(23 days)
o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.
The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.
Acceptance Criteria and Study for o.b.® Tampons:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The device performs equivalently to the predicate device of the same absorbency. |
| Syngyna Values (Absorbency) | Syngyna values were the same as the predicate device. |
| Toxicological Safety (No Untoward Results in Tests) | No untoward results were seen in the following tests on either the new material or the finished proposed device: - Cytotoxicity - Elution Method Cytotoxicity - Agarose Overlay Method Acute Systemic Toxicity in the Mouse - Mucosal (Vaginal) Irritation in the Rabbit - Dermal Irritation and Allergic Contact Sensitization: Human Repeat Insult Patch Test (RIPT) - Acute Intracutaneous Reactivity in the Rabbit - TSST-1, Tampon Sac Method |
| Clinical Safety (No Clinically Significant Differences vs. Commercially Available Tampon) | There were no clinically significant differences between the test (o.b.® Tampons) and control (commercially available tampon) products in a randomized, double-blind, two-way crossover study in healthy females over two menstrual cycles. Assessments included vaginal culture, speculum examinations (at screening, pre-, mid-, and post-menstrual visits), and vaginal and cervical colposcopy (at screening and post-menstruation). Subjects also completed a diary detailing tampon use. |
Study Information:
The provided document describes a modification to the o.b.® Tampons and aims to establish substantial equivalence to legally marketed o.b.® tampons. The study supporting this claim of substantial equivalence is outlined in the "Performance data" and "Clinical Equivalency" sections.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "healthy females" for the clinical equivalency study. However, the specific number of subjects in this study is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It does not explicitly state retrospective or prospective, but the description of a "randomized, double-blind, two-way crossover study" implies a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. The assessments mentioned (vaginal culture, speculum examinations, colposcopy) would typically be performed by medical professionals (e.g., gynecologists or trained clinicians), but their specific qualifications, number, or role in establishing ground truth (other than performing examinations) are not detailed.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the test set. It mentions assessments were performed, but not how disagreements or interpretations between multiple assessors (if any) were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
- Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding AI assistance is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?
- Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an algorithm or AI device.
7. The Type of Ground Truth Used
- The ground truth for the clinical equivalency study appears to be established through a combination of:
- Clinical Assessments: Vaginal culture, speculum examinations, vaginal and cervical colposcopy performed by healthcare professionals.
- Subjective Reporting: Subject diaries detailing tampon use.
- Lab Tests: The "Performance Data" section also details various in-vitro and animal toxicology studies (e.g., cytotoxicity, irritation tests, TSST-1).
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there is no "training set." The studies described are for direct evaluation of the medical device itself.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See response to #8.
{0}------------------------------------------------
Personal Products Company Division of McNeil – PPC, Inc. DEC 0 6 2002
Special 510(k), Device Modification
Page 37 of 43
510(k) Summary of Safety and Effectiveness
| Trade Name | o.b.® Tampons | |
|---|---|---|
| CommonName | Menstrual tampons | |
| ClassificationName | Unscented menstrual tampons(21 CFR 884.5470) | |
| Statement | This modification of the device is substantially equivalent to legally marketedo.b.® tampons. | |
| Devicedescription | The device is a cotton/rayon pledget with a removal string. It is available invarious absorbencies. | |
| Intended use | This device is intended to be used to vaginally absorb menstrual fluid. | |
| Performancedata | This device performs equivalently to the predicate device of the sameabsorbency.Syngyna values were the same. No untoward results were seen in the following tests on either the newmaterial or the finished proposed device: Cytotoxicity, Elution Method Cytotoxicity, Agarose Overlay Method Acute Systemic Toxicity in the Mouse Mucosal (Vaginal) Irritation in the Rabbit Dermal Irritation and Allergic Contact Sensitization: Human RepeatInsult Patch Test (RIPT) Acute Intracutaneous Reactivity in the Rabbit TSST-1, Tampon Sac Method Continued on next page | |
| ClinicalEquivalency | There was a randomized, double-blind, two-way crossover study in healthyfemales comparing the proposed device with that of a commercially availabletampon over two menstrual cycles. | |
| The tampons were assessed by vaginal culture and speculum examinationsperformed at screening and at pre-, mid-, and post menstrual visits, and byvaginal and cervical colposcopy performed at screening and post-menstruation. Subjects also completed a diary detailing tampon use. | ||
| There were no clinically significant differences between the test and controlproducts. | ||
| Conclusion | The proposed device is substantially equivalent to the legally marketedproducts in technology, intended use, and preclinical / clinical safety andsuitability characteristics. | |
| Contact | Diana L.B. UhlDirector, Regulatory Affairs, Engineered ProductsPersonal Products CompanyDivision of McNeil - PPC, Inc.199 Grandview Road SF106Skillman NJ 08558-9498 | |
| Phone / Fax /e-mail | Phone: 908 874 1402 Office908 874 1700 Line reserved for the FDA | |
| Fax:908 904 3748 | ||
| e-Mail:duhl@cpcus.jnj.com | ||
| Date | November 4, 2002 |
[Information in Brackets is considered CONFIDENTIAL]
els\Dule\WINWORD10(K)\Apollo 510(k)\Apollo 510(k)\S10k Apollo tampon: 110402.doc
{1}------------------------------------------------
Special 510(k), Personal Products Company Device Modification Division of McNeil – PPC, Inc.
510(k) Summary of Safety and Effectiveness, Continued
Performance Data (continued)
ICpcusskfpe0!VformelSDubliWTNWORDS10(K)Mpollo 510(k)Mpollo 510(k)10k Apollo lampon 110402.doc
[Information in Brackets is considered CONFIDENTIAL]
Page 38 of 43
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
9200 Corporate Boulevard ockville MD 20850
McNeil-PPC, Inc. % Ms. Diana L.B. Uhl Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558
Re: K023789
Trade/Device Name: o.b. Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: November 12, 2002 Received: November 13, 2002
Dear Ms. Uhl:
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.
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); 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.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Personal Products Company Division of McNeil - PPC, Inc.
Special 510(k), Device Modification
Indications for Use
510(k) Number; if known ·
KO23789
Device Name: o.b.® Tampons
Indications for Use: o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-the-Counter Use
David A. Larson
HAMILTON WORLDS 31(K), Apollo 51(K), Apollo 51(K), Apollo lampon 110402.doc
Page 42 of 43
[Information in Brackets is considered CONFIDENTIAL|
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).