The Albaad Plastic Applicator Tampons, Available in regularand super absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Device Description

The Albaad Tampons are unscented Plastic Applicator tampons. The Applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge. These tampons applicator types, will be marketed in 2 absorbencies: regular (6-9g) and super, (9-12g) These Tampons are made from 100% viscose, and a 100% cotton cord. The applicators are low density and high density polyethylene.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically tampons. It is not a study report about the performance of a device against acceptance criteria in the context of an AI/software device.

Therefore, many of the requested categories about acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of document or device.

Instead, this document describes a submission to the FDA demonstrating that a new device is "substantially equivalent" to a previously marketed predicate device. The performance is assessed through non-clinical testing to demonstrate safety and effectiveness, rather than a clinical trial with acceptance criteria for specific performance metrics like sensitivity, specificity, or accuracy which would be relevant for AI devices.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (Not applicable in the typical AI/software device sense):

The document does not present specific quantitative acceptance criteria or reported device performance in the format of an AI or software study. Instead, it relies on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness, primarily through non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated as numerical performance targets)	Reported Device Performance (Summary of non-clinical findings)
Biocompatibility (Acute Systemic Toxicity, Vaginal Irritation, Sensitization, Cytotoxicity)	"Lack of toxicity," "lack of impact on vaginal microflora and TSST-1 production."
Absorbency (Standard Syngina testing)	"Confirmed the absorbency of these Tampons."
Equivalence to predicate device for safety and effectiveness	"The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to the predicate device."

Detailed Study Information (Where applicable, based on the document):

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific tests. The non-clinical tests (biocompatibility, absorbency) would have involved a sufficient number of samples/replicates to generate statistically sound results for those specific tests, but these numbers are not provided in this summary.
- Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab ("nonclinical testing program was carried out for the G3 tampon"). The specific country is Israel, as the manufacturer is Albaad Massoud Itzhak Ltd Caesarea Industrial Park, Israel. These were prospective tests performed on the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of human expert ground truth for AI/software. The "ground truth" for these tests would be established by standard analytical methodologies and laboratory technicians/scientists in areas like toxicology, microbiology, and materials science, not by human expert review of images or data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for resolving discrepancies in human expert labeling or diagnosis in clinical studies, particularly for AI ground truth establishment. This document describes laboratory testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a physical medical device (tampon), not an AI or software device. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests would be based on:
  - Biocompatibility Standards: Adherence to ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11) and established toxicological/biological assays.
  - Absorbency Standards: Results from standardized "Syngina testing."
  - Microbiological Standards: Laboratory assays for vaginal microflora impact and TSST-1 production.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.

Summary relevant to the document provided:

The submission highlights the substantial equivalence of the new Albaad Plastic Applicator Tampons to the predicate device (Rostam Plastic Applicator Tampons K042773). Key non-clinical tests were conducted:

Biocompatibility testing: Performed according to ISO 10993 standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). The results indicated "lack of toxicity," and similar findings to historical results for the predicate device.
Impact on vaginal microflora and TSST-1 production: Showed "lack of impact on vaginal microflora and TSST-1 production," similar to historical results for the predicate device.
Absorbency: Standard Syngina testing "confirmed the absorbency."

The document states, "Clinical testing: N/A," further confirming that this submission relies on non-clinical data and equivalence rather than human clinical study outcomes.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2014

Albaad. Ltd. % Robert J. Staab Official Correspondent Regulatory and Technical Associates 30 Neck Road Old Lyme, CT 06371

K140077 Re:

Trade/Device Name: Albaad Plastic Applicator Tampons Unscented Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: August 20, 2014 Received: August 21, 2014

Dear Robert J. 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.

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Herbert P. Lerner -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

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Indications for Use

510(k) Number (if known): K140077

Device Name: ALBAAD Plastic Applicator Tampons (Various Trade Tampons Sold Under Private Labels As Plastic Applicators)

Indications for Use:

The Albaad Plastic Applicator Tampons, Available in regularand super absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

Device Name: Albaad Plastic Applicator Tampons

Name Address Telephone number of submitter, contact person dated 9/11/14 Robert J Staab, Ph.D. for Albaad as Official Correspondent RTA, Inc., 30 Neck Road, Old Lyme CT 06371 860 434 5872 Manufacturer Albaad Fem Israel Tampons Division of Albaad Massoud Itzhak Ltd Caesarea Industrial Park 38900 POB B 3541 Israel

The registration number is 9613295

Regulation number, Regulation name, Classification, product code for Albaad tampons OBGYN Panel, Unscented Menstrual Tampons, 21 CFR 884 5470, PRODUCT CODE HEB

Predicate Device: Rostam Plastic Applicator Tampons K042773

Indications for Use:

The Albaad Plastic Applicator Tampons available in regular and super absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Device description:

The Albaad Tampons are unscented Plastic Applicator tampons.

The Applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

These tampons applicator types, will be marketed in 2 absorbencies: regular (6-9g) and super, (9-12g)

These Tampons are made from 100% viscose, and a 100% cotton cord. The applicators are low density and high density polyethylene.

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The materials used in these tampons are similar to those used in other legally marketed tampons.

Technological Characteristics

To compare the Predicate Device:

The pledget/wadding material has not been dramatically changed; it is viscose ●
The withdrawal cord was not changed, it is 100% cotton: .
. The applicators design was slightly changed and the material is polyethylene, similar to the predicated device.

There are differences between the subject device and predicate device: (1) the difference in the pledget designs; (2) the lack of overwrap on the pledget in the subject device; it has been shown to be unnecessary; and (3) the difference in the attachment of the withdrawal cord to the pledget; the withdrawal cord is threaded through the crossed pattern pledget for adherence as opposed to sewing within the pledget.

These differences are similar to currently marketed products. The nonclinical testing program was carried out for the G3 tampon which included the differences noted above. This test program showed a lack of toxicity, lack of impact on vaginal microflora and TSST-1 production. The results observed were similar to historical results seen for the predicate device.

Assessment of Performance Standards: Not Applicable

Non-Clinical Testing: Biocompatibility testing and safety evaluations of tampon components were carried out for acute systemic toxicity,, vaginal irritation, sensitization and cytotoxicity as well as impact to vaginal microflora and toxic shock syndrome toxin 1.

The biocompatibility tests were conducted in accordance with ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization and vaginal irritation), and ISO 10993-11:2006 (acute systemic toxicity).

Standard Syngina testing confirmed the absorbency of these Tampons

Clinical testing: N/A.

Conclusions

The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to the predicate device. The review of existing toxicological data in the public literature, also confirms the safety of these standard tampons.

Regulation Number and Section

§ 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).