(184 days)
Not Found
No
The device description and performance studies focus on the mechanical and structural aspects of a rigid bronchoscope. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as a rigid bronchoscope for diagnosis and treatment through which instruments can be inserted; it is not performing a therapeutic function itself.
No
The device description explicitly states that a telescope and instruments for diagnosis and treatment can be inserted through the tubes. While it facilitates diagnosis, its primary described function is to provide access for both diagnostic and therapeutic tools, making it an interventional device rather than solely diagnostic.
No
The device description clearly states it is a rigid bronchoscope made of medical grade stainless steel, which is a physical hardware device.
Based on the provided information, the DUTAU-NOVATECH® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "rigid bronchoscopy" and for use "in trachea and bronchi" by "qualified surgeons during ENT endoscopic procedures." This describes a surgical instrument used directly on a patient for visualization and intervention within the respiratory tract.
- Device Description: The description details a physical instrument made of stainless steel, designed for insertion into the body, allowing for visualization and the insertion of other instruments. It also mentions ventilation connections. These are characteristics of a surgical or endoscopic device, not a device used to examine samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on the analysis of such samples. IVD devices are designed to perform tests on specimens obtained from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the DUTAU-NOVATECH® is a surgical/endoscopic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
EOO, EOQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea and bronchi
Indicated Patient Age Range
greater than 5 years of age.
- Children greater than 5 years of age and young people
- Adults
- Patients of all genders
Intended User / Care Setting
qualified surgeons during ENT endoscopic procedures.
- Operating theatre
- Treatment room
- Endoscopic procedure room
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
Not Found
Summary of Performance Studies
Benchtop performance tests (tension test based on ISO 5356-1, assembling test, compression and tensile test, connection stability tests, plug-in connection test, luer lock connection test, separating tensile force test, visual inspection for atraumatic design, rotational torque tests, leakage test) were carried out. All mechanical tests were passed, and the device met the requirements.
Biocompatibility testing: Overall summary of the biological assessment for the DUTAU-NOVATECH® components with body contact was provided. No adverse biological effects expected.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
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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)
| ☑ 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/0 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 is the word "Novatech" in a bold, blue font. Below "Novatech" is the tagline "new biotechnology for life" in a smaller, blue font.
DUTAU-NOVATECH®
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 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 |
| 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 |
| 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:
DUTAU-NOVATECH® | Predicate Device:
Karl Storz Bronchoscope
Accessories |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 510k | | K943700 |
| Product Code | EOQ | Same |
| Regulation
Number | 874.4680 | Same |
| Class | II | Same |
| Intended Use | The DUTAU-NOVATECH® is intended for rigid
bronchoscopy. For use in trachea and bronchi. | Intended to be used during endoscopic
ENT procedures |
| 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. | to aid the surgeon in removing fluid,
tissue and foreign bodies, and inducing |
| Item | Proposed Device:
DUTAU-NOVATECH® | Predicate Device:
Karl Storz Bronchoscope
Accessories |
| | The DUTAU-NOVATECH® is suitable for use
for a patient population greater than 5 years of
age. | hemostasis during endoscopic ENT
surgery. |
| Patient Target
Group | - Children greater than 5 years of age
and young people
- Adults
- Patients of all genders | Population who requires endoscopic
ENT procedures to be conducted. |
| Intended User | To be used by qualified surgeon during ENT
endoscopic procedures | Same |
| Anatomical Sites | to be introduced into the trachea or bronchi. | Same |
| Environment of
Use | - Operating theatre - Treatment room
- Endoscopic procedure room | Hospital |
| Energy used and
/ or delivered | No energy is used for this device | Same |
| | Bronchial Tube/Tracheal Tube | Bronchoscope Tubes |
| | Lengths 25 or 35 cm, Diameters (both
inner and outer) from 8.5-14 mm | Lengths ranging from 20-43 cm,
Diameters from 3.5- 13.6 mm |
| Design | Bronchoscope head
Ventilation element with Axial Retainer
and Axial Cap
Lateral Double Port with Lateral Caps
Injection Cannula | Caps and Telescope Guides
Seals end of tube for viewing,
allows for instrumentation |
| Photo of product
ready for use | Image: DUTAU-NOVATECH | Image: Karl Storz Bronchoscope Accessories |
| Materials | Stainless steel, surgical quality; caps: silicone | Same |
| Principles of
Operation | Manually operable | Same |
| Sterilization | Supplied non-sterile and reprocessed | Same |
| Shelf-Life | N/A | Same |
| Chemical Safety | No Hazardous substances | Same |
| Compatibility
with
environment and
other devices | Medical devices for diagnosis and therapy
intended for use in rigid bronchoscopy and
compatible with the length and diameter of the
respective tube | N/A |
| Mechanical
Safety | Mechanical testing demonstrates device is | Same |
| bronchial / tracheal tubes | bronchoscope head with all adaptable parts and connectors | |
| Nature of body contact:
externally communicating with direct patient contact | Nature of body contact:
Indirect patient contact via gas pathways (ventilation) | |
| Applicable standard:
ISO 10993-1 | Applicable standard:
ISO 18562 | |
| Chemical characterization 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) | Chemical characterization 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 | |
| Cytotoxicity Stainless steels are not known to be cytotoxic. in-vitro cytotoxicity test with reference device passed | | |
| Sensitization and irritation 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. in-vivo tests with reference device passed (Guinea Pig Maximization Test; Intracutaneous Irritation Test with rabbits) | | |
| Material-mediated pyrogenicity 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. | | |
| Acute systemic toxicity See chemical characterization No leaching of chemical substances through the passivating oxide layer of stainless steels expected. in-vivo tests with reference device passed (Acute systemic toxicity test with mice) | | |
| bronchial / tracheal tubes | bronchoscope head with all adaptable parts
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
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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 (