(205 days)
Instead Intimate Lubricant is intended to enhance the comfort and ease of intimate the continues and the cities and selectronic condoms instead intimate Eubricant is interest and polyurethane condoms.
Instead Intimate Lubricant is a water-glycerin based lubricant that uses mistead intimate Eubnount is a fragrances or petroleum-based chemicals are used in the formulation.
The provided document is a 510(k) summary for the Instead Intimate Lubricant, establishing its substantial equivalence to predicate devices. It focuses on comparing technological characteristics and presenting non-clinical and in-vivo testing results.
This document is a marketing submission to the FDA, not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. It presents data to demonstrate that the device is as safe and effective as previously approved devices.
Based on the information provided, here's a breakdown of what can be gleaned, and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in a quantitative manner as typically seen in a clinical trial or performance study (e.g., "sensitivity ≥ 90%"). Instead, it shows a comparison of technological characteristics to predicate devices and reports on various non-clinical and in-vivo tests that demonstrate safety and performance.
| Characteristic/Feature | Acceptance Criteria (Implied by Predicate & Testing) | Reported Device Performance (Instead Intimate Lubricant) |
|---|---|---|
| Technological Equivalence | ||
| Contains purified water | Yes (Same as predicates) | Yes |
| Contains glycerin | Yes (Same as predicates) | Yes |
| Contains thickening agents | Yes (Same as predicates) | Yes |
| Contains preservatives | Yes (Same as predicates) | Yes |
| Container Material | Plastic (Same as predicates) | Plastic |
| Label Condom Compatible | Yes (Same as predicates) | Yes |
| Sterile | No (Same as predicates) | No |
| Non-Clinical Performance | ||
| pH | Stable/Appropriate for intended use | Had better bioadhesive properties, maintained its initial pH better when mixed with semen. |
| Viscosity | Stable/Appropriate for intended use | Had better bioadhesive properties, maintained its initial viscosity better when mixed with semen. |
| Biometric properties | Maintained sperm motility (similar to or better than other lubricants) | May resulted in maintained sperm motility (Carg, S. 2001) |
| Condom Compatibility | No effect on latex and polyurethane condom performance after 24 hours (ASTM D3492-02) | No effect on condom performance was found. |
| In-vivo Testing | ||
| Penile and anal irritation | Biocompatible (no irritation) | Confirmed the biocompatibility. |
| Vaginal irritation | Biocompatible (no irritation) | Confirmed the biocompatibility (repeated dose vaginal irritation study). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified for any of the non-clinical or in-vivo tests. The document refers to studies by Carg, S. (2001) and Amaral, E., et al. (2000), but doesn't provide the sample sizes used within those studies explicitly for Instead Intimate Lubricant.
- Data Provenance:
- The document itself is a K033776 510(k) submission from the US.
- The nature of the non-clinical tests (e.g., pH, viscosity, condom compatibility) suggests laboratory-based testing.
- The in-vivo testing implies human or animal subjects, but specific countries or retrospective/prospective status are not mentioned within this summary. The cited external studies (Carg, S. 2001 and Amaral, E., et al. 2000) would contain this information, but are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the 510(k) summary. The testing described (e.g., pH, viscosity, ASTM D3492-02 for condom compatibility, in-vivo biocompatibility) relies on established scientific methods and instruments, rather than subjective expert assessment to establish "ground truth." The interpretation of results would be done by qualified scientists/technicians, but the document doesn't detail this.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (physical properties, in-vitro, and in-vivo biocompatibility), traditional adjudication methods (like 2+1 reader consensus for imaging studies) are generally not applicable. The results would be objectively measured and reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No. This is not applicable. The device is an intimate lubricant, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not applicable. The device is an intimate lubricant, not an algorithm.
7. The type of ground truth used
For the non-clinical and in-vivo tests, the "ground truth" is established by:
- Physical and Chemical Measurements: Objective measurements of pH, viscosity, and chemical composition.
- Standardized Tests: Adherence to established standards like ASTM D3492-02 for condom compatibility, which involves objective assessment of burst pressure and elongation.
- Biocompatibility Assessments: In-vivo studies (penile, anal, vaginal irritation) where "ground truth" would be the observed lack of adverse reactions or irritation, often assessed by clinical observation or histological examination in the cited full reports. The provided summary only states "confirmed the biocompatibility."
- Referenced Scientific Literature: The document references studies (Carg, S. 2001; Amaral, E., et al. 2000) that would have detailed methodologies for their assessments.
8. The sample size for the training set
Not applicable. This device is a physical product (lubricant), not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this device.
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Image /page/0/Picture/0 description: The image shows the logo for Instead, a brand of women's reproductive health products. The logo features the word "instead" in a stylized font, with the "in" part of the word inside of a black circle. Below the word "instead" are the words "women's reproductive health products" in a smaller font.
K033776
Page 1 of 2
..............................................................................................................................................................................
JUN 2 5 2004
Corporate Headquarters: 4370 La Jolla Village Drive, Suite 960 San Diego, CA 92122 Tel. 858.642.7515 Fax 858.623.6991
510K SUMMARY
This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510K number is:_
-
- Submitter's Identification:
- Instead Inc. 4370 La Jolla Village Drive, Suite 960 San Diego, California 92122 Telephone: 858-642-7515 Facsimile: 858-623-6991
Contact Person: Joe Pike, CEO/President
Date of Summary: 11-18-03
-
- Device Name: Instead Intimate Lubricant
-
- Classification Name: Lubricant (21 CFR 884.5300)
-
- Predicate Device:
-
- Intended Use: Instead Intimate Lubricant is intended to enhance the confort and miended ose. "Instead maintate adomitible with latex and polyurethane condoms.
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-
- Device Description/ Comparison:
Instead Intimate Lubricant is a water-glycerin based lubricant that uses mistead intimate Eubnount is a fragrances or petroleum-based chemicals are used in the formulation.
- Device Description/ Comparison:
A comparison of the technological characteristics of the Instead Intimate A companson of the technological charactories (shown in the table below) substantiates the Eubricant with the prodicate don't (Intimate Lubricant to the predicate devices.
| Characteristic/Feature | InsteadIntimateLubricant | The JustBetweenUSTM(K982673) | CVSPersonalLubricant(K983216) |
|---|---|---|---|
| Contains purified water | Yes | Yes | Yes |
| Contains glycerin | Yes | Yes | Yes |
| Contains thickening agents | Yes | Yes | Yes |
| Contains preservatives | Yes | Yes | Yes |
| Container Material | Plastic | Plastic | Plastic |
| Label Condom Compatible | Yes | Yes | Yes |
| Sterile | No | No | No |
| Table 1. Comparison of Technological Characteristics | ||
|---|---|---|
Non-clinical testing of the Instead Intimate Lubricant included measurement of Non-cillincal testing of the instead framato easen, viscosity and compatibility with bloadlesson, buttering copating of Instead Intimate Lubricant had better latex and polyulethane oonaoms: d its initial pH and viscosity better when mixed bioadnestve properties, maintained to ... The testing with semen suggested that with Sement than other labhounts weeks on the sperm motility (Carg, S. 2001). Latex the instead intimate Eubnount may rested in accordance with ASTM D3492-02 after exposure to Instead Intimate Lubricant for up to 24 hours. No effect on condom performance was found.
In-vivo testing (penile and anal irritation) confirmed the biocompatibility of the In-vivo lesting (penile and and and imaxill), a repeated dose vaginal irritation study instead Intimate Eubrisant. Addiscompatibility of the Instead Intimate Lubricant (Amaral et al. 2000).
Contraception, 64:67-75, 2001.
Amaral, E., et al. Study of the vaginal tolerance to acidform, an acid-buffering bioadhesive gel, Contraception, 60:361-366, 2000.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2014
Mr. Joe Pike CEO/President Instead, Inc. 4370 La Jolla Village Drive, Suite 960 SAN DIEGO, CA 92122
Re: K033776 Trade/Device Name: Instead Intimate Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): April 16, 2004 Received (Date on orig SE Itr): April 19, 2004
Dear Mr. Pike:
This letter corrects our substantially equivalent letter of June 25, 2004.
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. Iisting 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
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Page 2 -
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-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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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 R. 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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510k Number (if Known): K033776
Device Name: Instead Intimate Lubricant
Indications for Use:
Instead Intimate Lubricant is intended to enhance the comfort and ease of intimate
the continues and the cities and selectronic condoms instead intimate Eubricant is interest and polyurethane condoms.
Prescription Use: (Per 21 CFR 801.109)
Over-the-Counter Use: OR
X
- r
Concurrence of CFRH, Office of Device Evaluation (ODE)
David h. Sypman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.