(42 days)
The AUTO SUTURE* Biopsy Instrument** device is identical in safety and effectiveness to its currently marketed predicate - IMAGYN Medical Inc's biopsy instrument as described in Laparoscopic Instruments - 510(k) #K944129.
The AUTO SUTURE* Biopsy Instrument** device is a reusable biopsy instrument.
This 510(k) premarket notification for the "AUTO SUTURE* Biopsy Instrument** device" appears to be a predicate-based submission that relies on demonstrating substantial equivalence to a previously cleared device (IMAGYN Medical Inc's biopsy instrument, K944129) rather than a de novo submission requiring extensive new performance data and clinical studies.
Therefore, most of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, expert ground truth, and comparative effectiveness studies is not explicitly provided or applicable in the context of this specific 510(k) submission. This type of submission focuses on proving the new device is "identical in safety and effectiveness" to an existing, cleared device.
However, I can extract and infer what information is present in the provided text related to the closest concepts.
Here's a breakdown based on the provided text:
Acceptance Criteria and Study Details for the AUTO SUTURE Biopsy Instrument*
This 510(k) Premarket Notification (K960748) for the AUTO SUTURE* Biopsy Instrument** device primarily relies on demonstrating substantial equivalence to a predicate device, the IMAGYN Medical Inc's biopsy instrument (K944129). Therefore, the "acceptance criteria" and "study" are not presented in terms of novel performance metrics for this new device, but rather in terms of demonstrating that it matches the characteristics of the predicate device, which presumably met its own acceptance criteria during its clearance process.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence claim, the "acceptance criteria" relate to the new device matching the predicate. The "reported device performance" is implicitly that the new device performs identically to the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate K944129) | Reported Device Performance (AUTO SUTURE* Biopsy Instrument**) |
|---|---|
| Design: Identical to predicate | Device is identical in design to IMAGYN Medical Inc's biopsy instrument |
| Function: Identical to predicate | Device performs the exact same function in the same way as the predicate |
| Performance: Identical to predicate | Device is identical in performance to IMAGYN Medical Inc's biopsy instrument |
| Labeling: Identical to predicate | Device is identical in labeling to IMAGYN Medical Inc's biopsy instrument |
| Sterilization: Identical to predicate | Device is identical in sterilization to IMAGYN Medical Inc's biopsy instrument |
| Indication for Use: Same as predicate | Device is designed and indicated for the same procedures as the predicate |
| Manufacturing Process & Controls: Similar to other USSC devices | Manufactured in the same facilities, using similar processes and controls as other USSC devices |
| Packaging Process & Controls: Similar to other USSC devices | Packaged in the same facilities, using similar processes and controls as other USSC devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a de novo clinical test set for this 510(k). The submission relies on establishing equivalence. No specific "test set" of patient data is mentioned for this device.
- Data Provenance: Not applicable for a new clinical study. The "data" here refers to the engineering and design comparisons made between the new device and the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. This submission does not describe a process of establishing ground truth for a clinical dataset using experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This submission does not include an MRMC comparative effectiveness study to assess human reader improvement with or without AI assistance. The device is a biopsy instrument, not an AI diagnostic tool.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done? No. This device is a physical biopsy instrument, not a standalone AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the clinical sense (e.g., pathology, outcomes data). The "truth" being established here is the substantial equivalence of the new device's design, function, performance, labeling, and sterilization to its predicate. This is based on engineering and design comparisons rather than clinical ground truth derived from patient data.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical instrument, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable. No training set exists for this type of device submission.
Summary of the 510(k) Logic:
The core of this 510(k) submission is to argue that the AUTO SUTURE* Biopsy Instrument** is so similar to the already-cleared IMAGYN Medical Inc's biopsy instrument (K944129) that it presents no new questions of safety or effectiveness. The "study" here is essentially the detailed comparison showing:
- Identical design, function, performance, labeling, and sterilization.
- Same indications for use.
- Similar manufacturing and packaging processes to other existing devices by the same manufacturer (USSC).
This approach allows manufacturers to introduce new versions of devices or devices very similar to existing ones without undergoing the full clinical trial process required for novel 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.