K Number
K030854
Device Name
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
Manufacturer
Date Cleared
2003-04-16

(29 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Device Description
The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.
More Information

Not Found

No
The summary describes a device for administering CO2 for colon distention and does not mention any AI or ML capabilities.

No
The device administers CO2 as a distention media for imaging procedures (CT Colonography and conventional Colonoscopy), not to treat a disease or condition. While it aids in diagnosis, it is not a therapeutic device.

No

This device is an insufflator used to administer CO2 for colon distention during imaging procedures (CT Colonography and conventional colonoscopy), not to diagnose a condition itself.

No

The device description explicitly states that the system consists of three hardware components: the insufflator, consumable, and accessory cart. This indicates it is a hardware device with potentially embedded software, not a software-only medical device.

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 E-Z-EM PROTOCO2L COLON Insufflator is a device that administers and regulates carbon dioxide directly into the colon for distention during imaging procedures (CT Colonography and conventional Colonoscopy). It is a medical device used during a procedure, not a test performed on a sample outside the body.

The device's purpose is to facilitate imaging by distending the colon, not to analyze a biological sample for diagnostic information.

N/A

Intended Use / Indications for Use

The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

Product codes (comma separated list FDA assigned to the subject device)

78 FCX

Device Description

The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.
The performance improvements presented here do not affect or change the current indications and contraindications of the PROTOCO2L device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Rectal administration of CO2 via enema tip or catheter lumen

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Located Adjacent to CT Gantry

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.

K013219

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

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

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PROTOCO2L™ Insufflator With Performance Improvements 510(k) Summary

APR 1 6 2003

Submitter's Information:E-Z-EM, Inc.
717 Main Street
Westbury, NY 11590
Telephone Number:(516) 333-8230, ext. 2377
Fax Number:(516) 997-0282
Contact:Judy Hauser, Sr. Manager Regulatory Affairs
Date Prepared:March 13, 2003
Trade Name:PROTOCO₂L™ Colon Insufflator with Performance
Improvements
Common Name:Insufflator, Colonic
Classification Name:Endoscope and accessories
21 CFR 876.1500
78 FCX
Predicate Device:PROTOCO₂L™ Colon Insufflator

Indications for Use:

The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

K013219

Device Description:

The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.

The performance improvements presented here do not affect or change the current indications and contraindications of the PROTOCO2L device. A summary of the performance specification inprovements as compared to the predicate performance specifications are stated as follows:

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K c3c854 pg 2 of 11

Proposed Performance SpecificationPredicate Performance Specification
Start-Up RampStart-Up Ramp
At the onset of the procedure, flow of CO2 to
the patient to be ramped to the patient in
accordance with the following increments:At the onset of the procedure, flow of CO2
to the patient initiates itself to the
specified flow rate of:
1.0 Liters/Minute for 0 to 0.5 Liter of
Delivered Volume3 Liters/Minute
2.0 Liters/Minute for greater than 0.5 to 1.0
Liter Delivered Volume
3.0 Liters/Minute for Delivered Volumes
Greater than 1.0 Liter
Pressure ReliefPressure Relief
Electronic Pressure ReliefElectronic Pressure Relief
50 mm Hg for 5 seconds (absolute)6 mm Hg-second (relative)
Independent Redundant Mechanical ReliefIndependent Redundant Mechanical
Relief
75 mm Hg50 mm Hg
Volume DeliveryVolume Delivery
Upon Pressing the RUN/STOP Button at the
start of the procedure, the unit will remain in
run mode until 4 Liters of CO2 have been
delivered. Once 4 Liters has been delivered,
the unit automatically returns to stop mode.Upon pressing the RUN/STOP button at
the start of the procedure, the unit will
remain in run mode indefinitely until the
user presses this button a second time to
stop CO2 delivery.
Thereafter pressing the RUN/STOP button a
2nd time will resume the delivery of CO2 for
an additional 2 Liters of CO2. Once an
additional 2 Liters has been delivered, the unit
automatically returns to stop mode.Thereafter pressing the RUN/STOP
button a 3rd time will resume the delivery
of CO2 indefinitely until the user presses
the button to stop CO2delivery.

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R030854 pg 3 of 11
Subsequent presses of the RUN/STOP button will deliver additional 2 Liter boluses of CO2 as required by the user.

The user can always depress the RUN/STOP button during any of these volume increments to STOP delivery of CO2.

As with the predicate PROTOCO2L design, the PROTOCO2L with performance improvements unit is still based on the currently marketed Northgate 3315/6600 Insufflator product that is designed and manufactured by Northgate Technologies (OEM manufacturer), Elgin, Illinois (Model No. 6400). Other than the performance improvements outlined here, there are no changes to the insufflator cart and tubing set as prescribed by the original 510(k) for this device.

Comparative Information Regarding Substantial Equivalence:

The EZEM PROTOCO-L Colon Insufflator with performance improvements and the original PROTOCO>L Colon Insufflator are indicated for distention of the Colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

The proposed and predicate PROTOCO-L Colon Insufflator rely on proven and widely accepted gas metering technology to precisely regulate the flow, volume and pressure of CO2 on a continuous basis. With this technology the user has direct digital feedback on the actual colon pressure and distention volume for the duration of the procedure.

In summary both the proposed PROTOCO2L Colon Insufflator with performance improvements and the predicate PROTOCO2L Colon Insufflator:

  • Use CO2 as a colon distention media for radiographic exams ●
  • Use electronically controlled metering of CO2
  • Have the same operating principle and fundamental scientific technology .
  • Allow for the adjustment of distention pressure ●
  • Have the same maximum delivery pressure .
  • Have the same volume delivered display ●
  • . Have the same digital display of pressure and distention volume
  • Use the same hydrophobic filter technology to prevent contamination of the device .
  • Are made from the same materials ●
  • Specify use of an enema tip (rectal catheter) for colon access .

Where their significant differences are:

  • The Flow Rate for the initial volume of CO2 is gradually increased to 3 Liters/Minute versus initially ● delivering at 3 Liters/Minute.
    E-Z-EM PROTOCO2L Insufflator 510(k) Submission Page 3 of 11

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  • During delivery, pre-defined volume increments at 4 liters of CO2 and thereafter 2 liter volumes are ● administered versus continuous volume delivery until the operator intervenes.
  • Electro-pneumatic pressure relief valve is at 50 mmHg for 5 seconds versus a relative 6 mm Hg -. second pressure relief relative to set pressure.
  • Independent redundant mechanical pressure relief at 75 mm Hg. .

A comparison between the EZEM PROTOCO2L with software modifications and the predicate PROTOCO2L device is presented in the following tables.

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Comparative Summary Tables

Proposed DevicePredicate Device
Insufflator Unit, GeneralE-Z-EM PROTOCO2L WITH
PERFORMANCE
IMPROVEMENTSE-Z-EM PROTOCO2L
Indication for UseAdminister and regulate CO2 as a
distention media for the colon during
CT Colonography (CTC or Virtual
Colonoscopy)
and
conventional
colonoscopy.Same as proposed
DesignElectro-Mechanical Pneumatic
System to regulate both Flow and
Pressure of CO2Same as proposed
Anatomical SitesRectal administration of CO2 via
enema tip or catheter lumenSame as proposed
RadiationNo ionizing radiation emittedSame as proposed
ThermalNo thermal energy introduced into
patientSame as proposed
Proposed DevicePredicate Device
Insufflator Unit,
GeneralE-Z-EM PROTOCO₂L WITH
PERFORMANCE
IMPROVEMENTSE-Z-EM PROTOCO₂L
Insufflation UnitLocated Adjacent to CT GantrySame as Proposed
Power SupplySwitching Power Supply in
Dedicated EnclosureSame as Proposed
Flow Rate1 to 3 Liters/Minute based on the
volume delivered; Flow is ramped
up during first Liter:

Delivery volume from 0 to 0.5
Liter @ 1 Liter/Minute maximum

Delivery volume greater than 0.5
to 1 Liter @ 2 Liters/Minute
maximum

Delivery volume greater than 1
Liter @ 3 Liters/Minute
maximum

Accuracy: Not to exceed + 20%
@ 3 Liters/ minute | 1 to 3 Liters/Minute, Fixed
Accuracy: Not to exceed + 20%
@ 3 Liters/ minute |
| Delivery Pressure | 0 to 25 mm Hg in increments of 1
mm Hg
Accuracy: +/- 10% | Same as proposed |
| | Proposed Device | Predicate Device |
| Insufflator Unit, General | E-Z-EM PROTOCO₂L WITH
PERFORMANCE IMPROVEMENTS | E-Z-EM PROTOCO₂L |
| Delivery Volume | 1 to 999 Liters in 0.1 Liter increments
Accuracy: +/- 20 % | Same as proposed |
| Pressure Limiting | Yes | Yes |
| Over-Pressure Relief | Yes | Yes |
| | Electrical Relief Valve opens when colon
pressure goes above 50 mmHg for
sustained 5 seconds

Independent redundant Mechanical Relief
Valve opens when colon pressure is at 75
mmHg | Electrical Relief Valve opens
when colon pressure exceeds set
pressure by 5 mmHg for 2 seconds

Independent redundant
Mechanical Relief Valve opens
when colon pressure is at 50
mmHg |

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Pg 8 of 11

Proposed DevicePredicate Device
Insufflator Unit,
displays and ControlsE-Z-EM PROTOCO₂L WITH
PERFORMANCE IMPROVEMENTSE-Z-EM PROTOCO₂L
DisplayInsufflation Pressure: 2-Seven Segment
LEDsSame as Proposed
Volume: 3-Seven Segment LEDs
Supply Volume: Graduated LED Array
PressureRotary Adjustment KnobSame as Proposed
Flow RateFixed, No AdjustmentSame as Proposed
PowerSingle Acting ButtonSame as Proposed
Stop/RunSingle Acting ButtonSame as Proposed
Volume ResetSingle Acting ButtonSame as Proposed
Over Pressure Alarm ResetSingle Acting ButtonSame as Proposed
Consumable ConnectionMedical, CPC locking ConnectionSame as Proposed

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K 030854 py. 7 9/1

Proposed DevicePredicate Device
Insufflator Unit,
Environmental
RequirementsE-Z-EM PROTOCO2L WITH
PERFORMANCE IMPROVEMENTSE-Z-EM PROTOCO2L
Operating Temperature
Operating Humidity,
Operating Altitude &
Storage TemperatureMeets Requirements set forth in
IEC/EN60601-1, Medical Electrical
Equipment Part 1: General Requirements
for SafetySame as proposed
Electromagnetic Compatibility
(EMC)Meets Requirements set forth in IEC/EN
60601-1-2, Medical Electrical Equipment
Part 1: Collateral Standard,
Electromagnetic Compatibility
CISPR 11
IEC 801-2
IEC 801-3
IEC 801-4
IEC 801-5Same as proposed
UL/CSAMedical Device Listing to UL 2601-1 / CSA C22.2 No. 601.1, Electrical Class I,
Type B Isolation ratingSame as proposed

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| Insufflator Unit,
Environmental
Requirements | Proposed Device
E-Z-EM PROTOCO2L WITH
PERFORMANCE IMPROVEMENTS | Predicate Device
E-Z-EM PROTOCO2L |
|----------------------------------------------------|----------------------------------------------------------------------|--------------------------------------|
| Energy Requirements | 100/240 VAC 50/60 Hz
Auto Seeking | Same as proposed |
| Shock and Vibration | International Safe Transit Authority
(ISTA), Project 3C | Same as proposed |

:

.

10

$\qquad K_{0}30.854$

| Insufflator Consumable | Proposed Device
E-Z-EM PROTOCO₂L WITH
PERFORMANCE IMPROVEMENTS | Predicate Device
E-Z-EM
PROTOCO₂L |
|------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Consumable Tubing Set | E-Z-EM Designed and Manufactured non-
sterile tubing set using existing enema tip
for rectal access. | Same as
proposed |

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2003

Ms. Judy Hauser Sr. Manager Regulatory Affairs E-Z-EM, Inc. 717 Main Street WESTBURY NY 11590

Re: K030854

Trade/Device Name: E-Z-EM PROTOCO,L Colon Insufflator Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FCX Dated: March 17, 2003 Received: March 18, 2003

Dear Ms. Hauser:

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. 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.

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

12

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4654
Other(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

13

Confidential

KO30854

INDICATIONS FOR USE

510(k) Application: Special 510(k)

E-Z-EM PROTOCO₂L COLON INSUFFLATOR Device Name:

Indications for Use:

The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

E-Z-EM PROTOCO3L Insufflator 510(k) Submission Page 6 of 26