(136 days)
No
The 510(k) summary describes a standard condom and makes no mention of AI or ML technology.
No
Explanation: The device is intended for contraception and prevention of sexually transmitted diseases, which are prophylactic and hygienic purposes, not therapeutic.
No
Explanation: This device, the "Banana Gold condom," is described as being used for contraception and preventing the transmission of sexually transmitted diseases. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly indicates it is a physical condom, which is a hardware medical device, not software.
Based on the provided information, the Banana Gold condom is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and preventing the transmission of sexually transmitted diseases. This is a direct physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Personal hygienic medical devices for contraception and preventing from sexually transmitted disease." This aligns with a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
The testing mentioned (biocompatibility, airburst, dimensional specification) are relevant to the physical properties and safety of a condom, not to diagnostic performance.
Therefore, the Banana Gold condom is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes
HIS
Device Description
Personal hygienic medical devices for contraception and preventing from sexually transmitted disease.
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)
Non-Clinical Study performance:
- ISO 10993 Biological evaluation of medical devices (biocompatibility was conducted on subject device which included color additive)
- ISO 4074:2014 airburst and dimensional specification testing
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 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three overlapping human profiles facing to the right, with lines suggesting movement or flow.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
Hankook Latex Gongup Co., Ltd. Yang Ho Dong CEO Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, 135-768, KR
Re: K150857
Trade/Device Name: Banana Gold Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: May 13, 2015 Received: May 20, 2015
Dear Mr. Ho Dong,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150857
Device Name Banana Gold
Indications for Use (Describe)
The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information: | HANKOOK LATEX GONGUP CO., LTD.
61, Sakju-ro 145beon-gil, Chuncheon-si, Gangwon-do
200-160, Republic of Korea |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul, 135,768, Korea
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: onbix@naver.com |
| Date Summary Prepared: | Mar 12, 2015 |
Device Information:
Trade Name(s): Classification Name: Panel: Product code:
Banana Gold condom Obstetrics/Gynecology HIS
Predicate Device Information:
K896987 / RUBBER CONDOM (NON-COLORED)
Device Description:
Personal hygienic medical devices for contraception and preventing from sexually transmitted disease.
Intended Use:
The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- indications for use
-
- technological characteristics
-
- performance properties
Summary of the technological characteristics compared to the predicate device
new device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below
Comparison table is as follows
4
| | New device
Banana Gold | Predicate device
Rubber Condom - non-colored |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Manufacturer | Hankook Latex Gongup Co., Ltd. | same |
| 510(k) Number | K150857 | K896987 |
| Product code | HIS | HIS |
| Indications for use | Latex condoms are intended to
prevent pregnancy, HIV/AIDS, and
other sexually transmitted
infections | same |
| Material | Natural Rubber Latex Drc 60%
(high ammonia) | same |
| Biocompatibility | Meets the applicable requirement
of ISO 10993
(biocompatibility was conducted
on subject device which
included color additive) | Meets the applicable
requirement of ISO 10993 |
| Shape | Have projected nipple for reservoir
(2) Inside equally even
(3) Natural latex condom of circular
cone type with rim | same |
| Type | Ordinary Type | same |
| Length | 180 min | 180 ± 10 mm |
| Thickness | 0.07 ± 0.02 mm | same |
| Lubricant | Linear lydimethylsiloxanepolymer | same |
| Color | GOLD | Non-colored |
| Scent | none | none |
5
| Latex formulation | Natural rubber latex, sulphur, zinc
oxide, antioxidant, ammonia water,
tamol, silicone oil, corn starch | same |
|-------------------|---------------------------------------------------------------------------------------------------------------|------|
| Dusting agent | crosslinked corn-starch | same |
Non-Clinical Study performance
To be in compliance with biocompatibility, biocompatibility study has been applied to the new device in accordance with the following standard
- ISO 10993 Biological evaluation of medical devices (biocompatibility was conducted on subject device which included color additive)
- ISO 4074:2014 airburst and dimensional specification testing
Conclusion
Based on the information provided in this summary we conclude that Banana Gold is safe and effective and substantially equivalent to the predicate device K896987.