(163 days)
The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.
The Utepreva Endometrial Sampler (UP01) is a single-use, sterile device designed to obtain endometrial cytological and histological samples. The device is an Rx device that functions as follows: The Utepreva Endometrial Sampler is gently inserted though the cervix into the uterus. The skirt (guard) will reach the cervix indicating to the clinician to stop inserting the device. The brush is then extended by pushing the handle until resistance is felt when the tip meets the fundus of the uterus. The sponge on the tip is intended to minimize the risk of piercing of the fundus by the tip of the brush and enables additional tissue sampling by absorption of the fluid and the cells from the uterus. The Utepreva Endometrial Sampler is rotated in a clockwise or counterclockwise manner for four or five 360° rotations. Upon completion of the rotations, the handle is pulled back so that the brush and tip are withdrawn into the outer sheath. The suction created by the plunger located inside of the sheath provides aspiration of the cells and prevents loss of the sample from the brush, sponge and any fluid that was aspirated can then be immersed into the preservative solution to be used by the pathology lab.
The device materials consist of polydimethylsiloxane, high density polyethylene, cyanoacrylate adhesive, Loctite, Permabond polyolefin primer, stainless steel, Nylon, polycarbonate, and polypropylene. The device is packaged in a Tyvek® pouch. One pouch is then packaged in a unit box. Fifteen unit boxes are packaged within a single master box to create the final shipped product.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification letter from the FDA, and it focuses on the substantial equivalence of the "Utepreva Endometrial Sampler (UP01)" to a predicate device.
While it mentions non-clinical performance testing (biocompatibility, visual & dimensional inspection, tensile strength, torque, bristle retention, fluid retention, fluid transfer) and states that these tests "passed," it does not:
- Provide a table of specific acceptance criteria and reported device performance values. It only states "Pass" for each test.
- Detail the sample size used for the test set.
- Specify the data provenance (e.g., country of origin, retrospective/prospective).
- Mention the number or qualifications of experts used to establish ground truth.
- Describe any adjudication method.
- Indicate if a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Discuss standalone performance (algorithm only without human-in-the-loop).
- Elaborate on the type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Provide the sample size for the training set.
- Explain how the ground truth for the training set was established.
The document's purpose is to establish substantial equivalence based on indications for use, technological characteristics, and general performance testing, not to provide a detailed clinical or performance study breakdown with specific metrics and methodologies.
§ 884.1100 Endometrial brush.
(a)
Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(2) Labeling:
(i) Indication: Only to evaluate the endometrium, and
(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
(3) Design and testing:
(i) The sampling component is covered within the vagina, and
(ii) For adherence of the bristles and brush head.