(56 days)
The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
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.
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.
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.
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Kosollz 13. 11. 1 El
510(k) Summary
| Submitted by: | Prime Pacific Health Innovations Corporation8 - 145 Riverside DriveNorth Vancouver, BCV7H 1T6CanadaTel: (604) 929-7143 |
|---|---|
| Contact Person: | Delmar Vogel |
| Date Prepared: | November 25, 2004 |
| Proprietary Name: | Pro-Fit™ Disposable Speculum (Regular and Small Size) |
| Common Name: | Disposable Rectal Speculum |
| Classification Name: | System, Irrigation, Colonic (per 21 CFR section 876.5220) |
| Predicate Devices: | Clearwater Colon Hydrotherapy, Inc. Disposable SpeculumSpecialty Health Products Inc. Disposable SpeculumDotolo Research Corp. Disposable Speculum |
Description of Device: 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.
Intended use of the Device: To be used for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Technical Characteristics: The Pro-Fit™ disposable speculums have the same technological characteristics as, and are substantially equivalent to the SP01 and SP02 disposable speculums (K000388), manufactured by Clearwater Colon Hydrotherapy Inc. The only difference is the insertion stopper present on the Pro-Fit™ Disposable Speculum.
The material used to manufacture the speculum & obturator is Fortiflex® HDPE T50-2000 polyethylene copolymer which meets FDA requirements 21CFR 177.1520. The finished Pro-Fit™ Speculum was tested for biocompatibility by North American Science Associates, Inc. (NAMSA).
Kit components packaged with the Pro-Fit™ disposable speculum (water line, waste hose, & surgical lubricant) are substantially equivalent to those included with the SP01 and SP02 disposable speculums, manufactured by Clearwater Colon Hydrotherapy Inc. and the other predicate device manufacturers.
Image /page/0/Figure/9 description: The image shows a close-up of a metal object against a black background. The object appears to be a type of tool or fastener, possibly a bolt or pin with a handle. It has a cylindrical body with a few attachments, including a perpendicular bar and a curved piece extending from the side.
Pro Fit Disposable Speculum with Insertion Stopper.
*Insertion Stopper
Image /page/0/Picture/12 description: The image shows a dark background with a blurry, white object in the center. The object appears to be long and cylindrical, with a curved end. The object is not clearly defined, and it is difficult to determine what it is.
Clearwater Disposable Speculum.
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Pro Fit Disposable Rectal Speculum, Regular and Small Size
Indications for Use:
"The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination."
Prescription Use X (Part 21 CFR 801 Subpart D)
Comments of the warming and the commend of the commended to the commend of the comments of the comments of the comments of the comments of the comments of the comments of the
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, stacked vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 15 2005
Mr. Delmar Vogel President Prime Pacific Health Innovations Corporation 8-145 Riverside Drive North Vancouver, B.C. CANADA V7H 176
Re: K050112
KU50112
Trade/Device Name: Pro-Fit™ Disposable Speculum (Regular and Small Size) Regulation Number: 21 CFR §876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: 78 KPL Dated: January 11, 2005 Reccived: January 18, 2005
Dear Mr. Vogel:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainter netirely equivalent (for the indications
referenced above and have determined the device is substantially interests a referenced above and nave determined the actroedicate devices marketed in interstate for use stated in the enclosure for legally manatiment date of the Medical Device Amendments or to commerce prior to May 28, 1770, the charities with the provisions of the Federal Food. Drug, devices that have been reclassified in accordines market the device, subject to the general and Cosment Act (the Act). Tou may, alerere, mannel and the medical devices controls provisions of Act. Tiowever, you are respected in substantially equivalent under you use as components in the Rither Stiller Station 510(k) of the act), or were on the market prior to the premarket lionneation process (Society of Science Amendments. Please note: If your May 28, 1970, the enacinient une of the Unfinished) and further process (e.g., sterilize)
purchase your device components in bulk (i.e., unfinished) and further The separal purchase your ucvice components in oans (in) these components in your kit. The general you must submit a new JTo(t) before include requirements for annual registration, listing of devices, controls provisions of the Act merade requirements one against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) inte exting major regulations affecting your device can be it hay be subject to additional collives, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I each. Fregular resguare in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a subtainments with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must
{3}------------------------------------------------
Page 2 -- Mr. Delmar Vogel
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with all the Act S requirements, morading practice requirements as set CFR Part 807); labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
In addition, we have determined that your device kit contains sterile bacteriostatic surgical In duding which is subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component(s) of your Our substantially equivalent decemmation accommance a conter for Drug Evaluation and Research before device. We recommend you more comation on applicable Agency marketing your do receing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your aver convalence of your device to alegally premarket notification. "The PDF Iniding cification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation, please conact the Office If you desire specific advice for your de, please note the regulation entitled, "Misbranding by of Comphallet at (240) 270-0115. Thise, promoter 1979). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, intornation on your responsibilities ander the 110 here number (800) 638-2041 or (301) 443-6597, micriational and Consumers://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Broughton
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Pro Fit Disposable Rectal Speculum, Regular and Small Size
Indications for Use:
"The indication for use of this device must be restricted to colon cleansing when
"The indication for used of your of your redicleaing and examination." "The indication for use of this device must be restinced to one in the succession examination."
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Farst Creation)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
(PLEASE DO NOT WRITE BELOW - NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jancy C Brogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K050112 |
Page 1 of 1
§ 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.