(90 days)
To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
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.
This document is a 510(k) summary for a medical device (Lubricating Jelly, Low Viscosity). It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria in the context of diagnostic accuracy, clinical outcomes, or AI algorithm performance. It's a regulatory filing for a low-risk medical device, where the primary demonstration of safety and effectiveness often relies on showing substantial equivalence to an already marketed device, rather than extensive performance studies with acceptance criteria as one would find for diagnostic algorithms.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) because it is not present in the provided text. The document's purpose is to outline the device's characteristics and its equivalence to a predicate device, not to detail the results of a performance study with specific metrics and acceptance criteria.
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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
§ 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.