Z-Net reduces for up to 15 months house dust mites and their allergens in bedding, a leading cause of allergenic rhinitis, allergenic asthma, and allergenic eczema. Reductions are based on comparisons with untreated bed covers.

Device Description

The Z-Net allergy control device consists of a mattress cover and pillow cover created from polyester impregnated with permethrin. The treated fabric reduces the levels of house dust mites (HDM) and their allergens in the mattress and pillow which, in turn, provides relief to individuals suffering from atopic allergies.

AI/ML Overview

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Acceptance Criteria and Study Proving Device Meets Criteria:

Based on the provided 510(k) summary, the device is the Z-Net mattress and pillow covers, which are polyester impregnated with permethrin, intended to reduce house dust mites (HDM) and their allergens. The primary acceptance criterion is the long-term reduction of HDMs and their allergens in mattresses.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Intended Use)	Reported Device Performance
Reduction of house dust mites and their allergens in bedding for up to 15 months, leading to relief from allergenic rhinitis, allergenic asthma, and allergenic eczema. Reductions are based on comparisons with untreated bed covers. (Stated in "Indications For Use" and "Intended Use" sections)	"The results of the test confirmed that the use of permethrin-impregnated mattress covers reduces HDMs in bedding." This effectiveness was established over a study period that included samples collected at one month, two months, five months, fifteen months, and twenty-four months, implying the demonstrated reduction for at least 15 months. Comparisons were made between the test and placebo groups. (Stated in "Performance Data" section)

Acceptance Criteria (Intended Use)

Reported Device Performance

Reduction of house dust mites and their allergens in bedding for up to 15 months, leading to relief from allergenic rhinitis, allergenic asthma, and allergenic eczema. Reductions are based on comparisons with untreated bed covers. (Stated in "Indications For Use" and "Intended Use" sections)

"The results of the test confirmed that the use of permethrin-impregnated mattress covers reduces HDMs in bedding." This effectiveness was established over a study period that included samples collected at one month, two months, five months, fifteen months, and twenty-four months, implying the demonstrated reduction for at least 15 months. Comparisons were made between the test and placebo groups. (Stated in "Performance Data" section)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a number of subjects or items. The study refers to "test and placebo groups" and "dust samples" collected over time. It does not provide the specific count of mattresses, pillows, or homes involved.
Data Provenance: The primary study was conducted at the London School of Hygiene and Tropical Medicine (LSHTM), indicating international data (United Kingdom). The study was prospective, described as a "two-year, double-blind study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the number of experts used to establish the ground truth for the test set.
It refers to the LSHTM laboratory conducting the analysis of dust samples, suggesting laboratory technicians or researchers with expertise in dust mite and allergen quantification. Specific qualifications (e.g., allergist, microbiologist, with X years of experience) are not provided.

4. Adjudication Method for the Test Set:

The document describes the primary study as a "two-year, double-blind study." This indicates that neither the participants (those using the covers) nor the researchers/analysts were aware of whether they were in the permethrin-treated group or the placebo group. This blinding serves as a form of "adjudication" against bias in data collection and initial analysis, but it's not an adjudication method in the sense of multiple experts independently reviewing findings. No other multi-expert adjudication method (like 2+1 or 3+1) is mentioned.

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:

No, an MRMC comparative effectiveness study was not done. This device is a physical product (mattress/pillow cover) and not an AI-based diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm-only performance study was not done. As mentioned above, this is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was established through direct measurement of biological markers:
- Quantification of "House Dust Mites (HDM)"
- Quantification of "HDM allergens"
- These measurements were derived from "dust samples" collected from mattresses.

8. The sample size for the training set:

Not applicable. This device is a physical product that works through a chemical impregnation, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/algorithm, no ground truth was established for it.

Summary

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DEC 1 0 2001 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

The following summary is provided pursuant to Section 513(I)(3)(A) of the Federal Food, Drug, and Cosmetic Act.

A. Applicant Information

Submitter: Allergy Technology Ltd., Hankerton Field Farm, Crudwell Road, . Malmesbury, Wiltshire, United Kingdom
Contact: Wharton Shober, D.Sc., Chairman, Telephone: 001-44-1666-577-. 082, Facsimile: 011-44-1666-577-942, E-mail: Zacharias@btinternet.com
Summary Date: March 28, 2000, revised December 3, 2001 .

Device Name and Classification B.

Proprietary Name: Z-Net mattress and pillow covers ●
Common or Usual Name: Allergy control mattress and pillow covers ●
Classification Name: Mattress cover for medical purposes (per 21 CFR § ● 880.6190)
Predicate Device: Allergy Control Covers (K903382) and other mattress . covers classified under 21 CFR § 880.6190.

C. Device Description

D. Intended Use

Comparison to Predicate Device E.

The primary difference between the Z-Net and Allergy Control covers (and similar mattress covers) relates to the mechanism used by each device to reduce HDM allergens in bedding. The Allergy Control covers protect individuals from exposure to HDM allergens by trapping both the dust mites and the allergens within the covers. The

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covers are made of a finely-weaved, semi-permeable fabric, with pore openings significantly smaller than the dust mites or allergens. The device is designed to place between the allergens and the user a barrier through which neither the allergens nor the dust mites can pass. The reduction in exposure is usually short term but can be extended with regular washing of the product.

Rather than placing a barrier between the user and the HDM allergens, the Z-Net covers are treated with permethrin that kills the dust mites and eliminates the production of new allergens. Users are initially exposed to existing allergens, but over time, the allergens break down or migrate away from the mattress and pillow. This provides long term relief from HDM allergens without washing. In addition, whereas the Z-Net mattress cover only covers the top and sides of the mattress, the Allergy Control cover encases the entire mattress, top and bottom. The Z-Net fabric is broadly weaved and is 100 percent polyester. The Allergy Control cover is made of a finely-weaved, semipermeable, cotton-polyester blend fabric. Finally, the Z-Net is not supposed to be washed, whereas the Allergy Control covers require regular washing.

F. Performance Data

The effectiveness of the Z-Net cover was established primarily through testing conducted at the London School of Hygiene and Tropical Medicine (LSHTM). The twoyear, double-blind study was undertaken to determine whether a permethrin-impregnated mattress liner, placed on a mattress without further maintenance, achieved significant long-term reduction of HDMs and their allergens in mattresses. The LSHTM laboratory conducted a pre-intervention analysis of dust samples to confirm that the test and placebo groups were comparable prior to intervention. Dust samples were then collected one month post-intervention, using standardized sampling methods. Thereafter, samples were collected at two months, five months, fifteen months, and twenty-four months. The results of the test confirmed that the use of permethrin-impregnated mattress covers reduces HDMs in bedding. The effectiveness of the Z-Net cover was further established by supplemental documentation relating to the LSHTM study. In addition, many studies were provided demonstrating that a reduction of HDMs in bedding offers relief to sufferers of atopic allergies by reducing their exposure to HDM allergens.

Numerous studies were also submitted to establish the stability of permethrin in fabrics. In particular, reference was made to permethrin's drug master file on file with the Food and Drug Administration (FDA), which establishes the stability of the active ingredient under various storage conditions. Additionally, studies demonstrating the persistence of permethrin in fabrics after rinsing, washing, and exposure to weather and detergent were provided.

The safety of the device was established through direct biocompatability testing of the end product and through reports of various biocompatability reviews of permethrin conducted by the FDA, the Environmental Protection Agency (EPA) and the U.S. Military. The reports confirmed that permethrin has been safely used in topical drug treatments approved by FDA. In addition, EPA has registered technical grades of

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permethrin for use in household articles including mattresses and upholstered furniture, as well as in military uniforms – all of which will come into direct contact with the skin. Because permethrin has been used in military uniforms, it has been confirmed as safe by numerous U.S. Military studies. In particular, permethrin is not acutely or subchronically toxic, does not cause skin irritation or sensitization; and is not neurotoxic, immunotoxic, organ toxic, reproductive or developmentally toxic, or carcinogenic. The FDA, EPA, and U.S. Military have all concurred with the general literature in finding permethrin to be safe for use in impregnated fabrics.

G. Summary

The safety and effectiveness data submitted to FDA establishes that Z-Net is safe and effective for its intended use and is substantially equivalent to applicable predicate devices.

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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Inside the circle is a stylized graphic of three figures, represented by simple lines, standing close together.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2001

Demite Limited C/O Mr. William H.E. Von Oehsen Powell. Goldstein, Frazer & Murphy LLP 1001 Pennsylvania Avenue, NW 6th Floor Washington, District of Columbia 20004

K001003 Re:

Trade/Device Name: Z-Net Regulation Number: 21 CFR 880.6190 Regulation Name: Mattress Cover for Medical Purposes Regulatory Class: I Product Code: FMW Dated: September 21, 2001 Received: September 21, 2001

Dear Mr. Oehsen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Oehsen

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Whitmore

Timothy A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K001003

Device Name: Z-NET

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrica Cicerette (Optional Format 3-10-98)

(Division Sign-Off) Design of Dental, Infection Control, and Ceneral Hospital Davices 1. Ban Number _ 1. 1. C. C. ( C. C. ( C. C. 5

Regulation Number and Section

§ 880.6190 Mattress cover for medical purposes.

(a)
Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.