(141 days)
The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.
The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.
The provided document, K113689, describes a 510(k) premarket notification for the Dukal Sterile Lubricating Jelly. This is not for a software or AI-powered medical device, but rather a physical medical device. Therefore, many of the requested criteria (like sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set size, etc.) are not applicable in this context, as they relate to studies of diagnostic accuracy or performance of AI/software in interpreting data.
However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, aligning with the information that is present in the 510(k) submission for a non-AI device.
Acceptance Criteria and Device Performance for Dukal Sterile Lubricating Jelly
The submission for the Dukal Sterile Lubricating Jelly demonstrates substantial equivalence to a predicate device (Dynarex Sterile Lubricating Jelly, K092488) based on comparable technological characteristics, intended use, and safety/effectiveness profiles. The "acceptance criteria" here are implicitly the criteria for demonstrating substantial equivalence, primarily through direct comparison of features and performance to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For this non-AI medical device, the acceptance criteria are based on exhibiting similar technological characteristics and performance to the predicate device.
| Characteristic / Acceptance Criteria | Dukal Sterile Lubricating Jelly (Reported Performance) | Predicate Device (Dynarex Sterile Lubricating Jelly) |
|---|---|---|
| Intended Use | To lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required. | To lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required. |
| Composition | ||
| Purified Water | Yes | Yes |
| Carbomer Thickeners | Yes | Yes |
| Methylparabens | Yes | Yes |
| Labeled Water Soluble | Yes | Yes |
| Labeled Non Staining | Yes | Yes |
| Labeled Alcohol & Fragrance Free | Yes | Yes |
| Container Material | Plastic/Film Laminate | Plastic/Film Laminate |
| Sterile | Yes | Yes |
| Biocompatibility Testing | ISO 10993 compliant | ISO 10993 compliant |
| In-Vitro Cytotoxicity | Pass | Pass |
| Implantation | Pass | Pass |
| Irritation & Hypersensitivity | Pass | Pass |
| Systemic Toxicity | Pass | Pass |
| Sterilization Method | Gamma irradiation (validated per ISO/AAMI 11137 with SAL of 10⁻⁶) | (Not explicitly detailed for predicate in this document, but implied to be equivalent for a sterile product.) |
| Physical Tests | (Not explicitly detailed, but implied to be comparable to predicate for "Physical Tests") | (Not explicitly detailed, but implied to be comparable.) |
2. Sample Size for Test Set and Data Provenance
For physical medical devices undergoing a 510(k) submission based on substantial equivalence, the "test set" does not typically refer to a dataset of patient cases. Instead, it refers to samples of the device itself undergoing various physical, chemical, and biological tests.
- Sample Size for Test Set: Not specified in terms of number of units, but implies a sufficient number of samples of the Dukal Sterile Lubricating Jelly were used for the listed biocompatibility and sterilization validation tests.
- Data Provenance: The data arises from internal testing performed on the Dukal Sterile Lubricating Jelly and comparison to the publicly available characteristics of the predicate device (Dynarex Sterile Lubricating Jelly). It is retrospective in the sense that the predicate device's characteristics are already established.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This criterion is not applicable for this type of medical device submission. Ground truth, in the context of interpretation by experts, is relevant for diagnostic devices interpreting outputs like images or signals. For a lubricating jelly, "ground truth" is established through standardized laboratory testing (e.g., ISO standards for biocompatibility) and direct chemical/physical characterization, rather than expert interpretation of a test set.
4. Adjudication Method for the Test Set
This criterion is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data in diagnostic studies. For a physical device, performance is evaluated against objective standards and test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These types of studies are for evaluating the performance of diagnostic systems (often AI-assisted) and human readers in interpreting clinical cases. This device is a lubricating jelly, not a diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. This applies to software algorithms without human intervention. The Dukal Sterile Lubricating Jelly is a physical product directly applied by a human user as part of a medical procedure.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on:
- Objective Laboratory Testing: Adherence to established standards for biocompatibility (ISO 10993 series for In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, Systemic Toxicity).
- Sterilization Validation: Conformance to ISO/AAMI 11137 requirements for gamma irradiation sterilization with a specified Sterility Assurance Level (SAL).
- Chemical and Physical Characterization: Verification of ingredients and properties (e.g., water-soluble, non-staining, alcohol/fragrance-free) as listed on the label and compared to the predicate.
8. The Sample Size for the Training Set
Not applicable. This criterion refers to the dataset used to train an AI model. This submission is for a physical medical device and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model, this criterion does not apply.
{0}------------------------------------------------
MAY - 4 2012
ਾ
510(k) Summary (as required by 807.92(c)
| Submitter of 510(k): | Dukal Corporation2 Fleetwood CourtRonkonkoma, NY 11779 |
|---|---|
| Contact Person: | Patrick J. LambVP International/Operations Manager |
| Date of Summary: | December 5, 2011 |
| Trade/Proprietary Name: | Dukal Sterile Lubricating Jelly |
| Classification Name: | Lubricant, Patient |
| Product Code: | KMJ |
Intended Use:
. The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.
Device Description:
The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.
Device Packaging:
A typical packaging configuration for the Dukal Sterile Lubricating Jelly ls a 2.7g or 5gm foil packs and 2oz or 4oz tubes. Other sizes may become available.
Predicate Device:
Dynarex Sterile Lubricating Jelly, 510(k) K092488 is manufactured for Dynarex 10 Glenshaw St. Orangeburg, NY 10962.
Substantial Equivalence:
The Dukal Sterile Lubricating Jelly provides effective lubrication during the insertion of diagnostic and therapeutic devices into the body orifices. Its function and performance are similar to the predicate device as presented in this 510(k).
{1}------------------------------------------------
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: Dukal 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 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 | Dukal | Dynarex |
|---|---|---|
| Purified Water | Yes | Yes |
| Carbomer Thickeners | Yes | Yes |
| Methylparabens | Yes | Yes |
| Labeled Water Soluble | Yes | Yes |
| Labeled Non Staining | Yes | Yes |
| Labeled Alcohol andfragrance free | Yes | Yes |
| Container Material | Plastic/Film Laminate | Plastic/Film Laminate |
| Sterile | Yes | Yes |
| Physical Tests | ||
| BiocompatibilityTesting | ISO 10993 | ISO 10993 |
| In-Vitro Cytotoxicity -Pass | In-Vitro Cytotoxicity -Pass | |
| Implantation-Pass | Implantation-Pass | |
| Irritation & Hypersensitivity-Pass | Irritation & Hypersensitivity -Pass | |
| Systemic Toxicity - Pass | Systemic Toxicity - Pass |
Comparative Chart
Sterilization:
The Dukal 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) with SAL of 10°
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Patrick J. Lamb Vice President International/Operations Manager Dukal Corporation 2 Fleetwood Court Ronkonkoma, New York 11779
MAY - 4 2012
Re: K113689
Trade/Device Name: Dukal Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: II Product Code: KMJ Dated: April 17, 2012 Received: April 25, 2012
Dear Mr. Lamb:
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 misleading.
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.
{3}------------------------------------------------
Page 2 - Mr. Lamb
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name:
Dukal Sterile Lubricating Jelly
Indications for use:
The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to l he banal other of acilitate entry of diagnostic devices when a sterile field is required.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use X (Part 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)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_
All Ch 5/3/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113689
§ 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.