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510(k) Data Aggregation
Cotton High Tech, S.L.
COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid.
The subject device is an unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on three absorbencies: regular (6-9g), super (9-12g) and super plus (12-15g). Each COHITECH Cottonlock tampon is individual wrapped in a cellulose paper along with the reusable applicator in its carrying case and packaqed in a sealed multi-unit cardboard containers for retail sale. The subject device deals with inclusion of a reusable tampon applicator, cleared under K212479, to the packaging of tampons cleared under K211775.
The provided text is a 510(k) Premarket Notification from the FDA regarding a menstrual tampon with a reusable applicator. It details the device, its intended use, and its comparison to predicate and reference devices to establish substantial equivalence.
Based on the content, this document does not describe an AI/ML-driven medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, an MRMC study, or details about training and test sets, and ground truth establishment for an AI/ML model are not applicable to this document.
The document discusses the substantial equivalence of the COHITECH Cottonlock Tampons with Reusable Applicator to previously cleared devices (K211775 and K212479). The "acceptance criteria" in this context refer to the demonstration of this substantial equivalence through non-clinical testing.
Here's a breakdown of the relevant information provided, adapted to the context of a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate device and the reference reusable applicator, as well as adherence to relevant FDA guidance documents. The "device performance" is based on non-clinical testing and leveraging prior clearances.
| Acceptance Criteria (Implicit) | Reported Device Performance (Demonstrated by Substantial Equivalence) |
|---|---|
| Functional Equivalence: Device performs the same intended use as predicate. | COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid, which is identical to the indications for use of the predicate tampon (K211775). The reusable applicator is identical to the one cleared under K212479. |
| Material Equivalence: Materials are same as predicate/reference devices. | Tampon: 100% organic cotton (same as K211775). Withdrawal Cord: 100% organic cotton (same as K211775). Cover Material: 100% organic cotton (same as K211775). Applicator Material: Polyethylene (same as K212479). |
| Absorbency Equivalence: Tampon absorbency within defined ranges. | Regular: 6-9g; Super: 9-12g; Super Plus: 12-15g (same absorbency ranges as K211775). |
| Safety (Biocompatibility): Materials are safe for intended use. | The sponsor provided a statement certifying no changes to the tampons or applicator from their cleared versions. Therefore, new biocompatibility testing (per 2020 FDA guidance ISO 10993-1) was not considered necessary as the previously cleared components meet this criteria. |
| Performance (Bench Testing): Device performs as expected based on physical characteristics. | The sponsor leveraged testing on the K211775 tampons and K212479 reusable applicators. "Tampon compatibility testing" was performed, as per K212479. No new bench testing (per 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)") was deemed necessary due to the components being identical to previously cleared versions. |
| Reprocessing Effectiveness (for reusable components): Reusable applicator can be reprocessed safely and effectively. | No new reprocessing testing (per 2015 FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling") was deemed necessary as the reusable applicator is identical to the previously cleared version (K212479) which would have demonstrated reprocessing effectiveness. |
| Technological Characteristics: Differences do not raise new questions of safety or effectiveness. | The only technological difference is the packaging of the existing tampons with the existing reusable applicator. This difference was found not to raise new questions of safety and effectiveness. |
| Absence of Design-Related Recall: Predicate and reference devices have not been subject to design-related recalls. | Neither the predicate (K211775) nor the reference (K212479) device have been subject to a design-related recall, indicating their established safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to leveraging "testing on the K211775 tampons and K212479 reusable applicators." This implies that the testing performed for the original clearances of these components serves as the basis for the current submission. The data provenance would be from Cotton High Tech, S.L. and would typically be prospective non-clinical testing. Specific sample sizes for the absorbed fluid, biocompatibility, or other physical/chemical tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device requiring expert adjudication for a test set.
4. Adjudication method for the test set
Not applicable.
5. 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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on:
- Established industry standards and regulatory guidance: Such as those for tampon absorbency testing, biocompatibility, and reprocessing.
- Prior successful clearances: The fact that K211775 (tampons) and K212479 (reusable applicator) were independently cleared by the FDA implies that their safety and effectiveness characteristics (their "ground truth" for performance) were established during their respective review processes. The current submission leverages this existing "ground truth."
- Bench testing: Though not detailed, "tampon compatibility testing" implies physical testing to ensure the applicator and tampon work correctly together.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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(135 days)
Cotton High Tech S.L.
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
The subject device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.
The provided text describes the 510(k) summary for the COHITECH Organic Cotton Non-Applicator Cottonlock Tampons, which is a menstrual tampon. The document details studies performed to demonstrate substantial equivalence to a predicate device, focusing on non-clinical data. It does not describe an AI/ML powered device, therefore no AI-specific acceptance criteria or studies are mentioned.
Here's the information as requested, adapted to what is available in the document:
1. Table of Acceptance Criteria (Performance Standards) and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Vaginal Irritation | ISO 10993-10:2010 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Delayed Hypersensitivity | ISO 10993-10:2010 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Physical/Chemical Testing | ||
| Absorbency | Syngyna testing per 21 CFR 801.430(f)(2) | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Chemical Residues | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Tampon Integrity | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| String Strength | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Fiber Shedding | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Dimensional Analysis | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Preclinical Microbiology | ||
| S. aureus growth | Not enhance the growth of Staphylococcus aureus (FDA Guidance: 2005) | Does not enhance growth (Implied by "results of the non-clinical testing were acceptable") |
| TSST-1 production | Not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) (FDA Guidance: 2005) | Does not increase production (Implied by "results of the non-clinical testing were acceptable") |
| Vaginal microflora | Not alter the growth of the normal vaginal microflora (FDA Guidance: 2005) | Does not alter growth (Implied by "results of the non-clinical testing were acceptable") |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to "Biocompatibility studies" and "Preclinical microbiology" without providing the number of samples or specimens used in these tests. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the studies were performed "in accordance with the 2020 FDA guidance... and standard ISO 10993-1" and "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads... 2005," implying they were conducted as part of the regulatory submission process, likely prospectively for the purpose of this submission. The manufacturer is based in Spain, so it's plausible the testing involved European labs, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and is not provided. The studies outlined are laboratory tests and measurements against established physical, chemical, and biological standards, not diagnostic assessments requiring expert interpretation of "truth."
4. Adjudication method for the test set
Not applicable. The tests are scientific measurements and biological assays, not interpretations requiring adjudication by experts.
5. 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
Not applicable. The device is a menstrual tampon, not an AI-powered diagnostic or screening tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a menstrual tampon, not an AI-powered algorithm.
7. The type of ground truth used
The ground truth used for this device's evaluation is based on established physical, chemical, and biological performance standards and regulatory guidance. These include:
- ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Vaginal Irritation, Delayed Hypersensitivity, Acute Systemic Toxicity).
- 21 CFR 801.430(f)(2) for absorbency (Syngyna testing).
- FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads (2005) for other performance characteristics like chemical residues, tampon integrity, string strength, fiber shedding, dimensional analysis, and preclinical microbiology regarding Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.
8. The sample size for the training set
Not applicable. The device is a menstrual tampon and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set for this device.
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(60 days)
Cotton High Tech S.L.
COHITECH Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
The COHITECH Reusable Tampon Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to load the applicator with a legally marketed digital menstrual tampon. The use-life of the subject applicator is 4 years. The applicator requires the user to clean and disinfect the applicator before initial use, before longterm storage and at the end of the menstrual cycle, as well as to clean the device after each use.
The device consists of a polyethylene outer tampon housing and inner pusher, a polypropylene storage case, and a carrying case (optional).
This device is available in two sizes, one size for reqular and super digital tampons and another for super and super plus digital tampons. The total applicator length is 73.3 ± 0.2 mm for both sizes. The overall applicator diameter (outer housing and inner pusher) is 16 ± 0.1 mm for the regular/super digital tampon applicator and 19 ± 0.1 mm for the super/super plus digital tampon applicator. The applicator weight is 5.4 ± 0.2 for the regular/super tampon applicator and 5.7 ± 0.2 g for the super/super plus tampon applicator. The storage case weight is 7.9 ± 0.1 g and carrying case weight is 26.9 ± 0.1 g
The provided text describes a 510(k) premarket notification for the COHITECH Reusable Tampon Applicator. This device is not an AI/ML device, therefore, many of the requested categories in the prompt are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device (re.t.a™ Reusable Tampon Applicator) through non-clinical performance data, rather than clinical studies involving human readers or sophisticated ground truth establishment.
Here's a summary of the acceptance criteria and performance as presented in the document, along with explanations for the inapplicable sections:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Non-cytotoxic |
| Non-irritating | Non-irritating | |
| Non-sensitizer | Non-sensitizer | |
| Bench Testing | Device weight met specifications (implied) | 5.4 ± 0.2 g (regular/super), 5.7 ± 0.2 g (super/super plus) |
| Physical dimensions met specifications (implied) | Total applicator length: 73.3 ± 0.2 mm; Overall applicator diameter: 16 ± 0.1 mm (regular/super), 19 ± 0.1 mm (super/super plus) | |
| Functional evaluation (Injection force, Ejection force, Tampon compatibility) met specifications (implied) | Results were acceptable and met established acceptance criteria. | |
| Use-life testing met specifications (implied) | Results were acceptable and met established acceptance criteria. | |
| Reprocessing, Cleaning, and Disinfecting | Cleaning instructions and validated reprocessing met specifications (implied) | Cleaning instructions developed per FDA guidance, demonstrated effective for daily cleaning and end-of-cycle disinfection. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests, summarized under "SUMMARY DISCUSSION OF NON-CLINICAL PERFORMANCE DATA" on page 5 and 6 of the document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. For non-clinical bench testing and biocompatibility, sample sizes are typically determined by relevant ISO standards or engineering validation protocols, but the exact numbers are not provided.
- Data Provenance: Not explicitly stated, but the studies were performed in accordance with FDA guidance and ISO standards, suggesting they were conducted in a controlled, prospective manner following established protocols for medical device testing. The submitting company, Cotton High Tech S.L., is located in Spain.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Inapplicable: This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device's acceptance criteria primarily refers to engineering specifications, physical measurements, and biological responses to materials as assessed by standard laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Inapplicable: As this is a physical medical device, not an AI/ML diagnostic, there is no expert adjudication process for image or data interpretation. The test results are based on objective physical and chemical testing.
5. 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
- Inapplicable: This is not an AI/ML device, nor is it a diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Inapplicable: This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For biocompatibility, the ground truth is based on the biological response of cells/tissues to the device materials, as defined by international standards (ISO 10993). For bench testing, the ground truth is the engineering specifications, physical dimensions, and functional performance requirements of the device.
8. The sample size for the training set
- Inapplicable: This is not an AI/ML device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
- Inapplicable: As there is no AI/ML training set, this question is not relevant.
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(114 days)
COTTON HIGH TECH S.L.
Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or without polyethylene/polyester cover and a withdrawal cord. These tampons will be provided as three absorbencies: regular, super and super plus.
Each non applicator organic cotton tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Each compact applicator organic cotton tampon is inserted into a plastic compact applicator and wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
The provided document is a 510(k) summary for Cotton High Tech S.L.'s organic cotton tampons. It details the device's characteristics, intended use, and a summary of non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain the specific information requested about acceptance criteria for a device, nor does it describe a study that proves the device meets those criteria in the way envisioned for a diagnostic or AI-powered medical device.
The document discusses performance data related to the physical and biological properties of the tampons (e.g., absorbency, biocompatibility, microbiology), but it does not present these in the format of acceptance criteria with reported device performance in a table, nor does it involve the concepts of ground truth, expert consensus, MRMC studies, or training sets typical for AI/diagnostic device evaluations.
Therefore, I cannot fulfill your request with the provided input text in the format you've specified because the information is not present in the document. This document is a regulatory submission for a medical device that is a physical product (menstrual tampons), not a diagnostic or AI-driven system.
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