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.

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.

AI/ML Overview

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 <661>	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

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®.
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.
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

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.
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

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.
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.

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.
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.
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

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.
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.
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.

Summary

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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

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.

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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 <661>.

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

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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 < 0.005) in the corn oil lubrication group (group B, 159/168) than in the control group (group A, 145/170), and less time was needed for the corn oil group (P < 0.001). No significant differences were found with regard to time for examination at withdrawal and detection rates for colorectal diseases. Level of pain and degree of difficulty during colonoscopy were significantly lower in the com oil group (P < 0.001). In the crossover examinations done in subjects in whom total colonoscopy was not achieved, no statistical difference was found between the two groups.

No adverse effects were reported for any of the study subjects in either the corn oil (group B) or the control group (group A). No damage to the instrument (i.e., colonoscope) was observed in the study.

In another published study by Brocchi, et al. (2008), a prospective, randomized, controlled study was conducted in 510 eligible subjects who underwent a colonoscopy and were randomly assigned into three groups: a standard lubricating method (water-soluble KY jelly: group A, 170 subjects) was adopted in a control group, whereas the standard method plus instillation into the colon of corn seed oil (group B, 170 subjects) or warm water (group C, 170 subjects) was employed in the other groups.

In group A, 6/170 subjects were excluded from the study (total colonoscopy judged "impossible") because of obstructive cancers (5 subjects) or impassable strictures (1 subject). Additionally; 4/170 subjects in group B and 7/170 in group C were excluded because of obstructive cancers (2 subjects in group B and 4 subjects in group C) and strictures (2 subjects in group B and 3 subjects in group C). Impassable strictures were always due to diverticular disease and adherences at the level of the sigmoid colon.

Successful intubation to the cecum was reported in 138/164 subjects (84.1%) in group A, 155/166 subjects (93.4%) in group B, and 156/163 subjects (95.7%) in group C. The differences between groups A and B and between groups A and C were statistically significant (P < 0.01 and P < 0.001, respectively), whereas between groups B and C were not significant (P = 0.864).

The median time needed to reach the cecum was significantly (P < 0.001) shorter in groups B (9.2 min) and C (9.1 min) when compared with group A (13.2 min). However, there was no significant difference in the time to reach the cecum between groups B and C. The time of withdrawal was similar in all three groups, with no significant difference.

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Pain and technical difficulties experienced during the procedure were significantly lower in groups B and C than in group A (P < 0.001); no difference was found between groups B and C.

No adverse effects were noted in any of the subjects participating in the study. No damage to the instrument (i.e., colonoscope) was observed in the study. Thus, the use of patient lubricants in colonoscopy did not present any patient safety concerns in the study.

9. Conclusions Drawn from Non-Clinical and Clinical Tests

Colonglide® Lubricant has the same intended use and similar technological characteristics as the predicate devices. Colonglide® Lubricant and the predicate devices are all water-soluble lubricants for medical and/or professional use.

The formulation pHs for Colonglide® Lubricant and the predicates devices were evaluated and found to be equivalent. Biocompatibility testing of Colonglide® Lubricant showed it to be as safe as PDI Sterile Lubricating Jelly in both sensitization and irritation assays.

The clinical investigation of Colonglide® Lubricant to facilitate the performance of a colonoscopy demonstrated: (1) increased patient safety; (2) decreased use of external pressure maneuvers; and (3) increased efficiency in performing the procedure.

In clinical studies performed by Brocchi et al., the use of a standard lubricating method along with the instillation of either corn oil or warm water through the biopsy channel of a colonoscope demonstrated improved performance for facilitating the procedure when compared to the use of a standard lubricating method. No adverse effects were noted in any of the subjects participating in the studies.

The similarity of the technological characteristics and performance data from comparative and biocompatibility testing confirm that Colonglide® Lubricant is substantially equivalent to the predicate devices.

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	Colonglide® Lubricant	PDI® Sterile Lubricating Jelly(Nice-Pack Products Inc.)	Aquagel® Lubricating Jelly(DePuy Healthcare)
Regulatory Status	Proposed	K974768	K951431
Product Code	KMJ	KMJ	KMJ
Intended Use	Colonglide® Lubricant isintended for medical purposesfor use to lubricate a bodyorifice of a patient in order tofacilitate the entry of adiagnostic or therapeuticmedical device (such as anendoscope). This device isintended for use on order of aphysician.	PDI® Sterile Lubricating Jelly isintended for use to lubricate abody orifice of a patient in orderto facilitate the entry of adiagnostic or therapeuticmedical device (such as acatheter, enema tip, orendoscope). The device isintended for use on order of aphysician.	Aquagel® is intended for usein gynecological, digital andinstrument examinations andgeneral hospital procedures.
ContainsLubricationBase/Solvent	Yes	Yes	Yes
Contains pHadjuster or buffer	Yes	Yes	Yes
Containsthickening agent	Yes	Yes	Yes
Containspreservatives	Yes	Yes	Yes
Containssequestering agents	None	None	Yes
Physical state	Liquid, gel	Liquid, paste/gel	Gel
Clear Appearance	Yes	Yes	Yes
Odorless	Yes	Yes	Yes
pH*	5.88	5.98	6.78
Water soluble	Yes	Yes	Yes
Specific Gravity	1.042	1.03	1.045
Biocompatible	Yes	Yes, sensitization andirritation**	Yes
Size and packaging	250 mL plastic bottle	2.7 g and 5.0 g packet	142 g plastic tube, half gallon(1.9 L) plastic jug with pump
Shelf Life	2 years	Manufacturer information is notavailable	2 years
Sterile	No	Yes, gamma irradiation	No

Table 5-1. Side-by-Side Comparison of Colonglide® Lubricant with Predicate Devices

Comparative pH testing of Colonglide® Lubricant with predicate devices. *

** Comparative biocompatibility studies were conducted to evaluate the sensitivity and irritation of Colonglide® Lubricant and the predicate PDI® Sterile Lubricating Jelly.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

October 3, 2013

Pediatric Pharmaceuticals, Incorporated C/O Mr. Robert M. Harris Vice President Harris FRC Corporation 2137 Route 35 HOLMDEL NJ 07733

Re: K131617

Trade/Device Name: Colonglide Lubricant Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: August 15, 2013 Received: August 19, 2013

Dear Mr. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misseading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Harris

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Colonglide® Lubricant Device Name:

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/7/Picture/10 description: The image shows the letters FDA in a stylized font. The letters are made up of small squares, giving them a pixelated appearance. The letters are arranged horizontally, with the F on the left, the D in the middle, and the A on the right.

Richard C. Chapman 2013.10.03 09:56:43 -04'00'

Colonglide® Lubricant, Traditional 510(k) Pediatric Pharmaceuticals, Inc.

Page 4-1

Regulation Number and Section

§ 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.