ENTaxis™ Nasal Packings are intended for nasal epistaxis and as post operative nasal packings. ENTaxis™ Nasal Packing is intended for - Epistaxis - · Post operative nasal packing

Device Description

ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity and as post operative packings. ENTaxis™ nasal packings are 12" (30cm, 2g) "ropes" that are 100% composed of pure calcium alginate fibers.

AI/ML Overview

The provided text describes the 510(k) summary for the ENTaxis™ Nasal Packing device, which includes information regarding its clinical safety and efficacy study. Based on this information, here’s a summary conforming to your request:

Acceptance Criteria and Device Performance

The clinical study evaluated the ENTaxis™ Nasal Packing against conventional Merocel™ packing for post-operative use in sinus surgery, focusing on specific clinical endpoints. While specific numeric acceptance criteria (e.g., "bleeding must be reduced by X%") are not explicitly stated in a table format, the study's conclusions demonstrate superior performance of ENTaxis™ for the tested endpoints.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (ENTaxis™ vs. Merocel™)
Reduced epistaxis (degree of bleeding)	Significantly less bleeding (p=0.016) upon removal on Day 2.
Reduced pain on removal	Significantly less pain on removal (p=0.0001) upon removal on Day 2.
Improved quality-of-healing	Trend towards more complete healing with ENTaxis (10 patients) compared to Merocel (5 patients) by day 9, though not explicitly stated as statistically significant in the summary.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 50 patients (100 nasal cavities).
- Data Provenance: The study was a multi-center, randomized, and controlled clinical study. The specific country of origin is not explicitly stated, but the submitter is Laboratoires Brothier S.A. from France, suggesting European origin for the clinical trial, or at least a multi-national one. It was a prospective clinical study comparing two different types of packings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document refers to the study by R. Peynegre, P. Bonfils, L. Castillo, et al. from 1998, conducted in "five ENT surgery departments." This implies multiple clinicians were involved in the assessments. However, the exact number of experts establishing ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in the provided text. Assessments were made by clinical personnel within the ENT surgery departments.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text states, "Every patient served as their own control by being treated with both test products." This indicates a paired-comparison or within-subject design where individual patient outcomes for ENTaxis™ were compared against their own outcomes for Merocel™. Different assessments were made by clinicians during surgery, on Day 2 (epistaxis and pain on removal), and on Day 9 (quality-of-healing). There is no explicit mention of an adjudication panel or method like 2+1/3+1 consensus for resolving discrepancies in assessments.
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 was not an MRMC comparative effectiveness study involving AI or human readers. This study evaluated two medical devices (nasal packings) directly through patient outcomes after surgical procedures, not the diagnostic performance of human readers with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This study is a clinical trial evaluating the performance of a physical medical device (nasal packing) in human patients, not an algorithm, and thus standalone performance in an AI context is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was based on clinical outcomes data directly observed and assessed by medical professionals during and after sinus surgery. This includes objective measures (degree of bleeding) and subjective patient experiences (pain on removal), as well as clinical inspection of healing by ENT specialists.
The sample size for the training set:
- There is no mention of a "training set" in the context of this device study, as this is a physical medical device and not an AI or machine learning algorithm.
How the ground truth for the training set was established:
- Not applicable, as there was no training set for an algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the text "LES LABORATOIRES BROTHIER S.A." The logo is a stylized "b" in black. Above the text, the date "JAN 25 1999" is printed in a simple, sans-serif font.

K984069

510(k) SUMMARY

ENTaxis™ Nasal Packing (77 EMX)

SUBMITTER'S NAME 1.
CONTACT PERSON AT LABORATOIRES BROTHIER 2.
DATE THAT 510(k) SUMMARY WAS PREPARED 3.
NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary) 4.
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED ട.
DESCRIPTION OF THE DEVICE 6.
INTENDED USE OF THE DEVICE 7.
TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES 8.
SUMMARY OF PRECLINICAL SAFETY STUDIES AND CONCLUSIONS FROM PRECLINICAL 9. SAFETY STUDIES
SUMMARY OF PRECLINICAL PERFORMANCE STUDIES 10.
CLINICAL SAFETY AND EFFICACY STUDY 11.

1. SUBMITTER'S NAME
LABORATOIRES BROTHIER S.A.41 rue de Neuilly92000 Paris-NanterreFRANCE
Tel: 011-33-1-47 24 27 34Fax: 011-33-1 47 25 51 58

2.	U.S. REGULATORY CONTACT PERSON FORLABORATOIRES BROTHIER S.A.
	Evan Dick, Ph.D.E.G. Dick & Associates7527 Westmoreland AvenueSt. Louis, MO 63105
	Tel: (314) 721-0112Fax: (314) 721-7591

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DATE THAT 510(k) SUMMARY WAS PREPARED

November 13, 1998

4. NAME OF THE MEDICAL DEVICE
Classification name	Balloon, epistaxis (nasal)(Ear, Nose & Throat 77 EMX)
Common / usual name	Nasal Packing
Proprietary name	ENTaxis™ Nasal Packing

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

Algoderm Alginate Wound Dressing (Laboratoires Brothier, K905314) Algosteril Alginate Dressing (Laboratoires Brothier, K922540) Nu Gauze Plain Packing Strip (Johnson & Johnson, K821150) Curity Petrolatum Gauze (Kendall, K973511) Merocel Nasal Packing (Merocel, K920394)

DESCRIPTION OF THE DEVICE

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INTENDED USE OF THE DEVICE

ENTaxis™ Nasal Packings are intended for nasal epistaxis and as post operative nasal packings.

TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES

ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings. The packings are 12" (30cm) long, 2 gm "ropes", similar in dimensions to predicate gauze strip packings such as Nu Gauze Plain Packing Strip (K821150) and Curity Petrolatum Gauze (K973511). ENTaxis and these predicate devices are composed of chemically similar natural fibers.

ENTaxis™ nasal packings are physically and chemically identical to Laboratoires Brothier calcium alginate wound dressing products that have been in U.S. interstate commerce since 1990 and that were reviewed under:

Algoderm Alginate Wound Dressing (Laboratoires Brothier, K905314), and
· Algosteril Alginate Dressing (Laboratoires Brothier, K922540).

ENTaxis™ nasal packings and the identified predicate devices all act to help control nasal bleeding.

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SUMMARY OF PRECLINICAL SAFETY STUDIES AND CONCLUSIONS FROM PRECLINICAL SAFETY STUDIES ENTaxis™ Nasal Packing has been evaluated (under the brand name ENTaxis or Algosteril) though in vitro tests and animal safety studies. All of these results are consistent in indicating that this product is safe for use as a nasal packing. Preclinical safety tests and the conclusions drawn for the test articles: · Cytotoxicity: USP Elution Method > product met the requirements of the USP. · Cytotoxicity: USP Agar Diffusion Test ▷ product met the requirements of the USP. · Cytotoxicity: Hemolysis Test ▷ product was found to be nonhemolytic. · Sensitization: Beuhler Method ▷ product was found to be a non-sensitizer. · Sensitization: Magnusson and Kligman Method ▷ product was found to be a non-sensitizer. · Primary Skin Irritation (24 Hour) ▷ product was found to be neither a dermal irritant nor a dermal corrosive. · Primary Skin Irritation (5 Day) ▷ product passed the skin irritation test in the rabbit. · Intranasal Irritation (3 Day Repeated Dose) ▷ product was found to be a non-irritant to the nasal mucosa and to produce no microscopic changes in the nasal tissues of rats. · Eye Irritation (3 Day Repeated Dose) ▷ product was found to be a non-irritant in rabbit eyes. · Intracutaneous Reactivity ▷ product complies with British Standard 5736-Part 4. · Acute Systemic Toxicity > product passed i.v. and i.p. systemic injection tests in mice. · Repeated Dose Systemic Toxicity (7 Days) ▷ product was found to be non-toxic in mice with daily systemic dosing for seven days. · Microbiology: Effect On TSS-Associated Staphylococcus aureus > product did not enhance the growth of TSS-associated S. aureus. · Rabbit Pyrogen Test ▷ product was found to be nonpyrogenic.

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SUMMARY OF PRECLINICAL PERFORMANCE STUDIES The hemostatic efficay of Algosteril / ENTaxis (different brand names for an identical product) was evaluated in vitro and in vivo. · IN VITRO ASSESSMENT OF HEMOSTATIC EFFICACY Hemostatic Capacity Study of Algosteril Compared to Three Reference Test Articles. Biomatech S.A. Study No. 288E702. February 19, 1998. ▷ Algosteril / ENTaxis is hemostatic. · Hemostatic effects, in vitro, are equal to or greater than those of oxidized cellulose. · IN VIVO ASSESSMENT OF HEMOSTATIC EFFICACY Short-Term Study In Pigs of A Calcium Alginate (Algosteril): Assessment of Primary Hemostatic Efficacy. Biomatech S.A. Study No. 288E701 November 7, 1997. ▷ Product is hemostatic on actively bleeding surgical wounds. ▷ Hemostatic potency (both dry and wet) was equal to or greater than the hemostatic potency of oxidized cellulose. ▷ The hemostatic potency of Algosteril/ENTaxis calcium alginate is greater when moistened with saline than when dry & Algosteril / ENTaxis, when moistened with saline, releases more easily from a wound bed than either oxidized cellulose or

dry calcium alginate.

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11. CLINICAL SAFETY AND EFFICACY STUDY

ENTaxis™ Nasal Packing has been clinically evaluated as a hemostatic, post operative nasal packing in ENT sinus surgery. Results indicate that this product is safe and effective for this use.

R. Peynegre, P. Bonfils, L. Castillo, et al. 1998. Clinical Assessment of Efficacy and Safety of Two Nasal Packings, a Calcium Alginate (ENTaxis™) and Polyvinyl Acetal (Merocel™) in Bilateral ENT Surgery.

A multi-center, randomized, and controlled clinical study compared the efficacy and safety of two different types of post-operative packings in sinus surgery. The test products were ENTaxis (Algosteril) and Merocel. Clinical endpoints were epistaxis (degree of bleeding), pain on removal, and qualityof-healing.

Fifty (50) patients (100 nasal cavities) were enrolled in five ENT surgery departments. Every patient served as their own control by being treated with both test products. Clinical assessments were made during surgery (Day 1), on Day 2 (epistaxis and pain on removal), and on Day 9 (quality-ofhealing).

Upon removal of the sinus packings on Day 2, ENTaxis was associated with both significantly less bleeding than Merocel (p=0.016) and significantly less pain on removal (p=0.0001).

Inspection of nasal mucosas eight days post-operatively revealed a trend towards more complete healing with ENTaxis (10 patients) compared to Merocel (5 patients).

Overall, compared to Merocel, ENTaxis was associated with statistically significant reductions in bleeding and pain on removal, as well as a trend towards improved overall healing.

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Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of what appears to be an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Les Laboratories Brothier, S.A. C/O E.G. Dick & Associates Evan Dick, Ph.D. President 7527 Westmorland Ave. St. Louis, MO 63105

Re:

K984069 ENTaxis™ Nasal Packing Dated: November 16, 1998 Received: November 16, 1998 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX

Dear Mr. Dick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

ENTaxis™ Nasal Packing Device Name:

Indications For Use:

ENTaxis™ Nasal Packing is intended for

Epistaxis
· Post operative nasal packing

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number OR

V Prescription Use_ (per 21 CFR 801.109) Over-The-Counter Use_

(Optional Format 1-2-96)

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.