(114 days)
Not Found
No
The description focuses on the physical components and function of heating, humidifying, and filtering CO2 gas. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an accessory to heat, humidify, and filter CO2 gas for administration as a distention media during colonoscopy, not to directly treat a disease or condition.
No
The device is described as a gas conditioner accessory for heating, humidifying, and filtering a CO2 gas stream used as a distention media during colonoscopy procedures. Its function is to modify the gas before administration, not to provide diagnostic information about a patient's condition.
No
The device description clearly outlines physical components including a disposable filter heater/humidifier tubing set and a control module housing control and safety circuits, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "heat, humidify and filter a CO2 gas stream for administration as a distention media" during colonoscopy and intraoperative endoscopy procedures. This is a therapeutic or procedural support function, not a diagnostic one.
- Device Description: The description details how the device conditions CO2 gas for delivery into the patient's body. It does not involve the analysis of biological samples (blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Insuflow® CO2lonShield™ is a medical device used to facilitate a medical procedure, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Insuflow® CO2lonShield™ is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO2 gas stream for administration as a distention media.
Product codes
KOG, FCX
Device Description
The Insuflow® CO2lonShield™ device is a single use device that attaches to the outlet port of a regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to gas delivery during colonoscopy and intraoperative endoscopy procedures. The Insuflow® CO2lonShield™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Insuflow® CO2lonShield™ device, through the inline filter, continues along the tube to enter the Insuflow® CO2lonShield™ device cassette that contains the heating element and humidification media, through a tube that connects to an endoscope/colonoscope or rectal probe for gas delivery into the patient’s gastroenterological cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Extensive performance testing has been conducted to assure that the Insuflow CO2lonShield™ performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and are summarized in Section 5.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 1. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
JUL 2:3 2009
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for Insuflow® CO2lonShield™.
| SUBMITTER'S NAME: | LEXION Medical LLC |
|---|---|
| ADDRESS: | 5000 Township Parkway |
| St. Paul, MN 55110 | |
| CONTACT PERSON: | Bernard (Bud) Horwath |
| TELEPHONE NUMBER: | 651-361-8041 |
| FAX NUMBER: | 651-351-8001 |
| DATE OF SUBMISSION: | 30 March 2000 |
1. Identification of device
Proprietary Name: Insuflow® CO2lonShieldTM Common Name: Gas Conditioner Device Classification Status: Class II per regulations 876.1500 Endoscope and Accessories Product Code: KOG (Endoscopy Accessory) and FCX (Insufflator for Fndoscope)
2. Equivalent devices
LEXION Medical believes that Insuflow® CO2lonShield™ is substantially equivalent to the following devices:
Insuflow®, K063546 PROTOCO2L Colon Insufflator, K030854 Endoscopic CO2 Regulator, K053008
Insuflow CO2lonShield™ is the same gas conditioner accessory device as the Insuffow" cleared under 510(k) K063546 and has essentially the same intended use as the PROTOCO2L and Endoscopic CO2 Regulator predicate devices .
3. Description of the Device
The Insuflow® CO2lonShield™ device is a single use device that attaches to the outlet port of a regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to gas delivery during colonoscopy and intraoperative endoscopy procedures. The Insuflow® CO2lonShield™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system.
Regulated CO2 gas flows into the Insuflow® CO2lonShield™ device, through the inline filter, continues along the tube to enter the Insuflow® CO2lonShield™ device cassette that contains the heating element and humidification media, through a tube
1
that connects to an endoscope/colonoscope or rectal probe for gas delivery into the patient's gastroenterological cavity.
4. Intended use
Insuflow® CO2lonShield™ is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO2 gas stream for administration as a distention media.
Technological characteristics, comparison to predicate device. 5.
Technically, the Insuflow® CO2lonShield™ is identical to the Insuflow® cleared for market in 510(k) K063546 and essentially equivalent to the other predicates. The indications for use for the Insuflow® CO2lonShield™ are patterned after the predicate devices.
6. Discussion of performance testing.
Extensive performance testing has been conducted to assure that the Insuflow CO2lonShield™ performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and are summarized in Section 5.
7. Conclusion
Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that Insuflow® CO2lonShield™ is substantially equivalent to devices already on the market being used for these applications (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure with three arms or flowing lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 9 3 2009
Mr. Bernard Horwath Regulatory Consultant LEXION Medical, LLC 5000 Township Parkway ST PAUL MN 55110
Re: K090879
Trade/Device Name: Insuflow CO2lonShield" Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class; II Product Code: FCX Dated: July 20, 2009 Received: July 22, 2009
Dear Mr. Horwath:
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); medical device reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
A. INDICATIONS FOR USE
510(k) Number K090879
Device Name: Insuflow® CO2lonShield™
Indications for Use:
Insuflow® CO2lonShield™ is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO2 gas stream for administration as a dist,ention media.
(Please do not write below this line - continue on another page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
Over the Counter Use
Joam M. Whang
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number