(89 days)
The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.
The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.
The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue.
The Flex™ Endoscopic Instruments are electrosurgical and non-powered endoscopic instruments for use in endoscopic surgical procedures for tissue manipulation, dissection, cutting, and coagulation. The product family includes a Monopolar Maryland Dissector, Monopolar Needle Knife, Monopolar Spatula, Needle Driver, Fenestrated Grasper, Monopolar Scissor, and Laser Fiber Holder.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional and Durability Testing: Device function and durability for intended use. | "Bench testing... was performed to evaluate device function and durability. Mechanical testing and simulated use testing was conducted to confirm that the device has the necessary mechanical performance for its intended use." - Acceptable |
| Dimensional Verification: Device dimensions meet specifications. | "Dimensional verification was performed to confirm that the device dimensions are as specified." - Acceptable |
| Electrical Safety and EMC (IEC 60601-1, 60601-1-2, 60601-2-2): Compliance with relevant electrical safety and electromagnetic compatibility standards. | "Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with: IEC 60601-1: 2005 3d Edition; IEC 60601-1-2:2007; IEC 60601-2-2:2009. 5th Edition" - Acceptable |
| Biocompatibility (ISO 10993-1, 10993-5, 10993-10, 10993-11): Tissue contact materials are biocompatible. | "Biocompatibility testing was conducted according to the following ISO Standards: ISO 10993-1; ISO 10993-5:2009; ISO 10993-10:2002 (A1 :2006); ISO 10993-11:2006." "Tissue contact materials are biocompatible per ISO 10993" - Acceptable |
| Sterility Assurance Level: SAL of $10^{-6}$. | "$10^{-6}$" - Met |
| Device Locking Features: Ability to hold articulation position. | "Yes" - Met |
| Tip Rotation: 360-degree rotation. | "Yes, 360°" - Met |
| Shaft Rotation: 360-degree rotation. | "360°" - Met |
| Minimum Endoscopic Cannula Size: 4mm minimum. | "4 mm minimum" - Met |
| Electrosurgical Function (for monopolar devices): Yes, monopolar. | "Yes, monopolar" - Met |
| Generator Compatibility (where applicable): Compatible with monopolar generators (e.g., Covidien ForceTriad™ Energy Platform or equivalent). | "Monopolar generator e.g. Covidien ForceTriad™ Energy Platform or equivalent" - Met |
| Warnings, Cautions, and Contraindications: Stated in IFU. | "Stated in IFU" - Met |
| How Supplied: Sterile, single-use only. | "Sterile single use only" - Met |
Study Proving Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria is a suite of nonclinical performance tests and analyses, rather than a single clinical trial. This includes:
- Bench Testing: Mechanical and simulated use testing to evaluate device function and durability.
- Dimensional Verification: To confirm the device dimensions.
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conducted in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Biocompatibility Testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.
The submission concludes that "Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a defined sample size in the context of the type of studies typically seen with AI algorithms or diagnostic devices. The tests performed are engineering evaluations (bench testing, dimensional, electrical, biocompatibility), which would involve a sample of manufactured devices or materials. The document does not provide the exact number of devices or material samples used for each specific test.
The data provenance is from laboratory and engineering testing conducted by the manufacturer, Design Standards Corporation. There is no indication of clinical data (e.g., country of origin, retrospective/prospective clinical studies) being used for this 510(k) submission, as it focuses on demonstrating technological equivalence to predicate devices through bench and material testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable for this type of submission. The "ground truth" for engineering and biocompatibility tests is established by adherence to recognized standards (e.g., IEC, ISO) and internal specifications, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpreting ambiguous cases, typically involving human readers. The tests performed here are objective engineering and laboratory tests with defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant for this Class II surgical instrument that relies on mechanical, electrical, and biocompatibility safety and performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This device is a physical surgical instrument, not a software algorithm that performs diagnostic or analytical functions independently.
7. Type of Ground Truth Used
The "ground truth" is based on:
- Engineering Specifications: For dimensional, functional, and durability tests.
- Defined Standards: For electrical safety (IEC standards) and biocompatibility (ISO standards).
- Predicate Device Characteristics: For demonstrating substantial equivalence.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission.
8. Sample Size for the Training Set
This information is not applicable. This device does not employ an AI algorithm or machine learning model that requires a training set. The "training set" concept is relevant for AI-powered devices, not for traditional surgical instruments.
9. How the Ground Truth for the Training Set was Established
This information is 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.