(102 days)
The DANNIK Specimen Retrieval System is in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.
The DANNIK Specimen Retrieval System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The DANNIK Specimen Retrieval System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
The DANNIK Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms.
The DANNIK Specimen Retrieval System is comprised of a flexible plastic bag with and without a deployment mechanism.
The bag is made from polyurethane and/or rip-stop nylon and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The bags come in sizes from 50 to 3000 mL.
The deployment mechanism consists of a push-pull rod and introducer assembly. The push-pull rod consists of a handle, shaft and biasing arms and is made from a combination of Stainless Steel, Nitinol, ABS, and PC. The introducer assembly consists of a tube and is made from ABS and/or PC. The deployment mechanism allows easy insertion through the cannula and full deployment the use of the metallic biasing arms. Introducers range from 5 to 15 mm in diameter.
This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
Here's a breakdown of the acceptance criteria and study information for the DANNIK Specimen Retrieval System, based on the provided document:
This document describes a 510(k) premarket notification for a medical device. It's important to note that 510(k) clearances are for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria for disease detection/diagnosis. The "acceptance criteria" here therefore refer to the performance benchmarks against the predicate device in non-clinical settings.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing Against Predicate) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Appropriate introduction forces (comparable to predicate device) | Testing showed that the devices met the same requirements as the predicate device. |
| Seam strengths (comparable to predicate device) | Testing showed that the devices met the same requirements as the predicate device. |
| Fluid permeability (comparable to predicate device) | Testing showed that the devices met the same requirements as the predicate device. |
| Open/closure forces (comparable to predicate device) | Testing showed that the devices met the same requirements as the predicate device. |
| General operation (comparable to predicate device) | Testing showed that the devices met the same requirements as the predicate device. |
| Sterilization: | |
| Sterilization via Ethylene Oxide (EO) to achieve a Sterility Assurance Level (SAL) of $10^{-6}$ (ISO 11135:2014) | Validation of the Ethylene Oxide sterilization process was accomplished according to ISO 11135 to provide a SAL of $10^{-6}$. Validation of the Ethylene Oxide process remains unchanged from the original submission. |
| Packaging: | |
| Compliance with ISO 11607 series of standards for packaging | Packaging for these devices was designed and complies with the requirements of ISO 11607 series of standards. |
| Biocompatibility: | |
| Conformance to ISO 10993-1 and relevant sub-parts | Biocompatibility was evaluated in accordance with ISO 10993-1 and relevant sub-parts for the device, given the nature and duration of patient contact. (The predicate device's biocompatibility was "Unknown" in the comparison table, but the DANNIK device explicitly states conformance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a clinical test set in the traditional sense, as this was a non-clinical bench testing submission. The testing involved comparing the DANNIK Specimen Retrieval System to the predicate device, the Espiner Tissue Retrieval System (K111845), using various bench tests.
- Test Set: Non-clinical bench testing of the DANNIK Specimen Retrieval System.
- Data Provenance: The testing was conducted to demonstrate substantial equivalence to a legally marketed predicate device. The document does not specify the country of origin for the data, but it is for a US FDA submission, implying the tests were conducted under US regulatory guidelines or accepted international standards. The testing is retrospective in the sense that it compares features to an already marketed device, but the actual tests on the DANNIK device would be considered part of a prospective testing plan for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth as seen in diagnostic device studies is typically not required. The "truth" for these tests is defined by established engineering standards and performance specifications for medical devices.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical ground truth established by experts requiring an adjudication method. The assessment of performance against the predicate was based on objective-bench testing parameters.
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
Not applicable. This device is a physical specimen retrieval system, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical specimen retrieval system and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering specifications and performance characteristics of the DANNIK Specimen Retrieval System.
- Performance data from the predicate device (Espiner Tissue Retrieval System, K111845) which served as the benchmark for demonstrating substantial equivalence.
- International standards such as ISO 11135 (sterilization) and ISO 10993 (biocompatibility), and ISO 11607 (packaging).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device and does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 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.