(168 days)
No
The device description and performance studies focus on the physical properties and biological compatibility of a menstrual tampon and applicator, with no mention of AI or ML technology.
No
The device is a menstrual tampon used for absorbing menstrual or other vaginal discharge, which is a physical function rather than a therapeutic one.
No
Explanation: The device is a tampon designed to absorb menstrual or other vaginal discharge, not to diagnose a medical condition.
No
The device description clearly outlines a physical product (tampon with plastic applicator) made of various materials (rayon, polyethylene, polyester, cotton). The performance studies focus on biocompatibility and physical characteristics of the tampon and applicator, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual or other vaginal discharge. This is a physical function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description details a physical product designed for absorption and insertion into the body. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility and physical performance characteristics like absorbency, string strength, and microbial impact within the body, not on diagnostic accuracy or analytical performance.
This device is a medical device, specifically a menstrual tampon, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
The Sequel Tampon with Plastic applicator are menstrual tampons used to absorb menstrual fluid. These Tampons are available in Regular absorbency (6-9 grams).
These Tampons are made from rayon fibers and a polyethylene/polyester overwrap in which a cotton/polyester withdrawal cord is inserted. The applicator is a compact style polyethylene applicator with cylindrical barrel with a plunger. The assembled tampon with applicator is wrapped in a printed polypropylene wrapper. The tampon and applicator are single-use and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
The subject device was assessed for biocompatibility in accordance with the 2020 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" and ISO 10993-1 (2018). The tampon was assessed for the following endpoints:
- Cytotoxicity ISO 10993-5:2009/(R)2014
- Sensitization (Guinea Pig Maximization Test) – ISO 10993-10:2021
- Vaginal Irritation ISO 10993-23:2021
- Acute Systemic Toxicity - ISO 10993-11:2017
The test results show the tampon is not cytotoxic, non-sensitizing, non-irritating, and does not have acute systemic toxicity.
The following performance characteristics were assessed in accordance with the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submission (510(k)s) - Guidance for Industry and FDA Staff:
- Tampon Absorbency via Syngyna testing, per 21 CFR 801.430
- Assessment of Chemical Residues
- String Strength
- Fiber Shedding
- Tampon Integrity
- Microbial Testing to demonstrate the tampon does 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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August 3, 2023
Tampro, Inc. % Chris Staab Vice President of Quality/Regulatory Affairs Regulatory and Technical Associates 30 Neck Road Old Lyme, CT 06371
Re: K230419
Trade/Device Name: Sequel Tampon with Plastic applicator Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 28, 2023 Received: June 30, 2023
Dear Chris 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.
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
for
Jason R. Roberts, Ph.D. 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230419
Device Name Sequel Tampon with Plastic applicator
Indications for Use (Describe)
Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is 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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3
510(k) Summary K230419
Submitter: Tampro Inc. 1.0
| Name: | Greta Meyer |
|---|---|
| Address: | 3749 Buchanan Street #316 |
| San Francisco, California 94123 | |
| Phone: | 215 260 9081 |
| Email: | Greta@trysequel.com |
Date 510(k) Summary was prepared: July 26, 2023
Submission Correspondent: 2.0
| Name: | Chris Staab |
|---|---|
| Address: | 30 Neck Road |
| Old Lyme, CT 06371 | |
| Phone: | 860 575 5462 |
| Fax: | 860 434 5892 |
| Email: | RTA1ALI1@aol.com |
Name of the Device 3.0
Trade Name: Sequel Tampon with Plastic applicator
Device Name: Sequel Tampon with Plastic applicator
Common Name: Unscented Menstrual Tampon
Device Class: Class II
Regulation Name: Unscented menstrual tampon
Regulation Number: 21 CFR 884.5470
Product Code: HEB (Tampon, Menstrual, Unscented)
4.0 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.
4
5.0 Description of the Device
રે ની Device and Description
The Sequel Tampon with Plastic applicator are menstrual tampons used to absorb menstrual fluid. These Tampons are available in Regular absorbency (6-9 grams).
These Tampons are made from rayon fibers and a polyethylene/polyester overwrap in which a cotton/polyester withdrawal cord is inserted. The applicator is a compact style polyethylene applicator with cylindrical barrel with a plunger. The assembled tampon with applicator is wrapped in a printed polypropylene wrapper. The tampon and applicator are single-use and non-sterile.
5.2 Device Materials
The pledget absorbing fibers are made of rayon. The non-woven over-wrap is a bicomponent thermoplastic nonwoven. The withdrawal cord is made from polyester and cotton. Finally, the applicator is made from polyethylene.
The antiwicking agent for the withdrawal cord is a widely used paraffin wax emulsion. The tampon cord contains 2,000 micrograms paraffinic additive/tampon.
The finishing agent for the rayon fibers is a polyglycol ester and fatty alcohol mixture, Leomin or glycerol.
6.0 Indications for Use
The subject device has the following indications for use:
"Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge."
The predicate device indications for use are:
"Interlude and private label Unscented 3-piece applicator tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge."
The subject and predicate device have the same intended use, to absorb menstrual or other vaginal discharge. There are no intended use concerns.
7.0 Comparison of Technological Characteristics
The table below is a comparison of the subject and predicate device technological characteristics.
5
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Device Name | Interlude and Private Label Unscented | |
| 3 Piece Compact Applicator Tampon | Sequel Tampon with Plastic applicator | |
| Regulation (Product | ||
| Code) | 21 CFR 884.5470 (HEB) | 21 CFR 884.5470 (HEB) |
| Manufacturer | Albaad fem | Albaad fem |
| 510(k) Number | K173225 | K230419 |
| 510(k) Owner | Albaad fem | Tampro, Inc |
| Device Design | Compact style applicator with | |
| cylindrical barrel with finger grip and | ||
| two-piece plunger. Digital tampon with | ||
| round tip and straight grooves. | Compact style applicator with cylindrical | |
| barrel and a plunger. Digital tampon with | ||
| spiral grooves. | ||
| Absorbency | Regular (6-9 grams) | |
| Super (9-12 grams) | Regular (6-9 grams) | |
| Pledget | ||
| Composition | Viscose Rayon | Viscose Rayon |
| Withdrawal cord | ||
| composition | Polyester and Cotton | Polyester and Cotton |
| Overwrap | ||
| composition | Polyethylene / Polyethylene | |
| Terephthalate Nonwoven | Polyethylene / Polyester | |
| Plastic Applicator | High Density Polyethylene, Low | |
| Density Polyethylene, Polypropylene | Polyethylene | |
| Primary Packaging | Printed Polyethylene | Printed Polypropylene |
The Sequel Tampon with plastic applicator and Interlude and Private Label Unscented3 Piece Compact Applicator Tampon are similar in the pledget composition and components (tampon and applicator). The subject and predicate device differ in the tampon and applicator materials, available absorbencies, as well as the tampon and applicator design. These differences do not raise different questions of safety and effectiveness.
8.0 Summary of Performance Testing
The subject device was assessed for biocompatibility in accordance with the 2020 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" and ISO 10993-1 (2018). The tampon was assessed for the following endpoints:
6
- Cytotoxicity ISO 10993-5:2009/(R)2014 ●
- Sensitization (Guinea Pig Maximization Test) – ISO 10993-10:2021
- Vaginal Irritation ISO 10993-23:2021 ●
- Acute Systemic Toxicity - ISO 10993-11:2017
The test results show the tampon is not cytotoxic, non-sensitizing, non-irritating, and does not have acute systemic toxicity. The applicator is the same as the applicator cleared under K020535. Therefore, additional biocompatibility assessments were not completed for the applicator.
The following performance characteristics were assessed in accordance with the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submission (510(k)s) - Guidance for Industry and FDA Staff:
- Tampon Absorbency via Syngyna testing, per 21 CFR 801.430 ●
- Assessment of Chemical Residues
- String Strength ●
- . Fiber Shedding
- Tampon Integrity ●
- Microbial Testing to demonstrate the tampon does not: .
- O enhance the growth of Staphylococcus aureus
- increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) O
- alter the growth of normal vaginal microflora O
9. Conclusion
The subject and predicate device have the same intended use. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness. The performance data demonstrate that the Sequel Tampon with Plastic applicator is substantially equivalent to the predicate device.