(263 days)
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.
The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.
The provided document describes a medical device, the Jianerkang Sterile Lubricating Jelly, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study that assesses its performance against such criteria.
The document focuses on demonstrating that the Jianerkang Sterile Lubricating Jelly is substantially equivalent to the Dynarex Sterile Lubricating Jelly (predicate device K092488) based on technological characteristics and safety testing (biocompatibility and sterilization validation). This type of submission (510(k)) for a Class I device typically relies on demonstrating equivalence rather than establishing new performance benchmarks through clinical or extensive performance studies with specific statistical acceptance criteria.
Therefore, many of the requested fields cannot be answered as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria for performance or report specific device performance metrics beyond stating that it "provides effective lubrication" and meets biocompatibility and sterilization standards. The comparison is based on shared technological characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No specific "test set" for performance evaluation is mentioned. The biocompatibility tests (ISO 10993) would have involved samples, but the specific sample sizes for those tests or their provenance are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This question is typically relevant for studies evaluating diagnostic or AI-driven systems where expert consensus is used to label data. This is not applicable to a sterile lubricating jelly's submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for this type of device submission.
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
- N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be directly answered in the context of performance. For biocompatibility, the "ground truth" would be the established ISO 10993 standards and their interpretation by qualified testing laboratories. For sterility, it's validation against ISO/AAMI 11137. These are not "ground truth" in the sense of clinical outcomes or expert consensus on diagnostic images.
8. The sample size for the training set
- N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.
9. How the ground truth for the training set was established
- N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.
Summary of available information related to "acceptance criteria" and "study":
The "acceptance criteria" can be inferred from the comparison to the predicate device and the regulatory standards met.
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Acceptance Criteria (Inferred):
- Technological Characteristics: Must match or be equivalent to the predicate device (e.g., composition like purified water, carbomer thickeners, parabens; labels for water-soluble, colorless, alcohol/fragrance-free; container material).
- Sterility: Must be sterile, validated according to ISO/AAMI 11137 with an SAL of 10^-6.
- Biocompatibility: Must pass ISO 10993 standards including In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, and Systemic Toxicity. Specifically, In-Vitro Cytotoxicity - Pass* Grade 2 Result Response.
- Intended Use: Must align with the intended use of the predicate device.
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"Study" (Supporting Information):
- Biocompatibility Testing: The device underwent ISO 10993 testing, resulting in "Pass" for In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, and Systemic Toxicity, specifically a "Grade 2 Result Response" for In-Vitro Cytotoxicity.
- Sterilization Validation: The device is sterilized by gamma radiation, validated according to ISO/AAMI 11137 requirements with an SAL of 10^-6.
- Technological Characterization: A direct comparison table is provided, showing the Jianerkang product's characteristics are identical to the predicate device.
The study presented is not a comparative clinical trial, but rather a set of tests to demonstrate adherence to established safety and material standards and physical-chemical similarity to an already approved device.
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KII2110
APR 1 0 2012
510(K) SUMMARY (as required by 807.92 (c))
| Submitter of 510(k): | Jianerkang Medical Dressing CompanyZhixi TownJintan City, Jiangsu, PRC 213251Tel. 0086-519822444628 |
|---|---|
| Contact Person: | Jordan ChuVice General Manager |
| Date of Summary: | March 22, 2012 |
| Trade/Proprietary Name: | Jianerkang Sterile Lubricating Jelly |
| Classification Name: | Lubricant, Patient21 C.F.R. § 880.6375Class 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:
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510(K) SUMMARY (as required by 807.92 (c))
Summary comparing technological characteristics with predicate device:
| TECHNOLOGICALCHARACTERISTICS | Jianerkang Sterile Lubricating Jelly | Dynarex Sterile Lubricating Jelly |
|---|---|---|
| Purified Water | YES | YES |
| Carborner thickeners | YES | YES |
| Methylparaben andPropylparaben | YES | YES |
| Labeled water soluble | YES | YES |
| Labeled colorless | YES | Labeled "Non Staining" |
| Labeled alcohol andfragrance free | YES | YES |
| Container material | Plastic/Film Laminate | Plastic/Film Laminate |
| Sterile | YES | YES |
| Physical Tests | ||
| BiocompatibilityTesting | ISO 10993In-Vitro Cytotoxicity - PassImplantation - PassIrritation & Hypersensitivity-PassSystemic Toxicity -- Pass | ISO 10993In-Vitro Cytotoxicity - PassImplantation - PassIrritation & Hypersensitivity-PassSystemic Toxicity -- Pass |
| In-Vitro Cytotoxicity -Pass* Grade 2 ResultResponse | YES | YES |
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.
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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
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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
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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)
与
(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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§ 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.