(63 days)
No
The summary describes a physical medical device (condom) and a fitting kit. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are based on physical and biological testing, not data analysis or model training.
No
The device is primarily intended for contraception and prophylactic purposes, not for treating or preventing a disease or condition in a therapeutic sense.
No
Explanation: The device is a custom fit condom used for contraception and prophylactic purposes, not for diagnosing medical conditions.
No
The device description clearly states the device is a natural rubber latex sheath (a physical product) and includes a fitting kit, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted diseases. This is a physical barrier method, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition or disease.
- Device Description: The description details a physical device (a condom) and its components and features. It does not describe a test kit, reagents, or equipment used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting biomarkers, pathogens, or any other indicators of a medical condition.
Therefore, the JUD custom fit condom falls under the category of a medical device, specifically a contraceptive and prophylactic device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JUD custom fit 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
The JUD custom fit condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. JUD custom fit condoms are available in 23 sizes of different length/width combinations. There is a fitting kit and instructions included as part of safe and effective usage of the condom.
JUD custom fit condoms are provided pre-lubricated with a silicone-based lubricant. JUD custom fit condoms are not provided with spermicide, and contain no flavors or color additives. The user must use a fitting kit to select the appropriate size of the JUD custom fit condom.
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)
Bench testing included Dimensional tests, burst volume and pressure tests, freedom from holes and visible defects tests per WHO 2010 and ISO 4074:2015. Package seal integrity test per ISO 4074:2015. Results confirmed conformance to standards with no visible defects or damaged package seals.
Shelf life testing showed a 5-year shelf-life with maintained specifications.
Biocompatibility testing included:
- Cytotoxicity (ISO 10993-5:2009): No cytotoxic reactivity found.
- Acute systemic toxicity (ISO 10993-11:2006): No mortality or evidence of systemic toxicity.
- Vaginal irritation (ISO 10993-10:2010): Non-irritating.
- Skin sensitization (ISO 10993-10:2010): No skin sensitization induced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
They Fit Condom K150072
Reference Device(s)
They Fit Condom K122219
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
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1
510(k) SUMMARY
| Date of Summary: | September 26, 2017 |
|---|---|
| 510(k) Applicant: | Global Mailer Partners, LLC |
| 50 South Pointe Drive, | |
| Suite 1401, | |
| Miami Beach, LF 33139 | |
| Jud Ireland, CEO | |
| 516-279-7745 | |
| jp.ireland@gmail.com | |
| Contact Person: | Adam Harris, MM, RAC |
| Regulatory Consultant | |
| Associate Director, Regulatory Affairs | |
| Target Health Inc. | |
| 261 Madison Ave 24th Floor | |
| New York, NY 10016 | |
| Phone: 646-218-2009 | |
| Fax: 212-682-2105 | |
| aharris@targethealth.com | |
| Proprietary/Trade Name: | JUD custom fit condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom |
| Device Classification | Class II per 21 CFR §884.5300 |
| Product Code | HIS, Condom |
| Predicate Device | They Fit Condom K150072 |
| Reference Device | They Fit Condom K122219 |
The predicate and reference devices have not been subject to a design-related recall.
Device Description:
The JUD custom fit condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. JUD custom fit condoms are available in 23 sizes of different length/width combinations. There is a fitting kit and instructions included as part of safe and effective usage of the condom.
JUD custom fit condoms are provided pre-lubricated with a silicone-based lubricant. JUD custom fit condoms are not provided with spermicide, and contain no flavors or color additives. The user must use a fitting kit to select the appropriate size of the JUD custom fit condom.
2
Indications for Use
The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
| | SIZE
CODE | LENGTH
(mm) | WIDTH (mm) |
|-----|--------------|----------------|------------|
| 1. | 54W | 130 | 45 |
| 2. | 54E | 130 | 47 |
| 3. | 54J | 130 | 51 |
| 4. | 36J | 150 | 51 |
| 5. | 75J | 173 | 51 |
| 6. | 54M | 130 | 49 |
| 7. | 36M | 150 | 49 |
| 8. | 54N | 130 | 57 |
| 9. | 36N | 150 | 57 |
| 10. | 75N | 173 | 57 |
| 11. | 29N | 199 | 57 |
| | SIZE CODE | LENGTH (mm) | WIDTH (mm) |
| 12. | 36P | 150 | 60 |
| 13. | 75P | 173 | 60 |
| 14. | 29P | 199 | 60 |
| 15. | 75R | 173 | 64 |
| 16. | 29R | 199 | 64 |
| 17. | 54S | 130 | 53 |
| 18. | 36S | 150 | 53 |
| 19. | 75S | 173 | 53 |
| 20. | 54U | 130 | 55 |
| 21. | 36U | 150 | 55 |
| 22. | 75U | 173 | 55 |
| 23. | 29U | 199 | 55 |
Comparison of Technological Characteristics
| Characteristic | Subject Device | Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Device Name | Jud custom fit condom | They Fit Condom | They Fit Condom | N/A |
| 510(k) Number | K172414 | K150072 | K122219 | N/A |
| Common Name | Male Latex Condom | Male Latex Condom | Male Latex Condom | N/A |
| Manufacturer | Richter Rubber Technology, Sdn. Bhd. | |||
| Plot 33 Kuala Ketil Industrial Estate, 09300 Kuala Ketil, Malaysia | They Fit Condom Michael Cecil, MD | |||
| 4140 Tate Street Covington, GA 30014 | They Fit Condom Michael Cecil, MD | |||
| 4140 Tate Street Covington, GA 30014 | N/A | |||
| Indications for Use | The JUD custom fit condom is used for contraception and for prophylactic purposes (to help | The condom is used for contraception and for prophylactic purposes to help | The condom is used for contraception and for prophylactic purposes (to help | Same |
3
| | prevent pregnancy
and the transmission
of sexually
transmitted
diseases). | prevent pregnancy
and the
transmission of
sexually
transmitted
diseases. | prevent pregnancy
and the
transmission of
sexually
transmitted
diseases). | |
|----------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Size(s) | Varied sizes with
different
length/width
combinations. | Varied sizes with
different
length/width
combinations. | Varied sizes with
different
length/width
combinations. | Same |
| Length | 130mm, 150mm,
173mm, 199mm | 123mm, 133mm,
143mm, 153mm | 163mm, 178mm,
193mm, 208mm | Different;
subject
device
lengths fall
within the
range of the
predicate
and
reference
devices. |
| Width | 45 mm, 47mm,
49mm, 51mm,
53mm, 55mm,
57mm, 60mm,
64mm | 45mm, 47mm,
49mm, 51mm,
53mm, 57mm,
60mm, 64mm | 49mm, 51mm,
53mm, 55mm,
57mm, 60mm,
64mm | Same |
| Reservoir tip | yes | yes | yes | Same |
| Single use
device | yes | yes | yes | Same |
| Natural Latex | yes | yes | yes | Same |
The principle of operation of the JUD custom fit condoms, placing condom on erect penis before sexual contact to avoid transmission of bodily fluid and infectious organisms within, is identical to predicate. As noted in the table above, JUD custom fit condoms have the same indications for use and basic technological characteristics as the predicate and reference condoms. The JUD custom fit condoms are made of natural rubber latex, are prelubricated, and have similar sizes to the predicate. The JUD custom fit condom dimensions fall within the range of sizes of the predicate and reference devices, though they are offered in different size configurations. The difference in available sizes of the JUD custom fit condoms does not raise different questions of safety and effectiveness.
4
Nonclinical Testing Summary
Bench testing
Dimensional tests, burst volume and pressure tests, and freedom from holes and visible defects tests have been conducted per WHO 2010 and ISO 4074:2015. Package seal integrity test has been conducted per ISO 4074:2015. The dimensions and burst volume and pressure of the condoms tested conform to the aforementioned standards. There were no visible defects or damaged package seal identified in the tested samples.
| Description | Summary and Conclusion |
|---|---|
| Dimensional | ISO 4074: Acceptance criteria met |
| Lubricant quantity | ISO 4074: Acceptance criteria met |
| Burst Volume and Pressure | ISO 4074: Acceptance criteria met |
| Freedom from Holes and Visible Defects | ISO 4074: Acceptance criteria met |
| Package Seal Integrity | ISO 4074: Acceptance criteria met |
Shelf Life
The JUD custom fit condom has a shelf-life of 5 years. The results of shelf life testing show that each condom variant maintained its specifications for the proposed shelf-life.
Biocompatibility
The JUD custom fit condom is considered a surface contacting device of category A – limited contact of