(45 days)
No
The device description and performance studies focus on CO2 detection and equivalence to predicate devices, with no mention of AI/ML.
No.
The device is used for verification of tube location, not for treatment or therapy. It assists in determining proper placement via CO2 detection.
Yes
The device aids in verifying tube location during gastric tube placement by detecting CO2, which is a form of diagnostic information used to determine proper placement.
No
The device description explicitly states it is a "disposable device" used for CO2 detection, indicating it is a physical hardware device, not software only.
Based on the provided information, 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.
- Device Function: The Kendall CO2nfirm NOW™ CO2Detector is used to detect CO2 in exhaled breath to verify the location of a gastric tube. This is a direct measurement of a physiological process (respiration) and not a test performed on a sample taken from the body.
- Intended Use: The intended use is to assist in the placement of a medical device (gastric tube), not to diagnose a disease or condition based on a biological sample.
Therefore, the device falls under the category of a medical device used for monitoring or procedural assistance, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.
Product codes
78 KNT
Device Description
The Kendall CO2nfirm NOW™ CO2Detector is a disposable device that is used during the oral or nasal placement of a gastric tube to preliminarily determine if the tube is properly placed by detection of CO2
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
adults
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the industry accepted criteria for such devices as defined in EN1615:2000 and ISO 594, Parts 1&2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Kendall C02nfirm NOW™ C02 Detector
NOV - 5 2004
510(k) Summary
In accordance with section 513(1) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: September 13, 2004
1. Contact Person
Bridget Gardner Manager, Regulatory Affairs (508) 261-6384
2. Name of Medical Device
| Classification Name: | Tubes, Gastrointestinal (and accessories) |
|---|---|
| Common or Usual Name: | Gastrointestinal tube accessory |
| Trade Name: | Kendall CO2nfirm NOW™ CO2 Detector |
റ്റ് Legally Marketed Devices to Which Substantial Equivalence Is Claimed
- Easy Cap® CO2 detector, 510(k) number K894053, cleared on 7/20/89 .
- Pedi-Cap® CO2 detector, 510(k) number K944400, cleared on 9/27/94 .
4. Device Description
The Kendall CO2nfirm NOW™ CO2Detector is a disposable device that is used during the oral or nasal placement of a gastric tube to preliminarily determine if the tube is properly placed by detection of CO2
5. Device Intended Use
Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.
-
- Product Comparison
The proposed device has the same technological characteristics as the predicate devices. Both the proposed and predicate devices function by colorimetric detection of CO2 in air. The construction and materials of the devices, as well as the detector chemistry and sensitivity are identical between the proposed and predicate devices. The inlet and outlet ports of the proposed device have been modified to accommodate the new intended use, and the device printing has been modified to replace the quantitative scale with a qualitative (yes/no) scale.
- Product Comparison
1
Kendall C02nfirm NOW™ C02 Detector
510(k) Summary (Continued)
7. Nonclinical Testing
Testing was conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the industry accepted criteria for such devices as defined in EN1615:2000 and ISO 594, Parts 1&2.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
Ms. Bridget Gardner Manager, Regulatory Affairs Kendall TYCO Healthcare Group, LP 15 Hampshire Street MANSFIELD MA 02048
Re: K042572
Trade/Device Name: Kendall CO2nfirm NOW™ CO2 Detector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: September 13, 2004 Received: September 21, 2004
Dear Ms. Gardner:
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 for are varior 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
3
Page 2 – Ms. Bridget Gardner
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 (21 CFR Part 807); 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.
This letter will allow you to begin marketing your device as described in your Section 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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
4
K042572 page lot 1
510(k) PREMARKET NOTIFICATION
Kendall C02nfirm NOW™ C02 Detector
Indications for Use
510(k) Number (if known): K042572
Device Name: Kendall CO₂nfirm NOW™ CO₂Detector
Indications For Use:
Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Nancy C Brogdon
(Division Sign-Off Division of Reproductive, Abo and Radiological Devi 510(k) Number