CLINIJEL

{0} K970581 p192 HOSPICON PRODUCTS PHARMACEUTICAL SUPPLIES TO HOSPITALS EXHIBIT 7 SEP - 3 1997 # CLINIJEL ## 510(K) NOTIFICATION SUMMARY & SE COMPARISON We submit this 510(K) application in the belief that Clinijel would be considered substantially equivalent to: H R Lubricating Jelly Triad Lubricating Jelly (K871169) K-Y Jelly because (1) all four products make similar intended use statements, (2) Clinijel and K-Y Jelly use Hydroxyethylcellulose as a gelling agent while H R Lubricating Jelly and Triad Lubricating Jelly contain Hydroxypropyl Methylcellulose, which is similar in use to Hydroxyethylcellulose. A small additional quantity of Carbomer 934P in H R Lubricating Jelly and Triad Lubricating Jelly may be to facilitate sterilisation in sachet form. See Triad’s 510(K) notification submission K871169, which claimed SE with H R Lubricating Jelly in sachet form, and (3) all of them target the same population. Other comparative features may be seen in the SE Comparison table on the next page. {1} EXHIBIT 7 | | CLINIEJL | H R LUBRICATING JELLY* | TRIAD LUB JELLY | K-: JELLY | | --- | --- | --- | --- | --- | | APPEARANCE | water white clear jelly | water white clear jelly | Not known | water white clear jelly | | GELLING AGENT | Hydroxyethyl-cellulose | Hydroxypropyl Methyl-cellulose, Carbomer 934P | Hydroxypropyl Methylcellulose, Carbomer 934P | Hydroxyethylcellulose | | PRESERVATIVES | Methylparaben & Propylparaben | Methylparaben & Propylparaben | Methylparaben & Propylparaben | Methylparaben | | PROPYLENE GLYCOL/ GLYCEROL | Propylene Glycol | Propylene Glycol | Propylene Glycol | Glycerin | | pH ADJUSTMENT WITH | Sodium Hydroxide | Sodium Hydroxide | Sodium Hydroxide | Sodium Hydroxide | | CONTAINER | Aluminium-lined tube | Aluminium-lined tube | Aluminium-lined sachet | Aluminium-lined tube | | SHELF LIFE | Up to 5 years | 5 years | Not known | 3 years | *We understand that H R Lubricating Jelly was marketed prior to May 1976. A method to prepare a jelly using H R Lubricating Jelly's ingredients is described on page 740 of Extra Pharmacopoeia Martindale, 25 th edition (19679. K970581 p2912 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 3 1997 Mr. Sadguru Y. Gaitonde Hospicon Products 67 Compton Road London N21 3NU UNITED KINGDOM Re: K970581 Clinijel Lubricating Jelly Dated: July 18, 1997 Received: July 28, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS Dear Mr. Gaitonde: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} Page 1 of 1 510(k) Number (if known): K970581 Device Name: Clinijel lubricating jelly Indications For Use: Clinijel is specially formulated to provide vaginal moisture, lubricate condoms, and help ease insertion of tampons, rectal thermometers, enaema and douche nozzles.  (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K970581 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use ☑ (Optional Format 1-2-96)