(62 days)
The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.
The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.
Acceptance Criteria and Study Details for Injectra Injection Needle
This submission (K061222) pertains to the Injectra Injection Needle and demonstrates its substantial equivalence to a predicate device. The performance data focuses on verification that the new device meets established requirements and maintains safety, rather than providing complex clinical trial outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (GIP/Medi-Globe Sclerotherapy Needle, K955558) | The Injectra Injection Needle meets the same performance requirements as the predicate device. |
| Safety and Effectiveness Equivalence to Predicate Device | The Injectra Injection Needle is "as safe and effective as the predicate GIP/Medi-Globe device." |
| Biocompatibility/Biological Safety | Biological testing performed due to a change in indirect patient-contacting materials indicated that the Injectra Needle "does not affect the biological safety of the patient." |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in the traditional sense of a clinical or analytical study with a defined dataset. The performance data section refers to "Design verification data" and "Biological testing," which are typically internal engineering and laboratory tests.
- Test Set Sample Size: Not explicitly stated as a defined "sample size" for a dataset. Design verification and biological testing are usually conducted on a set number of manufactured devices or materials.
- Data Provenance: The nature of "Design verification data" and "Biological testing" suggests these are results from internal testing conducted by the manufacturer, Medi-Globe Corporation. The country of origin and whether it is retrospective or prospective are not specified, but such tests are generally prospective (performed on new designs or materials).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This submission does not involve expert-established ground truth for a test set in the context of diagnostic accuracy. The "ground truth" for this type of device (an injection needle) is largely based on engineering specifications, material properties, and established biological safety standards. There is no mention of external experts being used to establish a ground truth for performance.
4. Adjudication Method for the Test Set
Not applicable. The performance data described are based on objective engineering and laboratory tests, not subjective interpretations requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Injectra Injection Needle is an interventional accessory device.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (algorithm only) was not conducted. This device is a physical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance relies on:
- Engineering Specifications and Performance Requirements: Measured against pre-defined functional parameters (e.g., fluid delivery capability, structural integrity, compatibility with endoscopes).
- Predetermined Safety Standards: Biological testing confirms the device meets accepted biocompatibility standards.
- Equivalence to Predicate Device: The primary ground truth is established by demonstrating that the new device performs identically or equally well to the legally marketed predicate device (K955558) in terms of its intended function and safety profile.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.