(255 days)
Not Found
No
The device description and performance studies focus on the physical properties, absorbency, and biocompatibility of a menstrual tampon, with no mention of AI or ML.
No
Explanation: This device is clearly described as being used to absorb menstrual or other vaginal discharge, which is a supportive and not a therapeutic function.
No
Explanation: The device, a menstrual tampon, is described as absorbing menstrual or other vaginal discharge. Its intended use is for fluid absorption, not for detecting, monitoring, or diagnosing any medical condition.
No
The device description clearly states it is a physical product (tampons with applicators) made of materials like rayon, cotton, polyester, and polyethylene, and the performance studies focus on physical and biological characteristics, not software.
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 by being inserted into the vagina. This is a physical function within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the physical components of a tampon and applicator, designed for absorption.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic to provide diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics (absorbency, strength, integrity), biocompatibility, and microbial effects, all related to the device's function as an absorbent product used internally. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health or condition. This tampon does not fit that description.
N/A
Intended Use / Indications for Use
Interlude and private label Unscented 3-piece applicator tampons are 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
Interlude and private label Unscented 3-piece compact applicator tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 2 absorbencies, regular and super. These tampons are made from rayon fibers and polymeric overwrap. The withdrawal cord is made of cotton and polyester. The applicator tubes are made of polyethylene (PE) and include a cylindrical barrel with a finger grip and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
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)
Biocompatibility studies were performed in accordance with the 2016 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 10993-1:2009. All tests were performed on the tampon and applicator separately. The results of this testing demonstrated that the subject device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Performance characteristics 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:
- Dimensional information
- Absorbency range
- Chemical residues
- Withdrawal cord strength
- Fiber shedding
- Tampon integrity
Microbial Testing per the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) – Guidance for Industry and FDA Staff:
- Zone of inhibition assay assessing the effects of the subject device on the representative microorganisms considered as normal microflora and/or microflora from the infected genitourinary tract
- Evaluation of the tampon's effect on Staphylococcus aureus growth and Toxic Shock Syndrome Toxin-1 production using the tampon-sac/device-sac method
The tests performed met the recommendations of the 2005 FDA guidance document.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2018
ALBAAD fem % Robert Staab Official Correspondent Regulatory Technical Associates 30 Neck Road Old Lyme, Connecticut 06371
Re: K173225
Trade/Device Name: Interlude and private label Unscented 3-piece compact applicator tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: Class II Product Code: HEB Dated: May 14, 2018 Received: May 14, 2018
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. 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael T. Bailey -S
for
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
2
Indications for Use
510(k) Number (if known) K173225
Device Name
Interlude and private label Unscented 3-piece compact applicator tampon
Indications for Use (Describe)
Interlude and private label Unscented 3-piece applicator tampons 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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3
K173225 510(k) SUMMARY
| ALBAAD fem
1.0
| Submitter: |
|---|
| --------------------------------- |
Name: Shlomo Helvits Address: 1, Alon Hatavor St. Caesarea Ind. Park 3800900 Israel
FDA Est Reg#: 9613295 Phone No: +972-4-6223860 Fax No: +972-4-6277022
Date 510(k) Summary was prepared: 06/14/2018
- 2.0 Submission Correspondent:
| Name: | Robert J. Staab |
|---|---|
| Address: | 30 Neck Road |
| Old Lyme, CT 06371 | |
| Phone No: | +1 (860) 434-5872 |
| Fax No: | +1 (860) 434-5892 |
| Email: | rta1ali1@aol.com |
3.0 Name of the device:
| Trade Name: | Interlude and private label Unscented 3-piece compact applicator tampon |
|---|---|
| Device Name: | Unscented 3-piece compact applicator tampon |
| 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 K090071, Rostam Fragranced and Unfragranced Compact Applicator Tampons, Rostam Limited
The predicate device has not been subject to a design-related recall
4
- 5.0 Description of the Device:
- A. Device Description and Dimensions
Interlude and private label Unscented 3-piece compact applicator tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 2 absorbencies, regular and super.
These tampons are made from rayon fibers and polymeric overwrap. The withdrawal cord is made of cotton and polyester. The applicator tubes are made of polyethylene (PE) and include a cylindrical barrel with a finger grip and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
- B. Physical Properties and Weight
- a. Dimensions and Weight
Regular size length = 114.4 mm Regular size diameter = 14 mm Regular size weight = 2.25 g
Super size length = 114.4 mm Super size diameter = 16 mm Super size weight = 2.4 g
-
b. Absorbency
Regular size absorbency = 6-9 grams Super size absorbency = 9-12 grams -
C. Device Materials
- The pledget absorbing fibers are made of rayon. The finishing a. agent for the rayon fibers is a polyglycol ester and fatty alcohol mixture. Leomin or glycerol.
- b. The non-woven over-wrap is a bi-component thermoplastic nonwoven.
- The withdrawal cord is made from polyester and cotton, and c. includes an antiwicking agent consisting of a paraffin wax emulsion.
- d. The applicator is made from high density polyethylene (HDPE), low density polyethylene (LDPE) and polypropylene
5
- 6.0 Indications for Use
Interlude and private label Unscented 3-piece applicator tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
9.0 Predicate Device Comparison
The table below shows similarities and differences between the predicate device and the subject device.
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Device Name | Rostam Scented and | |
| Unscented plastic | ||
| COMPACT applicator | ||
| Tampons | Interlude and private label | |
| Unscented 3-piece compact | ||
| applicator tampon | ||
| Manufacturer | Rostam Limited | ALBAAD fem |
| 510(k) | K090071 | K173225 |
| Indications for Use | The Rostam Fragranced and | |
| Unfragranced Compact | ||
| Applicator Tampons | ||
| are inserted into the vagina | ||
| and used to absorb | ||
| menstrual or other vaginal | ||
| discharge | Interlude and private label | |
| Unscented 3-piece | ||
| applicator tampons are | ||
| inserted into the vagina and | ||
| used to absorb menstrual or | ||
| other vaginal discharge. | ||
| Device Design | Compact applicator with | |
| cylindrical barrel and one- | ||
| piece plunger. W folded | ||
| tampon with round | ||
| mushroom tip | Compact style applicator | |
| with cylindrical barrel with | ||
| finger grip and two-piece | ||
| plunger. Tampon with | ||
| round tip and straight | ||
| grooves. | ||
| Overwrap | ||
| composition | Polyethylene/Polypropylene | |
| Nonwoven | Polyethylene/Polyethylene | |
| Terephthalate Nonwoven | ||
| Withdrawal cord | ||
| composition | Cotton | Polyester and Cotton |
| Pledget composition | Viscose Rayon | Viscose Rayon |
| Plastic Applicator | Polyethylene | HDPE, LDPE, |
| polypropylene | ||
| Primary Packaging | ||
| (i.e. wrapper) | Printed Polypropylene | Printed Polyethylene |
The Interlude and private label Unscented 3-piece compact applicator tampon is a modification of the Rostam Scented and Unscented plastic COMPACT applicator Tampons. The modifications include material and physical design changes, including differences in the overwrap composition, applicator composition, packaging, and minor dimensional differences in the applicator and pledget.
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These differences do not raise different questions of safety and effectiveness. The intended use of the subject and predicate device are identical, to absorb menstrual or other vaginal discharge
10.0 Summary of Performance Testing:
Biocompatibility
Biocompatibility studies were performed in accordance with the 2016 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 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006) .
All tests were performed on the tampon and applicator separately. The results of this testing demonstrated that the subject device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Performance Characteristics
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:
- Dimensional information ●
- . Absorbency range
- Chemical residues ●
- Withdrawal cord strength
- Fiber shedding ●
- Tampon integrity ●
Microbial Testing
Per the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) – Guidance for Industry and FDA Staff, tampon manufacturers should demonstrate that the subject device in its final, finished form 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 ●
7
To assess these parameters, the following tests were performed:
- Zone of inhibition assay assessing the effects of the subject device on the . representative microorganisms considered as normal microflora and/or microflora from the infected genitourinary tract
- Evaluation of the tampon's effect on Staphylococcus aureus growth and . Toxic Shock Syndrome Toxin-1 production using the tampon-sac/devicesac method
The tests performed met the recommendations of the 2005 FDA guidance document.
11.0 Conclusion:
The results of the performance testing described above demonstrate that the Interlude and private label Unscented 3-piece compact applicator tampon is as safe and effective as the predicate device and supports a determination of substantial equivalence.