(45 days)
Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.
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
Based on the provided 510(k) summary for the Kendall C02nfirm NOW™ C02 Detector, here's an analysis of the acceptance criteria and supporting study information:
The Kendall C02nfirm NOW™ C02 Detector is a disposable device used to assist in the verification of gastric tube placement by detecting CO2.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria or specific performance metrics for the Kendall C02nfirm NOW™ CO2 Detector. Instead, it relies on demonstrating equivalence to predicate devices and meeting industry standards.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices (Easy Cap® CO2 detector, Pedi-Cap® CO2 detector) in technological characteristics, construction, materials, detector chemistry, and sensitivity. | 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." |
| Adherence to industry accepted criteria for such devices as defined in EN1615:2000 and ISO 594, Parts 1&2. | "Testing was conducted to demonstrate that the design of the proposed device... met the industry accepted criteria for such devices as defined in EN1615:2000 and ISO 594, Parts 1&2." (No specific performance data against these standards is provided in the summary.) |
| Modified inlet/outlet ports to accommodate new intended use (gastric tube placement). | "The inlet and outlet ports of the proposed device have been modified to accommodate the new intended use." (Implied successful modification, no specific performance data given.) |
| Modified device printing to replace quantitative scale with qualitative (yes/no) scale. | "The device printing has been modified to replace the quantitative scale with a qualitative (yes/no) scale." (Implied successful modification, no specific performance data given.) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on a specific "test set" in terms of subject or patient data. The non-clinical testing described focuses on demonstrating design equivalence to predicate devices and adherence to industry standards for device construction and function. It does not mention a clinical study involving human subjects or patient data. Therefore, there's no information on sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set with human subjects or patient data is described, there is no mention of experts being used to establish ground truth in this context. The evaluation appears to be purely technical and comparative against existing devices and standards.
4. Adjudication Method for the Test Set
Given the absence of a clinical test set and expert review for ground truth, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance. The device is a diagnostic tool, not an AI-powered image analysis system.
6. Standalone Performance Study
The summary describes "Nonclinical Testing" conducted to demonstrate design equivalence and adherence to industry standards. This can be considered a form of standalone testing in the sense that the device itself was tested for its physical and functional characteristics. However, it's not a standalone clinical performance study in the way it's typically understood for diagnostic algorithms (e.g., performance metrics like sensitivity, specificity on a clinical dataset). The testing described is more about the intrinsic properties of the device (colorimetric detection, materials, construction) rather than its diagnostic accuracy in a clinical setting.
7. Type of Ground Truth Used
For the nonclinical testing, the "ground truth" implicitly used would be:
- Predicate Device Performance: The established functionality and performance of the Easy Cap® CO2 detector and Pedi-Cap® CO2 detector.
- Industry Standards: The requirements and specifications outlined in EN1615:2000 and ISO 594, Parts 1&2.
The summary does not mention pathology, outcomes data, or expert consensus in a clinical context as ground truth.
8. Sample Size for the Training Set
No training set is mentioned. This device is a passive, colorimetric CO2 detector, not a machine learning or AI-driven system that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable. The device's function is based on a well-understood chemical principle, not on learned patterns from a dataset.
{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
§ 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.