(94 days)
No
The summary describes a standard condom with warming lubricant and makes no mention of AI or ML technology.
No.
The device is indicated for contraception and prophylactic purposes to prevent pregnancy and the transmission of STDs, which are preventative rather than therapeutic uses.
No
The description explicitly states its use for "contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases," not for diagnosis.
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:
- 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.
- Device Description: The Divas Dual Pleasure condom is a physical barrier device used for contraception and disease prevention. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for contraception and preventing the transmission of STDs, which are physical functions, not diagnostic tests.
The information provided clearly describes a physical barrier device, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
Page 1: "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. The warming condom lubricant has the same intended use as the predicate personal lubricants when used as an accessory to a condom. It relieves friction and facilitates ease and comfort of intimate sexual activity."
Page 4: "The Divas Dual Pleasure condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases."
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
Page 1: "This condom is made of a natural rubber latex sheath, which Description of the Device: Description of the Device - The closely fitted membrane. The device is shaped, teat ended, lubricated condom, which is lubricated with a water based warming lubricant. The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted."
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): 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.
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
Page 1 of 2
AUG 1 9 2005
510(k) Summary II.
| Submitted by: | Eagle TWE, Inc.
2090 Tucker Industrial Road, Suite A-5
Tucker, GA 30084 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bill Taffs
Phone (678) 937-0571
Fax (678) 937-9545
E-mail Bill@eagletwe.com |
| Date Prepared: | May 12, 2005 |
| Proprietary Name: | Divas Dual Pleasure Male Latex Condom |
| Common Name: | Condom |
| Classification Name: | Condom (Rubber) Contraceptive |
| Predicate Device: | Durex Warming Pleasure Latex Condom
510K # K042957
KY Warming liquid personal lubricant
510K # K021492
Invigra Male Latex Condom
510K # K991374 |
510K # K984488
This condom is made of a natural rubber latex sheath, which Description of the Device: Description of the Device - The closely fitted membrane. The device is shaped, teat ended, lubricated condom, which is lubricated with a water based warming lubricant. The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted.
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. The warming condom lubricant has the same intended use as the predicate personal lubricants when used as an accessory to a condom. It relieves friction and facilitates ease and comfort of intimate sexual activity.
1
Page 2 of 2
Technological Characteristics: The latex condom has the same technological characteristics as a the predicate condom identified above. The condom described in K042957 are manufactured of natural rubber latex with the same shape as the condoms in this application. The competitor natural rubber latex with the same shape as the condoms with "The Printer ondoms with "Warm Sensation" lubricant to help enhance sexual pleasure.
The K-Y Warming liquid (K021492) is a water based, condom compatible personal lubricant on The K-Y Warming liquid (K021492) is a water based, consent on the warming lubricant on the Divas condom in this submission.
The condom design conforms to domestic and international regulations: ASTM D3942 and ISO The condom design conforms to donestic and international results in conformance with required specifications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2005
Mr. Bill Taffs President Eagle T.W.E., Inc. P.O. Box 1511 TUCKER GA 30085-1511 Re: K051273
Trade/Device Name: Diva's Dual Pleasure Male Latex Condom with Warming Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 8, 2005 Received: August 9, 2005
Dear Mr. Taffs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave 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 the enorstate) to regary mant date of the Medical Device Amendments, or to devices that have been May 20, 1710, the chance 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 do not require to the general controls provisions of the Act. The general controls provisions of the Act actio, suojoet to the generation, 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 11 your a vise to the subject to such additional controls. Existing major regulations affecting your Approvatify to they of basyone of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
. This letter will allow you to begin marketing your intial equivalence of your device to a legally premarket notification. The IDA inding of substantial of a loves 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 If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation Childer, "thisorial on your responsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number (800) DIVISIOn of (301) 443-6597 or at its Internet address 056-2011 01 /www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Divas Male Latex Condom with Warming Lubricant
Premarket Notification [510(k)] application
Indications for Use Statement
510(k) Number:
051273________________________________________________________________________________________________________________________________________________________________________
$
Device name:
Indications for Use:
Divas Dual Pleasure Latex Condom
The Divas Dual Pleasure condom is used for contraception The Divas Dual Ficasare poses to help prevent pregnancy and the transmission of sexually transmitted diseases.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTI Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Cragdon
(Division Sign-Off) ive, Abdominal, Division of Reproduce Officiological Devices 310(k) Number