(223 days)
The single use BullDog® Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The Medovations Disposable Biopsy Valve is a single piece construction of molded thermoplastic elastomer. The biopsy valve has a cylindrical body with an open inner diameter for device passage. This cylindrical body has a connected cap with a slit to allow for endoscopic device passage and exchange, to help maintain sufflation, to minimize leakage of biomaterial from the biopsy port throughout endoscopic procedures, and to provide access for irrigation. The distal part of the biopsy valve body is molded to fit the biopsy/suction channel of the endoscope. The proximal part of the biopsy valve body is molded to fit around the cap when it is in the closed position. The Medovations Disposable Biopsy Valves are manufactured in two configurations one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. The Olympus®/Fujinon® versions are sold as both sterile and non-sterile devices. The Pentax® version is sold non-sterile. The Irrigating Adaptor accessory is comprised of a metal tube with standard luer lock and can be used with the biopsy valve to provide access for irrigation.
The provided documentation describes the Medovations BullDog® Biopsy Valve and details non-clinical bench testing conducted to demonstrate its substantial equivalence to a predicate device (US Endoscopy BioShield® ERCP Biopsy Valve, K070420).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, the performance evaluation is based on comparison to a predicate device, aiming to show "as well as or better than" performance.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fluid Flush Performance | No fluid backsplash onto the user. (Performance comparable to predicate device) | Performed as well as the predicate device; no fluid backsplash identified. |
| Leak Testing | Maintain sufflation and minimize leakage. (Performance comparable to or better than predicate device) | Performed as well as or better than the predicate device in maintaining applied vacuum pressures. |
| Compatibility with Endoscope | Remaining seated on biopsy/suction channel. (Performance comparable to predicate device) | Performed as well as the predicate device in remaining seated. |
| Squeegee Performance | Effectively remove materials from a device passing through it. (Performance comparable to predicate device) | Visually performed as well as the predicate device in removing materials. |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶; EO residuals below defined maximum levels; maintain sterile barrier for at least 5 years. | Achieved SAL of 10⁻⁶; EO residuals below maximums; packaging maintains sterile barrier for at least 5 years. |
| Shelf Life | 3-year expiration date. | 3-year expiration date, supported by material equivalence and existing packaging data. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that testing was performed on "Medovations samples from initial production lots." It does not specify the exact sample size for each test (e.g., number of biopsy valves tested for fluid flush, leak testing, etc.).
- Sample Size for Test Set: Not explicitly stated as a number, but refers to "initial production lots."
- Data Provenance: The studies were non-clinical bench tests conducted by Medovations, Inc. The data is internal to the manufacturer. No country of origin for the data is specified beyond being conducted by Medovations (Milwaukee, WI, USA). The studies are prospective in the sense that they were conducted specifically for this submission, but they are bench studies, not human or animal studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The "ground truth" for these tests was established through objective measurements and visual assessments based on predefined criteria, not expert consensus or interpretation of medical images. For example, leak testing involved measuring vacuum, and squeegee performance involved visual evaluation against a predicate.
4. Adjudication Method for the Test Set
This section is not applicable. The tests performed are objective bench tests, not requiring adjudication methods like those used in clinical trials (e.g., 2+1, 3+1).
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
This section is not applicable. This submission is for a physical medical device (biopsy valve), not an AI/software device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. As mentioned above, this is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical bench tests was based on objective physical measurements and visual assessments against predefined performance indicators and comparison to a legally marketed predicate device. For example:
- Fluid Flush: Visual confirmation of no backsplash.
- Leak Testing: Quantitative measurement of vacuum maintenance.
- Compatibility: Visual confirmation of secure fit and function.
- Squeegee Performance: Visual evaluation of material removal.
- Sterilization/Shelf Life: Laboratory tests measuring SAL, residuals, and packaging integrity.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" as this is a physical device submission, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
§ 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.