NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.

Device Description

NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) premarket notification for a medical device (NasalCEASE™), and it primarily focuses on establishing substantial equivalence to a predicate device.

Here's what can be extracted based on the provided text, and where the requested information is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overall "acceptance criteria" here is substantial equivalence to the predicate device, ENTaxis (K985069).
Reported Device Performance:
- "NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity."
- "Upon contact with blood or other physiological fluids in the nasal cavity it adsorbs those fluids and swells to apply a compressive force."
- "Both physicians and patients were able to use the device correctly and effectively" (referring to the non-clinical testing).

Since the document is a 510(k) summary, detailed performance data against specific acceptance criteria (e.g., success rate, time to stop bleeding) is typically not included in this summary section but would have been part of the full submission.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified. The non-clinical testing mentions "A panel of physicians used the device and provided it to patients for use at home," but no number is given for either physicians or patients.
Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be from a clinical setting, but whether it was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified. "A panel of physicians" is mentioned, but their number or specific qualifications (e.g., specialty, years of experience) are not provided.
Qualifications of Experts: Only "physicians" is stated.

4. Adjudication method for the test set:

Not specified. The text only says "A panel of physicians used the device and provided it to patients for use at home."

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. This device is a physical medical device (nasal packing), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

Based on "Both physicians and patients were able to use the device correctly and effectively," the ground truth appears to be based on expert (physician) and user (patient) assessment of usability and effectiveness. This is closer to observational data or user feedback rather than a formal medical "ground truth" like pathology or clinical outcomes in a randomized controlled trial for therapeutic efficacy.

8. The sample size for the training set:

Not applicable/Not specified. There is no mention of a "training set" in the context of this physical device. If "training set" refers to pre-market testing, it's covered by the "panel of physicians" and "patients" mentioned above, for which no sample size is given.

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

Not applicable/Not specified. As above, no "training set" or explicit ground truth establishment method in this context. The "ground truth" for the non-clinical testing would be the real-world observation by physicians and patients regarding the device's functionality and effectiveness in stopping minor nosebleeds at home.

Summary

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JUL 01 2004

Summary Statement as defined in 21CFR 807.3

Les Laboratoires Brothier, S.A. Submitter: 41 rue de Neuilly Nanterre Paris, FRANCE 92000 Phone: 011-33-1-56 38 30 00 Fax: 011-33-1-41 20 93 70

Contact Ms. Benedicte Noury, Director of International Marketing

Trade Name: NasalCEASETM Name: Common name: N/A Classification name: calcium alginate
Substantially Equivalent to: ENTaxis (K985069)

Description of the device: NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.

Intended Use: NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.

Technological Characteristics: NasalCEASE™ is comprised of interwoven strands of calcium alginate that can be rolled along its long or short axis and inserted into the anterior nasal cavity. Upon contact with blood or other physiological fluids in the nasal cavity it adsorbs those fluids and swells to apply a compressive force. ENTaxis acts in exactly the same way.

Non-clinical testing. A panel of physicians used the device and provided it to patients for use at home. Both physicians and patients were able to use the device correctly and effectively.

Summary: The NasalCEASE™ device described in this submission is substantially equivalent to the predicate device, is safe and effective, and sufficiently simplified and explained to be sold as an OTC product.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures facing to the right, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 1 2004

LES Laboratories, S.A. c/o Richard J. Freer, Ph.D. Chairman and COO 601 Biotech Drive Richmond, VA 23235

Re: K041446

Trade/Device Name: NasalCEASE™ Regulation Number: 21 CFR 874.4100 Regulation Name: Epistaxis balloon Regulatory Class: Class I Product Code: EMX Dated: May 20, 2004 Received: June 1, 2004

Dear Mr. Freer:

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.

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.

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Page 2 - Richard J. Freer, Ph.D.

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Akalyi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:	K041446
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Device Name: NasalCEASE™

Indications for Use:

This device has the following intended use.

NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. 1. It is intended to be marketed and sold as an Over-The-Counter device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Karen H. Baker

(Division Sign-Off) Division of Ophthalmic Ear Nose and Throat Devi

510(k) Number

3 I

Regulation Number and Section

§ 874.4100 Epistaxis balloon.

(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(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 § 874.9.