(1169 days)
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No
The summary describes a spermicidal lubricated condom and does not mention any AI or ML technology.
No
The device is described as a contraceptive to prevent pregnancy and reduce the risk of sexually transmitted diseases, which are preventative measures rather than therapeutic treatments for existing conditions.
No
The provided text describes a spermicidal lubricated condom, which is a contraceptive and disease prevention device, not a diagnostic tool used to identify or characterize a disease.
No
The device description clearly states it is a spermicidal lubricated condom, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for preventing pregnancy and reducing the risk of sexually transmitted diseases. This is a physical barrier method and a drug delivery system (spermicide), not a test performed on samples taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The device is a condom, which is a physical barrier.
- Lack of IVD Characteristics: The description does not mention any testing, analysis of biological samples, or diagnostic purposes.
IVD devices are typically used to diagnose, monitor, or screen for diseases or conditions by analyzing samples like blood, urine, or tissue. This device does not fit that description.
N/A
Intended Use / Indications for Use
Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).
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SAFETY AND EFFECTIVENESS SUMMARY
AY 2 2 1996
Classification name : Condom (Rubber) Contraceptive
Classification Number : 85 HIS
Proprietary Name : The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.
Intended Use and Performance Claim : Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.
Physical Composition : Condoms are manufactured from natural latex FA. The latex is purchased from traditional territories of type Malaysia and is of the highest quality which is tested according to ISO 2004.
Specifications : All specifications for these condoms meet or exceed all ASTM and ISO standards for condoms according to FDA requirements.
Safety Guidlines: When using a condom follow all instructions included with the condom. To assure that the condom will perform to its maximum quality level, follow this safety guideline:
Do Not Use the Condom If : The external package has visual signs of being tampered with, or shows physical damage possibly due to mishandling. The individual foil wrapping of the condom is damaged. The condom itself has damage (a tear or rip, is cracked or dried up any deformities as compared to a regular Spermicidal or has lubricated condom). Any other apparent damage that would cause a suspicion of the loss of integrity to the condom. The condoms should be stored in the cool and dry place.