(122 days)
The Colonglide® Lubricant Is indicated for medical purposes for use to lubricate a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.
Colonglide® Lubricant is a clear, colorless, non-sterile, odorless, water-based patient lubricant. The subject device is packaged for individual use in a 250 mL round plastic bottle sealed with a screw cap with a foil induction innerseal liner.
The Colonglide® Lubricant is intended for medical purposes for use to lubricate a body orifice of a patient to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit quantitative acceptance criteria for each performance metric of the Colonglide® Lubricant. However, we can infer some criteria from the non-clinical and clinical testing performed to establish safety and effectiveness.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance (Colonglide® Lubricant) |
|---|---|
| Non-Clinical Testing: | |
| Appearance: Clear, colorless | Clear, colorless |
| Odor: Odorless | Odorless |
| Physical State: Liquid, gel | Liquid, gel |
| pH: Equivalent to predicate devices (PDI® Sterile Lubricating Jelly: 5.98, Aquagel® Lubricating Jelly: 6.78) | 5.88 (reported as equivalent to predicate devices) |
| Viscosity: Meets pre-determined criteria (specific values not provided in document) | Meets all pre-determined acceptance criteria |
| Specific Gravity: Comparable to predicate devices (PDI®: 1.03, Aquagel®: 1.045) | 1.042 |
| Preservatives: Presence | Contains preservatives (Yes) |
| Microbial Limits: Meets pre-determined criteria (specific values not provided in document) | Meets all pre-determined acceptance criteria |
| Container Testing: Meets USP requirements for Plastics | Met all test method acceptance criteria |
| Biocompatibility (Sensitization & Irritation): No adverse effects, as safe as predicate PDI® Sterile Lubricating Jelly (negative test results) | Negative test results for both sensitization and irritation, confirming it is as safe as the predicate device. |
| Water Solubility: Yes | Yes |
| Sterility: Not sterile (compared to sterile predicate, but also to non-sterile predicate) | No (consistent with one predicate, differs from the other, but overall device class KMJ does not require sterility) |
| Shelf-Life: 2 years (final target) | 6-months (with testing ongoing to support 24-month shelf-life). Note: The table lists "2 years" for Colonglide®, suggesting this is the target/expected final supported shelf-life, which implies the ongoing testing is expected to yield this. The narrative states 6 months currently. |
| Clinical Testing (Pilot Study): | |
| Effectiveness to facilitate colonoscopy: Reported effectiveness by investigators. | Facilitated colonoscopy in 57% of the total study population (24/30 patients required minimal or moderate external pressure). Each investigator reported facilitation in at least 50% of patients. |
| Successful Intubation to Cecum: 100% successful intubation (demonstrates effectiveness/safety). | 100% successful intubation to the cecum. |
| Median Time to Cecum: Reasonable time frame (implicitly compared to predicate performance/clinical norm). | 7 minutes. |
| Adverse Effects: No adverse effects reported related to use (patient safety). | No adverse effects reported by study investigators or subjects within 72 hours. |
| Decreased Use of External Pressure: Qualitative assessment of reduced applied external pressure. | Most patients (24/30) required either minimal or moderate amount of applied external pressure during their procedure, supporting decreased use. |
| Increased Efficiency in Performing Procedure: Qualitative assessment of procedure facilitation. | "Increased efficiency in performing the procedure" (supported by 100% cecum intubation and 7-minute median time, implying ease of use). |
| Safety with Instrument (Colonoscope): No damage to instrument (in Brocchi studies, inferred for Colonglide® due to similar composition and clinical use). | (No explicit statement for Colonglide® but noted as "no damage to the instrument (i.e., colonoscope) was observed" in the Brocchi studies used to support the safety profile of lubricating methods for colonoscopy, which would extend to the proposed device due to its similar nature to the standard lubricating methods.) |
2. Sample Sizes Used for the Test Set and Data Provenance
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Non-Clinical Tests:
- pH Test: Colonglide® Lubricant and predicate devices were tested; specific number of samples not given, but formulations were compared.
- Biocompatibility Testing (Sensitization and Irritation): Performed according to ISO 10993-I:2009. The predicate device, PDI® Sterile Lubricating Jelly, was used as a control. This generally involves animal models (e.g., guinea pigs for sensitization, rabbits for irritation), but specific numbers are not provided.
- Provenance: Likely US-based laboratories given the FDA submission context. Retrospective for predicate data, prospective for Colonglide®.
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Clinical Testing (Pilot Study for Colonglide® Lubricant):
- Sample Size: 30 patients.
- Data Provenance: Not explicitly stated, but implies within the US, likely at collaborating medical centers (3 study investigators). Prospective study.
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Referenced Published Studies (Brocchi et al.): These studies provide supporting evidence for the general safety and effectiveness of lubricants in colonoscopy, rather than direct testing of Colonglide®.
- Brocchi, et al. (2005): 346 subjects (170 in control group A, 168 in corn oil group B). Provenance: Likely Italy, as Brocchi is an Italian name and medical studies often originate from specific regions. Prospective, randomized, controlled study.
- Brocchi, et al. (2008): 510 eligible subjects (170 in group A (standard), 170 in group B (corn oil), 170 in group C (warm water)). Provenance: Likely Italy. Prospective, randomized, controlled study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
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For Colonglide® Lubricant Pilot Study:
- Number of Experts: Three study investigators.
- Qualifications: "Study investigators enrolling 10 patients each into the study." These would presumably be physicians (likely gastroenterologists or colonoscopy specialists) qualified to perform and assess colonoscopies, but specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. They evaluated the effectiveness of the lubricant.
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For Brocchi et al. studies:
- Not specified, but assumed to be qualified gastroenterologists/endoscopists performing and evaluating the colonoscopies.
4. Adjudication Method for the Test Set
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For Colonglide® Lubricant Pilot Study: Not explicitly stated, but since "three study investigators enrolling 10 patients each into the study" and each reported individually on effectiveness ("Each study investigator reported that Colonglide® Lubricant facilitated the colonoscopy in at least 50% of the patients"), it doesn't appear a formal adjudication process was used for their individual findings. The overall effectiveness was a simple aggregation (57% of total). It's possible there was internal consistency review or standard protocol application, but no formal adjudication method like "2+1" or "3+1" is described.
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For Brocchi et al. studies: As prospective, randomized controlled clinical trials, they would follow established clinical trial methodologies including blinding (if applicable and possible) and standardized assessment protocols, but specific adjudication methods are not detailed in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for Colonglide® Lubricant.
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The Colonglide® clinical study was a pilot study with 3 investigators assessing individual patients. It was not designed as a comparative effectiveness study against other lubricants or unassisted procedures, nor did it involve multiple readers interpreting the same cases.
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The referenced Brocchi studies were comparative effectiveness studies between different lubrication methods (standard vs. corn oil vs. warm water) but did not involve "multi-reader" aspects in the sense of multiple independent readers evaluating the same cases, nor did they involve "AI assistance." They were clinical trials comparing interventions.
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Effect Size: Not applicable as no MRMC study with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, this is a patient lubricant device, not an AI/algorithm-based diagnostic or therapeutic device. Thus, there is no "algorithm only" performance to evaluate. The device's "performance" is its physical and chemical properties and its ability to facilitate a medical procedure, as observed by human practitioners.
7. The Type of Ground Truth Used
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Non-Clinical Testing:
- Chemical/Physical Properties (pH, Viscosity, Specific Gravity, etc.): Measured values against established chemical and physical standards or comparative values of predicate devices. This is objective measurement.
- Biocompatibility: Established by standardized ISO 10993-I:2009 in vitro/in vivo testing protocols and controls.
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Clinical Testing (Colonglide® Pilot Study):
- Effectiveness: Physician (investigator) assessment/observation during the procedure (e.g., did it facilitate, amount of external pressure, successful intubation, time to cecum). This is expert observation/assessment.
- Safety: Physician observation and patient reporting of adverse effects/gastrointestinal problems. This is expert and patient-reported outcomes data.
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Referenced Published Studies (Brocchi et al.):
- Effectiveness: Objective metrics (successful intubation to cecum, time to cecum, time for withdrawal) and patient-reported outcomes (level of pain, degree of difficulty).
- Safety: Physician observation and patient-reported adverse effects, and observational assessment of instrument damage.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI medical device (lubricant). There is no "training set" in the context of machine learning or AI. The development process involved formulation, non-clinical testing, and a pilot clinical study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm. The device development relied on scientific principles of chemistry and material science, then validated through standard non-clinical safety/performance tests and clinical observations.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.