(312 days)
Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).
Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility. The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing). The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts. The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir
The provided text describes a 510(k) submission for Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" here refer to demonstrating this substantial equivalence through various tests, primarily non-clinical, rather than specific performance metrics against a disease outcome.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are typically demonstrating equivalence in design, technical characteristics, intended use, indications for use, sterilization processes, and materials, as well as meeting established performance standards for safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance (Endoservice Endoscopic Instruments) | Predicate Device (GIMMI ALPHA® Instruments, K012660) |
|---|---|---|
| Design & Technical Characteristics | Diameters & Lengths: |
- Tube: 3.5-12.5mm, 70-150cm
- Cystoscope, Resectoscope, Urethrotome: Length 298-310mm, Diameter 2.7mm, 2.8mm, 2.9mm, 4.0mm | Diameters & Lengths:
- Tube: 3.5-12.5mm, 40-105cm
- Laparoscope: Length 270-330mm, Diameter 5.0mm, 10mm, 11mm
- Cystoscope, Resectoscope, Urethrotome: Length 300mm, Diameter 4.0mm |
| Materials | Steel 1.4301; plastic PPSU; adhesive hysol-resin; sapphire lens | Stainless Steel; Insulation material |
| Components | Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Punches, Tube, Sheath, Needle holder, and Inserts. | Dismantable and Non-dismantable; Insulated and non-insulated; Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knife, Hook, Knot Guide, Retractors, Divers and Blades. |
| Intended Use & Indications for Use | Intended for qualified physicians to provide access and visualization of internal structures (e.g., bladder, urethra, kidneys, prostate) and manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing). | Identical to GIMMI ALPHA® Instruments (implied by "identical to the predicate device...in terms of...intended use, indications for use"). |
| Sterilization Processes | Identical to GIMMI ALPHA® Instruments (stated). Validation Tests of Sterilization, Disinfection and Cleaning (automatically) performed. | Follows predicate device's sterilization processes. |
| Biocompatibility | Body contact portions composed of surgical grade stainless steel, "long history of biocompatibility." Cytotoxicity Test performed. | Implied by established predicate. |
| Safety and Effectiveness (Non-clinical Performance) | Successfully tested according to ISO 8600, ISO 10993, ISO 11737, ISO 17665, ISO 15883, and ISO 14971. Bending Tests, Material Tests, Bench Tests, and Microbiological Test for determination of microorganisms performed. Conclusions: devices are as safe and as effective, and perform as well as or better than the legally marketed device, and do not raise new issues regarding safety and effectiveness. | Legally marketed predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the "sample size" in terms of number of devices or components used for each non-clinical test. It lists the types of tests conducted (Bending Tests, Material Tests, Bench Tests, Validation Tests of Sterilization, Disinfection and Cleaning, Cytotoxicity Test, Microbiological Test). The data provenance is implied to be from internal testing conducted by Endoservice Optical Instruments GmbH (a German company), and it is retrospective in the sense that these tests were performed and results compiled for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For a non-clinical 510(k) submission for instruments like these, "ground truth" as it's typically understood in diagnostic AI studies (e.g., expert consensus on medical images) is not directly applicable. The "ground truth" here is adherence to engineering standards and safety tests, which are objective measurements rather than subjective expert interpretations.
4. Adjudication Method for the Test Set
This information is not provided and is not typically relevant for non-clinical testing of medical instruments. Adjudication methods (like 2+1 or 3+1) are usually found in clinical studies involving interpretation of data where disagreements among reviewers need resolution.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those using AI, where human performance with and without assistance is measured. This submission is for direct-use endoscopic instruments, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm-only) performance study was not done. This is not an AI or algorithm-based device. The device itself is the instrument used by a human physician directly.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the objective measurements and results from the non-clinical performance tests conforming to recognized international standards (e.g., ISO 8600, ISO 10993). This includes:
- Material properties: Verifying that materials meet specified compositions and strength.
- Dimensional accuracy: Ensuring diameters and lengths are within acceptable ranges.
- Biocompatibility: Results of cytotoxicity tests.
- Sterilization efficacy: Validation of cleaning and sterilization processes.
- Functional integrity: Results from bending and bench tests demonstrating durability and performance.
- Microbiological tests: Confirming absence of microorganisms where required.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm requiring a training set. This is a conventional medical instrument.
9. How the Ground Truth for the Training Set was Established
This information 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.