(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.
§ 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.