(39 days)
The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.
The RB12 consists of a gamma sterilized single use polystyrene closed end cylinder shaped capsule with a small hole at the closed end which contains a stainless steel cutting blade and a polyethylene seal. The capsule connects to a re-useable handpiece (HP1000) via a quick twist and lock system and suits both left and right handed operators. The HP1000 has an inner piston which automatically locates in the internal seal when the capsule is connected. This creates an airtight loop to the attached syringe via the suction tube/syringe adaptor. The inner piston is pushed forward when the thumb trigger is activated pushing the blade forward past the capsule hole cutting the specimen. The RBI2 design uses a combination of a re-useable handpiece and a disposable (single use) capsule. The capsule is supplied to the end users in a sterile state completely assembled with an internal blade and seal. A syringe is connected to the rear end of the internal trigger tube via a piece of suction tube and a syringe/tube adaptor (supplied sterile with capsules). The disposable is placed onto the outer tubing that is housed within the handle. While placing the capsule the internal trigger tube automatically locates and passes through the seal. When capsule is placed onto the handpiece it creates an air loop from the syringe to the front section of the capsule. The capsule is placed against the mucosal wall of the rectum of the patient covering the capsule port. When the syringe is withdrawn this causes negative pressure in the capsule sucking the mucosal and sub mucosal into the capsule. The thumb trigger is pushed forward which pushes the blade forward cutting the tissue that has been sucked into the port. The front of the capsule remains airtight as the trigger/inner tube slides through the internal seal.
The provided text describes a medical device, the RB12 Suction Rectal Biopsy System, and its 510(k) summary for FDA clearance. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.
The document primarily focuses on:
- Device description and indications for use.
- Substantial equivalence comparison with a predicate device.
- Voluntary standards applied (related to quality systems, sterilization, biocompatibility, etc.).
- Performance data mentioning "bench testing" including a "seal test, a chisel blade test, and an assembled capsule test."
- A "critical evaluation" performed by a pediatric surgeon.
- The FDA's 510(k) clearance letter.
Therefore, I cannot provide the requested information from the given text.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, or details of a specific study proving performance.
- Number or qualifications of experts used to establish ground truth for a test set.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This is a non-AI medical device).
- Information about a standalone (algorithm only) performance study. (This is a non-AI medical device).
- The type of ground truth used (e.g., pathology, outcomes data) in a performance study.
- Sample size for a training set. (This is a non-AI medical device).
- How ground truth for a training set was established. (This is a non-AI medical device).
The "Performance Data" section briefly mentions "bench testing," but it does not elaborate on the specific criteria, results, or the study design in enough detail to answer the prompt. The "Critical Evaluation" by a pediatric surgeon is an expert assessment, but it is not presented as a structured study with quantifiable acceptance criteria and performance metrics.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.