TRACHEOBRONXANE™ DUMON®

K243126 · Novatech SA · NWA · Oct 29, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K243126
• Device Name: TRACHEOBRONXANE™ DUMON®
• Applicant: Novatech SA
• Product Code: NWA · General, Plastic Surgery
• Decision Date: Oct 29, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of: - Tracheobronchial tumors - Tracheal stenoses with scarring - Stenoses following surgical anastomosis, resection or pulmonary transplantation.

Device Story

TRACHEOBRONXANE™ DUMON® stents are flexible, medical-grade silicone tracheobronchial tubes designed to maintain airway patency by exerting radial force. Available in various profiles (TD, TF, BD, Y, ST), sizes, and thicknesses to conform to individual patient anatomy; some models include barium sulfate for radiopacity. Stents feature studs to facilitate anchorage on cartilage rings. Used in operating rooms, treatment rooms, or endoscopy suites by physicians. Stents are implanted to support the trachea or bronchi; they improve respiration capacity and limit mucus obstruction risk. Device is supplied sterile and intended for long-term use. Clinical benefit includes maintaining an open airway in patients with obstructive pathologies.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing included fatigue testing simulating normal usage, weighing tests for absorption/disposal of substances, compression tests for radial performance, and elongation tests. Biocompatibility testing conducted per ISO 10993-1, including chemical characterization, cytotoxicity, sensitization, irritation, and material-mediated pyrogenicity, demonstrated no adverse biological effects.

Technological Characteristics

Medical-grade silicone with barium sulfate for radiopacity. Radial force support mechanism. Various profiles (TD, TF, BD, Y, ST) with integrated anchorage studs. Supplied sterile via steam sterilization. 3-year shelf life. No energy source. Manual operation. Compliant with ISO 10993-1 for long-term tissue contact.

Indications for Use

Indicated for infants, children, and adults of any gender requiring airway maintenance following dilation or resection of obstructions, including tracheobronchial tumors, scarring, or post-surgical/transplant stenoses.

Regulatory Classification

Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• ENDOXANE® (K971509)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 29, 2024

Novatech SA Stuart K. Montgomery President Boston Medical Products, Inc. Z.I. Athélia III -1058, Voie Antiope La Ciotat CEDEX, 13705 France

Re: K243126

Trade/Device Name: Tracheobronxane™ Dumon® Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: NWA Dated: September 19, 2024 Received: September 30, 2024

Dear Stuart K. Montgomery:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

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Sincerely,

# Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

Device Name

## TRACHEOBRONXANE™ DUMON®

Indications for Use (Describe)

For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of:

- · Tracheobronchial tumors
- · Tracheal stenoses with scarring
- · Stenoses following surgical anastomosis, resektion or pulmonary transplantation

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/7 description: The image shows the logo for Novatech, a biotechnology company. The logo features a blue square on the left side, with a white outline of lungs inside. To the right of the square, the word "Novatech" is written in a bold, blue font. Below "Novatech", the phrase "new biotechnology for life" is written in a smaller, blue font.

## TRACHEOBRONXANE™ DUMON®

## 510(k) Summary

NOVATECH SA Z.I. Athélia III – 1058, Voie Antiope 13705 La Ciotat CEDEX FRANCE

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Image /page/5/Picture/0 description: The image shows the logo for Novatech. The logo features a blue square on the left side with a white outline of lungs inside. To the right of the blue square, the word "Novatech" is written in a bold, sans-serif font. Below "Novatech" is the tagline "new biotechnology for life" in a smaller, lighter font.

#### 1 Submitter

NOVATECH SA Z.I. Athélia III – 1058, Voie Antiope 13705 La Ciotat CEDEX FRANCE

## Contact Person

Stuart K. Montgomery President Boston Medical Products Inc. 70 Chestnut Street Shrewsbury, MA 01545, USA Ph: 508-898-9300 ext. 240 Fax: [phone]

## Date Prepared

September 19, 2024

#### 2 Device

| Device Name: | TRACHEOBRONXANE™ DUMON® |
|------------------------------------|----------------------------------------|
| Regulation Number and Description: | 878.3720 Tracheal Prosthesis |
| Medical Specialty | GENERAL AND PLASTIC SURGERY<br>DEVICES |
| Product Code: | NWA |
| Device Class: | 2 |

#### Predicate Device 3

| Device Name: | ENDOXANE® |
|---------------------|------------------------------|
| Original Applicant: | NOVATECH SA |
| 510(k) Number: | K971509 |
| Regulation Number: | 878.3720 Tracheal Prosthesis |
| Product Code: | NWA |
| Device Class: | 2 |

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Image /page/6/Picture/1 description: The image shows a logo for Novatech. The logo is comprised of a blue square on the left side of the image. Inside the blue square is a white outline of a pair of lungs. To the right of the blue square is the word "Novatech" in a large font, and below that is the phrase "new biotechnology for life" in a smaller font.

#### Device Description 4

The TRACHEOBRONXANE™ DUMON® stents are flexible tracheobronchial tubes made of medical grade silicone, designed to improve patient respiration capacity while acting as trachea or bronchi support. These medical devices are designed to conform to individual anatomies.

Each stent has a specific treatment, to improve the evacuation of mucus in order to limit the risk of obstruction.

A large range of shape, thickness and sizes is available depending on the pathology to be treated, patient intrinsic factor and location of the implantation. Indeed, the TRACHEOBRONXANE™ DUMON® range consists of various models which vary from each other in the following characteristics:

- The stents type: TD, TF, BD, Y, ST corresponding to various profiles made of silicone with different hardness;
- . The dimensions: each profile consists of different sizes in diameter and length;
- The radiopacity: stents can be provided radiopaque or not radiopaque; barium sulfate . is added during the manufacturing process in order to make the stent radiopaque which allows obtaining a better visibility by X-rays radiography.

The TRACHEOBRONXANE™ DUMON® stents have been designed with studs in order to facilitate their anchorage in the trachea or bronchi (on cartilage rings). The number of stud rows is depending on the stent profile and stent final destination (bronchi or trachea).

The TRACHEOBRONXANE™ DUMON® stent holds the respiratory tract open by exerting a radial force.

#### 5 Intended Use

For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of:

- Tracheobronchial tumors
- Tracheal stenoses with scarring
- Stenoses following surgical anastomosis, resection or pulmonary transplantation. ●

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Image /page/7/Picture/1 description: The image shows the logo for Novatech. The logo features a blue square on the left side with a white outline of lungs inside. To the right of the blue square, the word "Novatech" is written in a bold, sans-serif font. Below "Novatech", the phrase "new biotechnology for life" is written in a smaller, lighter font.

#### 6 Comparison of technological characteristics with predicate device

## Table 1: Side-by-Side Comparison of TRACHEOBRONXANE™ DUMON® with the Predicate Device

| Item | Proposed Device:<br>TRACHEOBRONXANE™ DUMON® | Predicate Device:<br>ENDOXANE® | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------|
| 510k | TRACHEOBRONXANE™ DUMON® | K971509 | |
| Product Code | NWA | same | |
| Regulation Number | 878.3720 - Tracheal prosthesis | same | |
| Class | 2 | same | |
| Intended Use | The product is intended for use in the trachea<br>and/or bronchus to keep the airway open<br>The product is for long-term use. | same | |
| Indication for Use | For maintaining open the airway, after dilation of<br>the stenosis or resection of the obstruction, in<br>particular in case of:<br>• Tracheobronchial tumors<br>• Tracheal stenoses with scarring<br>• Stenoses following surgical anastomosis,<br>resection or pulmonary transplantation | same | |
| Patient Target Group | • Infants and young children<br>• Children and young people<br>• Adults<br>• Patients of any gender | same | |
| Intended User | Physician | same | |
| Anatomical Sites | trachea and/or bronchus | same | |
| Environment of Use | • Operating room<br>controlled area with access restrictions,<br>strict hygiene concept, controlled airflow and<br>ideal illumination; product to be used under<br>sterile conditions only<br>• Treatment room<br>operating room with lesser requirements but<br>has controlled hygiene concept; product<br>may be used under sterile or non-sterile<br>conditions<br>• Endoscopy suite | same | |
| Energy used and / or<br>delivered | No energy is used for this device | same | |
| Item | Proposed Device:<br>TRACHEOBRONXANE ™ DUMON® | | Predicate Device:<br>ENDOXANE® |
| Design | Stent profile | Scheme | Same, additionally<br>TRACHEOBRONXANE ™<br>DUMON® BB - Ultra Thin<br>Stent |
| | TRACHEOBRONXANE ™<br>DUMON® BD<br>Bronchial Stent | | |
| | TRACHEOBRONXANE ™<br>DUMON® TD<br>Tracheal Stent | | |
| | TRACHEOBRONXANE ™<br>DUMON® TF<br>Thin Tracheal Stent | | |
| | TRACHEOBRONXANE ™<br>DUMON® ST<br>Hourglass Stent | | |
| | TRACHEOBRONXANE ™<br>DUMON® Y<br>Bifurcation Stent | | |
| | | | |
| Materials | medical grade silicone, barium sulfate | | same |
| Principles of<br>Operation | Manually operable | | same |
| Sterilization | Supplied sterile | | Supplied non-sterile |
| Shelf-Life | 3 years | | 5 years |
| Chemical Safety | No hazardous substances | | same |
| Compatibility with<br>environment and<br>other devices | The manufacturer recommends using a delivery<br>system type TONN ™ / NOVATECH | | same |
| Mechanical Safety | Visual examination, weighing test, compression<br>test and elongation test has been performed on<br>TRACHEOBRONXANE ™ DUMON® stents.<br>Additionally, a fatigue test simulated the normal<br>usage of the stents has been performed. | | same |

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## Table 1: Side-by-Side Comparison of TRACHEOBRONXANE™ DUMON® with the Predicate Device

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Image /page/9/Picture/1 description: The image shows the logo for Novatech. The logo consists of a blue square on the left side with a white outline of lungs inside. To the right of the square is the word "Novatech" in a bold, sans-serif font, with the words "new biotechnology for life" underneath in a smaller font.

#### 7 Performance Data

## Biocompatibility Testing

According to its intended purpose and ISO 10993-1, TRACHEOBRONXANE™ DUMON® is categorized as:

| Category | Contact | Contact duration |
|------------------------|---------|------------------------|
| Implant medical device | Tissue | C-Long term (>30 days) |

#### Table 1: Side-by-Side Comparison of TRACHEOBRONXANE™ DUMON® with the Predicate Device

| TRACHEOBRONXANE™ DUMON® | ENDOXANE® |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Applicable standard: ISO 10993-1 | same |
| Chemical characterization<br>Chemical characterization of final products, manufacturing process,<br>packaging, sterilization, and storage revealed no risk of adverse<br>effects on the patient.<br>Chemical testing and subsequent risk mitigating assessment<br>revealed no risk of systemic toxic effects.<br>Therefore, the biological effects as follows can be excluded:<br>systemic toxicity systemic implantation effects genotoxicity carcinogenicity reproductive and developmental toxicity toxicokinetics | same |
| Cytotoxicity<br>in-vitro studies on NuSil medical-grade silicones passed.<br>in-vitro studies on DUMON® final stents passed. | same |
| Sensitization and irritation<br>Chemical testing did not reveal sensitizing substances.<br>In-vivo studies on NuSil medical-grade silicones passed.<br>Long history of safe clinical use. | same |
| Irritation<br>Chemical testing did not reveal irritating substances.<br>In-vivo studies on NuSil medical-grade silicones passed.<br>Long history of safe clinical use. | same |
| Material-mediated pyrogenicity<br>The devices do not contain any of the substances listed in DIN EN<br>ISO 10993-11:2018, Annex G, and are not made of biologically-<br>derived materials.<br>In-vivo studies on NuSil medical-grade silicones revealed no risk for<br>material-mediated pyrogenicity.<br>Long history of safe clinical use. | same |

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Image /page/10/Picture/0 description: The image shows the logo for Novatech. The logo consists of a blue square on the left side with a white outline of lungs inside. To the right of the square is the word "Novatech" in a bold, sans-serif font. Below "Novatech" is the tagline "new biotechnology for life" in a smaller font.

#### Record's title

#### TRACHEOBRONXANE™ DUMON® 510(k) Summary

| TRACHEOBRONXANE™ DUMON® | ENDOXANE® |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Systemic toxicity (acute, subacute, subchronic, chronic) | |
| See chemical characterization.<br>In-vivo studies on NuSil medical-grade silicones passed.<br>Long history of safe clinical use. | same |
| Implantation effects | |
| See chemical characterization.<br>In-vivo studies on NuSil medical-grade silicones passed.<br>Atraumatic design without sharp edges.<br>Removal of device after 12 months recommended.<br>Long history of safe clinical use. | same |
| Genotoxicity | |
| See chemical characterization.<br>In-vitro studies on NuSil medical-grade silicones passed. | same |
| Carcinogenicity | |
| See chemical characterization.<br>Long history of safe clinical use and extensive clinical data. | same |
| Reproductive and developmental toxicity | |
| See chemical characterization.<br>Long history of safe clinical use. | same |
| Degradation | |
| Due to the non-polar nature of silicone (body contacting material) no<br>degradation isexpected in physiological surrounding.<br>Chemical testing on DUMON® stents revealed no degradation<br>products.<br>Conducted shelf-life tests gave no hint for degradation of material.<br>Long history of safe clinical use. | same |
| Toxicokinetics | |
| Chemical testing on DUMON® stents revealed no substances in<br>toxicologically relevant amounts. | same |
| Conclusion: | Conclusion: |
| No adverse biological effects expected. | No adverse biological effects<br>expected. |

According to the available biological information and experimental data, and supported by the long history of safe use of TRACHEOBRONXANE™ DUMON® there is no reason to doubt the biological suitability of this device.

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Image /page/11/Picture/1 description: The image shows the logo for Novatech. The logo features a blue square on the left side with a white outline of lungs inside. To the right of the square, the word "Novatech" is written in a bold, sans-serif font. Below "Novatech", the phrase "new biotechnology for life" is written in a smaller, less bold font.

## Benchmark Performance Tests

Several performance tests on TRACHEOBRONXANE™ DUMON® stents have been carried out to analyze the device characteristics.

The following tests demonstrate the technical equivalence of aged stents with new manufactured products.

## Fatique

Specific test procedures were performed on brand new stents and stents, which were stressed by fatigue test. This fatigue test simulated the normal usage of the stents. The gathered data of stressed and unstressed stents were compared. Additionally, stents were stored unstressed in a water bath to influence of the water bath in comparison to the influence of the fatigue test.

#### Weighing

A weighing test was conducted on the stents to assess the absorption or disposal on substances out of or into the stent.

The weighing test was performed on the stents treated in the water bath and treated in the fatigue test.

#### Compression

The compression test examines the radial performance of the stents.

Stents from fatigue test are compressed with the use of a defined compression stamp to examine the force required to compress the stents.

#### 8 Shelf Life/Sterilization

| Method of Sterilization: | Steam Sterilization |
|--------------------------|---------------------|
| Shelf-Life: | 3 years |

#### 9 Conclusion

The subject device TRACHEOBRONXANE™ DUMON® is substantially equivalent to predicate device, ENDOXANE®.

ENDOXANE® is the submitter's own legally marketed predicate device.

The only difference between the products is TRACHEOBRONXANE™ DUMON® is supplied sterile and ENDOXANE® is supplied non-sterile.

The indications for use and materials of construction remain unchanged between the subject device and the manufacturer's existing device.