K Number
K112110
Device Name
STERILE LUBRICATING JELLY
Date Cleared
2012-04-10

(263 days)

Product Code
Regulation Number
880.6375
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
Device Description
The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.
More Information

Not Found

No
The 510(k) summary describes a sterile lubricating jelly and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.

No.
The device is a lubricating jelly used to facilitate the entry of other devices, not to provide therapy itself.

No
Explanation: This device is a sterile lubricating jelly intended to facilitate the entry of medical devices. It does not perform any diagnostic analysis or provide diagnostic information.

No

The device description clearly states it is a "clear, greaseless, water-soluble sterile lubricating jelly," which is a physical substance, not software.

Based on the provided information, the Jianerkang Sterile Lubricating Jelly is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to lubricate body orifices to facilitate the entry of diagnostic or therapeutic devices. This is a physical function to aid in a medical procedure, not a diagnostic test performed in vitro (outside the body) on a sample.
  • Device Description: The description is of a lubricating jelly, which is a physical substance used for lubrication. It doesn't describe a device that analyzes biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring specific substances (analytes)
    • Providing diagnostic information about a patient's health status

The device is a medical device used in conjunction with diagnostic or therapeutic procedures, but it is not a diagnostic device itself.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

KMJ

Device Description

The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

body orifices

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Safety and Effectiveness of the Device is as safe and effective as the predicate device based on the following:
Biocompatibility Testing: ISO 10993 In-Vitro Cytotoxicity - Pass, Implantation - Pass, Irritation & Hypersensitivity-Pass, Systemic Toxicity -- Pass. In-Vitro Cytotoxicity - Pass* Grade 2 Result Response YES

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K092488

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

KII2110

APR 1 0 2012

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

| Submitter of 510(k): | Jianerkang Medical Dressing Company
Zhixi Town
Jintan City, Jiangsu, PRC 213251
Tel. 0086-519822444628 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jordan Chu
Vice General Manager |
| Date of Summary: | March 22, 2012 |
| Trade/Proprietary Name: | Jianerkang Sterile Lubricating Jelly |
| Classification Name: | Lubricant, Patient
21 C.F.R. § 880.6375
Class I |
| Common Name | Sterile Lubricating Jelly |
| Product Code: | KMJ |

Intended Use: The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

Device Description: The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.

Device Packaging: A typical packaging configuration for the Jianerkang Sterile Lubricating Jelly is 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 Jianerkang Sterile Lubricating Jelly provides effective lubrication for the insertion of diagnostic and therapeutic devices into body orifices. Its function, performance, technological characteristics, and indications for use are substantially equivalent to the predicate device as presented in this 510(k).

Safety and Effectiveness of the Device is as safe and effective as the predicate device based on the following:

1

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

Summary comparing technological characteristics with predicate device:

| TECHNOLOGICAL

CHARACTERISTICSJianerkang Sterile Lubricating JellyDynarex Sterile Lubricating Jelly
Purified WaterYESYES
Carborner thickenersYESYES
Methylparaben and
PropylparabenYESYES
Labeled water solubleYESYES
Labeled colorlessYESLabeled "Non Staining"
Labeled alcohol and
fragrance freeYESYES
Container materialPlastic/Film LaminatePlastic/Film Laminate
SterileYESYES
Physical Tests
Biocompatibility
TestingISO 10993
In-Vitro Cytotoxicity - Pass
Implantation - Pass
Irritation & Hypersensitivity-Pass
Systemic Toxicity -- PassISO 10993
In-Vitro Cytotoxicity - Pass
Implantation - Pass
Irritation & Hypersensitivity-Pass
Systemic Toxicity -- Pass
In-Vitro Cytotoxicity -
Pass* Grade 2 Result
ResponseYESYES

Sterilization: The Jianerkang Sterile Lubricating Jelly is sterilized by gamma radiation 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 an SAL of 10th.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

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

Mr. Jordan Chu Vice General Manager Jianerkang Medical Dressing Company Zhixi Town Jintan City, Jiangsu CHINA 213251

Re: K112110

Trade/Device Name: Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: February 22, 2012 Received: February 29, 2012

Dear Mr. Chu:

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.

APR 1 0 2012

3

Page 2 -- Mr. Chu

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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: K112110

Device Name: Sterile Lubricating Jelly

Indications for Use:

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

Prescription Use (21 C.F.R. Part 801, Subpart D)

AND/OR

Over-the-Counter Use X (21 C.F.R. Part 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 Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112110

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