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.

AI/ML Overview

The provided document describes a 510(k) submission for the PROTOCOL™ Insufflator with Performance Improvements. This submission focuses on comparing the improved device to its predicate device to demonstrate substantial equivalence, rather than a standalone study proving novel acceptance criteria.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, specific ground truth types) are NOT applicable or NOT explicitly stated in this type of regulatory submission. The document primarily highlights modifications to existing performance specifications and confirms that the indications for use remain the same.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of the proposed device's performance specifications against the predicate device's specifications. The improvements themselves serve as the "acceptance criteria" for the new design, aiming to meet or exceed previous performance in specific areas while maintaining core functionalities.

Specification Category	Acceptance Criteria (Proposed Device)	Reported Device Performance (Implied by submission)
Start-Up Ramp (Flow Rate)	At the onset of the procedure, flow of CO2 to the patient to be ramped to the patient in accordance with the following increments:1.0 Liters/Minute for 0 to 0.5 Liter of Delivered Volume2.0 Liters/Minute for greater than 0.5 to 1.0 Liter Delivered Volume3.0 Liters/Minute for Delivered Volumes Greater than 1.0 Liter	The proposed device is designed to implement these ramped flow rates, indicating its performance meets these criteria. (The 510(k) submission implicitly states the device performs according to its proposed specifications to demonstrate substantial equivalence).
Electronic Pressure Relief	50 mm Hg for 5 seconds (absolute)	The proposed device's electronic relief valve opens when colon pressure goes above 50 mmHg for a sustained 5 seconds. This is the intended performance.
Independent Redundant Mechanical Relief	75 mm Hg	The proposed device's independent redundant mechanical relief valve opens when colon pressure is at 75 mmHg. This is the intended performance.
Volume Delivery Logic	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.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.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.	The proposed device is designed to operate according to these sequential, volumentrically controlled delivery modes. (Implied performance based on design changes for 510(k)).
Flow Rate Accuracy	Not to exceed ± 20% @ 3 Liters/minute	The proposed device maintains this accuracy, similar to the predicate device.
Delivery Pressure (Range & Accuracy)	0 to 25 mm Hg in increments of 1 mm HgAccuracy: +/- 10%	The proposed device maintains this range and accuracy, similar to the predicate device.
Delivery Volume Accuracy	+/- 20 %	The proposed device maintains this accuracy, similar to the predicate device.
Environmental Requirements (Safety Standards)	Meets Requirements set forth in IEC/EN60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety.	The proposed device is stated to meet these requirements.
EMC Requirements	Meets Requirements set forth in IEC/EN 60601-1-2, CISPR 11, IEC 801-2, 801-3, 801-4, 801-5.	The proposed device is stated to meet these requirements.
UL/CSA Compliance	Medical Device Listing to UL 2601-1 / CSA C22.2 No. 601.1, Electrical Class I, Type B Isolation rating.	The proposed device is stated to meet these requirements.

2. Sample size used for the test set and the data provenance

Not explicitly stated. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on design, material, and performance specifications. It does not typically include detailed study results with sample sizes for specific tests conducted on the modified device, unless a new clinical trial was deemed necessary (which appears not to be the case here, as it's a "special 510(k)"). The performance improvements are described as design changes substantiated by technical data, likely bench testing or engineering verification rather than a clinical human subject study testing the acceptance criteria.
Data provenance: Not specified, but likely from in-house engineering and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not stated. This type of information would be relevant for studies evaluating a device's diagnostic accuracy or clinical effectiveness against a gold standard, often involving expert review of images or clinical outcomes. For modifications to an insufflator that primarily affect flow, pressure, and volume delivery mechanisms, the "ground truth" is established through physical measurements and engineering standards rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

Not applicable/Not stated. Adjudication methods like 2+1 or 3+1 are used in studies where multiple experts evaluate cases and a consensus is needed to establish ground truth or resolve discrepancies in interpretations (e.g., in diagnostic AI studies). This is not relevant for the type of engineering verification demonstrated in this 510(k) submission.

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

No. This device is an insufflator, not an AI-powered diagnostic tool. MRMC studies are used to evaluate changes in human reader performance (e.g., radiologists) when assisted by AI. This is entirely outside the scope of this device and submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question pertains to AI algorithms. The PROTOCOL™ Insufflator is a medical device for physical CO2 delivery, not an algorithm.

7. The type of ground truth used

For the performance specifications (flow rate, pressure relief, volume delivery logic, accuracy figures), the "ground truth" would be established through engineering measurements and calibration standards. This involves using validated equipment to measure CO2 flow, pressure, and volume output from the device under specified conditions and comparing these measurements against the defined performance specifications. Compliance with international safety and EMC standards (IEC/EN60601-1, IEC/EN 60601-1-2) would also be verified through standardized testing procedures.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which is not what this device is.

9. How the ground truth for the training set was established

Not applicable. As stated above, this device does not involve machine learning or training sets.

Summary

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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 PerformanceImprovements
Common Name:	Insufflator, Colonic
Classification Name:	Endoscope and accessories
	21 CFR 876.1500
	78 FCX
Predicate Device:	PROTOCO₂L™ Colon Insufflator

Indications for Use:

K013219

Device Description:

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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Proposed Performance Specification	Predicate Performance Specification
Start-Up Ramp	Start-Up Ramp
At the onset of the procedure, flow of CO2 tothe patient to be ramped to the patient inaccordance with the following increments:	At the onset of the procedure, flow of CO2to the patient initiates itself to thespecified flow rate of:
1.0 Liters/Minute for 0 to 0.5 Liter ofDelivered Volume	3 Liters/Minute
2.0 Liters/Minute for greater than 0.5 to 1.0Liter Delivered Volume
3.0 Liters/Minute for Delivered VolumesGreater than 1.0 Liter

Pressure Relief	Pressure Relief
Electronic Pressure Relief	Electronic Pressure Relief
50 mm Hg for 5 seconds (absolute)	6 mm Hg-second (relative)
Independent Redundant Mechanical Relief	Independent Redundant MechanicalRelief
75 mm Hg	50 mm Hg
Volume Delivery	Volume Delivery
Upon Pressing the RUN/STOP Button at thestart of the procedure, the unit will remain inrun mode until 4 Liters of CO2 have beendelivered. Once 4 Liters has been delivered,the unit automatically returns to stop mode.	Upon pressing the RUN/STOP button atthe start of the procedure, the unit willremain in run mode indefinitely until theuser presses this button a second time tostop CO2 delivery.
Thereafter pressing the RUN/STOP button a2nd time will resume the delivery of CO2 foran additional 2 Liters of CO2. Once anadditional 2 Liters has been delivered, the unitautomatically returns to stop mode.	Thereafter pressing the RUN/STOPbutton a 3rd time will resume the deliveryof CO2 indefinitely until the user pressesthe button to stop CO2delivery.

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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 Device	Predicate Device
Insufflator Unit, General	E-Z-EM PROTOCO2L WITHPERFORMANCEIMPROVEMENTS	E-Z-EM PROTOCO2L
Indication for Use	Administer and regulate CO2 as adistention media for the colon duringCT Colonography (CTC or VirtualColonoscopy)andconventionalcolonoscopy.	Same as proposed
Design	Electro-Mechanical PneumaticSystem to regulate both Flow andPressure of CO2	Same as proposed
Anatomical Sites	Rectal administration of CO2 viaenema tip or catheter lumen	Same as proposed
Radiation	No ionizing radiation emitted	Same as proposed
Thermal	No thermal energy introduced intopatient	Same as proposed
	Proposed Device	Predicate Device
Insufflator Unit,General	E-Z-EM PROTOCO₂L WITHPERFORMANCEIMPROVEMENTS	E-Z-EM PROTOCO₂L
Insufflation Unit	Located Adjacent to CT Gantry	Same as Proposed
Power Supply	Switching Power Supply inDedicated Enclosure	Same as Proposed
Flow Rate	1 to 3 Liters/Minute based on thevolume delivered; Flow is rampedup during first Liter:Delivery volume from 0 to 0.5Liter @ 1 Liter/Minute maximumDelivery volume greater than 0.5to 1 Liter @ 2 Liters/MinutemaximumDelivery volume greater than 1Liter @ 3 Liters/MinutemaximumAccuracy: Not to exceed + 20%@ 3 Liters/ minute	1 to 3 Liters/Minute, FixedAccuracy: Not to exceed + 20%@ 3 Liters/ minute
Delivery Pressure	0 to 25 mm Hg in increments of 1mm HgAccuracy: +/- 10%	Same as proposed
	Proposed Device	Predicate Device
Insufflator Unit, General	E-Z-EM PROTOCO₂L WITHPERFORMANCE IMPROVEMENTS	E-Z-EM PROTOCO₂L
Delivery Volume	1 to 999 Liters in 0.1 Liter incrementsAccuracy: +/- 20 %	Same as proposed
Pressure Limiting	Yes	Yes
Over-Pressure Relief	Yes	Yes
	Electrical Relief Valve opens when colonpressure goes above 50 mmHg forsustained 5 secondsIndependent redundant Mechanical ReliefValve opens when colon pressure is at 75mmHg	Electrical Relief Valve openswhen colon pressure exceeds setpressure by 5 mmHg for 2 secondsIndependent redundantMechanical Relief Valve openswhen colon pressure is at 50mmHg

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	Proposed Device	Predicate Device
Insufflator Unit,displays and Controls	E-Z-EM PROTOCO₂L WITHPERFORMANCE IMPROVEMENTS	E-Z-EM PROTOCO₂L
Display	Insufflation Pressure: 2-Seven SegmentLEDs	Same as Proposed
	Volume: 3-Seven Segment LEDs
	Supply Volume: Graduated LED Array
Pressure	Rotary Adjustment Knob	Same as Proposed
Flow Rate	Fixed, No Adjustment	Same as Proposed
Power	Single Acting Button	Same as Proposed
Stop/Run	Single Acting Button	Same as Proposed
Volume Reset	Single Acting Button	Same as Proposed
Over Pressure Alarm Reset	Single Acting Button	Same as Proposed
Consumable Connection	Medical, CPC locking Connection	Same as Proposed

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	Proposed Device	Predicate Device
Insufflator Unit,EnvironmentalRequirements	E-Z-EM PROTOCO2L WITHPERFORMANCE IMPROVEMENTS	E-Z-EM PROTOCO2L
Operating TemperatureOperating Humidity,Operating Altitude &Storage Temperature	Meets Requirements set forth inIEC/EN60601-1, Medical ElectricalEquipment Part 1: General Requirementsfor Safety	Same as proposed
Electromagnetic Compatibility(EMC)	Meets Requirements set forth in IEC/EN60601-1-2, Medical Electrical EquipmentPart 1: Collateral Standard,Electromagnetic CompatibilityCISPR 11IEC 801-2IEC 801-3IEC 801-4IEC 801-5	Same as proposed
UL/CSA	Medical Device Listing to UL 2601-1 / CSA C22.2 No. 601.1, Electrical Class I,Type B Isolation rating	Same as proposed

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Insufflator Unit,EnvironmentalRequirements	Proposed DeviceE-Z-EM PROTOCO2L WITHPERFORMANCE IMPROVEMENTS	Predicate DeviceE-Z-EM PROTOCO2L
Energy Requirements	100/240 VAC 50/60 HzAuto Seeking	Same as proposed
Shock and Vibration	International Safe Transit Authority(ISTA), Project 3C	Same as proposed

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Insufflator Consumable	Proposed DeviceE-Z-EM PROTOCO₂L WITHPERFORMANCE IMPROVEMENTS	Predicate DeviceE-Z-EMPROTOCO₂L
Consumable Tubing Set	E-Z-EM Designed and Manufactured non-sterile tubing set using existing enema tipfor rectal access.	Same asproposed

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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.

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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

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Confidential

KO30854

INDICATIONS FOR USE

510(k) Application: Special 510(k)

E-Z-EM PROTOCO₂L COLON INSUFFLATOR Device Name:

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 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.