(484 days)
The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.
The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MD™ MATTRESS Suture Placement Device.
Important Note: The provided document is a 510(k) Premarket Notification from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving independent effectiveness from scratch. Therefore, the "study" described here is primarily a comparison and verification against the predicate device and established standards, not a de novo clinical trial to establish efficacy in humans.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" against specific numerical performance targets for the device's clinical operation (e.g., suture strength, success rate in tissue approximation). Instead, its acceptance criteria are primarily focused on:
- Meeting Design Input Requirements: All aspects of the device design and functionality must perform as intended.
- Equivalence to Predicate Device: The MD™ MATTRESS Device should perform comparably to the RD180® - THE RUNNING DEVICE®.
- Safety and Biocompatibility: The device should not introduce new risks and must be safe for patient contact.
- Sterility and Packaging Integrity: The device must maintain sterility and be appropriately packaged for its shelf life.
The reported device performance is largely qualitative and comparative, focusing on meeting these overarching criteria through various non-clinical tests.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Device must perform as intended (e.g., facilitate placement of a stitch, advance/retract needles, pick up suture, rearm). | "Functional Design Verification and Validation Testing to ensure the Design Input Requirements were met." (Result: Met) |
| Substantial Equivalence | Must demonstrate comparable intended use, indications for use, technological characteristics, target population, environment of use, and sterility/materials/packaging to the predicate device, without introducing new risks or negatively impacting safety/efficacy. | "Non-clinical performance data has demonstrated the subject device is substantially equivalent to the predicate device." "The MD™ MATTRESS Device and the predicate RD180® Device are substantially equivalent. The subject and predicate devices are comparable, and the differences do not introduce any new risks, and have no negative impact on the safety and efficacy of the MD™ MATTRESS Device." |
| Biocompatibility | Must conform to ISO 10993-1:2018 standards for externally communicating medical devices with limited contact (≤24 hours). Specific tests include chemical characterization, cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, and acute systemic toxicity. | "Biocompatibility per ISO 10993-1:2018... The battery of testing included: Chemical characterization, Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity." (Results met acceptance criteria) |
| Sterility | Must be sterilized with ethylene oxide to achieve a minimum lethality of 10⁻⁶. | "To be sterilized with ethylene oxide such that a minimum lethality of 10⁻⁶ is achieved." (Implicitly met through process, not a test result reported here for this specific device, but a manufacturing requirement.) |
| Packaging/Shelf-life | Must conform to ISO 11607-1:2019 and demonstrate a 2-year shelf life, ensuring packaging integrity and sterility maintenance. | "Packaging/Shelf-life Testing per ISO 11607-1:2019 demonstrating a 2 year shelf life." (Result: Met) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of devices or tests performed) for the "Functional Design Verification and Validation Testing," "Biocompatibility" tests, or "Packaging/Shelf-life Testing." The nature of these tests (e.g., material testing, functional checks) typically involves specific batch sizes or replicates determined by testing protocols, but these numbers are not disclosed in the summary.
- Data Provenance: The tests are explicitly stated as "Bench top performance testing" and "non-clinical tests." This indicates the data is from laboratory (in-vitro) or simulated environments, not from human subjects. The country of origin for the data is not specified but implicitly would be from the manufacturer's testing facilities or contract labs. The data is prospective in the sense that these tests were specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (biocompatibility, functional design, packaging) is established by adherence to recognized international standards (e.g., ISO 10993, ISO 11607), engineering specifications, and comparison to the predicate device. There is no mention of "experts" in the sense of clinical reviewers establishing a diagnostic ground truth for a test set. The evaluation of the test results against the acceptance criteria would be performed by qualified engineers, toxicologists, and regulatory experts.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers or readers interpreting data (e.g., imaging studies) where there might be inter-reader variability. For bench-top and non-clinical engineering tests, the results are typically objectively measured and evaluated against predetermined specifications, not subject to subjective adjudication among multiple human readers.
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
This is not applicable. The MD™ MATTRESS Suture Placement Device is a mechanical, hand-operated surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is entirely outside the scope of this device and submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. As stated above, this device is a mechanical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For this device, the "ground truth" for the non-clinical tests is established by:
- Engineering Specifications and Design Input Requirements: For functional performance, the device is tested against its own design specifications and expected performance characteristics.
- International Standards: For biocompatibility (ISO 10993) and packaging/shelf-life (ISO 11607), the "ground truth" is adherence to the scientifically validated methodologies and acceptance limits defined by these standards.
- Predicate Device Performance: For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the legally marketed predicate device (RD180® - THE RUNNING DEVICE®). The new device is evaluated to ensure it performs comparably and introduces no new risks.
There is no "pathology" or "outcomes data" directly from human patients contributing to the ground truth for this submission, as clinical testing was not performed or deemed necessary.
8. The Sample Size for the Training Set
This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
§ 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.