(178 days)
Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.
PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
The provided text describes a 510(k) submission for a personal lubricant device and does not contain information about acceptance criteria, device performance metrics, or a study that typically involves ground truth, experts, or comparative effectiveness for an AI/ML device. The "Performance Data" section solely refers to stability and microbial studies for the lubricant.
Therefore, most of the requested information cannot be extracted from the given text.
However, I can extract what little "performance data" is mentioned:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Shelf life stability | Confirmed through 24 months |
| Microbial conformance | In accordance with USP standards |
Regarding the other requested information:
- Sample sized used for the test set and the data provenance: Not applicable. The "performance data" concerns product stability and microbial testing, not a test set for an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/ML device.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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510(k) Summary
| Submitter | PharmaPac, LLC110 Industrial Park RoadDeKalb, MS 39328 | |
|---|---|---|
| Contact Person | Tom Otto(601) 743-9771 phone(601) 743-9772 fax | AUG 3 1 2007 |
| Date Prepared | January 26, 2007 | |
| Proprietary Name | PharmaPac Lubricating Jelly Personal Lubricant | |
| Common Name | Personal Lubricant | |
| Classification Name | Patient Lubricant | |
| Predicate Device | K-Y® Brand Lubricating Jelly (K810310) |
Description of Device
PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
Intended Use
Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, tampons, and diagnostic or therapeutic devices. It is also compatible with latex condoms.
Technological Characteristics of Device Compared to Predicate
The technological characteristics of the PharmaPac Lubricating Jelly are identical to those of the predicate device.
Performance Data
Stability of the PharmaPac Lubricating Jelly was confirmed throughout its labeled shelf life (24 Months) by an accelerated stability study for 90 days at 40°C / 75% R.H. and parallel microbial study in accordance with USP standards
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 3 1 2007
PharmaPac. LLC c/o Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
K070623 Re:
Trade Name: PharmaPac Lubricating Jelly Regulation Number: 21 CFR $884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 16, 2007 Received: August 17, 2007
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. At the very bottom of the logo are three stars arranged horizontally. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
toting and Promoting Publio Hodlio Hodlin
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Enclosure
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): _ K070623
Device Name: _ PharmaPac Lubricating Jelly____________________________________________________________________________________________________________________________________
Indications for Use:
Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) +
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.