(46 days)
Kden:Not Found
No
The 510(k) summary describes a physical condom and does not mention any software, algorithms, or AI/ML capabilities.
No
The primary uses stated are contraception and prophylactic purposes (preventing disease transmission), which are preventive rather than therapeutic in the sense of treating an existing condition.
No
Explanation: The device is a condom, used for contraception and preventing STDs, which are prophylactic purposes, not diagnostic.
No
The device description clearly states it is a physical condom made of natural rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Sheer Thin condom is for contraception and prevention of STDs. This is a physical barrier device used externally on the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The description clearly indicates a physical barrier device, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Sheer Thin condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.
Product codes
85 HIS
Device Description
The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight shafted, nipple end condom having a nominal width of 52 mm, nominal length of 180 mm and nominal thickness of 0.060 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K9844488
FEB 1 1935
510(k) Summary
| Submitted By: | TWE Companies, Inc.
46 Franklin Street
P.O. Box 23
Avondale Estates, GA 30002
Phone (404) 296-0750 |
| --------------- | ---------------------------------------------------------------------------------------------------------------- |
|---|
Keith F. Heintz Contact Person:
Date Prepared: December 16, 1998
Proprietary Name: Sheer Thin
Latex Condom Common Name:
Classification Name: Condom
Trojan Ultra Thin Predicate Device: 510(k) #K912901
The condom is made of a natural rubber latex sheath, which Description of the Device: completely covers the penis with a closely fitted membrane. This condom is straight shafted, nipple end condom having a nominal width of 52 mm, nominal length of 180 mm and nominal thickness of 0.060 mm.
Intended Use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.
Technological Characteristics: This condom made of natural rubber and is similar in design and composition to the predicate condom identified above. The design is in conformance with the ASTM Latex Condom Standard D-3492. The condom is fitted over the penis as is the predicate device and is of similar nominal measurements to the predicate condom.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Mr. Keith Heintz Vice President TWE Companies, Inc. 46 Franklin Street P.O. Box 23 Avondale Estates, GA 30002
K984488 Re: Sheer Thin - Natural Rubber Latex Condom Dated: December 16, 1998 Received: December 17, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS
Dear Mr. Heintz:
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 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). 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 requirements, 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.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
2
Page 2 - Mr. Keith Heintz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. 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/dsma/dsmamain.html".
Sincerely yours,
.
CAPT. Daniel C. Schul
ČAPT. Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use Statement
| 510(k) Number: | K984488 |
|---|---|
| Device Name: | Sheer Thin - Natural Rubber Latex Condom |
| Indications for Use: | The Sheer Thin condom is used for contraception and for |
| prophylactic purposes to help prevent pregnancy and the | |
| transmission of sexually transmitted diseases. |
(LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Proscription Use (Per 21 CFR §801.109) OR Over-The-Counter Use
s.ter
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 84488 510(k) Number