(166 days)
The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.
EndoClot® Applicator is a medical device composed of applicator (catheter, gas/powder mixing chamber), connecting tube and gas filter, with a tube connecting to gas source in hospital. The device has good biocompatibility. By combining with external gas source, it can deliver the powdered hemostatic agent to the treatment site in endoscopic surgical procedures.
This document is a 510(k) premarket notification for a medical device called the "EndoClot® Applicator," which is intended to assist in the delivery of a powdered hemostatic agent during endoscopic surgeries.
The acceptance criteria and study proving the device meets these criteria are not described in detail in the provided text in the way a clinical study for a new AI/software medical device would be. This document is a 510(k) summary for a Class II medical device, which demonstrates substantial equivalence to a previously cleared predicate device, rather than proving novel effectiveness through rigorous clinical trials and statistical goals.
Here's a breakdown based on the provided text, and where it falls short of the requested information for an AI/software device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria in a quantitative, measurable way for performance as one would expect for an AI/software device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" for a 510(k) are typically met by demonstrating:
- Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device.
- Meeting Recognized Standards: Compliance with relevant international and FDA-recognized standards for medical devices (e.g., biocompatibility, sterility, performance testing).
Reported Device Performance (as inferred from the document):
| Acceptance Criteria (Inferred for 510(k)) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are not harmful to the body. | Meets Standards: Testing conducted in accordance with ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and sensitization), and ISO 10993-11:2006 (systemic toxicity). The document states "Test data and report information are included in this submission," indicating the tests were performed and results were acceptable. |
| Sterility: Device is sterile for its intended use. | Meets Standards: EO sterilization method is used, which is the same as the predicate device. Compliance with relevant sterility standards (implied, as it's a critical safety aspect for medical devices). |
| Performance (Functional Equivalence): Delivers powdered agent effectively and safely. | Demonstrated through Equivalence to Predicate: "The working situation and environment of EndoClot® Applicator is the same as that of the MEDAFOR DIRECT Gas-Assisted Application System, the technological characteristics of this product is designed to make same as that of the equivalence product." Specific performance metrics (e.g., flow rate, dispersion pattern, delivery accuracy) are not detailed beyond stating functional similarity and "performance testing" was conducted. ASTM F756-13 (Standard Practice for Assessment of Biomaterials for Surgical Implants) and ISO 11607-1:2006 (Packaging for terminally sterilized medical devices) are mentioned, which relate to material and packaging integrity, important for performance and safety. |
| Shelf Life: Device maintains integrity over time. | 3 Years: Same as the predicate device. |
| Packaging: Maintains sterility and integrity until use. | Tyvek and PETG: Same as the predicate device. Compliance with ISO 11607-1:2006 for packaging. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of clinical cases or patient data. The "tests" mentioned are non-clinical, involving materials, sterilization, and basic functional characteristics.
- Data Provenance: The tests were "conducted related non-clinical tests" by the submitter (EndoClot Plus Co., Ltd.). The location of the company is China (Suzhou Industrial Park). No human data or patient samples are referenced for these non-clinical tests.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable in this context. This device is a mechanical applicator, not an AI/software device requiring expert interpretation of diagnostic images or patient outcomes for ground truth establishment. The "ground truth" for this submission revolves around physical and chemical properties and functional equivalence to a predicate device, assessed through laboratory testing and engineering analysis, not expert clinical consensus.
4. Adjudication Method for the Test Set:
- Not applicable. There's no test set in the sense of clinical cases requiring adjudication by multiple readers or experts. Device testing (biocompatibility, sterility, etc.) typically involves passing pre-defined criteria in laboratory settings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not performed/applicable. This type of study is specifically designed for AI/software devices where human readers' performance with and without AI assistance is evaluated. This 510(k) is for a mechanical medical device, not an AI.
6. Standalone (Algorithm Only) Performance:
- Not applicable. As this is a mechanical applicator, there is no "algorithm" or standalone software component to evaluate.
7. Type of Ground Truth Used:
- The "ground truth" for this device's substantial equivalence determination is based on engineering specifications, material properties, predicate device characteristics, and compliance with recognized international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, ISO 11607 for packaging). It is not based on expert consensus, pathology, or outcomes data from a clinical trial.
8. Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, there is no ground truth establishment process for it relevant to AI/ML.
In summary: The provided document describes a 510(k) submission for a physical medical device (EndoClot® Applicator). The "proof" that it meets acceptance criteria (substantial equivalence) is primarily through non-clinical bench testing, material characterization, and direct comparison of design and intended use to a legally marketed predicate device (MEDAFOR DIRECT Gas-Assisted Application System in K123325). The document does not involve or require the types of studies (clinical trials, expert consensus, MRMC studies) typically associated with establishing performance and ground truth for AI/software medical devices.
§ 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.