(136 days)
The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Personal hygienic medical devices for contraception and preventing from sexually transmitted disease.
This document is a 510(k) premarket notification for the "Banana Gold" condom, asserting its substantial equivalence to a predicate device (K896987 / RUBBER CONDOM (NON-COLORED)).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which implies that the new device meets established standards for condoms. The relevant performance criteria are drawn from the international standard ISO 4074:2014, specifically "airburst and dimensional specification testing," and ISO 10993 for biocompatibility.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Banana Gold) |
|---|---|
| ISO 4074:2014 | Complies with "airburst and dimensional specification testing" |
| - Length | 180 min (mm) |
| - Thickness | 0.07 ± 0.02 mm |
| ISO 10993 | Meets the applicable requirements (biocompatibility was conducted on subject device which included color additive) |
Note: The predicate device for length has an acceptance criterion of "180 ± 10 mm", while the new device specifies "180 min". This suggests that the new device is at least 180mm, which would fall within the predicate's range. For thickness, both are "0.07 ± 0.02 mm".
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the "airburst and dimensional specification testing" or the biocompatibility studies.
- Data Provenance: The manufacturing company, Hankook Latex Gongup Co., Ltd., is located in the Republic of Korea. The testing would presumably be conducted by or for this manufacturer, likely in Korea or by a certified laboratory. The document does not specify if the testing was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not applicable to the performance testing of physical devices like condoms. Ground truth in this context refers to the defined metrics and acceptable limits within the ISO standards themselves, not expert interpretation of results, as would be the case for image-based diagnostic AI. The standards are the "ground truth."
4. Adjudication Method for the Test Set:
Not applicable in the sense of expert adjudication as used for clinical trial data or AI performance. The results of the non-clinical tests (e.g., airburst volume, dimensions) are objectively measured against the specified limits of ISO 4074:2014.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This is a physical medical device (condom), not an AI algorithm intended for human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for evaluating the device's performance against the acceptance criteria is defined by international recognized standards:
- ISO 4074:2014 (for airburst and dimensional specifications)
- ISO 10993 (for biocompatibility)
These standards specify the methods of testing and the acceptable ranges for physical properties and biological safety.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the manufacturing and testing of a physical product like a condom.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for a physical device.
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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
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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-do200-160, Republic of Korea |
|---|---|
| Contact Person: | Ho Dong, YangOnbix Corporation#821 Samil Plaza, 837-26 Yeuksam-dongGangnam-gu, Seoul, 135,768, KoreaTel: *82-2-566-3360 / Fax: *82-2-6280-3360Email: 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
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| New deviceBanana Gold | Predicate deviceRubber 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 toprevent pregnancy, HIV/AIDS, andother sexually transmittedinfections | same |
| Material | Natural Rubber Latex Drc 60%(high ammonia) | same |
| Biocompatibility | Meets the applicable requirementof ISO 10993(biocompatibility was conductedon subject device whichincluded color additive) | Meets the applicablerequirement of ISO 10993 |
| Shape | Have projected nipple for reservoir(2) Inside equally even(3) Natural latex condom of circularcone 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 |
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| Latex formulation | Natural rubber latex, sulphur, zincoxide, 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.
§ 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.