Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

Device Description

Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.

AI/ML Overview

The provided document is a 510(k) summary for the Dynarex Sterile Lubricating Jelly, asserting its substantial equivalence to a predicate device (E-Z Lubricating Jelly, K041060). It does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of measuring device performance against a predefined threshold.

Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence for a Class I medical device (patient lubricant). This process primarily involves comparing the new device's characteristics to those of a legally marketed predicate device.

However, I can extract the information and present it in the requested format, interpreting "acceptance criteria" as the shared characteristics and test results that enable the claim of substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present or not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are the characteristics of the predicate device, which the new device (Dynarex Sterile Lubricating Jelly) must match or be substantially equivalent to. "Reported device performance" refers to the new device's characteristics and test results, demonstrating this equivalence.

Acceptance Criteria (Predicate Device Characteristic)	Reported Device Performance (Dynarex Sterile Lubricating Jelly)
Composition/Formulation
Purified water	Yes
Carbomer thickeners	Yes
Methylparaben	Yes
Labeling Claims
Labeled water soluble	Yes
Labeled non-staining	Yes
Labeled alcohol and fragrance free	Yes
Physical Characteristics
Container material (Plastic)	Plastic/Film Laminate
Sterile	Yes
Physical Tests (Viscosity & pH)	Viscosity & pH
Physical Tests (Preservative effectiveness)	Preservative effectiveness
Physical Tests (Sterility Test Study)	Sterility Test Study
Biocompatibility Testing (ISO 10993)
In-Vitro Cytotoxicity - Pass	In-Vitro Cytotoxicity - Pass* (Grade 2 Result due to preservatives and low concentration of sodium hydroxide, which is common and acceptable for these components)
Implantation - Pass	Implantation - Pass
Irritation & Hypersensitivity - Pass	Irritation & Hypersensitivity - Pass
Systemic Toxicity - Pass	Systemic Toxicity - Pass
Sterilization Method
Sterilization Method (similar to predicate, implied by sterility)	Gamma irradiation, validated according to ISO/AAMI 11137 requirements (Method: Vdmax25 with an SAL of 10-6)

2. Sample size used for the test set and the data provenance

Sample size for the test set: Not explicitly stated as a "test set" in the context of performance metrics for an AI/ML device. For physical and biocompatibility testing, standard laboratory sample sizes would have been used, but specific numbers are not provided in this summary.
Data provenance: The data is generated from testing of the Dynarex Sterile Lubricating Jelly and comparison to the predicate device. It is not "data" in the sense of patient records or imaging. The testing would have been conducted by the manufacturer or contracted laboratories. It is prospective testing on the device model. Country of origin not specified for the testing itself, but the submitter is based in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable to a submission for a sterile lubricating jelly demonstrating substantial equivalence. There is no "ground truth" established by experts in the sense of clinical annotations or diagnostic interpretations. The "truth" is established by laboratory testing standards (e.g., ISO 10993 for biocompatibility).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no "adjudication" in this context. The determination of "pass" for tests like biocompatibility or sterility would follow established testing protocols and expert interpretation of those results by the testing laboratory, aligning with regulatory standards.

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

Not applicable. This is not an AI/ML device, nor is it a diagnostic imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" (or basis for acceptance) primarily stems from established international standards and regulations for medical device safety and performance, specifically:
- ISO/AAMI 11137 for sterilization validation.
- ISO 10993 for biocompatibility testing.
- Pharmacopoeial standards (implied for purity, viscosity, pH, preservative effectiveness).
- The characteristics and regulatory history of the predicate device (E-Z Lubricating Jelly, K041060) serve as the benchmark for "truth" in the context of substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary

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K092488

DEC 1 8 2009

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):	Dynarex Corporation10 Glenshaw StreetOrangeburg, NY 10972USAPhone: (845) 365-8200Fax: (845) 365-8201
Contact Person:	Daniel Consaga
Date of Summary:	December 17, 2009
Trade/Proprietary Name:	Dynarex Sterile Lubricating Jelly
Classification Name:	Lubricant, Patient
Product Code:	KMJ

Intended Use:

Device Description:

Predicate Device:

E-Z Lubricating Jelly, 510k Number K041060 is manufactured by Chester Labs, Inc. 1900 Section Rd., Cincinnati, OH 45237.

Substantial Equivalence:

The Dynarex Sterile Lubricating Jelly provides effective lubrication during the insertion of diagnostic and therapeutic devices into body orifices. Its function and performance are similar to the predicate device as presented in this 510(k)

Safety and Effectiveness of the device:

This device is as safe and effective as the predicate device cited above based on .

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510(K) SUMMARY (as required by 807.92(c))

Safety and Effectiveness of the device:

This device is as safe and effective as the predicate device cited above based on the following;

Summary comparing technological characteristics with other predicate device: Dynarex Sterile Lubricating Jelly is similar in terms of intended use and technological characteristics to predicate devices reviewed as a lubricating jelly to facilitate the entry of a diagnostic or therapeutic device. The device is substantially equivalent with respect to indications for use and other physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Please find below a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution.

TECHNOLOGICALCHARACTERISTICS	Dynarex Lubricating Jelly	E-Z Lubricating Jelly
Purified water	Yes	Yes
Carbomer thickeners	Yes	Yes
Methylparaben	Yes	Yes
Labeled water soluble	Yes	Yes
Labeled non-staining	Yes	Yes
Labeled alcohol andfragrance free	Yes	Yes
Container material	Plastic/Film Laminate	Plastic
Sterile	Yes	Yes
Physical Tests	Viscosity & pH	Viscosity & pH
	Preservative effectiveness	Preservative effectiveness
	Sterility Test Study	Sterility Test Study
	ISO 10993	ISO 10993
BiocompatabilityTesting	In-Vitro Cytotoxicity - Pass*	In-Vitro Cytotoxicity - Pass
	Implantation - Pass	Implantation - Pass
	Irritation & Hypersensitivity - Pass	Irritation & Hypersensitivity - Pass
	Systemic Toxicity - Pass	Systemic Toxicity - Pass
In-Vitro Cytotoxicity -Pass* Grade 2 ResultResponse	The two preservatives (Methylparaben and Propylparaben) are wellknown to cause this type result. Sodium Hydroxide also can causethis phenomena, but the concentration in the gel of sodiumhydroxide is very low (less than 1%) so it is believed that its'contribution to this grade 2 result is very low if any.

Sterilization:

The Dynarex Sterile Lubricating Jelly is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization). Method: Vdmax25 with an SAL of 10-6.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Daniel Consaga Regulatory Affairs Engineer Dynarex Corporation 10 Glenshaw Street Orangeburg, New York 10962

DEC 1 8 3009

Re: K092488

Trade/Device Name: Dynarex Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: October 26, 2009 Received: December 8, 2009

Dear Mr. Consaga:

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.

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. Consaga

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 (21 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH

/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Susan Runez

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, 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):

Device Name:

Dynarex Sterile Lubricating Jelly

Indications for Use:

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

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

An Stin for liz

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K 992488

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.