(90 days)
K/DEN number: Not Found
Not Found
No
The device is a lubricating gel with an expanded indication for breast self-examination, and the summary contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is a lubricating gel intended to facilitate breast self-examination, which is a diagnostic or preventative action, not a therapeutic treatment for a disease or condition. The predicate devices are also lubricants, consistent with a non-therapeutic classification.
No
The device is a lubricating gel intended to facilitate breast self-examination, not to diagnose any condition. Its predicate devices are all gels for conductivity or massage, further indicating it's a facilitating tool rather than a diagnostic one.
No
The device is described as a "Clear, water-soluble lubricating gel," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to facilitate breast self-examination, which is a physical examination performed directly on the body, not on a specimen taken from the body.
- The device description is a lubricating gel. Lubricating gels are typically used topically to reduce friction during physical procedures or examinations.
- The intended use is for breast self-examination. This is a physical examination technique, not a diagnostic test performed on a sample.
The information provided clearly indicates a device intended for physical examination, not for in vitro diagnostic testing of biological specimens.
N/A
Intended Use / Indications for Use
The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.
Product codes
Not Found
Device Description
Clear, water-soluble lubricating gel
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Avenue | |
| Newark, 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 which | |
| Equivalence 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.
1
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.