(90 days)
510K882506
Not Found
No
The summary describes a simple lubricating jelly and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The 'Intended Use' states that the device is "To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device," indicating it aids the use of other devices, not that it is therapeutic itself.
No
The device is a lubricant to facilitate the entry of a diagnostic or therapeutic device, but it is not itself performing a diagnostic function.
No
The device description clearly states it is "Lubricating Jelly," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device." This describes a physical action performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description reinforces the intended use as a "patient lubricant."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information about a patient's health status based on sample analysis
IVDs are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This lubricating jelly does not fit that definition.
N/A
Intended Use / Indications for Use
To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Product codes
Not Found
Device Description
Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body orifice
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
510K882506
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
JUL 18 1996
Image /page/0/Picture/1 description: The image shows the logo for Span-America Medical Systems, Inc. The logo is in a rectangular box, with the words "SPAN-AMERICA" in large, bold letters. Below that, in a black box, are the words "MEDICAL SYSTEMS, INC." The number K961502 is written above the logo.
510 SUMMARY _ LUBRICATING JELLY, LOW VISCOSITY
1.0. SUBMITTER: Span-America Medical Systems, Inc. 70 Commerce Center; Greenville, SC 29615 ADDRESS: TELEPHONE: 864-288-8877 FACSIMILE: 864-288-8692 CONTACT PERSON: Wanda J. Totton, Director of Quality Polly Thompson, Manager of Quality Assurance DATE PREPARED: April 15, 1996 2.0. TRADE NAME: Lubricating Jelly COMMON NAME: Lubricating Jelly CLASSIFICATION NAME: Lubricant, Patient 3.0. PREDICATE DEVICE: Lubricating Jelly, 510K882506 4.0. DESCRIPTION: Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. 5.0. INDICATIONS FOR USE: To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. 6.0. SUBSTANTIAL The product is similar in function and intended EQUIVALENCE: use to Lubricating Jelly, 510K882506.
WPWINA:TOTTON\LUBE510K.C96
P.O. Box 5231, Greenville S.C. 20606 = 000 000 000 000