(201 days)
Not Found
No
The summary describes a lubricating jelly and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is indicated to provide vaginal moisture and aid in the insertion of various medical devices, which are generally functions of a lubricant and not typically considered therapeutic.
No
The intended use of Clinijel is to provide vaginal moisture and aid in the insertion of various medical devices, not to diagnose a medical condition.
No
The intended use and predicate devices clearly indicate this is a 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 describes the device as a lubricant for vaginal moisture and for facilitating the insertion of various items (tampons, thermometers, nozzles). This is a physical function, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Metrics: There are no mentions of sensitivity, specificity, AUC, or other metrics typically associated with diagnostic tests.
Therefore, Clinijel, as described, functions as a medical device for lubrication and insertion assistance, not as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Clinijel is specially formulated to provide vaginal moisture, Clinijel is specially formarated to projection of tampons, rectal thermometers, enaema and douche nozzles.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal, rectal
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
H R Lubricating Jelly Triad Lubricating Jelly (K871169), K-Y Jelly
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a three-dimensional geometric shape that appears to be a tetrahedron or a pyramid with a triangular base. The shape is composed of several triangular faces, some of which are colored black and others white, creating a contrast that highlights the geometric structure. The arrangement of the triangles gives the object a complex, multifaceted appearance. The lighting and shadows suggest a three-dimensional form, enhancing the depth and perspective of the image.
PHARMACEUTICAL SUPPLIES TO HOSPITALS
PRODUC
HOSPICON
15970581
8102
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 Hydroxvethylcellylose 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 facilitation 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
CLINIJEL
និង COMPARISON
| 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.
g70581
p2292
EXHIBIT 7
2
DEPARTMENT OF HEALTH & HUM
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 1997
Re: K970581 Cliniiel Lubricating Jelly Dated: July 18, 1997 Received: July 28, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS
Mr. Sadguru Y. Gaitonde Hospicon Products 67 Compton Road London N21 3NU UNITED KINGDOM
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, 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 (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 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 predication 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".
Sincereiy yours,
h.7.Liau Yu
Lillian Yiu, Ph.D.
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, Clinijel is specially formarated to projection 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)
Robert R Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 14 510(k) Number
Prescription Use_ (Per 21 CFR 801.109)
CH
Over-The-Counter Use レ
(Optional Format 1-2-96)