(90 days)
The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.
Clear, water-soluble lubricating gel
This 510(k) summary (K961222) describes the EVRON GEL, a lubricating gel intended to facilitate breast self-examination. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document focuses on demonstrating substantial equivalence to pre-amendment devices and other legally marketed lubricants, primarily by emphasizing its long history of safe use and the common mechanism of lubrication. Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets such criteria because this information is not present in the provided text.
Here’s why the requested information cannot be extracted:
- No quantifiable acceptance criteria are stated. The document asserts the device's effectiveness based on its lubricating properties and its similarity to soapy water for reducing friction. There are no numerical targets or thresholds provided for lubrication, friction reduction, or other performance metrics.
- No specific study or clinical trial is described. The document relies on the device's long history of commercial distribution (over 25 years) and the lack of reported safety concerns as evidence for its safety. For effectiveness, it uses logical reasoning about lubrication being similar to soapy water. This is not a study with the elements requested (sample size, ground truth, expert opinions, etc.).
Therefore, for all the requested points (1-9), the answer is "Not applicable" or "Information not provided in the document." The submission focuses on demonstrating substantial equivalence through established use and a common mechanism, rather than presenting a performance study against specific acceptance criteria.
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SECTION A
JUN 26 1996
510(k) Summary
Required by 21 C.F.R. § 807.92
| I. | Submitter | |
|---|---|---|
| A. | Name: Pharmaceutical Innovations, Inc. | |
| B. | Address: 897 Frelinghuysen AvenueNewark, NJ 07114-2195 | |
| C. | Phone and Fax Numbers: (201) 242-2900 Fax No.: (201) 242-0578 | |
| D. | Contact Person: Gilbert Buchalter | |
| II. | Date of Preparation of this Summary: March 27, 1996 | |
| III. | Trade Name: EVRON GEL | |
| IV. | Common Name: Lubricant | |
| V. | Identification of Legally Marketed Device whichEquivalence is Claimed: | |
| ULTRA/PHONIC Conductivity Gel and related products (NDC#36-1000-00) | ||
| ULTRA/PHONIC SG Scanning Gel (NDC#36-1001-00) | ||
| GAMMA Massage and Ultrasound Gel (NDC#36-1150-00) | ||
| VI. | Product Description: Clear, water-soluble lubricating gel | |
| VII. | Statement of Intended Use Compared to Legally Marketed Device | |
| Submitter's lubricant is substantially equivalent to, and has the same intended use as, other |
products in commercial distribution in the United States prior to May 28, 1976. The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.
Discussion of Technological Characteristics: VIII.
When doing breast self-examination on dry skin, the individual is hampered by friction between her breast and her fingers. When doing this examination in the shower with soapy water, as recommended by the National Cancer Institute and the American Cancer Society, the examination is easier because of the lubrication provided by soapy water. EVRON GEL provides this lubrication in a dry setting (e.g. the individual's bedroom). No other claims are made as to the advantage of EVRON GEL in this context. It is a skin lubricant comparable to the use and offering the advantage of soapy water.
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IX. Safety
The device for which the added claim for breast self-examination is being made is the same as Submitter's pre-amendment and currently marketed devices. These devices have been in commercial distribution for more than twenty five years and are for use in contact with the human body for periods of time longer than required for self-examination. There have been no changes in the composition, materials or method of manufacture of the device. Thus, there are no new questions of safety and no known information to suggest any concern about safety.
X. Effectiveness
The effectiveness of Submitter's lubricant for use to facilitate breast self-examination is due to its ability to reduce friction through its lubricating properties, therefore making it easier to do a breast self-examination.
Although chemically different from soapy water, the basic mechanism by which both provide increased sensitivity is the same, i.e., increased lubrication or slickness to the surface of the skin. This device provides consumers with the convenience of the soapy shower for the dry portion of the exam and is consistent with adequate instructions for use as recommended by the National Cancer Institute, the American Cancer Society, and other breast self-examination procedures.
§ 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.