PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

K050112 · Prime Pacific Health Innovations Corporation · KPL · Mar 15, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050112
• Device Name: PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
• Applicant: Prime Pacific Health Innovations Corporation
• Product Code: KPL · Gastroenterology, Urology
• Decision Date: Mar 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Device Story

Pro-Fit™ disposable rectal speculum; non-metal (polyethylene) device; used to introduce water into colon and dispose of waste during colonic irrigation. Includes insertion stopper; kit includes water line, waste hose, and surgical lubricant. Used in clinical settings for colon cleansing; operated by healthcare professionals. Device facilitates irrigation procedures; provides physical access to colon for cleansing; benefits patient by preparing bowel for diagnostic imaging or endoscopy.

Clinical Evidence

Bench testing only. Biocompatibility testing performed by North American Science Associates, Inc. (NAMSA). No clinical data provided.

Technological Characteristics

Material: Fortiflex® HDPE T50-2000 polyethylene copolymer (meets 21 CFR 177.1520). Form factor: Disposable rectal speculum with insertion stopper. Non-metal construction. Kit includes water line, waste hose, and surgical lubricant.

Indications for Use

Indicated for colon cleansing in patients requiring preparation for radiological or endoscopic examination.

Regulatory Classification

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).

Predicate Devices

• Clearwater Colon Hydrotherapy, Inc. Disposable Speculum
• Specialty Health Products Inc. Disposable Speculum
• Dotolo Research Corp. Disposable Speculum

Reference Devices

• SP01 and SP02 disposable speculums (K000388)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitted by: | Prime Pacific Health Innovations Corporation<br>8 - 145 Riverside Drive<br>North Vancouver, BC<br>V7H 1T6<br>Canada<br>Tel: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>Specialty Health Products Inc. Disposable Speculum<br>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.

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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)

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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

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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 [phone]

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 [phone]. 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 [phone] or [phone], 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 |

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