(294 days)
The COR-KNOT MICRO™ device with COR-KNOT MICRO™ fastener when used in conjunction with USP 6-0, 7-0, or 8-0 polypropylene surgical suture, is indicated for use in the approximation of soft tissue.
The COR-KNOT MICRO™ Device is a sterile, single patient use device provided to the user preloaded with a single COR-KNOT MICRO™ fastener. Made from medical grade titanium, the COR-KNOT MICRO™ fastener is a hollow sleeve with a rounded base. A white plastic target holds the loop shape of a wire snare. The wire snare passes through the COR-KNOT MICRO™ fastener and is attached to a snare puller knob. A suture slot in the device shaft lies under the opening in the snare puller. The ends of a USP 6-0, 7-0, or 8-0 polypropylene suture are passed through the wire snare and subsequently threaded into the titanium fastener. The snare puller attached to its wire snare is pulled up along the device shaft until it snaps onto the puller retainer feature of the purple knob, which also has an integrated indicator fin. The suture slot and the indicator fin are located on the same side of the device shaft. The subsequently crimped fastener and remnant trimmed suture tails bend slightly in the direction away from or opposite from the suture slot and indicator fin. By rotating the purple knob and the device's white handle, the surgeon can ergonomically orient the direction of the suture tails, if desired. A yellow lever stop is located behind the purple lever to restrict inadvertent squeezing of the lever during device handling before crimping. The lever stop is removed by pinching its sides together and pulling it out of the handle. By squeezing the purple lever, the COR-KNOT MICRO™ Device crimps the COR-KNOT MICRO™ fastener to fasten together segments of suture and trims away excess suture.
One COR-KNOT MICRO™ Device is provided per package, and the COR-KNOT MICRO™ Device is not intended to be reloaded or reused.
The COR-KNOT MICRO™ device is intended for use in the approximation of soft tissue.
The acceptance criteria and device performance information for the COR-KNOT MICRO™ device are derived from the provided FDA 510(k) summary.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (COR-KNOT MICRO™) |
|---|---|---|
| Functional Verification & Validation | ||
| Knot Pull Apart (KPA) Force | A Fastener must secure 6-0, 7-0, and 8-0 polypropylene suture with knot pull apart (KPA) forces exceeding USP standards. Both the predicate and subject devices exceed USP KPA specifications for their compatible suture. | The COR-KNOT MICRO™ device successfully secured 6-0, 7-0, and 8-0 polypropylene suture, exceeding USP KPA standards. This was demonstrated through bench testing and a simulated "malignant hypertension pressure simulator" study. In the latter, 60 fasteners (20 for each suture size) held without compromise through 5,591,970 distinct hypertensive pulses each, totaling over 335 million pulses cumulatively. |
| Fastener Integrity | Fastener shall not be damaged prior to deployment. | All functional verification and validation tests were met, including ensuring the fastener was not damaged prior to deployment. |
| Device Retention of Fastener | Device shall retain fastener prior to crimping/cutting without the fastener dislodging from the tip of the device. | All functional verification and validation tests were met. |
| Fastener Release | Releasing the crimped fastener from the device shall not damage the fastener. | All functional verification and validation tests were met. |
| Suture Cutting | The device shall cut the suture after a completed crimp. | All functional verification and validation tests were met. |
| Tissue Damage | Crimped fastener shall not cause more damage to anatomy than hand tied suture/knots. | An acute animal study compared COR-KNOT MICRO™ fasteners to hand-tied knots. The COR-KNOT MICRO™ titanium fastener provided superior or equivalent – and never inferior – results for ease of use, wound approximation, hemostasis, burst strength, and tensile strength compared to controls. |
| Device Compatibility | The device shall be compatible with only COR-KNOT MICRO™ fasteners. | All functional verification and validation tests were met. |
| Suture Compatibility | System compatible with 6-0, 7-0, and 8-0 sized polypropylene sutures. | The device is specifically designed and indicated for use with USP 6-0, 7-0, or 8-0 polypropylene surgical suture. Performance testing confirmed compatibility and efficacy with these suture sizes. |
| Reloading Prevention | The device will prevent reloading in the field. | The device is explicitly stated as sterile, single-patient use, and not intended to be reloaded or reused. Functional testing verified this. |
| Shaft Length | Inserted shaft length shall be comparable to other related surgical devices demonstrated to reach superficial surgical access sites and most open and minimally invasive surgical site locations. | All functional verification and validation tests were met. |
| Surgical Site Visibility | Device shall allow for surgical site visibility. | All functional verification and validation tests were met. |
| Tissue Damage Mitigation | Inserted portion of device and entirety of fastener shall be shaped to reduce risk of tissue damage or other iatrogenic injury. | All functional verification and validation tests were met, supported by the animal study showing no inferior results for tissue damage compared to hand-tied knots. |
| Function in Surgical Conditions | The device and fastener must function with exposure to typical surgical conditions. | All functional verification and validation tests were met. The malignant hypertension simulation specifically tested extreme conditions. |
| Single Fastener Firing | Device must be capable of firing the single fastener provided with the device. If multiple fasteners are required within a case, multiple devices must be used. | All functional verification and validation tests were met. |
| Suture Loading Ease | The device shall allow suture to be easily loaded through the titanium fastener and distal end of the device. | All functional verification and validation tests were met. |
| Lever Stop Removal | The user must be able to remove Lever Stop prior to use of the device. | All functional verification and validation tests were met. |
| One-Handed Crimping | The user must be able to crimp a fastener with one hand. | All functional verification and validation tests were met. |
| User Safety | The device shall not cause harm to the user. | All functional verification and validation tests were met. |
| Biocompatibility | Per ISO 10993-1:2018. The COR-KNOT MICRO™ device is made from identical materials as the predicate device (stainless steel and polymer delivery device with a titanium fastener), which conforms to ISO 10993. | The device successfully met biocompatibility requirements per ISO 10993-1:2018. |
| Packaging/Shelf-life | Per ISO 11607-1 demonstrating a 3 year shelf life. The device is comparably packaged to the predicate (rigid thermoformed blister tray with Tyvek cover vs. PETG tray and snap retainer lid sealed in Tyvek/nylon pouch). | Packaging/Shelf-life testing per ISO 11607-1 demonstrated a 3-year shelf life. |
| Durability/Worst-Case Scenario | Secure and maintain closure under extreme physiological conditions (e.g., supraphysiologic pressure, prolonged healing time, high heart rate, worst-case wound repair). | A custom malignant hypertension pressure simulator study successfully demonstrated the strength and stability of the fasteners. 60 fasteners (20 of each suture size: 6-0, 7-0, 8-0) held without compromise for 6 weeks under >360/240 mmHg arterial pressure at 90 pulses/minute, totaling 5,591,970 distinct hypertensive pulses per closure. Burst strengths in an acute animal study also exceeded supraphysiologic worst-case anticipated conditions. |
| Ease of Use & Efficacy in Vivo | Comparable or superior performance to hand-tied knots regarding ease of use, wound approximation, hemostasis, burst strength, and tensile strength in an acute animal model. | An acute animal study confirmed that the device is easy to use and provides excellent wound approximation resulting in hemostasis, with superior or equivalent (never inferior) results compared to hand-tied knots for the specified endpoints. Burst strength of harvested specimens exceeded supraphysiologic worst-case anticipated conditions. |
Study Details:
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A table of acceptance criteria and the reported device performance: (Provided above)
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Sample sizes used for the test set and the data provenance:
- Bench Testing (Functional Verification & Validation): The specific sample sizes for each of the functional verification and validation tests are not explicitly stated as numerical values in the provided text. The text states "all results met the performance and risk-based acceptance criteria," implying that adequate samples were tested for each criterion.
- Malignant Hypertension Pressure Simulator (Durability):
- Test Set: 60 COR-KNOT MICRO™ titanium fasteners (20 each for 6-0, 7-0, and 8-0 polypropylene suture).
- Data Provenance: Retrospective, conducted in a laboratory setting (bench testing). No geographical data provenance is specified, but it's an in-vitro simulation.
- Acute Animal Study (Safety & Effectiveness):
- Test Set: Specific number of animal subjects is not given, but the study compared the COR-KNOT MICRO™ Device in worst-case size blood vessels to hand-tied knots under the same conditions.
- Data Provenance: Prospective, conducted in an animal model (in vivo pig model). No geographical data provenance is specified beyond it being an "acute animal study."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The provided text does not indicate the use of experts to establish a "ground truth" in the traditional sense of human readers/interpreters adjudicating medical images or clinical outcomes.
- The "ground truth" for this device appears to be established through objective performance metrics from standardized bench testing protocols, validated simulation models, and comparison to a known standard (e.g., USP KPA standards) or predicate device performance.
- For the animal study, the "ground truth" for clinical endpoints (ease of use, wound approximation, hemostasis, burst strength, tensile strength) would have been established by the study investigators/veterinary surgeons performing the procedures and analyses, but their specific number or qualifications beyond being part of the "LSI" team are not detailed.
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Adjudication method for the test set:
- Not applicable in the context of human reader/AI adjudication. The testing involved objective measurements and comparisons against predetermined criteria and a predicate device's performance.
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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:
- No MRMC comparative effectiveness study was done. This is a medical device, not an AI software intended for image interpretation assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a standalone medical device (a knot-tying device), not an algorithm. Therefore, "standalone performance" refers to the device's inherent mechanical and functional performance, which was extensively tested without human "interpretation" in the loop. The device's performance is tested directly (e.g., crimping strength, cutting ability, durability).
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The type of ground truth used:
- Objective Performance Metrics / Engineering Specifications: For functional verification, validation, and durability testing (e.g., KPA force, proper crimping, suture cutting, structural integrity under pressure). These are derived from established engineering standards and the device's design inputs.
- Comparison to USP Standards: For Knot Pull Apart (KPA) force.
- Comparison to Predicate Device Performance: The underlying performance of the predicate device serves as a benchmark for equivalence.
- Animal Model Outcomes: For in-vivo safety and effectiveness, including measures like ease of use, wound approximation, hemostasis, burst strength, and tensile strength, compared to hand-tied knots. These are physiological outcomes observed and measured in the animal subjects.
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The sample size for the training set:
- Not applicable. This is a physical, mechanical medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.