(68 days)
The device is intended for manual insufflation of medical grade talc into the pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
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 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 device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
The provided text describes a 510(k) submission for the NOVATECH® TALCAIR™ device, which is a powder blower for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The submission primarily seeks to add a new indication for use to an already approved device (K151832), and thus leverages the previous performance data.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format with numerical targets. Instead, it demonstrates substantial equivalence to a predicate device (the previously approved NOVATECH® TALCAIR™) by showing that the proposed device maintains the same technological characteristics and meets established safety and performance benchmarks (primarily focused on biocompatibility and physical performance for a talc insufflator).
However, based on the performance data section, we can infer the tested aspects and their outcomes:
| Performance Aspect | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets EN ISO 10993-1, -5, -10, -11, -12, -18 standards for external communicating devices with limited contact. | The device was evaluated for cytotoxicity, irritation, delayed type hypersensitivity, acute systemic toxicity, and chemical characterization according to the specified ISO 10993 standards. Other risks (systemic toxicity (subchronic, chronic), implantation, genotoxicity, hemocompatibility, carcinogenicity, reproductive and developmental toxicity, biodegradation, toxicokinetics, and immunotoxicity) were deemed not relevant or applicable. The submission implies successful demonstration of biocompatibility as part of the overall substantial equivalence determination. |
| Talc Ejection Volume in Relation to Flow | Equivalent or better performance compared to KARL STORZ ENDOSCOPY POWDER BLOWER. | The study from the K151832 submission (used as benchmark performance) showed that NOVATECH® TALCAIR™ had an "equal or better performance" for talc distribution. |
| Talc Distribution Pattern / Spray Coverage | Equivalent or better performance compared to KARL STORZ ENDOSCOPY POWDER BLOWER. | The study from the K151832 submission showed that NOVATECH® TALCAIR™ had an "equal or better performance" for spray coverage pattern. |
| Pressure Safety and Volume Changes | Equivalent or better performance compared to KARL STORZ ENDOSCOPY POWDER BLOWER. | The study from the K151832 submission showed that NOVATECH® TALCAIR™ had an "equal or better performance" for pressure safety and yield of dosage. |
| Sterile Barrier Integrity (Transport) | Maintains sterile barrier after simulated transport. | A sterile barrier test after distribution transport simulation was performed using ISTA procedure 2A. Seal strength tests (EN 868-10) and dye penetration tests (ASTM F1929) were conducted. The product can be provided sterile to the end-user after exposure to transport situations covered by ISTA 2A. |
| Shelf Life | 5 years. | Two test reports were provided to support a shelf life of 5 years. |
| Sterilization | Sterility Assurance Level (SAL) of 10-6 with Gamma Radiation. | Method: Gamma Radiation. SAL: 10-6. Radiation Dose: 15 kGy. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Bench Performance Tests: Not explicitly stated for each test (e.g., number of devices tested for ejection volume, distribution, pressure). The phrasing "The results show that NOVATECH® TALCAIR™ has an equal or better performance..." implies quantitative testing was performed.
- Data Provenance: The benchmark performance tests (ejection volume, distribution pattern, pressure/volume changes) referenced are from the K151832 submission for the same device, which serves as the predicate. This suggests these were likely retrospective data for the current submission, originally collected for the initial clearance of the device. The country of origin of the data is not specified, but the applicant (NOVATECH S.A.) is based in France.
- Biocompatibility Testing: Not specified for sample size. These tests are typically conducted on material samples rather than whole devices.
- Transport Validation: Not specified for sample size (e.g., number of packages tested).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This section is not applicable as the studies described are primarily analytical performance tests (biocompatibility, physical performance of the insufflator, sterilization, shelf life, sterile barrier integrity) rather than clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is based on objective measurements and adherence to international standards.
4. Adjudication Method for the Test Set:
This is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a manual medical instrument (powder blower), not an AI-powered diagnostic or assistive tool. There is no AI component or human-in-the-loop scenario described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical, manual medical instrument and does not involve an algorithm.
7. The Type of Ground Truth Used:
- Biocompatibility: Ground truth is established by adherence to international standards (EN ISO 10993 series) and acceptance criteria defined within those standards (e.g., no cytotoxicity, no irritation).
- Bench Performance Tests (Talc Ejection, Distribution, Pressure): Ground truth is based on quantitative measurements and comparison to a legally marketed predicate device (KARL STORZ ENDOSCOPY POWDER BLOWER) to demonstrate equivalence or superiority in functional performance.
- Sterile Barrier & Shelf Life: Ground truth is established by standardized testing protocols (ISTA, EN 868-10, ASTM F1929) and demonstrating that the product meets pre-defined physical and sterility performance metrics over time and under simulated stress.
8. The Sample Size for the Training Set:
This is not applicable as the device is a physical medical instrument, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
This is not applicable as there is no training set for a physical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2017
NOVATECH S.A. % Mr. Stuart K. Montgomery President Boston Medical Products Inc. 70 Chestnut Street Shrewsbury, Massachusetts 01545
Re: K170030
Trade/Device Name: NOVATECH TALCAIR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 2, 2017 Received: January 4, 2017
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
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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.
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.
Sincerelv.
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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) K170030
Device Name NOVATECH® TALCAIR™
Indications for Use (Describe)
The device is intended for manual insufflation of medical grade talc into the pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
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
1 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. 70 Chestnut Street Shrewsbury, MA 01545, USA
Ph: 508-898-9300 ext. 240 Fax: 508-898-2373
Date Prepared
January 2, 2017
2 Device
| Trade Name: | NOVATECH® TALCAIR™ |
|---|---|
| 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: | GCJ |
| Device Class: | 2 |
3 Predicate Device
| Device Name: | NOVATECH® TALCAIR™ |
|---|---|
| Original Applicant: | Novatech S.A. |
| 510(k) Number: | K151832 |
| Product Code/Regulation Number: | GCJ/876.1500 Endoscope and Accessories |
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No reference devices were used in this submission.
NOVATECH® TALCAIR™ (510(k) number - K151832) is approved for the indication: "Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid". NOVATECH S.A. is submitting this 510(k) notification to add that the device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
In addition, NOVATECH S.A. is using NOVATECH® TALCAIR™ (approved under K151832) as a predicate device for this submission. The device remains exactly the same with only the addition of a new indication.
4 Device Description
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 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 device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
5 Indication for Use
The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
6 Comparison of technological characteristics with the predicate device
The NOVATECH® TALCAIR™ has the same operating principle and incorporates the same basic design as the predicate device, the NOVATECH® TALCAIR™. A summary
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of the technological characteristics of NOVATECH® TALCAIR™ compared to NOVATECH® TALCAIR™ is provided below.
| Item | Proposed Device:NOVATECH® TALCAIR™ | Predicate Device:NOVATECH® TALCAIR™ |
|---|---|---|
| Product Code | GCJ | Same |
| Regulation Number | 876.1500 | Same |
| Class | 2 | Same |
| Intended Use | The device is intended for manualinsufflation of medical grade talcinto the pleural cavity duringpleurodesis. The device is indicatedfor use according to the approvedindication for use of the medicalgrade talc. | Administration of medical gradetalc via thoracoscopy. The deviceis intended to treat patients withmalignant pleural effusion. |
| Indication for Use | The device is intended for manualinsufflation of medical grade talcinto the pleural cavity duringpleurodesis. The device is indicatedfor use according to the approvedindication for use of the medicalgrade talc. | Treatment of malignant pleuraleffusion by insufflation ofmedical grade talc followingdrainage of pleural fluid. |
| Patient Population | Adults diagnosed with any of theindications approved for themedical grade talc that requiresmanual insufflation of medicalgrade talc into the pleural cavityduring pleurodesis. | Those diagnosed with malignantpleural effusion. |
| Anatomical Sites | Introduced into the pleural cavity. | Same |
| Environmental of Use | Hospital | Same |
| Energy used and / ordelivered | Air insufflation occurs by themanually operated rubber bulb. | Same |
| Principal Operator | Physicians with experience inpleurodesis in cooperation withtrained staff | Same |
| Design | Powder Blower comprising aninsufflation cannula with anattached vial coupling, and aseparate insufflation bulb.The semi-rigid insufflation cannulahas an effective length of about16.5 inches (42 cm) at an outerdiameter of 0.118 inches (3 mm). | Same |
| The attached vial coupling is usedto snap-fit the vial. | ||
| The separate insufflation bulb hastwo valves controlling the one-waydirection of airflow. Insufflationbulb and vial coupling areconnected by luer connectorsbefore device use. | ||
| Materials | PVC, Polyethylene, Polycarbonate | Same |
| Principles ofOperation | The NOVATECH® TALCAIR™vial coupling is inserted into thevial by pressing the vial couplingonto the vial. The insufflation bulbis then attached to the vial coupling. | Same |
| Sterilization | NOVATECH® TALCAIR™ is asingle use product and is suppliedsterile.Instructions for sterilization and re-sterilization/re-use of the productare unnecessary.Therefore, effectiveness of any kindof reuse and reprocessing has notbeen demonstrated. | Same |
| Sterility | NOVATECH® TALCAIR™ issupplied sterile and is intended forsingle use according to thesterilization validation of theproduct. | Same |
| Shelf Life | 5 years | Same |
Tabular Comparison to Predicate Device
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7 Performance Data
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 Process 2 (including Technical Corrigendum 1, published on 15 June 2010), as well as Blue Book Memorandum G 95-1 / FDA Draft Guidance dated
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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
Not applicable, NOVATECH S.A. is submitting this 510(k) notification to add the indication that the device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc. NOVATECH S.A. is using NOVATECH® TALCAIR™ (approved under K151832) as a predicate device. The device will remain exactly the same with only the addition of a new indication. However, a summary of Bench Performance testing data from K151832 submission is provided below.
Benchmark performance tests on NOVATECH® TALCAIR™ aims 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
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.
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Shelf Life / Sterilization 8
Transport Validation
A sterile barrier test after distribution transport simulation was performed on NOVATECH® TALCAIR™. The purpose of this evaluation was to demonstrate that the sterile barrier of the primary package remains intact using the actual materials, sealing parameters, secondary packaging, usual shipping boxes and configurations.
To validate the sterile sealing seam a 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.
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 |
9 Conclusion
Based on above criteria's, substantial equivalence between NOVATECH® TALCAIR™ and the predicate device - NOVATECH® TALCAIR™ can be established.
Pursuant to section 21 CFR 807.100 Novatech SA has determined that NOVATECH® TALCAIR™ is substantially equivalent to Predicate device - NOVATECH® TALCAIR™ through the data and information presented. No safety or effectiveness issues were identified.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.