(29 days)
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.
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.
0
Image /page/0/Picture/1 description: The image shows a logo with a globe on the left and the text "ECMI" on the right. Below the logo is the text "Visualize a healthier world". The globe is a wireframe design, and the text "ECMI" is in a bold, sans-serif font.
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.
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 Specification | Predicate Performance Specification |
---|---|
Start-Up Ramp | Start-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 Volume | 3 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 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 Mechanical |
Relief | |
75 mm Hg | 50 mm Hg |
Volume Delivery | Volume 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. |
2
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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Ko 30 854 Jag 4 8 11
- 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.
4
K 030 854 Pg. 5 of 4
Comparative Summary Tables
Proposed Device | Predicate Device | |
---|---|---|
Insufflator Unit, General | E-Z-EM PROTOCO2L WITH | |
PERFORMANCE | ||
IMPROVEMENTS | E-Z-EM PROTOCO2L | |
Indication for Use | Administer and regulate CO2 as a | |
distention media for the colon during | ||
CT Colonography (CTC or Virtual | ||
Colonoscopy) | ||
and | ||
conventional | ||
colonoscopy. | Same as proposed | |
Design | Electro-Mechanical Pneumatic | |
System to regulate both Flow and | ||
Pressure of CO2 | Same as proposed | |
Anatomical Sites | Rectal administration of CO2 via | |
enema tip or catheter lumen | Same as proposed | |
Radiation | No ionizing radiation emitted | Same as proposed |
Thermal | No thermal energy introduced into | |
patient | Same as proposed | |
Proposed Device | Predicate Device | |
Insufflator Unit, | ||
General | E-Z-EM PROTOCO₂L WITH | |
PERFORMANCE | ||
IMPROVEMENTS | E-Z-EM PROTOCO₂L | |
Insufflation Unit | Located Adjacent to CT Gantry | Same as Proposed |
Power Supply | Switching Power Supply in | |
Dedicated Enclosure | Same as Proposed | |
Flow Rate | 1 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 |
5
K 0.30 854 Pg 6 of "
6
K. 030 854 Pg 7 of ""
7
K 0308.54
Pg 8 of 11
Proposed Device | Predicate Device | |
---|---|---|
Insufflator Unit, | ||
displays and Controls | E-Z-EM PROTOCO₂L WITH | |
PERFORMANCE IMPROVEMENTS | E-Z-EM PROTOCO₂L | |
Display | Insufflation Pressure: 2-Seven Segment | |
LEDs | 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 |
8
K 030854 py. 7 9/1
Proposed Device | Predicate Device | |
---|---|---|
Insufflator Unit, | ||
Environmental | ||
Requirements | E-Z-EM PROTOCO2L WITH | |
PERFORMANCE IMPROVEMENTS | E-Z-EM PROTOCO2L | |
Operating Temperature | ||
Operating Humidity, | ||
Operating Altitude & | ||
Storage Temperature | Meets Requirements set forth in | |
IEC/EN60601-1, Medical Electrical | ||
Equipment Part 1: General Requirements | ||
for Safety | Same 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 801-5 | 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 |
9
K 030 854 Pg 10 of 11
| 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 |
11
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