(90 days)
The Coherent Tissue Morcellator Kit is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
The Coherent Tissue Morcellator Kit is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Coherent Tissue Morcellator Kits are comprised of the following main components:
- a Morcellator handpiece;
- a variety of cutting blade sets;
- an aspiration pump;
- a variable speed control unit;
- a footswitch;
- a sterilization tray
The Coherent Morcellator Handpiece/Drive Units are provided as non-sterile, ready to be sterilized devices. The Cutting Blade Sets are provided either as sterile, single-use items, or as non-sterile, limited reuse, ready to be sterilized items. An optional sterilization tray may be used to sterilize the Morcellator Handpiece/Drive Units and the limited reuse cutting blade sets.
Here's the analysis of the provided text regarding the Coherent Tissue Morcellator Kit, focusing on acceptance criteria, a study proving it, and related details.
Analysis of Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Coherent Tissue Morcellator Kit does not contain explicit acceptance criteria in the form of quantitative performance metrics (e.g., "device shall achieve a cutting rate of X g/min with a tissue integrity index of Y").
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means the primary "acceptance criterion" is that the new device performs as safely and effectively as legally marketed predicate devices, as demonstrated through similar design features, indications for use, and physical/biocompatibility testing.
Here's a breakdown based on your request, with "N/A" where the information is not present in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | The Coherent Tissue Morcellator Kit was found to be substantially equivalent to: |
- Cook Urological/Cook OB/GYN, Inc. Tissue Morcellator (K925851 and K910939)
- Lasersonics Tissue Morcellator Set (Heraeus Surgical, Inc., K935604)
This equivalence is based on shared indications for use and similar design/functional features. |
| Acceptable Physical Performance | "Physical testing was conducted to demonstrate performance of the Coherent Tissue Morcellator Kit in accordance with product specifications." "Physical...test results demonstrated that the Coherent Tissue Morcellator Kit has acceptable performance characteristics." (Specific metrics are not provided.) |
| Acceptable Biocompatibility | "The component materials with expected and potential patient contact were tested to demonstrate acceptable biocompatibility." |
| Sterilization Efficacy | "Cleaning and sterilization will be conducted prior to commercial distribution." (Implies that sterilization is effective, but no specific study details are given.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "Physical testing was conducted," but it doesn't mention the number of devices, tissue samples, or other units tested.
- Data Provenance: N/A. The document does not specify the origin of any data (e.g., country of origin, retrospective/prospective). It describes lab-based physical and biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Given that the testing described is primarily focused on physical performance and biocompatibility rather than diagnostic accuracy or clinical outcomes, the concept of "ground truth established by experts" in the traditional sense for AI/diagnostic devices does not apply here. The "ground truth" would be the engineering specifications and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This is not applicable to the type of physical and biocompatibility testing described.
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
N/A. This is a medical device for tissue removal, not a diagnostic or AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm or AI device. The "performance" is that of the mechanical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The implicit "ground truth" for the performance claims appears to be:
- Engineering Specifications: For physical performance testing, the device's ability to meet its design specifications (e.g., cutting functionality, mechanical integrity) would be the ground truth.
- Biocompatibility Standards: For biocompatibility testing, compliance with established standards for material safety in medical devices would be the ground truth.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness profile of the legally marketed predicate devices.
8. The sample size for the training set
N/A. This is not an AI/machine learning device; there is no training set.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no training set.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the (implied) acceptance criteria is described as "Physical testing" and "Biocompatibility testing."
- Physical Testing: "Physical testing was conducted to demonstrate performance of the Coherent Tissue Morcellator Kit in accordance with product specifications." The results "demonstrated that the Coherent Tissue Morcellator Kit has acceptable performance characteristics." No specific study design details, methodologies, or quantitative outcomes are provided in this summary. It's implied this testing showed the device functioned as intended and met its internal design and performance specifications appropriate for a device of its type (e.g., cutting speed, tissue removal efficiency, mechanical durability).
- Biocompatibility Testing: "The component materials with expected and potential patient contact were tested to demonstrate acceptable biocompatibility." This testing ensures that the materials used in the device are safe for contact with human tissue and do not cause adverse biological reactions.
The overall "study" demonstrating the device meets the acceptance criteria (substantial equivalence) is the compilation of these physical and biocompatibility tests, alongside a comparison of the device's indications for use and design features to those of the predicate devices. The FDA's letter confirms that, based on this information, the device was found substantially equivalent.
§ 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.