(56 days)
Not Found
No
The device description and intended use clearly describe a simple mechanical device for colon irrigation, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is used for colon cleansing prior to examinations, not for treating a disease or condition. While "medically indicated," its purpose is diagnostic preparation rather than therapeutic intervention.
No
The device is used for colon cleansing to prepare the colon for examination, not to perform the examination or diagnose medical conditions.
No
The device description explicitly states it is a "disposable rectal speculum," which is a physical, non-software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "disposable rectal speculum" used to "introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure." This is a physical device used for a procedure performed directly on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is "colon cleansing," which is a procedural indication, not a diagnostic one.
Therefore, based on the provided information, the Pro-Fit™ disposable rectal speculum is a medical device used for a procedure, not an in vitro diagnostic test.
N/A
Intended Use / 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."
Product codes (comma separated list FDA assigned to the subject device)
78 KPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Kosollz 13. 11. 1 El
510(k) Summary
| Submitted by: | Prime Pacific Health Innovations Corporation
8 - 145 Riverside Drive
North Vancouver, BC
V7H 1T6
Canada
Tel: (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 Speculum
Specialty Health Products Inc. Disposable Speculum
Dotolo 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.
1
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)
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2
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
4
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 |
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