(79 days)
This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.
The Endoscopic Applicator is a re-usable applicator used to deliver hemostatic agents to bleeding surgical sites. The Endoscopic Applicator consists of two components; (1) a non-reflective stainless steel cannula, and (2) a stainless steel stylet (obturator). The Endoscopic Applicator is to be thoroughly cleaned and sterilized before each use, and can be used up to 20 times.
The provided text is a 510(k) summary for the Baxter Healthcare Corporation Endoscopic Applicator. This document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) submission for a device like the Endoscopic Applicator typically does not include studies demonstrating the device meets a set of acceptance criteria in the same way a diagnostic AI device would. Instead, the primary "study" in a 510(k) is the demonstration of substantial equivalence to existing, legally marketed predicate devices through a comparison of features, intended use, materials, and performance characteristics. The acceptance criteria are implicit in meeting the performance characteristics of the predicate devices and ensuring the new device does not raise new questions of safety and effectiveness.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not explicitly detailed in this type of regulatory submission. The document focuses on demonstrating similarity to already approved devices rather than proving performance against specific clinical metrics through direct studies.
However, I can extract information relevant to the equivalence demonstration as a proxy for how the "device meets acceptance criteria" within the context of a 510(k).
Acceptance Criteria and Device Performance (within the context of Substantial Equivalence):
The "acceptance criteria" for a 510(k) are essentially that the new device shares similar intended use, design, components, materials, and performance characteristics with predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is a comparison of these characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria (Implied) | Baxter Endoscopic Applicator (Reported Performance - New Device) | Predicate Devices (MedChem K913172, MedChem K932466, Davol K930147) (Benchmark) |
|---|---|---|
| Intended Use | Delivers hemostatic agents to bleeding surgical sites through 5mm or larger trocar. | Deliver surgical products into the body (e.g., maintain pneumoperitoneum, facilitate delivery of adjunctive surgical products, facilitate delivery of surgical mesh). |
| Anatomical Sites | Endoscopic / Laparoscopic | Endoscopic, Various, Laparoscopic (abdominal soft tissue) |
| Sheath Outer Diameter | 5mm | 0.394" (approx. 10mm), 0.197"-0.750" (approx. 5-19mm), 9.7mm |
| Sheath Length | 292mm | 13.31" (approx. 338mm), 8"-13" (approx. 203-330mm), 8" (approx. 203mm) |
| Cannula Size Use With | 5mm or larger | Minimum 10mm OD, Various, 10mm or larger |
| Main Components | Cannula, Stylet | Sheath, Plunger, Plunger O-Ring; Introducer Sheath/Handle, Introducer Rod/Handle |
| Main Materials | Stainless Steel, Stainless Steel, ME-92 Coating | Polycarbonate, Silicone, Medical Grade; Stainless Steel/PVC |
| Sterilization Method | Non-sterile (user cleans and sterilizes before/after each use) | Gamma or dry heat cycle (SAL 10-6), EtO (SAL 10-6) |
| Expiration Date | N/A - reusable up to 20 times | Unknown (for predicate single-use devices) |
| Single Use Only | Reusable | Single Use |
| Packaging | PETG tube, LDPE poly tubing, Vinyl End Cap, 200 lb. test #3 white cardboard box (non-sterile barrier) | Polycarbonate plastic tray sealed with a polyethylene lid; Tyvek pouch in a plastic blister tray (sterile barrier implied for single-use devices) |
G. Substantial Equivalence Statement: The Endoscopic Applicator is claimed to be "substantially equivalent to the predicate devices in intended use, design and components, materials, and performance characteristics." The differences (e.g., reusability vs. single-use, user sterilization vs. pre-sterilized) are implicitly argued not to raise new safety or effectiveness concerns.
Detailed Study Information (as requested, but largely Not Applicable for a 510(k) of this device type):
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This 510(k) does not describe a clinical study with a "test set" in the context of evaluating diagnostic performance. The "test" is the comparison to predicates and potentially bench testing to ensure mechanical properties, but no clinical outcome data or diagnostic performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. No "ground truth" for a test set is established in this document, as it is not a diagnostic device or a device requiring clinical performance evaluation against a diagnostic standard.
4. Adjudication method for the test set:
- Not Applicable / Not Provided.
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:
- Not Applicable / Not Provided. This is a surgical instrument, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable / Not Provided. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided.
8. The sample size for the training set:
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided.
Summary of Device Acceptance (Regulatory Perspective):
The "acceptance criteria" in this case are primarily regulatory and descriptive. The device "meets the acceptance criteria" by demonstrating that:
- Intended Use is similar: The device delivers agents to surgical sites, similar to the predicate devices.
- Technological Characteristics are similar: Despite some differences (e.g., dimensions within a functional range, reusability vs. single-use, user sterilization), the fundamental method of operation (delivery of agents through a trocar) and materials are considered functionally similar to the predicates.
- Performance Data (implicitly): The submission implies that any necessary engineering or bench testing (not detailed here) would demonstrate the device performs as expected for a surgical applicator (e.g., structural integrity, sterility after user processing, material compatibility) and that these performances are comparable to the predicates or acceptable for its intended use without raising new safety or effectiveness concerns. The FDA's issuance of the 510(k) clearance (K031882) confirms that the agency found the device substantially equivalent to its predicates, thus "accepting" the device under those criteria.
§ 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.