(86 days)
The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.
The SPIDER® Flexible Monopolar Instruments are surgical instruments used to facilitate laparoscopic surgery. The instruments are a part of the SPIDER® Flexible Surgical Instruments family. They are intended for use with the SPIDER® Single Port Device. The instruments may be used with or without electrocautery. The flexible electrocautery instruments are pre-sterilized, single use, disposable devices. The devices have a ring handle with ratchets where applicable, a rotation knob for rotating the shaft and distal tips, an electrocautery post for cable connection to an electrosurgical generator, a flexible shaft, and distal tips to manipulate tissue. The instruments may be used without connecting to a power source. However, when connected by a standard cable to an electrosurgical generator, the instruments may be used for cutting and coagulation of tissue. The instrument set includes: Flexible graspers for grasping tissue, Flexible shears for cutting tissue, Flexible dissectors for dissecting tissue.
The provided document describes the K122299 510(k) Summary for the SPIDER® Flexible Monopolar Surgical Instruments. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding AI-specific studies and detailed performance metrics is not directly applicable or available in this document.
However, I can extract the relevant information from the document regarding the device's testing and acceptance.
Device: SPIDER® Flexible Monopolar Surgical Instruments (Flex Monopolar Graspers, Wavy Ratcheted; Flex Monopolar Graspers, Serrated Ratcheted; Flex Monopolar Maryland Dissectors; Flex Monopolar Shears)
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Testing | Perform intended functions for laparoscopic surgical procedures and electrocautery functions; reliability. | "functionally tested and found to perform their intended functions for laparoscopic surgical procedures as well as their electrocautery functions and have been tested for reliability." |
| System Compatibility | Meet internal acceptance criteria for system compatibility with the SPIDER® platform. | "tested with the SPIDER® device and found to meet the internal acceptance criteria for system compatibility with the SPIDER® platform." |
| Sterility | Achieve a sterility assurance level (SAL) of 1x10⁻⁶; verified sterile per ISO 11137-1, -2, -3. | "Gamma sterility testing has been conducted... and has been shown to achieve a sterility assurance level of 1x10⁻⁶. The devices were verified as sterile via a dose audit study in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3." |
| Sterile Barrier & Shelf Life | Maintain sterility during shelf life; in accordance with ISO 11607-1, 11607-2, and ASTM F1980-07. | "the sterile barrier packaging has been tested for the SPIDER® Flexible Instruments family in accordance with ISO 11607-1 and 11607-2 and ASTM F1980-07 and has been found to maintain sterility during shelf life testing. The SPIDER® Flexible Monopolar Instruments have likewise been tested for functionality over time and have been found to maintain performance in accordance with the design specifications." |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing; in accordance with ISO 10993-1. | "tested for biocompatibility in accordance with ISO 10993-1 based on type and duration of contact to assure that they are non-cytotoxic, non-irritating and non-sensitizing." |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2; insulation integrity (HIPOT, dielectric withstand). | "evaluated and/or tested for compliance to the medical electrical safety standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 and found to be compliant. The device insulation has also been tested using high potential test (HIPOT) and dielectric withstand testing to assure that the insulation maintains its properties and does not breakdown." |
| Preclinical Performance | Perform as intended in laparoscopic procedures; no new safety/efficacy issues compared to predicates. | "The SPIDER® Flexible Monopolar Surgical Instruments have been tested in a preclinical swine study to evaluate their performance and success in laparoscopic procedures. The study found that the SPIDER® Flexible Monopolar Instruments performed as intended. When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy..." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size:
- Functional Testing: Not specified.
- Sterility: Not specified (refers to a "dose audit study" an ISO standard, but specific counts not given).
- Sterile Barrier/Shelf Life: Not specified.
- Biocompatibility: Not specified.
- Electrical Safety: Not specified.
- Preclinical Swine Study: Not specified.
- Data Provenance:
- Preclinical Swine Study: Conducted internally ("tested... in a preclinical swine study"). This would typically be considered prospective and controlled.
- Other tests (Functional, Sterility, Biocompatibility, Electrical Safety, etc.): Performed in-house or by accredited labs as part of the device development and verification process. No geographical origin or retrospective/prospective nature is specified, but these are generally considered prospective verification tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This document describes a medical device (surgical instruments), not an AI/algorithm-based diagnostic or imaging device where "ground truth" is established by human experts for test sets.
- The preclinical swine study involved evaluation of performance, likely by veterinarians, surgeons, or device engineers, but the specific number or qualifications are not mentioned. Their role was to observe and confirm device performance, not to establish ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set:
- Not applicable as this is a physical surgical instrument and not a diagnostic or AI system requiring adjudication of results or classifications against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as this is not an AI/imaging device. The study performed was a preclinical animal study to evaluate instrument performance.
- The document implies a comparison to predicate devices, stating "When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy," justifying why clinical data was not deemed necessary. This is a functional and design comparison, not an impact on human reader performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not applicable, as this is a physical surgical instrument. The device is always used with a human surgeon.
7. Type of Ground Truth Used:
- For this type of device, "ground truth" refers to the confirmed physical, mechanical, and biological properties and performance characteristics of the instrument. This was established through:
- Direct Measurement/Verification: Functional tests, dimensional checks, electrical tests (HIPOT, dielectric), biocompatibility assays.
- Standardized Protocols: Adherence to ISO standards for sterility, packaging, and biocompatibility.
- Preclinical Observation: Direct observation and assessment of performance in a live animal model (swine study) by qualified personnel (likely veterinarians/surgeons).
8. Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of this device. The development process would involve iterative design, prototyping, and testing against design specifications, but not data-driven training in the AI sense.
§ 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.