K151832 · Novatech SA · GCJ · Mar 31, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K151832
Device Name
NOVATECH TALCAIR
Applicant
Novatech SA
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Mar 31, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid.
Device Story
Novatech Talcair is a sterile, single-use powder blower for administering medical grade talc into the pleural cavity during thoracoscopy. The device consists of an insufflation cannula, a vial coupling, and a manually operated insufflation bulb with two one-way valves. The physician attaches the coupling to a talc vial, connects the bulb via luer connector, and manually pumps the bulb to insufflate talc through the cannula into the patient's pleural cavity. Used in hospital settings by physicians experienced in thoracoscopy. The device facilitates pleurodesis to treat malignant pleural effusion. It replaces reusable predicate devices with a single-use, pre-sterilized design, eliminating the need for reprocessing and reducing potential for cross-contamination.
Clinical Evidence
Bench testing only. No clinical data provided. Performance testing included ejection volume, flow, talc distribution pattern, and pressure/volume safety compared to the predicate. Biocompatibility testing performed per ISO 10993-1. Sterile barrier integrity validated per EN 868-10 and ASTM F1929-12 following ISTA 2A transport simulation.
Technological Characteristics
Manual powder blower. Materials: Polypropylene (coupling), Polyethylene (cannula), Soft-PVC (bulb/tube), Radiation-grade Polycarbonate (luer connector). Dimensions: 16.5 inch (42 cm) cannula length, 3 mm outer diameter. Energy: Manual air insufflation via rubber bulb. Sterilization: Gamma radiation (15 kGy, SAL 10^-6). Single-use. No software.
Indications for Use
Indicated for patients diagnosed with malignant pleural effusion requiring treatment via insufflation of medical grade talc following pleural fluid drainage.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a family of three people in profile. The symbol is composed of three curved lines that form the shape of human heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Novatech S.A. % Mr. Stuart Montgomery Boston Medical Products Incorporated 117 Flanders Road Westborough, Massachusetts 01581
Re: K151832
Trade/Device Name: Novatech® Talcair Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 2, 2016 Received: March 7, 2016
Dear Mr. 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 (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. 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.
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 devicerelated adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K151832
Device Name NOVATECH® TALCAIR
Indications for Use (Describe)
Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(K) SUMMARY
#### I. SUBMITTER
NOVATECH S.A. Z.I. Athélia III - 1058, Voie Antiope 13705 La Ciotat CEDEX FRANCE
Ph: +33 (0) 442 98 15 63 Fax: +33 (0) 442 98 15 63
## Contact Person(s)
Dr. Jennifer Neff Director Regulatory & Medical Affairs
Stuart K. Montgomery President Boston Medical Products Inc. 117 Flanders Road Westborough, MA, 01581
Ph: 508-898-9300 ext. 240 Fax: 508-898-2373
## Date Prepared
March 26, 2015
### II. DEVICE
NOVATECH® TALCAIR™ Trade Name: Common Name: Powder Blower Device Classification Name: Laparoscope, General & Plastic Surgery Regulation Number and Description: 876.1500 Endoscope and accessories Review Panel: General & Plastic Surgery Product Code: GCI Device Class: 2
### III. PREDICATE DEVICE
Device Name: KARL STORZ ENDOSCOPY POWDER BLOWER Original Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. 510(k) Number: K952443 Product Code/Regulation Number: GCJ/876.1500 Endoscope and Accessories
No reference devices were used in this submission.
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### DEVICE DESCRIPTION IV.
NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial.
The device is a sterile, single use medical device which is sterilized by gamma sterilization.
The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the tube of the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started.
The medical device is intended for the administration of medical grade talc via thoracoscopy. The device is intended to treat patients with malignant pleural effusion.
### V. INDICATION FOR USE
Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid.
### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE
The NOVATECH® TALCAIR™ has the same indication for use, uses the same operating principle and incorporates the same basic design as the predicate device. the KARL STORZ ENDOSCOPY POWDER BLOWER. A summary of the technological characteristics of NOVATECH® TALCAIR™ compared to KARL STORZ ENDOSCOPY POWDER BLOWER is provided below.
| Tabular Comparison to Predicate Device | | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device:<br>NOVATECH® TALCAIR™ | Predicate Device:<br>KARL STORZ ENDOSCOPY<br>POWDER BLOWER |
| Product Code | GCJ | Same |
| Regulation Number | 876.1500 | Same |
| Class | 2 | Same |
| Intended Use | Administration of medical grade talc<br>via thoracoscopy. The device is<br>intended to treat patients with<br>malignant pleural effusion. | Same |
| Indication for Use | Treatment of malignant pleural<br>effusion by insufflation of medical<br>grade talc following drainage of<br>pleural fluid. | Same |
| Patient Population | Those diagnosed with malignant<br>pleural effusion. | Same |
| Anatomical Sites | Introduced into the pleural cavity. | Same |
| Environmental of Use | Hospital | Same |
| Energy used and / or delivered | Air insufflation occurs by the manually operated rubber bulb. | Same |
| Principal Operator | Physicians with experience in thoracoscopy in cooperation with trained staff | Same |
| Design | Powder Blower comprising an insufflation cannula with an attached vial coupling, and a separate insufflation bulb.<br><br>The semi-rigid insufflation cannula has an effective length of about 16.5 inches (42 cm) at an outer diameter of 0.102 inches (3 mm).<br><br>The attached vial coupling is used to snap-fit the vial.<br><br>The separate insufflation bulb has two valves controlling the one-way direction of airflow. Insufflation bulb and vial coupling are connected by luer connectors before device use. | Powder Blower comprising a glass bottle, an insufflation cannula, and an insufflation bulb.<br><br>The rigid insufflation cannula has a length of about 16.5 inches (42 cm) at an outer diameter of 0.2 inches (5 mm).<br><br>The attached vial coupling is used to screw the device to a vial.<br><br>The separate insufflation bulb has two valves controlling the one-way direction of airflow. Insufflation bulb and vial coupling are connected by an additional tube segment featuring luer connectors before device use. |
| Materials | PVC, Polyethylene, Polycarbonate | PVC, Stainless Steel |
| Principles of Operation | The NOVATECH® TALCAIRTM vial coupling is inserted into the vial by pressing the vial coupling onto the vial. The insufflation bulb is then attached to the vial coupling. | Same |
| Sterilization | NOVATECH® TALCAIRTM is a single use product and is supplied sterile.<br><br>Instructions for sterilization and re-sterilization/re-use of the product are unnecessary.<br><br>Therefore, effectiveness of any kind of reuse and reprocessing has not been demonstrated. | Cleaning and sterilization instructions are supplied by STORZ which recommends a steam sterilization at 134°C, for 5 minutes. |
| Sterility | NOVATECH® TALCAIRTM is | Delivered un-sterile |
| | for single use according to the<br>sterilization validation of the<br>product. | |
| Shelf Life | 5 years | unknown |
## Tabular Comparison to Prodicate Device
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#### PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
## Biocompatibility Testing
The assessment of biological risks, the procedures and provisions of EN ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process2 (including Technical Corrigendum 1, published on 15 June 2010), as well as Blue Book Memorandum G 95-1 / FDA Draft Guidance dated April 23, 2013 "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were applied.
NOVATECH® TALCAIR™ is biological classified "external communicating device" with "limited" (<24 h) contact to "tissue, bone or dentin".
In accordance with the aforementioned standards and regulatory documents the following biological risks were particularly evaluated:
| • Cytotoxicity | EN ISO 10993-5:2009 |
|---------------------------------|----------------------|
| • Irritation | EN ISO 10993-10:2010 |
| • Delayed type hypersensitivity | EN ISO 10993-10:2010 |
| • Acute systemic toxicity | EN ISO 10993:11:2009 |
| • Chemical characterization | EN ISO 10993-18:2009 |
For sample preparation and dosing EN ISO 10993-12:2012 is applicable.
All other risks mentioned in EN ISO 10993-1, including serious risks like systemic toxicity (subchronic, chronic), implantation, genotoxicity, hemocompatibility, carcinogenicity, reproductive and developmental toxicity, biodegradation, toxicokinetics and immunotoxicity are deemed not relevant, respectively not applicable.
## Benchmark Performance Tests
This 510(k) includes a test report for benchmark performance tests on NOVATECH® TALCAIR™. The purpose of this evaluation was to demonstrate the technical equivalence of the NOVATECH® TALCAIR™ powder blower with the KARL STORZ ENDOSCOPY POWDER BLOWER. The following were tested for both devices:
- -Ejection volume in relation to flow
- -Distribution pattern of sprayed talc
- Pressure and volume changes -
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The results show that NOVATECH® TALCAIR™ has an equal or better performance for talc distribution, spray coverage patter, pressure safety and yield of dosage against the KARL STORZ ENDOSCOPY POWDER BLOWER.
## VIII. SHELF LIFE / STERILIZATION
## Transport Validation
A sterile barrier test after distribution transport simulation was performed on NOVATECH® A sterile barrier test after distribution transport simulation was performed on NOVATECH® TALCAIR™. The purpose of this evaluation is to demonstrate that the sterile barrier of the primary package remains intact using the actual materials, sealing paramaters, secondary packaging, usually shipping boxes and configurations. Seal strength tests according to EN 868-10 and dye penetration tests according to ASTM F1929 have been performed after exposure to simulated transport conditions according to ISTA procedure 2A for international shipping up to a shipping unit weight of 68 kg.
To validate the sterile sealing seam a seal strength tests according to EN 868-10 and a dye penetration leakage test according to ASTM F1929-12 have been performed.
It can be assumed that the product can be provided sterile to the end-user after being exposed to transport situations covered by the ISTA 2A procedure which is representative for shipping units up to 68 kg to worldwide destinations only restricted by extreme climate beyond the simulation parameters.
## Shelf Life
The shelf life for NOVATECH® TALCAIR™ is five years. For shelf life tests on NOVATECH® TALCAIR™ two test reports were provided.
## Sterilization
| Method of Sterilization: | Gamma Radiation |
|----------------------------|-----------------|
| Sterility Assurance Level: | 10-6 |
| Radiation Dose: | 15 kGy |
### IX. CONCLUSION
Based on above criteria's, substantial equivalence between NOVATECH® TALCAIR™ and the predicate device - KARL STORZ ENDOSCOPY POWDER BLOWER can be established.
Pursuant to section 21 CFR 807.100 Novatech SA has determined that NOVATECH® TALCAIR 1111 is substantially equivalent to Predicate device - KARL STORZ ENDOSCOPY POWDER BLOWER through the data and information presented. No safety or effectiveness issues were identified.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
