Interlude Rolled Tampons in Plastic Applicator

K191431 · Albaad Fem · HEB · Oct 7, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K191431
• Device Name: Interlude Rolled Tampons in Plastic Applicator
• Applicant: Albaad Fem
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Oct 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Device Story

Interlude rolled tampons are menstrual hygiene devices consisting of an organic cotton pledget with a polymeric overwrap and cotton withdrawal cord, housed in a plant-based polyethylene plastic applicator. The device is intended for over-the-counter use by females to absorb menstrual or vaginal discharge. The user inserts the tampon into the vagina using the applicator; the device functions via passive absorption of fluid. It is a non-sterile, single-use device. No clinical decision-making or healthcare provider intervention is required for use.

Clinical Evidence

No clinical data. Bench testing only. Performance assessed per 2005 FDA guidance: dimensions, absorbency, chemical residues, withdrawal cord strength, fiber shedding, and tampon integrity. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity). Microbiology testing conducted to ensure no enhancement of S. aureus growth, TSST-1 production, or alteration of normal vaginal microflora.

Technological Characteristics

Rolled tampon with organic cotton pledget, polymeric overwrap, and cotton withdrawal cord. Applicator: plant-based polyethylene (cylindrical barrel, one-piece plunger). Absorbency ranges: Regular (6-9g), Super (9-12g), Super Plus (12-15g). Non-sterile. Biocompatibility per ISO 10993-5, 10993-10, 10993-11.

Indications for Use

Indicated for females requiring absorption of menstrual or other vaginal discharge.

Regulatory Classification

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.

Predicate Devices

• Interlude and private label Unscented 3-piece compact applicator tampon (K173225)

Submission Summary (Full Text)

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October 7, 2019

ALBAAD fem c/o Robert Staab Official Correspondent Regulatory Technical Associates 30 Neck Road Old Lyme, CT 06371

Re: K191431

> Trade/Device Name: Interlude Rolled Tampons in Plastic Applicator Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: August 30, 2019 Received: September 4, 2019

Dear Robert Staab:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Sharon Andrews Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191431

Device Name

Interlude Rolled Tampons in Plastic Applicator

Indications for Use (Describe)

Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

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 - K191431

#### 1. Submitter Information

| Applicant: | ALBAAD fem |
|------------|-------------------------------------------------------------|
| Contact: | Shlomo Helvits |
| Address: | 1, Alon Hatavor St.<br>Caesarea Ind. Park 3088900<br>Israel |
| Phone: | [phone] |
| Fax: | [phone] |

#### 2. Correspondent Information

| Contact: | Robert. J. Staab |
|----------|-------------------------------------|
| | Regulatory Technical Associates |
| Address: | 30 Neck Road, Old Lyme, CT 06371 US |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

#### 3. Date Prepared: October 01, 2019

#### 4. Device Information

| Device Name: | Interlude Rolled Tampons in Plastic Applicator |
|--------------------|------------------------------------------------|
| Common Name: | Unscented Menstrual Tampon |
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Tampon, Menstrual, Unscented |
| Regulatory Class: | Class II |
| Product Code: | HEB |

## 5. Predicate Device Information

The predicate device is Interlude and private label Unscented 3-piece compact applicator tampon (K173225). This predicate device has not been subject to a design-related recall.

## 6. Device Description

Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.

- Regular size absorbency = 6 - 9 grams
- Super-size absorbency= 9 12 grams ●
- . Super plus size absorbency = 12 -15 grams

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# 7. Indications for Use

Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

| | Subject Device (K191431) | Predicate Device (K173225) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Interlude Rolled Tampon in<br>Plastic Applicator | Interlude and private label<br>Unscented 3-piece<br>compact applicator tampon |
| Classification<br>Regulation | 884.5470 | 884.5470 |
| Product Code | HEB | HEB |
| Intended Use | Interlude rolled<br>tampons in plastic<br>applicator are inserted<br>into the vagina and<br>used to absorb<br>menstrual or other<br>vaginal discharge. | Interlude and other<br>private label unscented<br>3-piece compact<br>applicator tampons are<br>inserted into the vagina<br>and used to absorb<br>menstrual or other<br>vaginal discharge. |
| Sterile? | No | No |
| Design | Compact style<br>applicator with<br>cylindrical barrel with<br>finger grip and one-<br>piece plunger. Digital<br>tampon with round tip<br>and straight grooves. | Compact style<br>applicator with<br>cylindrical barrel with<br>finger grip and two-<br>piece plunger. Digital<br>tampon with round tip<br>and straight grooves. |
| Syngyna Absorbency<br>(gram) | Regular 6.0 - 9.0<br>Super 9.0 - 12.0<br>Super plus 12.0 - 15.0 | Regular 6.0 - 9.0<br>Super 9.0 - 12.0<br>NA |
| Pledget Length (mm) | 46±2 | 46+2 |
| Pledget Diameter<br>(mm) | 11±1, 14±1, 16±1 | 14±1, 16±1 |
| Overwrap<br>composition | PE/PES | PE/PES |
| Pledget composition | Organic cotton | Viscose rayon |
| Withdrawal cord | Organic cotton | Polyester cotton |
| Cord length | 110-140 mm | 110-130 mm |
| Applicator | LDPE | LDPE/HDPE barrel; PP pushers |
| Primary packaging | Polypropylene | Polypropylene |

## 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

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The subject and predicate devices have intended use - to absorb menstrual or other discharge in the vagina. They have the same design and comparable dimensions and absorbencies. The differences in technological characteristics do not raise different questions of safety and effectiveness.

## 9. Summary of Non-Clinical Performance Testing

## Performance testing

The following performance characteristics were assessed in accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".

- Dimensions ●
- Absorbency range
- Chemical residues
- Withdrawal cord strength
- Fiber shedding
- Tampon integrity

## Biocompatibility Testing

Biocompatibility studies were performed in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" issued in 2016 and ISO 10993 standards as follows:

- Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
- . Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 (R) 2014
- Irritation (Vaginal Irritation Test) per ISO 10993-10:2010 (R) 2014 ●
- Acute Systemic Toxicity per ISO 10993-11:2006 ●

These tests were performed on the subject tampons and applicators, and the results met the requirements of the ISO standards.

#### Microbiology Testing

Per the 2005 FDA guidance document mentioned above, microbiology testing was conducted to demonstrate that the subject devices do not:

- Enhance the growth of Staphylococcus aureus
- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
- Alter the growth of normal vaginal microflora

## 10. Conclusions

The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.