(122 days)
Not Found
No
The device description and performance studies focus on a lubricant and its physical properties and effectiveness in facilitating a medical procedure, with no mention of AI or ML.
No.
Explanation: The device is a lubricant intended to facilitate the entry of a diagnostic or therapeutic medical device, rather than providing therapy itself.
No
The device is a lubricant intended to facilitate the entry of a medical device, not to perform a diagnostic function itself.
No
The device description clearly states it is a "clear, colorless, non-sterile, odorless, water-based patient lubricant," which is a physical substance, not software.
Based on the provided information, the Colonglide® Lubricant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 describes a device used on the patient's body to aid in a procedure, not a device used to examine specimens from the body.
- Device Description: The description details a "water-based patient lubricant" packaged for individual use. This aligns with a topical or procedural aid, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Colonglide® Lubricant's function is purely mechanical – to reduce friction during device insertion.
N/A
Intended Use / Indications for Use
Colonglide® Lubricant is intended 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KMJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body orifice
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's order
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
An open-label pilot study was conducted to evaluate the use of Colonglide® Lubricant in 30 patients undergoing a routine screening colonoscopy.
The effectiveness of Colonglide® Lubricant to facilitate the performance of a colonoscopy was evaluated by three study investigators enrolling 10 patients each into the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Performance testing conducted on Colonglide® Lubricant meets all the pre-determined acceptance criteria for appearance, pH, viscosity, specific gravity, preservatives, and microbial limits to support the safety and effectiveness of the finished device.
A comparative pH test was performed on the device formulations for Colonglide® Lubricant and the predicate devices: the formulations were determined to be equivalent.
Physicochemical testing conducted on the device plastic bottle met all test method acceptance criteria in accordance with current USP requirements for Containers-Plastics .
The current shelf-life is 6-months with testing ongoing to support a 24-month shelf-life.
Biocompatibility testing was conducted on the finished device according to ISO 10993-I :2009.
The predicate device. PD19 Sterile Lubricating Jelly, was used as a control article in the biocompatibility safety tests evaluating the sensitization and irritation of Colonglide® Lubricant. The negative test results reported for both sensitization and irritation confirm that Colonglide® Lubricant is as safe as the predicate device, PD10 Sterile Lubricating Jelly.
Clinical Testing:
An open-label pilot study was conducted to evaluate the use of Colonglide® Lubricant in 30 patients undergoing a routine screening colonoscopy. The effectiveness of Colonglide® Lubricant to facilitate the performance of a colonoscopy was reported for 57% of the total study population. Each study investigator reported that Colonglide® Lubricant facilitated the colonoscopy in at least 50% of the patients. Most patients (24/30) required either minimal or moderate amount of applied external pressure during their procedure. Successful intubation to the cecum was reported in 100% of the study patients. The median time needed to reach the cecum was 7 minutes. No adverse effects related to the use of Colonglide® Lubricant were reported by the study investigators. Also, there were no adverse effects or gastrointestinal problems reported by any of the study subjects contacted within 72 hours of the completed procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Effectiveness: 57% (facilitated colonoscopy)
- External Pressure: 24/30 patients required minimal or moderate pressure
- Successful Intubation to Cecum: 100%
- Median time to reach cecum: 7 minutes
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PDI® Sterile Lubricating Jelly (Nice-Pack Products Inc., K974768), Aquagel® Lubricating Jelly (DePuy Healthcare, K951431)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
1. Submitter/510(k) Holder
Pediatric Pharmaceuticals, Inc. 120 Wood Avenue South Suite 200 lselin, NJ 08830
| Contact Person: | Robert C. Stites, President |
|---|---|
| Telephone: | (732) 603-7708 |
| Fax: | (732) 603-7732 |
Date Prepared: May 20, 2013
OCT 0 3 2013
2. Device Name
| Trade Name: | Colonglide® Lubricant |
|---|---|
| Common Name: | Patient lubricant |
| Classification Name: | Lubricant, Patient, 21 CFR 880.637 |
| Device Class: | Class I |
| Classification Panel: | General Hospital Panel |
| Product Code: | KMJ |
3. Predicate Devices
PDI® Sterile Lubricating Jelly (Nice-Pack Products Inc., K974768) Aquagel® Lubricating Jelly (DePuy Healthcare, K951431)
4. Device Description
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.
5. Indication for Use
Colonglide® Lubricant is intended 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.
6. Technological Characteristics
A tabular summary comparing the technological characteristics of Colonglide® Lubricant to the predicate devices is presented in Table 5-1 below.
1
7. Non-Clinical Testing
Performance testing conducted on Colonglide® Lubricant meets all the pre-determined acceptance criteria for appearance, pH, viscosity, specific gravity, preservatives, and microbial limits to support the safety and effectiveness of the finished device.
A comparative pH test was performed on the device formulations for Colonglide® Lubricant and the predicate devices: the formulations were determined to be equivalent. The pH results (average) reported for Colonglide® Lubricant and the predicate devices are provided in Table 5-1.
Physicochemical testing conducted on the device plastic bottle met all test method acceptance criteria in accordance with current USP requirements for Containers-Plastics .
The current shelf-life is 6-months with testing ongoing to support a 24-month shelf-life.
Biocompatibility testing was conducted on the finished device according to ISO 10993-I :2009.
The predicate device. PD19 Sterile Lubricating Jelly, was used as a control article in the biocompatibility safety tests evaluating the sensitization and irritation of Colonglide® Lubricant. The negative test results reported for both sensitization and irritation confirm that Colonglide® Lubricant is as safe as the predicate device, PD10 Sterile Lubricating Jelly.
8. Clinical Testing
An open-label pilot study was conducted to evaluate the use of Colonglide® Lubricant in 30 patients undergoing a routine screening colonoscopy.
The effectiveness of Colonglide® Lubricant to facilitate the performance of a colonoscopy was evaluated by three study investigators enrolling 10 patients each into the study. The effectiveness of Colonglide® Lubricant to facilitate the performance of a colonoscopy was reported for 57% of the total study population. Each study investigator reported that Colonglide® Lubricant facilitated the colonoscopy in at least 50% of the patients.
Most patients (24/30) required either minimal or moderate amount of applied external pressure during their procedure. Successful intubation to the cecum was reported in 100% of the study patients. The median time needed to reach the cecum was 7 minutes.
No adverse effects related to the use of Colonglide® Lubricant were reported by the study investigators. Also, there were no adverse effects or gastrointestinal problems reported by any of the study subjects contacted within 72 hours of the completed procedure.
In a published study by Brocchi, et al. (2005), a prospective, randomized, controlled study was conducted to determine whether the performance of a colonoscopy could be facilitated by
2
instillation of corn oil through the biopsy channel of the colonoscope during the procedure when compared to a standard lubricating method.
A total of 346 subjects underwent a colonoscopy with a standard lubricating method (using water-soluble KY jelly; group A) or with the standard method plus seed oil (corn oil) instillations through the biopsy channel (group B).
Successful intubation to the cecum was significantly more frequent (P