(604 days)
Not Found
No
The description focuses on mechanical and fluid control aspects of colon cleansing and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is intended for colon cleansing to remove fecal residues when medically indicated, which is a therapeutic purpose.
No
The device is intended for colon cleansing to remove fecal residues before examinations, not for diagnosing medical conditions.
No
The device description explicitly states it comprises different models of the Bio Fluff device (HT and HTP) and associated components (disposable specula), indicating it includes hardware components. The performance studies also include biocompatibility and functional testing of the physical device models.
Based on the provided information, the Bio Fluff System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination." This is a therapeutic or preparatory procedure performed directly on the patient's body.
- Device Description: The device instills water into the colon through a speculum. This is a physical intervention within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Bio Fluff System does not perform any such tests on samples.
The Bio Fluff System is a medical device used for a physical procedure within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
Product codes
KPL
Device Description
The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal Cleansing is carried out by inserting water in the patient's rectum at controlled temperature and pressure through the disposable specula. This action allows the cleaning of the lower tract of the colon. The Bio Fluff System comprises:
- different models of the Bio Fluff device:
- I HT model, for professional use,
- HTP model, portable version of HT model, I
- associated components:
- disposable HT specula for both Bio Fluff model HT and Bio Fluff model HTP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colon / Rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Bio Fluff models HT and HTP are for professional use in medical environments, trained healthcare practitioner
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
Non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device.
Biocompatibility testing was performed on both models (HT and HTP) of the finished device. The biocompatibility studies were conducted by third party laboratory on all components that contact patients directly or indirectly. The following tests were performed:
- Cytotoxicity: ISO 10993-5: 2009 a.
- Sensitization: ISO 10993-10: 2010 b.
- Irritation: ISO 10993-10: 2010 C.
The devices do not arise any issues of biocompatibility for their intended use.
Bench tests Functional testing showed correct operation of the Bio Fluff System as per its intended use, specifically including: - Pressure Safety
- Flow Control
- Temperature Safety
- Leak Resistance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2022
Gnali Bocia S.R.L. Katy Gnali External Consultant Via Brescia, 41/M-N Lumezzane, 25065 ITALY
Re: K201861
Trade/Device Name: Bio Fluff System Regulation Number: 21 CFR 876.5220 Regulation Name: Colonic irrigation system Regulatory Class: Class II Product Code: KPL Dated: February 23, 2022 Received: February 28, 2022
Dear Katy Gnali:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201861
Device Name Bio Fluff System, models HT and HTP
Indications for Use (Describe)
The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K201861
Applicant:
| Company Name: | Gnali Bocia S.R.L. |
|---|---|
| Company Address: | Via Brescia, 41/M-N |
| 25065 Lumezzane (BS) | |
| ITALY | |
| Company Phone: | +39 030-871498 |
| Official Contact for Correspondence: | Katy Gnali |
| Phone: | +39 030-871498 |
| E-mail: | regulatorybiofluff@gnalibocia.it |
Date Summary Prepared:
October 11, 2021
Colonic Irrigation System
21 CFR§ 876.5220, Class II
Bio Fluff System, models HT and HTP
DEVICE IDENTIFICATION
Device name: Generic/ Common Name: Classification number:
| Classification name: | Colonic Irrigation System |
|---|---|
| Product Code: | KPL |
| Product Code Name | Colonic Irrigation System |
| Regulatory Class | Class II |
| Device Panel: | Gastroenterology/Urology |
PREDICATE DEVICE:
Aqua Cleanse, Quality Medical Supply, K150381
DEVICE DESCRIPTION
The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal Cleansing is carried out by inserting water in the patient's rectum at controlled temperature and pressure through the disposable specula. This action allows the cleaning of the lower tract of the colon. The Bio Fluff System comprises:
-
different models of the Bio Fluff device:
-
I HT model, for professional use,
-
HTP model, portable version of HT model, I
-
associated components:
-
disposable HT specula for both Bio Fluff model HT and Bio Fluff model HTP.
4
INDICATIONS FOR USE
The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
DISCUSSION OF NON-CLINICAL TESTS
Non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the applicable sections of the standards listed below:
Biocompatibility
Biocompatibility testing was performed on both models (HT and HTP) of the finished device. The biocompatibility studies were conducted by third party laboratory on all components that contact patients directly or indirectly. The following tests were performed:
- Cytotoxicity: ISO 10993-5: 2009 a.
- Sensitization: ISO 10993-10: 2010 b.
- Irritation: ISO 10993-10: 2010 C.
The devices do not arise any issues of biocompatibility for their intended use.
Bench tests
Functional testing showed correct operation of the Bio Fluff System as per its intended use, specifically including:
- · Pressure Safety
- Flow Control
- · Temperature Safety
- · Leak Resistance.
SUBSTANTIAL EQUIVALENCE
The Bio Fluff System is substantially equivalent in indications for use, intended use, design and material as those of the predicate Aqua Cleanse (K150381).
Both the subject and the predicate device are intended to introduce warm filtered water into the colon through a speculum inserted into the rectum to assist with the evacuation of the lower colon, they fill and empty water into and out of the colon thus cleansing it of its contents.
In further support of a substantial equivalence determination, hereunder is a comparison chart with the submitted device and the predicate device.
5
| SPECIFICATIONS | Subject device:
Bio Fluff System | Predicate device:
Aqua Cleanse K150381 | CONCLUSION |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Gnali Bocia S.r.l. | Quality Medical Supply | |
| Common name | colonic irrigation system | colonic irrigation system | |
| Indications For Use | The Bio Fluff System is
intended for colon cleansing to
remove fecal residues when
medically indicated, such as
before radiological or
endoscopic examination. | This device is intended for
colon cleansing when
medically indicated, such
as before radiological or
endoscopic examination. | substantially equivalent: colon
cleansing implies removal of
fecal residues. |
| Classification | 21 CFR§ 876.5220 | 21 CFR§ 876.5220 | same |
| Product code | KPL | KPL | same |
| Intended User | Bio Fluff models HT and HTP
are for professional use in
medical environments, trained
healthcare practitioner | Aqua Cleanse is for
professional use only | Same |
| Insertion point | Anus | Anus | same |
| Antibacterial Filters | yes | yes | substantially equivalent |
| Flow regulator | yes | yes | same |
| Temperature gauge | yes | yes | same |
| Temperature safety | Thermostatic valve enacts
when water temperature
reaches 38 °C
Thermostatic mixer for the
regulation of water temperature | Mixing valve to maintain
water temperature | substantially equivalent |
| Flow control | Flowmeter
excess flow valve | flow control valve | substantially equivalent |
| Pressure Gauge | yes | yes | same |
| Pressure control | Safety valve opens at 200
mbar (2.90 pounds per sq. inch
(psi) | Safety valve
allow 3.00 pounds per sq.
inch | substantially equivalent |
| Timer | Yes | yes | substantially equivalent |
| Outgoing waste
material observation | little window for inspection | glass observation tube | substantially equivalent |
| Circuit cleaning
system | yes
can be activated when the
device is not being used for
treatment | yes
can be activated when the
device is not being used
for treatment | substantially equivalent |
| Electrical
components | no | yes | this difference does not affect
the safety or effectiveness of the
subject device; the performances
of the two devices are
substantially equivalent |
| Biocompatibility | ISO 10993-1 compliance | ISO 10993-1 compliance | substantially equivalent |
| Performance test | • Pressure Safety
• Temperature Safety
• Leak Resistance
• Flow control | • Pressure Safety
• Temperature Safety
• Electrical Safety
• Leak Resistant | substantially equivalent
There are no electronic
components in the subject
device, thus electrical safety is
not to be tested |
6
SUBSTANTIAL EQUIVALENCE DISCUSSION:
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have similar design and same intended use
The subject and predicate devices are based on the same or similar technological elements and are made with the materials largely used for the same type of medical devices already on the market.
The minor differences in the technological characteristics of the devices do not impact the safety and effectiveness of the subject device. The performance data demonstrate that the subject device is as safe and effective as the cited predicate.
CONCLUSION:
Based on the available information, the Bio Fluff System is substantially equivalent to the existing legally marketed predicate device under Federal Food, Drug and Cosmetic Act.