(55 days)
Not Found
No
The device description and intended use clearly define a mechanical barrier product made of organic ingredients, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to alleviate mild allergic symptoms by acting as a mechanical barrier to airborne allergens, which is a therapeutic function.
No
The device acts as a mechanical barrier to prevent allergens from entering the nasal cavity and does not provide any diagnosis of medical conditions.
No
The device is a physical balm applied topically, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- HayMax™ Function: HayMax™ is a topical balm applied around the nostrils. Its mechanism of action is a mechanical barrier to trap airborne allergens before they enter the body. It does not perform any test on a sample from the body to diagnose or monitor a condition.
- Intended Use: The intended use is to alleviate symptoms by preventing allergen entry, not by analyzing a biological sample.
Therefore, HayMax™ falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HayMax™ organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (i.e, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.
Product codes
NUP
Device Description
HayMax™ is a drug free viscous topical nasal balm consisting of a mixture of organic beeswax and organic sunflower oil. There are three further variants: one containing organic freeze dried 200:1 Aloe Vera powder, another containing organic Lavender essential oil and the last containing organic Frankincense essential oil, all in very small quantities.
HayMax™ is used as a pollen blocker prophylaxis for seasonal allergic rhinitis caused by airborne allergens. The product is sparingly applied around the base of the nostrils with a finger, or suitable applicator, eq., cotton swab. where it acts as a mechanical barrier. It traps pollen before it reaches the nasal cavity, thus reducing pollen entering the body. If this maintains the pollen (or other airborne allergen) in a person's body below their sensitivity level then they will not react to the allergen. It is reapplied regularly as required, and after sneezing or blowing the nose. It is intended for topical use and is provided non-sterile. The balm is chemically inert to the body and nasal membranes, and is certified organic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Around the base of the nostrils / Nasal cavity
Indicated Patient Age Range
The device is considered suitable for children as it is drug-free and organic.
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
HayMax's own simple trial, (appendix 2), the independent research on HayMax™ pollen barrier balm carried out by The National Pollen and Aerobiology Research Unit (NPARU), University of Worcester in July 2009, (appendix 3), and January 2012, (appendix 6), the testimonials, (appendix 4), and the independent tests and reviews, (appendix 5), demonstrate that it does not raise new questions of safety and effectiveness and that the device is as effective as the legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).
0
MAY 1 7 2012
The Award Winning, Organic, Natural, Drug-Free, Pollen Barrier Stop the pollen before it makes you sneeze! www.haymax.biz
510 (K) Submission
HayMax™ Limited
SUMMARY SECTION 5
Submitter's Name: Address:
HayMax™ Limited Postern Piece Farm Bedford Street Ampthill Bedfordshire MK45 2EX United Kingdon
Telephone No: Fax:
Contact Person: Telephone: Email:
Max Wiseberg + 44 1525 406600
Date Summary Prepared:
Name of device Trade Name:
Common Name:
Classification name:
Predicate Devices
Approval Date Device Manufacturer 510(K) NasalGuard® 02/22/2006 KO53625 Turtech Corporation, USA Dr Theiss Alergol 05/16/2005 Dr Theiss K042610 Pollen Blocker Naturwaren Gmbh, Germany Cream
Postern Piece Farm, Bedford Street, Ampthill, Beds, MK45 2EX Phone: 01525 406600 Fax: 0845 299 1424 info@haymax.biz Company Registration Number 5300396
Image /page/0/Picture/19 description: The image shows a logo for the Vegetarian Society Awards 2010. The logo features a five-pointed star with a stylized "V" shape inside it, representing vegetarianism. Arched lines are above the star. Below the star, the text "Vegetarian Society AWARDS 2010" is displayed in a simple, bold font.
Image /page/0/Picture/20 description: The image shows a black and white seal with the words "Natural Lifestyle Awards 2018" written on it. The seal has a jagged edge and the text is arranged in a circular fashion. The text is bold and the seal appears to be a logo or emblem.
Image /page/0/Picture/21 description: The image shows a black and white graphic of a skull with a banner across the bottom. The skull is facing forward and has dark eye sockets and a dark nose cavity. The banner is partially obscured by the skull, but it appears to have some text on it. The image is high contrast and has a slightly rough, textured appearance.
Image /page/0/Picture/22 description: The image shows a logo for the Soil Association Organic. The logo is a circular shape with the words "SOIL ASSOCIATION ORGANIC" written around the outside. Inside the circle is a symbol that looks like three leaves joined together in a triangular shape. The logo is black and white.
Image /page/0/Picture/23 description: The image shows a logo for the Vegetarian Society Approved. The logo is circular and contains a stylized "V" in the center, with the top half of the "V" being white and the bottom half being black. The words "Vegetarian Society" are written around the top of the circle, and the word "APPROVED" is written around the bottom. The website address "www.vegsoc.org" is printed below the logo.
tural
tradeshow
+44 1525 406600 +44 845 2991424
15th March 2012
HayMax™Organic Drug-Free Pollen Barrier Balm Pollen Barrier Balm
Unclassified
1
Image /page/1/Picture/0 description: The image shows a logo with the words "Hay Max" inside of a circle. The word "Hay" is underlined, and the word "Max" is below it. A registered trademark symbol is located in the upper right corner of the circle. The logo is black and white.
Device description
HayMax™ is a drug free viscous topical nasal balm consisting of a mixture of organic beeswax and organic sunflower oil. There are three further variants: one containing organic freeze dried 200:1 Aloe Vera powder, another containing organic Lavender essential oil and the last containing organic Frankincense essential oil, all in very small quantities.
HayMax™ is used as a pollen blocker prophylaxis for seasonal allergic rhinitis caused by airborne allergens. The product is sparingly applied around the base of the nostrils with a finger, or suitable applicator, eq., cotton swab. where it acts as a mechanical barrier. It traps pollen before it reaches the nasal cavity, thus reducing pollen entering the body. If this maintains the pollen (or other airborne allergen) in a person's body below their sensitivity level then they will not react to the allergen. It is reapplied regularly as required, and after sneezing or blowing the nose. It is intended for topical use and is provided non-sterile. The balm is chemically inert to the body and nasal membranes, and is certified organic.
Intended Use
HayMax™ is intended to promote alleviation of mild allergic symptons. (i.e. mild nasal irritation, including itchy, runny, or congested nasal passages). triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander. It is intended to be used by anyone who experiences symptoms of hayfever or allergic rhinitis. As it is drug-free and organic it is also considered suitable for children and breast feeding or pregnant women.
Pharmaceutical and Physical Characteristics
HayMax™ Pure (0.17 ounces) contains only certified organic sunflower oil, (helianthus annus), and organic beeswax, (cera flava). The variant, HayMax™ Lavender, (0.17 ounces) also contains a tiny amount of organic lavender essential oil (lavendula anqustifolla). The variant, HavMax™ Frankincense (0.17 ounces) also contains a tiny amount of organic frankincense essential oil (Boswellia carterii). The variant HayMax™ Aloe Vera (0.17 ounces) also contains a tiny amount of organic aloe barbadensis leaf juice powder.
All variants have no preservatives and both HayMax™ Pure and HayMax™ Aloe Vera have no odoriferous substances. All ingredients appear on FDA GRAS list.
2
Image /page/2/Picture/0 description: The image shows a logo with the words "Hay Max" inside of a circle. The word "Hay" is on top of the word "Max". There is a registered trademark symbol to the right of the word "Hay".
Summary of technological characteristics of device compared to predicate devices
HavMax™ Pollen Barrier Balm, Alergol Pollen Blocker Cream, and NasalGuard Allergen Blocker Gel are designed to alleviate mild allergic symptoms triggered by the inhalation of various allergens. All are intended for topical use and provided as non-sterile, available in small, similar, (approx 4.6g) quantities and for non prescriptive over the counter use. The application for each requires using finger, (or cotton swab), to wipe product around nasal cavity area, with the purpose of reducing or filtering the amount of inhaled allergens into the nasal interior and thus reducing the intensity of allergic rhinitis symptoms. All products require reapplication at intervals during the day, at non specific times. All products are made from similar substances with similar properties, and although one is called a gel, one a cream, and one a balm they all have similar viscosity and appearance.
These common characteristics indicate that HayMax™ has the same intended use as the predicates. Its substantial similarity to the predicates, the evidence provided by HayMax's own simple trial, (appendix 2), the independent research on HayMax™ pollen barrier balm carried out by The National Pollen and Aerobiology Research Unit (NPARU), University of Worcester in July 2009, (appendix 3), and January 2012, (appendix 6), the testimonials, (appendix 4), and the independent tests and reviews, (appendix 5), demonstrate that it does not raise new questions of safety and effectiveness and that the device is as effective as the legally marketed devices.
Safety Testing & Shelf Life
By using organic, natural, drug free materials which are found on the GRAS list, HayMax™ is considered an innocuous and safe product. There have been no reports of any serious adverse effects resulting from its use over six years of trading in the UK, with sales approaching one million units.
HayMax™ is registered as a Class 1 Medical Device in the United Kingdom, complying with the requirements of English and European Law (Medical Devices Regulations 2002 and Medical Devices Directive 93/42/EEC respectively).
Stability (appendix 7), and safety assessments (appendix 8), on HayMax™ carried out by Innovant Research and Innovia International, show that the products are relatively simple blends and contain ingredients that are known to be stable in such formulations. If stored under suitable conditions a best before date of three years from manufacture can typically be applied, and that there are no likely safety hazards from normal use of the product.
Summary Conclusions
By virtue of its physical characteristics and intended use, HayMax™ Pollen Barrier Nasal Balm is substantially equivalent to devices legally cleared to be
Summary 510K
Section 5
3
Image /page/3/Picture/0 description: The image is a logo for "Hay Max". The words "Hay" and "Max" are stacked on top of each other inside of a circle. There is a line underneath the word "Hay", and a registered trademark symbol in the upper right corner of the circle.
marketed in the United States, specifically Dr Theiss Alergol Pollen Blocker Cream and NasalGuard Allergy Blocker Gel.
HayMax™ poses no safety threat or health risk to users and has been demonstrated to trap airborne allergens and work as intended. Because of the physical mode of action of the preparation and its topical administration there are no known interactions with other medicines and it can be safely used complimentary to other forms of treatment for allergic rhinitis.
Verification of Summary
HayMax™ Ltd can verify that the summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
HayMax™ Ltd c/o Mr. Max Wiseberg Managing Director Postern Piece Farm Bedford Street Ampthilol, Bedfordshire United Kingdom, MK45 2EX
MAY 1 7 2012
Re: K120894
Trade/Device Name: HayMax™ Pollen Barrier Nasal Balms Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: NUP Dated: March 15, 2012 Received: March 23, 2012
Dear Mr. Wiseberg:
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.
5
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 (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.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.
Sincerely yours,
Ester m J
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
(SECTION 4)
Device Name:
HayMax™ Pollen Barrier Nasal Balms
510(k) Number:
Indications for Use:
HayMax™ organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (i.e, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.
Prescription Use NO and/or (Part 21 CFR 801 Subpart D)
Over the Counter Use YES (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)
(Division Stga-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Sign-Off)
Over-the-Counter Use,
510(k) Number
KI 20894