DUTAU-NOVATECH®

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date February 6, 2025. The text is written in a clear, legible font. The date is presented in a standard format, with the month, day, and year clearly indicated. The image is simple and straightforward, focusing solely on the date itself. Image /page/0/Picture/9 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration". Novatech SA Stuart K. Montgomery President Boston Medical Products, Inc. Z.I. Athélia III -1058, Voie Antiope La Ciotat CEDEX, 13705 France Re: K242324 Trade/Device Name: DDUTAU-NOVATECH® Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: January 8, 2025 Received: January 8, 2025 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/cdrh/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. {1}------------------------------------------------ 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" (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 QS regulation requires device manufacturers to review and approve changes to device design and production (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 (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 bear a unique 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-advice-comprehensiveregulatory-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-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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-devices/device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Joyce C. Lin -S for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242324 Device Name DUTAU-NOVATECH® Indications for Use (Describe) The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. To be used by qualified surgeons during ENT endoscopic procedures. The DUTAU-NOVATECH® is suitable for use for a patient population greater than 5 years of age. Type of Use (Select one or both, as applicable) | <span style="font-size:10px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------| | <span style="font-size:10px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |-----------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Athélia III – 1058, Voie Antiope 13705 La Ciotat CEDEX FRANCE {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Novatech. The logo consists of a blue square with a white outline of lungs in the upper left corner. To the right of the square, the word "Novatech" is written in a bold, sans-serif font, with the words "new biotechnology for life" written in a smaller font underneath. #### 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: 508-898-2373 ## Date Prepared October 29, 2024 #### 2 Device | Device Name: | DUTAU-NOVATECH® | |------------------------------------|--------------------------------------------------------------| | Regulation Number and Description: | 874.4680 Bronchoscope (flexible or rigid) and<br>accessories | | Medical Specialty | Ear Nose & Throat | | Product Code: | EOQ | | Device Class: | 2 | #### Predicate Device 3 | Device Name: | Karl Storz Bronchoscope Accessories | |---------------------|--------------------------------------------------------------| | Original Applicant: | Karl Storz Endoscopy - America, Inc. | | 510(k) Number: | K943700 | | Product Code: | EOQ | | Regulation Number: | 874.4680 Bronchoscope (flexible or rigid) and<br>accessories | | Device Class: | 2 | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Novatech, a biotechnology company. The logo features a stylized outline of lungs in white, positioned above the company name. The word "Novatech" is written in a bold, sans-serif font, with the tagline "new biotechnology for life" appearing in a smaller font below it. The background color behind the lungs and company name is a bright, solid blue. #### 4 Device Description DUTAU-NOVATECH® is a rigid bronchoscope that consists of a bronchoscope head and replaceable tubes and is fully dismantlable. It is made of medical grade stainless steel. The tracheal tube mounted on the bronchoscope head is inserted into the trachea. The bronchial tube mounted on the bronchoscope head is inserted through the trachea into the bronchi. A telescope and instruments for diagnosis and treatment can be inserted through these tubes into the bronchi (bronchial tube) or the trachea, respectively. To ventilate the patient, the ventilation tube can be connected either to the bronchoscope head or directly to the respective tube. The tubes are colour coded depending on the size and have a scale to measure stenosis. DUTAU-NOVATECH® is supplied unsterile and must be cleaned, disinfected, and sterilized prior to its use. #### 5 Intended Use The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. #### 6 Indication for Use The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. To be used by qualified surgeons during ENT endoscopic procedures. The DUTAU-NOVATECH® is suitable for use for a patient population greater than 5 years of age. #### 7 Comparison of technological characteristics with predicate device The DUTAU-NOVATECH® has the same operating principle and incorporates the same basic design as the predicate device, Karl Storz Bronchoscope Accessories. A summary of the technological characteristics of DUTAU-NOVATECH® compared to Karl Storz Bronchoscope Accessories is provided below: | Item | Proposed Device:<br>DUTAU-NOVATECH® | Predicate Device:<br>Karl Storz Bronchoscope<br>Accessories | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | 510k | | K943700 | | Product Code | EOQ | Same | | Regulation<br>Number | 874.4680 | Same | | Class | II | Same | | Intended Use | The DUTAU-NOVATECH® is intended for rigid<br>bronchoscopy. For use in trachea and bronchi. | Intended to be used during endoscopic<br>ENT procedures | | Indication for<br>Use | The DUTAU-NOVATECH® is intended for rigid<br>bronchoscopy. For use in trachea and bronchi.<br>To be used by qualified surgeons during ENT<br>endoscopic procedures. | to aid the surgeon in removing fluid,<br>tissue and foreign bodies, and inducing | | Item | Proposed Device:<br>DUTAU-NOVATECH® | Predicate Device:<br>Karl Storz Bronchoscope<br>Accessories | | | The DUTAU-NOVATECH® is suitable for use<br>for a patient population greater than 5 years of<br>age. | hemostasis during endoscopic ENT<br>surgery. | | Patient Target<br>Group | - Children greater than 5 years of age<br>and young people<br>- Adults<br>- Patients of all genders | Population who requires endoscopic<br>ENT procedures to be conducted. | | Intended User | To be used by qualified surgeon during ENT<br>endoscopic procedures | Same | | Anatomical Sites | to be introduced into the trachea or bronchi. | Same | | Environment of<br>Use | - Operating theatre<br>- Treatment room<br>- Endoscopic procedure room | Hospital | | Energy used and<br>/ or delivered | No energy is used for this device | Same | | | <b>Bronchial Tube/Tracheal Tube</b> | <b>Bronchoscope Tubes</b> | | | Lengths 25 or 35 cm, Diameters (both<br>inner and outer) from 8.5-14 mm | Lengths ranging from 20-43 cm,<br>Diameters from 3.5- 13.6 mm | | Design | Bronchoscope head<br>Ventilation element with Axial Retainer<br>and Axial Cap<br>Lateral Double Port with Lateral Caps<br>Injection Cannula | Caps and Telescope Guides<br>Seals end of tube for viewing,<br>allows for instrumentation | | Photo of product<br>ready for use | Image: DUTAU-NOVATECH | Image: Karl Storz Bronchoscope Accessories | | Materials | Stainless steel, surgical quality; caps: silicone | Same | | Principles of<br>Operation | Manually operable | Same | | Sterilization | Supplied non-sterile and reprocessed | Same | | Shelf-Life | N/A | Same | | Chemical Safety | No Hazardous substances | Same | | Compatibility<br>with<br>environment and<br>other devices | Medical devices for diagnosis and therapy<br>intended for use in rigid bronchoscopy and<br>compatible with the length and diameter of the<br>respective tube | N/A | | Mechanical<br>Safety | Mechanical testing demonstrates device is | Same | | bronchial / tracheal tubes | bronchoscope head with all adaptable parts and connectors | | | <b>Nature of body contact:</b><br>externally communicating with direct patient contact | <b>Nature of body contact:</b><br>Indirect patient contact via gas pathways (ventilation) | | | <b>Applicable standard:</b><br>ISO 10993-1 | <b>Applicable standard:</b><br>ISO 18562 | | | <b>Chemical characterization</b> Standard surgical instrument steels in compliance with ASTM F899 and EN 10088 no toxicity according to literature no E&L expected no degradation products expected (corrosion resistant) absence of residues from manufacturing and packaging (validated final cleaning) | <b>Chemical characterization</b> Standard surgical instrument steels in compliance with ASTM F899 and EN 10088 no toxicity according to literature no chemical reaction with air or water expected no degradation products expected (corrosion resistant) absence of residues from manufacturing and packaging (validated final cleaning) short contact duration no further testing deemed necessary | | | <b>Cytotoxicity</b> Stainless steels are not known to be cytotoxic. <i>in-vitro</i> cytotoxicity test with reference device passed | | | | <b>Sensitization and irritation</b> Stainless steels are not known to be sensitizing or irritating due to high corrosion resistance. Short contact duration. Therefore, low probability of eliciting sensitization or irritation. <i>in-vivo</i> tests with reference device passed (Guinea Pig Maximization Test; Intracutaneous Irritation Test with rabbits) | | | | <b>Material-mediated pyrogenicity</b> Device does not contain any of the substances listed in DIN EN ISO 10993-11 Annex G and is not made of biologically derived materials. | | | | <b>Acute systemic toxicity</b> See chemical characterization No leaching of chemical substances through the passivating oxide layer of stainless steels expected. <i>in-vivo</i> tests with reference device passed (Acute systemic toxicity test with mice) | | | | bronchial / tracheal tubes | bronchoscope head with all adaptable parts<br>and connectors | | | Conclusion: | Conclusion: | | | No adverse biological effects expected. | No adverse biological effects expected. | | ### Table 1: Side-by-Side Comparison of DUTAU-NOVATECH® with the Predicate Device {7}------------------------------------------------ Image /page/7/Picture/1 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 blue square, the word "Novatech" is written in a bold, blue font. Below "Novatech", the phrase "new biotechnology for life" is written in a smaller, red font. # Table 1: Side-by-Side Comparison of DUTAU-NOVATECH® with the Predicate Device {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows a 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 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. #### 8 Performance Data ## Biocompatibility Testing DUTAU-NOVATECH® is an externally communicating: tissue/bone/dentin device and has contact for a limited time (<24 hours). Table 2 provides an overall summary of the biological assessment for the the DUTAU-NOVATECH® components with body contact. # Table 1: Side-by-Side Comparison of DUTAU-NOVATECH® with the Predicate Device {9}------------------------------------------------ Record's title Image /page/9/Picture/1 description: The image shows the text "DUTAU-NOVATECH® 510(k) Summary". The text is in a bold, sans-serif font. The words are arranged on a single line. The text is centered on the image. According to the available biological information and experimental data, and supported by the long history of safe use of DUTAU-NOVATECH®, there is no reason to doubt the biological suitability of this device. # Benchmark Performance Tests To verify the disconnect stability and safety for all relevant connectors of the DUTAU-NOVATECH® bronchoscope, tension test based on ISO 5356-1 have been carried out. The test results have been checked against the requirements stated in the relevant standard or against the performance of the predicate device. An assembling test was carried out under internal protocol. The devices were assembled without conspicuousness. A visual inspection was performed after assembling the device. The requirements are fulfilled for all the test samples. There are no damages on the DUTAU-NOVATECH® The compression and tensile test were passed as well, no damage of the bronchoscope tubes were observed. All tubes reached the maximum test force without any conspicuities. The test was carried out under internal protocol. The connection stability tests were passed as well. No damage or disconnection of the tube and the snap fit connection below the defined compression load and tensile load was observed. The test was carried out under internal protocol. The plug-in connection test between bronchoscope head and injection cannula or lateral double port was passed as well. The connection must not loosen due to slight load and it must be possible to loosen it with manual force. The test was carried out under internal protocol. The luer lock connection test performed could withstand the force until the injection cannula detaches from the plugin connection. The test was carried out under internal protocol. Lastly based on ISO 5356-1 test procedures a separating tensile force is applied on the respiration tube that is connected to the bronchoscope with its female connector. No disconnection under a tensile load of 50 Newton for a minimum of 10 seconds was observed. The DUTAU-NOVATECH® shall be designed atraumatic. The visual inspection of the bronchoscope passed. No sharp edges were found, the product is atraumatic. The test was carried out under internal protocol. The requirements are fulfilled for all the test samples regarding the rotational torque tests. No damage of the tube and the snap fit connection below the defined load was observed. The test was carried out under internal protocol. Leakage test which was carried out shows that bronchoscopes have no leakage at clinically relevant pressures. The test was carried out under internal protocol. #### 9 Shelf Life/Sterilization | Method of Sterilization (reprocessing): | Steam Sterilization | |-----------------------------------------|-------------------------------------------------------------------------------------| | Applied Standards: | ISO 14937:2010 / ISO 17665-1:2006 (equal to ISO<br>17665:2024, half-cycle approach) | | Shelf-Life: | N/A | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a table with the text "Record's title" at the top. Below that is the beginning of a word, "DUTAU-NO". The image is a close-up of the text, and the rest of the table is not visible. # 10 Conclusion The subject device DUTAU-NOVATECH® is substantially equivalent to predicate device, Karl Storz Bronchoscope Accessories. The DUTAU-NOVATECH® has the same intended use and set of indications for use as the predicate device, both use the same operating principle and incorporates the same basic design as the predicate device. The DUTAU-NOVATECH® has the similar technological characteristics as the predicate device. The tubes of both devices are intended to facilitate the introduction and removal of instruments. They are both made of the same material and their dimensions hardly differ from one another. The tube lengths of the proposed device are within the range of the predicate device. The bronchoscope heads of both devices, consisting of caps and telescope guides, are made of the same materials and offer the same features. Both devices are provided with an injection cannula for jet ventilation and insertion guides (ports) which can be sealed with caps. The subject device and the predicate device both are manually operable.