PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

• K Number: K050112
• Device Name: PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
• Manufacturer: PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
• Date Cleared: 2005-03-15 ( 56 days)
• Product Code: KPL
• Regulation Number: 876.5220
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K000388

Intended Use

The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Device Description

The Pro-Fit™ disposable rectal speculum is a non-metal (Polyethelene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.

AI/ML Overview

This document is a 510(k) Summary for the Pro-Fit™ Disposable Speculum. A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission does not typically include detailed studies proving acceptance criteria in the same way clinical trials for novel devices would.

Therefore, the requested information points (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and are not found in this document.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices.

Here's a breakdown of what is provided and why the requested information isn't present:

1. A table of acceptance criteria and the reported device performance:

• Not applicable / Not present. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance claims against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable / Not present. No clinical or performance test set data beyond biocompatibility is discussed for comparison to specific acceptance criteria. The document relies on the existing safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable / Not present. Ground truth determination by experts for a test set is not part of a substantial equivalence claim for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not present. No test set requiring expert adjudication is described.

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:

• Not applicable / Not present. This device is a manual, non-AI medical device (a rectal speculum). MRMC studies are completely irrelevant to its function or regulatory pathway.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not present. This is a physical, non-AI medical device. Standalone algorithmic performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / Not present. Ground truth, in the context of diagnostic accuracy, is not relevant for a physical medical device like a speculum in a 510(k) submission.

8. The sample size for the training set:

• Not applicable / Not present. This device does not involve any machine learning algorithms, so there's no training set.

9. How the ground truth for the training set was established:

• Not applicable / Not present. As there is no training set, there's no ground truth to establish for it.

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What the document DOES provide, relevant to its 510(k) purpose:

• Device Description: The Pro-Fit™ disposable rectal speculum is a non-metal (Polyethelene) device used for colonic irrigation.
• Intended Use: To be used for colon cleansing when medically indicated (e.g., before radiological or endoscopic examination).
• Predicate Devices: The document identifies three predicate devices (Clearwater Colon Hydrotherapy, Inc. Disposable Speculum; Specialty Health Products Inc. Disposable Speculum; Dotolo Research Corp. Disposable Speculum). The primary comparison is made to the SP01 and SP02 disposable speculums (K000388) by Clearwater Colon Hydrotherapy Inc.
• Substantial Equivalence Claim: The Pro-Fit™ disposable speculums have the "same technological characteristics as, and are substantially equivalent to" the specified predicate devices.
• Key Difference from Predicate: The only difference noted is the "insertion stopper present on the Pro-Fit™ Disposable Speculum." The document implies this difference does not raise new questions of safety or effectiveness.
• Materials: Fortiflex® HDPE T50-2000 polyethylene copolymer, which meets FDA requirements 21CFR 177.1520.
• Biocompatibility: The finished Pro-Fit™ Speculum was tested for biocompatibility by North American Science Associates, Inc. (NAMSA). This is a type of acceptance criteria (safety), but specific numerical criteria and results are not detailed in this summary.
• Kit Components: Other components (water line, waste hose, surgical lubricant) are also claimed to be substantially equivalent to those included with predicate devices.
• Regulatory Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to predicate devices, allowing it to be marketed. They also noted that the surgical lubricant is regulated as a drug and requires separate review by the Center for Drug Evaluation and Research.

Regulation Number and Section

§ 876.5220 Colonic irrigation system.

(a)
Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.