(384 days)
ForPlay, SLIP and PrePair personal Lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of diagnostic or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are recommended as personal lubricants and are principally intended to supplement the body's natural lubrication, to moisturize and enhance the comfort and ease of intimacy with or without a condom.
"ForPlay, SLIP and PrePair Personal Lubricants" are colorless, odorless, non-sticky, non-greasy, nonirritating water based lubricants. They are water-soluble, high viscosity gels and liquids. Because they are water-soluble, ForPlay, SLIP and PrePair Personal Lubricants are easily rinsed off with water leaving NO residue.
The provided document is a 510(k) summary for personal lubricants ("ForPlay, SLIP and PrePair Personal Lubricants"). This type of submission focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than establishing novel safety and effectiveness criteria through extensive clinical studies with specified acceptance criteria.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This document primarily compares the technological characteristics of the new devices to predicate devices. It doesn't define specific performance criteria (e.g., efficacy rates, accuracy metrics) or report performance against such criteria.
- Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a diagnostic or AI device is not applicable here.
- 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: This is not an AI or diagnostic imaging device; therefore, an MRMC study is irrelevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is a comparison of technological characteristics to predicate devices to demonstrate substantial equivalence.
The relevant comparison table (from Section {2}) is formatted below:
| Feature | ForPlay | SLIP | PrePair | Lifestyles | K-Y Liquid |
|---|---|---|---|---|---|
| 510(K) # | N/A | N/A | N/A | K033076 | K955648 |
| Manufacturer | TRIMENSAPharmaceuticals | TRIMENSAPharmaceuticals | TRIMENSAPharmaccuticals | AnsellHealthcare, Inc | McNeil-PPC, Inc |
| ContainsPurified Water | Yes | Yes | Yes | Yes | Yes |
| ContainsGlycerine | Yes | Yes | Yes | Yes | Yes |
| ContainsCelluloseThickeners | Yes | Yes | Yes | Yes | Yes |
| ContainsMethylparaben | Yes | Yes | Yes | Yes | Yes |
| ContainsPropylparaben | Yes | Yes | Yes | Yes | Yes |
| LabeledWater soluble | Yes | Yes | Yes | Yes | Yes |
| LabeledNon-Staining | Yes | Yes | Yes | Yes | Yes |
| LabeledCondomCompatible | Yes | Yes | Yes | Yes | Yes |
| ContainerMaterial | Plastic | Plastic | Plastic | Plastic | Plastic |
| Sterile | No | No | No | No | No |
This table demonstrates that the new devices share the same key technological characteristics (ingredients, water solubility, non-staining, condom compatibility, container material, non-sterility) as the predicate devices. The "study" for this type of submission is essentially the comparison of these characteristics to establish substantial equivalence, rather than a clinical performance study with defined acceptance criteria.
{0}------------------------------------------------
Koslbea
510(K) Summary
JUL 1 2 2006
| Applicant: | TRIMENSA PHARMACEUTICALS1050 Lawrence DriveNewbury Park CA 91320 USA |
|---|---|
| Phone: | (805) 499-2446 |
| Fax: | (805) 499-4366 |
| Contact: | Robin James Ogilvie (ex. 102) |
| Email: | robin@trimensa.com |
| Date: | June 20, 2005 |
MULTIPLE Trade Name(s): Device:
| ForPlay | Personal Lubricant(s) |
|---|---|
| SLIP | Personal Lubricant(s) |
PrePair Personal Lubricant(s)
{1}------------------------------------------------
| Common name | Personal Lubricant(s) |
|---|---|
| Classification name(s): | Patient LubricantProduct Code: 85 MMS / 21CFR section 880.6375Regulatory Class: I |
| and | |
| CondomProduct Code: 85 HIS / 21 CFR section 884.5300 |
Reguatory Class: II
McNeil-PPC, Inc.
Information supporting the claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic act, with respect to safety and effectiveness is summarized below: For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final ruling on,"510(K) Summaries and 510(K) Statements" (21CFR 807).
New Device Names: ForPlay Personal Lubricant(s) SLIP Personal Lubricant(s) PrePair Personal Lubricant(s) Lifestyles Liquid Personal Lubricant, Predicated Devices: Ansell Healthcare, Inc. K033076 K-Y Liquid Personal Lubricant
{2}------------------------------------------------
Technological Characteristics:
ForPlay, SLIP and PrePair Personal Lubricant(s) formulations contain ingredients which are Substantially Equivalent to the predicate devices submitted Below,
Summary of Technological Characteristics:
The table below compares the technological characteristics of ForPlay, SLIP and PrePair Personal Lubricant(s) to the predicate device brands of: Lifestyles Liquid Personal Lubricant, Lifestyles Liquid Personal Lubricant with Aloe & Vitamin E, Lifestyles Liquid Personal Lubricant Strawberry and K-Y Liquid Personal Lubricant.
| Feature | ForPlay | SLIP | PrePair | Lifestyles | K-Y Liquid |
|---|---|---|---|---|---|
| 510(K) # | N/A | N/A | N/A | K033076 | K955648 |
| Manufacturer | TRIMENSAPharmaceuticals | TRIMENSAPharmaceuticals | TRIMENSAPharmaccuticals | AnsellHealthcare, Inc | McNeil-PPC, Inc |
| ContainsPurified Water | Yes | Yes | Yes | Yes | Yes |
| ContainsGlycerine | Yes | Yes | Yes | Yes | Yes |
| ContainsCelluloseThickeners | Yes | Yes | Yes | Yes | Yes |
| ContainsMethylparaben | Yes | Yes | Yes | Yes | Yes |
| ContainsPropylparaben | Yes | Yes | Yes | Yes | Yes |
| LabeledWater soluble | Yes | Yes | Yes | Yes | Yes |
| LabeledNon-Staining | Yes | Yes | Yes | Yes | Yes |
| LabeledCondomCompatible | Yes | Yes | Yes | Yes | Yes |
| ContainerMaterial | Plastic | Plastic | Plastic | Plastic | Plastic |
| Sterile | No | No | No | No | No |
{3}------------------------------------------------
Device Description:
"ForPlay, SLIP and PrePair Personal Lubricants" are colorless, odorless, non-sticky, non-greasy, nonirritating water based lubricants. They are water-soluble, high viscosity gels and liquids. Because they are water-soluble, ForPlay, SLIP and PrePair Personal Lubricants are easily rinsed off with water leaving NO residue.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 2 2006
Mr. Robin J. Ogilvie President Trimensa Pharamaceuticals 1050 Lawrence Drive NEWBURY PARK CA 91320
Re: K051688
Trade/Device Name: ForPlay, SLIP and PrePair Personal Lubricants Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 6, 2006 Received: June 7, 2006
Dear Mr. Ogilvie:
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/4/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. There are three stars below the word "Centennial". The logo is surrounded by text that reads "Dedicated to Leaders in Consumer Protection in the Science of Food".
{5}------------------------------------------------
Page 2 -
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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): K051688
Device Name: ForPlay: SLIP and PrePair
Indications For Use:
ForPlay, SLIP and PrePair personal Lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of diagnostic or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are recommended as personal lubricants and are principally intended to supplement the body's natural lubrication, to moisturize and enhance the comfort and ease of intimacy with or without a condom.
NO Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
AES Over-The-Counter Use (21 CFR 801 Subpart C)
Use YES
(C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CONTINUE
Division Sign Off
CONTINUE ON ANOTHER PAGE IF
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
§ 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.