(372 days)
The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.
The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.
This document describes a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than "prove" performance against acceptance criteria in the manner of a novel device study. Therefore, the questions related to AI studies, multi-reader multi-case studies, and ground truth for training sets are not applicable here.
Here's an analysis based on the provided text, focusing on how the device demonstrates equivalency rather than meeting specific performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate device, K033842 Nubert, and relevant safety and performance standards. The "reported device performance" for the Mediflex 24003-MF is its characteristic comparison to the predicate.
| CHARACTERISTICS | Mediflex 24003-MF (Reported Device Performance) | Acceptance Criteria (Predicate Device K033842 Nubert and Standards) | Met/Not Applicable |
|---|---|---|---|
| Sterility Method | ISO11135-1 EO method (SAL: 10-6) | Radiation process (SAL: 10-6) | Met (Equivalent SAL) |
| Sterile Bag Material | PU coated on nylon polyamide | PU coated on nylon polyamide | Met |
| Size (Area Dimension) | 195mm x 90mm | 195mm x 90mm | Met |
| Open/Close Method | Instruction (1 page) | Instruction (2 pages) | Met (Identical procedure) |
| Disposal | One (1) time use | One (1) time use | Met |
| Function | Collection, extraction of tissue via 10mm, 11mm or 12mm cannula | Collection, extraction of tissue via 10mm, 11mm or 12mm cannula | Met |
| Biocompatibility | ISO10993-1 | ISO10993-1 | Met |
| Durability/Life | ISO11607 / 5 year shelf (with Tyvek Peel Pouch) | ISO11607 / 5 year shelf | Met |
| Body Contact Type/Duration | Tissue, Blood / |
§ 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.