(51 days)
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures.
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is an endoscopic stapling device. The device is disposable and is supplied sterile.
This 510(k) premarket notification (K96399) for the United States Surgical Corporation's AUTO SUTURE* Modified Endoscopic Fascia Stapler** is very limited in the detail it provides regarding performance testing. It lacks sufficient information to address most of your specific questions.
Here's an analysis based on the provided text, highlighting what's available and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fastener Security | "adequate fastener strength." |
- Comment: The document doesn't provide specific quantitative acceptance criteria (e.g., minimum tensile strength in Newtons, or a pass/fail rate for fastener pull-out). It simply states the device was tested to evaluate fastener security and that the results demonstrated "adequate fastener strength." This is a very high-level and subjective statement.
2. Sample Sized Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
- Comment: The document only mentions "tested both in-vivo and in-vitro." No details on the number of staples, animals, or human subjects used for either type of testing are provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This device is a surgical stapler, not an diagnostic imaging or AI device. Ground truth as typically understood in the context of expert review for AI performance is not relevant here. The "ground truth" would be the mechanical integrity and biological response to the staples, evaluated through direct measurement or observation.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not relevant for a surgical stapler. MRMC studies are typically used for diagnostic or screening devices where human readers interpret data (e.g., medical images), and the effect of AI on their performance is being evaluated.
6. Standalone Performance Study
- Yes, implicitly. The document states "The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device was tested both in-vivo and in-vitro to evaluate fastener security." This testing would represent the standalone performance of the device itself.
- Comment: While "standalone" is usually used in the context of AI, for a physical medical device, testing its performance without human intervention (i.e., the device's inherent mechanical properties) would be considered standalone.
7. Type of Ground Truth Used
- Mechanical Measurement and Biological Observation: The "ground truth" for fastener security would likely have been established through:
- In-vitro: Mechanical testing (e.g., pull-out strength, sheer strength, burst pressure in model tissue) using standardized methods.
- In-vivo: Direct observation of staple line integrity, healing, and absence of complications (e.g., leakage, dehiscence) in animal models.
- Comment: No specific details are provided in the document.
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/machine learning algorithm. The concept of a "training set" for AI is not relevant here. The design and manufacturing process would be informed by prior engineering principles and potentially previous device data, but not in the same way an AI algorithm is "trained."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of Limitations:
This 510(k) summary provides very sparse information about the performance testing. It lacks granular details such as:
- Specific quantitative acceptance criteria.
- The number of test articles or subjects.
- The specific tests performed (e.g., what kind of in-vitro tests, what animal model for in-vivo).
- The actual numerical results obtained from these tests.
- A direct comparison to the predicate device in terms of performance metrics.
This level of detail is typical for older 510(k) summaries which were often considerably less comprehensive than current submissions. The statement "The results of this testing demonstrate that the subject device provides adequate fastener strength" is a very broad conclusion without supporting data in this summary.
§ 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.