(157 days)
This procedure kit is intended to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. It is to be used only by surgeons trained in laparoscopic surgery.
The components of the Mctra PS Procedure Kit are One needle point suture passer, one grasper, one knot pusher/ positioning device, suture matcrial, and two suture guides.
This document is a 510(k) premarket notification for the Inlet Medical Inc. Metra Positioning System (PS) Procedure Kit. It claims substantial equivalence to a predicate device and does not involve AI or complex software. As such, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is not applicable to this type of medical device submission.
Here's why and what information can be extracted:
Not Applicable Sections & Why:
- Acceptance Criteria & Reported Device Performance Table: This device is a manual surgical instrument. Its "performance" is primarily related to its mechanical function, material compatibility, and similarity to a known predicate. There are no quantifiable performance metrics like sensitivity, specificity, accuracy, or F1-score typically associated with AI/software devices. Equivalence is based on design and intended use.
- Sample size for the test set and data provenance: No test set in the AI/software sense exists. Evaluation for such devices typically involves design verification, manufacturing controls, and comparison to a predicate.
- Number of experts used to establish the ground truth for the test set and qualifications: Ground truth, in the context of AI, refers to expert labeling or definitive diagnoses. This is not relevant for a manual surgical instrument.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as there is no AI component to measure human improvement with or without.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable, as this is a manual instrument requiring human operation.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- Sample size for the training set: Not applicable, as there is no AI algorithm to train.
- How the ground truth for the training set was established: Not applicable.
What can be extracted/inferred from the document regarding "acceptance" and "study":
-
Acceptance Criteria (Implicit - Substantial Equivalence): The primary "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to a predicate device already legally marketed in the US. This means showing that the new device is as safe and effective as the predicate.
- Key aspects of substantial equivalence are:
- Same intended use.
- Similar technological characteristics (design, materials, operating principles).
- Any differences do not raise new questions of safety or effectiveness.
- Key aspects of substantial equivalence are:
-
Reported Device Performance (Implicit - Similarity to Predicate):
- Intended Use: "To facilitate passage of suture through the soft tissues of the body during laparoscopic surgery." (Identical to predicate)
- Design/Technological Characteristics: "The Inlet Medical Inc. disposable Metra PS Procedure Kit is substantially equivalent to the Needle-Point Suture Passer Instruments Set. Both the Metra PS Procedure Kit and the predicate device, Needle Point Suture Passer Instrument Sct (K980123), are similar in design. The predicate device consists of a Needle Point Suture Passer and 2 suture guides." The new kit adds a grasper, knot pusher/positioning device, and suture material for convenience, which are considered non-significant differences that do not alter the fundamental safety or effectiveness of the suture passing function.
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The "Study" (Comparison to Predicate):
- The "study" in this context is a comparison of technological characteristics and intended use between the new device and the predicate device, as presented in Section 6 of the submission. The FDA reviews this comparison to determine substantial equivalence.
Summary based on the provided document:
| Criteria/Aspect | Description/Finding |
|---|---|
| Acceptance Criteria | Demonstration of Substantial Equivalence to a Predicate Device. This involves showing: |
- Same intended use.
- Similar technological characteristics (design, materials, operating principles).
- Any differences do not raise new questions of safety or effectiveness. |
| Reported Device Performance | The device's "performance" is deemed substantially equivalent to the predicate device, the Inlet Medical Needle Point Suture Passer Instrument Set (K980123). Both are intended to facilitate suture passage during laparoscopic surgery and are similar in design. The additional components in the Metra PS Procedure Kit (grasper, knot pusher/positioning device, suture material) are for convenience and do not alter the core function or safety/effectiveness of the suture passing mechanism compared to the predicate's core components. |
| Sample Size (Test Set) | Not applicable (no test set in the context of AI/software performance evaluation). This is a manual surgical instrument. |
| Data Provenance | Not applicable. |
| Number of Experts (Ground Truth) | Not applicable. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness | Not applicable (no AI component). |
| Standalone Performance | Not applicable (manual instrument, not an algorithm). |
| Type of Ground Truth | Not applicable. |
| Sample Size (Training Set) | Not applicable (no AI component or training set). |
| Ground Truth for Training Set | Not applicable. |
§ 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.