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.

AI/ML Overview

The provided document is a 510(k) summary for the Novatech® Talcair™ device, which is a powder blower used for the administration of medical grade talc to treat malignant pleural effusion. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a stand-alone study with acceptance criteria and device performance as typically understood for diagnostic AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are standard for AI/ML device studies, is not present in this regulatory submission. This submission does not describe a clinical study of an AI/ML device.

However, based on the provided text, I can extract information related to the device's technical performance and comparison with its predicate.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the typical sense of a clinical study for a diagnostic device. Instead, it details benchmark performance tests comparing the Novatech® Talcair™ to its predicate device. The implicit acceptance criterion for these tests is "equal or better performance" than the predicate.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Novatech® Talcair™)
Benchmark Performance Tests	Equal or better performance than the KARL STORZ ENDOSCOPY POWDER BLOWER	Equal or better performance than the predicate device
Ejection volume in relation to flow	Equal or better than predicate	Equal or better performance for talc distribution against the predicate device
Distribution pattern of sprayed talc	Equal or better than predicate	Equal or better performance for spray coverage pattern against the predicate device
Pressure and volume changes (safety)	Equal or better than predicate (specifically pressure safety)	Equal or better performance for pressure safety against the predicate device
Yield of dosage	Equal or better than predicate	Equal or better performance for yield of dosage against the predicate device
Biocompatibility Testing	Compliance with EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-10, EN ISO 10993-11, EN ISO 10993-18, EN ISO 10993-12	All risks were evaluated according to the mentioned standards, and relevant tests were performed. Deemed not relevant/applicable for other serious risks.
Sterile Barrier Test	Maintain sterile barrier after transport simulation (according to ISTA procedure 2A)	Passed; can be assumed that the product can be provided sterile to the end-user
Seal Strength	According to EN 868-10	Tests performed and passed
Dye Penetration Leakage	According to ASTM F1929-12	Tests performed and passed
Shelf Life	Confirmed for 5 years	Two test reports support a 5-year shelf life
Sterilization Assurance Level (SAL)	10^-6	Achieved with Gamma Radiation at 15 kGy

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes benchmark performance tests and biocompatibility testing of the device itself, not a clinical study involving patient data. The "test sets" refer to the physical devices or materials used in laboratory/engineering tests, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is not a study assessing AI/ML diagnostic performance. The "ground truth" here relates to the objective measurements of the device's physical performance characteristics, which would be established through engineering and laboratory testing protocols, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for studies where human expert disagreement on interpretation needs to be resolved to establish ground truth for a diagnostic task. This document concerns a physical medical device's performance characteristics.

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

No MRMC study was done, as this submission is for a physical medical device (powder blower), not an AI/ML diagnostic software. Therefore, there is no information on human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical medical instrument, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on objective engineering measurements and standardized test methods for physical and biological properties. For example:

Benchmark Performance Tests: Quantitative measurements of ejection volume, observation of talc distribution patterns, and pressure monitoring.
Biocompatibility Testing: Laboratory assay results aligned with ISO 10993 standards.
Sterile Barrier Testing: Physical tests like seal strength (EN 868-10) and dye penetration (ASTM F1929-12) with defined pass/fail criteria.
Sterilization: Validation of a specific Sterility Assurance Level through microbiological testing and dosimetry.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device study.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" or "ground truth for a training set" in the context of this device submission.

Summary

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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.

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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.

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:NOVATECH® TALCAIR™	Predicate Device:KARL STORZ ENDOSCOPYPOWDER BLOWER
Product Code	GCJ	Same
Regulation Number	876.1500	Same
Class	2	Same
Intended Use	Administration of medical grade talcvia thoracoscopy. The device isintended to treat patients withmalignant pleural effusion.	Same
Indication for Use	Treatment of malignant pleuraleffusion by insufflation of medicalgrade talc following drainage ofpleural fluid.	Same
Patient Population	Those diagnosed with malignantpleural 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.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).The attached vial coupling is used to snap-fit the vial.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.The rigid insufflation cannula has a length of about 16.5 inches (42 cm) at an outer diameter of 0.2 inches (5 mm).The attached vial coupling is used to screw the device to a vial.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.Instructions for sterilization and re-sterilization/re-use of the product are unnecessary.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 thesterilization validation of theproduct.
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.

Regulation Number and Section

§ 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.