the bougie, illuminating the oral cavity and pharynx for proper insertion. The GLG connects to a battery powered light handle that are 510(k) exempt under product codes FSW and HJM. The GLG transilluminates the anterior stomach wall while suction holds it in place, highlighting the shape of the bougie and allowing the surgeon to see the best path for stapling. The GLG is inserted at the beginning of the procedure and not removed until after the leak test. The GLG is composed of a double lumen tube composed of medical grade PVC with holes and an atraumatic tip. There is a blue connector for use with standard suction equipment 36 Fr. The light wire is a 3mm diameter wire composed of PMMA with several cut-outs. The light wire does not make patient contact. There is a black connector 10 Fr for the light wire to be connected to a reusable light handle, battery operated LED light source. There is only one model available GLG001, size 36 Fr and 1000mm in length with a closed lightwire channel. The GLG devices are packaged in paper/film packages of material suitable for ethylene oxide sterilization. The units are sold in carton boxes which contain 6 intermediate boxes of 5 units of GLG each.
The medical device in question is the Nasmed Gastric Lightguide (GLG). The provided text describes the acceptance criteria and the studies conducted to demonstrate its performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied by Standard/Purpose) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Blood Interactions | No hemolytic activity (per ISO 10993-4) | Device does not exhibit hemolytic activity. |
| Cytotoxicity | Acceptable cytotoxicity rating (per ISO 10993-5) | Device has a rating of "1" (slight reactivity). |
| Intradermal Reactivity | No intradermal reactivity (per ISO 10993-10) | Device does not show any intradermal reactivity. |
| Irritation & Sensitizing Effect | No skin sensitization (per ISO 10993-10) | Device does not show any skin sensitization. |
| Acute Systemic Toxicity | No increased toxic effects (per ISO 10993-11) | Device does not show increased toxic effects. |
| Sterilization & Shelf Life | ||
| Ethylene Oxide Residuals | EO residuals meet requirements (per ISO 10993-7) | EO residuals met requirements (less than 0.05 mg/instrument in one study and less than 0.9888 mg/instrument in another study). |
| Sterilization Validation | Sterility Assurance Level (SAL) of 10^-6 (per ISO 11135-1:2014) | EO cycles produce medical devices with an SAL of 10^-6. |
| Aging Study | Support for 5-year shelf life, including chemical stability, packaging integrity, and sterility, with stable light wire functionality (per ISO 11607-1, ISO 11607-2, ASTM F88) | Real-time aging study supports 5-year shelf life, including chemical stability (alkalinity, acidity, reductive compounds), packaging integrity (intact seals, water permeability, seal strength, visual and dimensional), and sterility. Accelerated aging study verified light wire stability (no change to structure, flexibility, light intensity, or color). |
| Physical Performance | ||
| Tightness & Strength of Connector and Drain Connection | Catheter can withstand weights for 60 seconds and no air bubbles visible (per EN 1618:1997) | Catheter can within 60 seconds with weights attached to it and there were no air bubbles visible during testing. |
| Heat Emission Testing | Distal and proximal ends of lightwire do not get hot or produce a temperature that would cause burn injuries. External device temperature remains safe. | Study #1: Max temperature 24.5°C (distal tip) and 29.5°C (proximal tip) using standard xenon light source at max setting. Study #2: Max temperature 22.0°C (4 hours, portable light source) and 21.5°C (5 hours, stationary light source). Both considered safe and not causing burn injuries. |
| Design Verification | Dimensions, strength, tightness of joints, and gravitational flow meet specifications. | Dimensions, strength and tightness of joints and gravitational flow were verified during design verification. (Specific performance metrics are not given, but "verified" implies meeting predefined acceptance criteria). |
| Kinking Resistance | (Reference to EN 13868 implies a kinking test methodology was used and passed, but no specific criteria or results are given) | EN 13868 was used as a reference to test methodology. (Implied successful testing, but no specific performance data provided beyond methodology reference). |
| Catheter Common Properties | (Reference to EN 1618 implies that common properties were tested according to this standard, and passed) | EN 1618 was used as a reference to method methodology. (Implied successful testing, but no specific performance data provided beyond methodology reference). |
| Clinical Performance | No safety issues or complications, successful usage in intended procedures. | No safety issues or complications in 112 sleeve gastrectomy surgeries. Successful usage demonstrated. |
2. Sample size used for the test set and the data provenance
- Non-Clinical Performance Testing (Biocompatibility, Sterilization, Physical Performance, Aging): The document does not specify a distinct "test set" sample size for each performance test in the same way clinical studies do. Instead, standard laboratory testing methodologies are typically applied to representative samples of the device until acceptance criteria are met. For example, for Ethylene Oxide Residuals, two studies are mentioned, and for aging, both real-time and accelerated studies were performed. The specific number of devices tested for each non-clinical performance test is not explicitly stated.
- Clinical Performance (Usability Study):
- Sample Size: 112 surgeries.
- Data Provenance: The study was conducted by Dr. Naser in Poland. This indicates it was a prospective clinical study in an international setting (Poland).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Non-Clinical Testing: For laboratory tests, subject matter experts in the respective fields (e.g., toxicology, microbiology, materials science) conduct the testing and interpret results against established standards. The specific number and qualifications of these experts are not detailed in the summary document.
- Clinical Performance (Usability Study): The clinical study involved surgeries performed by "Dr. Naser". While this implies a qualified surgeon, the number of experts (surgeons) involved in establishing the "ground truth" (i.e., safety and successful usage) is implied to be at least one (Dr. Naser), and potentially more if a team was involved in observation/data collection. Their specific qualifications (e.g., years of experience in bariatric surgery) are not explicitly stated beyond being a doctor conducting the surgeries.
4. Adjudication method for the test set
- Non-Clinical Testing: No formal adjudication method is typically described for standard lab tests. Results are generally objective measurements against pre-defined acceptance criteria from standards. Any deviations or ambiguities would be handled through internal quality processes.
- Clinical Performance (Usability Study): For the clinical usability study, the phrase "There were no safety issues or complications" suggests direct observation and reporting by the clinician (Dr. Naser) or their team during and after the 112 surgeries. There is no mention of an independent adjudication committee or blinded review process for safety outcomes, implying a direct assessment by the surgical team.
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
- No MRMC comparative effectiveness study was done. This device is a surgical instrument (gastric bougie with a lightguide), not an AI/imaging diagnostic tool that involves "human readers" or AI assistance in interpretation. The safety and effectiveness are assessed based on its physical properties, biocompatibility, sterilization, and clinical usability in surgery, not on diagnostic reading performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical Testing: The ground truth for these tests is based on adherence to established international and national standards (e.g., ISO, EN, ASTM), which themselves represent a form of expert consensus and validated methodologies for assessing device properties.
- Clinical Performance (Usability Study): The ground truth for the clinical study was based on observational outcomes data directly gathered during and after the 112 surgeries (e.g., absence of safety issues or complications). This is a direct measure of the device's performance in its intended clinical setting.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable as this is a physical medical device, not an AI or machine learning model.
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