(431 days)
Not Found
No
The device description details a purely mechanical and chemical process using indicator papers for detection, with no mention of computational analysis, algorithms, or learning.
No.
The device is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment, which is a diagnostic function, not a therapeutic one. It does not provide treatment or mitigation of a disease or condition.
No
The device is intended to indicate the presence of acidic or CO2 environments, which can aid in determining the general location of a tube (e.g., in the stomach or airway), but it is explicitly stated that the device "is NOT intended to confirm the location of the naso/oro gastric tube." This statement distinguishes it from a diagnostic device, which would typically provide a definitive diagnosis or confirmation of a state or condition. Instead, it seems to provide an indication or a piece of information rather than a diagnosis itself.
No
The device description clearly states it is a "hand-held, non-powered disposable device" consisting of physical components like chambers, ports, and indicator papers. It is a hardware device that uses chemical reactions (color change of indicator papers) to provide information, not software processing.
Based on the provided information, the DoubleCHEK device is likely considered an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment. This involves analyzing a sample (aspirated liquid or gas) taken from the patient.
- Mechanism: The device uses indicator papers (pH and CO2) that change color based on the chemical properties of the aspirated sample. This is a classic method used in in vitro diagnostic tests to detect the presence or level of specific substances in a biological sample.
- Sample Type: The device analyzes aspirated liquid (stomach contents) or gas (exhalation gas), which are biological samples.
- Purpose: While the device is not intended to confirm the location of the tube, it is intended to provide information about the environment the tube tip is in, which is derived from analyzing a sample from that environment. This information is used to aid in the placement process.
Key aspects that align with the definition of an IVD:
- It is used to examine specimens derived from the human body (aspirated liquid/gas).
- It provides information about a physiological state (acidic or CO2 environment).
- It uses chemical indicators to perform the analysis.
While the device is used in conjunction with a medical procedure (tube placement), the core function of analyzing a biological sample in vitro (outside the body) to provide diagnostic information about the environment is consistent with the definition of an IVD.
The fact that it's a simple, non-powered device doesn't preclude it from being an IVD. Many simple tests, like pH strips or some rapid diagnostic tests, are considered IVDs.
N/A
Intended Use / Indications for Use
Intended Use: DoubleCHEK is intended to indicate whether the tip of a naso/oro gastric tube tip is in an acidic or CO2 environment during or after initial placement. The DoubleCHEK is NOT intended to confirm the location of the naso/oro gastric tube.
Indications for Use:
The DoubleCHEK is indicated for use with an in-situ naso/oro gatric tube. It is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. It is NOT intended to confirm the location of the naso/oro gastric tube.
The device is intended to be used by Health Care Professionals on all patients within a health care setting. The device is intended to be used with a single patient for up to 24 hours.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The proposed device, DoubleCHEK DC-1001 is a hand-held, non-powered disposable device which consists of CO2 and pH chambers ultrasonically welded to the device upper (top) and the reservoir interface. pH and CO2 indicator papers are integrated into the design directly underneath the top so they are visible to the users next to the primary device label which contains the color scale.
There are three ports where accessories are intended to the device to enable use:
- 0 The Syringe Port: A male ENFit connector designed per ISO 80369-3:2016.
- The NG Tube (NGT) Port: A female ENFit connector designed per ISO 80369-3:2016.
- The Reservoir Interface: A 22 mm bung style connector. ●
To use the proposed device, the user attaches the reservoir to the reservoir interface, the naso/orogastric tube to the NGT Port and the syringe to the Syringe Port. The user then pumps the syringe (withdraws the plunger) to aspirate either liquid (stomach contents) or gas (exhalation gas). The gaseous aspirate will traverse the sample pathway to the CO2 indicator paper [5], where the presence or absence of CO2 can be detected via a color change in the paper. The liquid aspirate will traverse through the sample pathway to the pH paper, which will indicate pH level via a color change in the paper.
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
Health Care Professionals on all patients within a health care setting.
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)
Non-Clinical Performance Testing was conducted. Clinical performance testing and animal testing were not required. The non-clinical performance testing demonstrated that the DoubleCHEK DC-1001 is as safe and effective as the predicate device and substantially equivalent.
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
§ 876.5980 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2022
Nasogastric Feeding Solutions, Ltd. % Crystal Koelper President Koelper Consulting, LLC 268 Biltmore Drive North Barrington, IL 60010
Re: K212316
Trade/Device Name: DoubleChek DC-1001 Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: August 27, 2022 Received: August 29, 2022
Dear Crystal Koelper:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212316
Device Name DoubleChek DC-1001
Indications for Use (Describe) Intended Use: DoubleCHEK is intended to indicate whether the tip of a naso/oro gastric tube tip is in an acidic or CO2 environment
during or after initial placement.
The DoubleCHEK is NOT intended to confirm the location of the naso/oro gastric tube.
Indications for Use:
The DoubleCHEK is indicated for use with an in-situ naso/oro gatric tube. It is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. It is NOT intended to confirm the location of the naso/oro gastric tube.
The device is intended to be used by Health Care Professionals on all patients within a health care setting. The device is intended to be used with a single patient for up to 24 hours.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Safety and Effectiveness
Submitter / 510(k) Holder
| Company: | NasoGastric Feeding Solutions, Ltd. doing business as Enteral Access
Technologies, Ltd. |
|-----------------|--------------------------------------------------------------------------------------------|
| Address: | 131 Mount Pleasant
Liverpool L3 5TF
Great Britain |
| Phone: | +44 151 705 3466 |
| Contact Person: | George Gallagher |
| Date Prepared: | October 30, 2021 |
Device Name and Classification
| Trade Name: | DoubleCHEK |
|---|---|
| Model Number(s): | DC-1001 |
| Classification Name: | Gastrointestinal Tubes with Enteral Specific Connectors (21 CFR 876.5980) |
| Product Code: | KNT |
| Class: | II |
Predicate Device
| Trade Name: | Kendall CO₂nfirm NOW™ CO₂ Detector |
|---|---|
| Model Number(s): | 777702 |
| Classification Name: | Gastrointestinal Tubes with Enteral Specific Connectors (21 CFR 876.5980) |
| Product Code: | KNT |
| Class: | II |
| 510(k) Number: | K042572 |
4
Device Description
The proposed device, DoubleCHEK DC-1001 is a hand-held, non-powered disposable device which consists of CO2 and pH chambers ultrasonically welded to the device upper (top) and the reservoir interface. pH and CO2 indicator papers are integrated into the design directly underneath the top so they are visible to the users next to the primary device label which contains the color scale.
There are three ports where accessories are intended to the device to enable use:
- 0 The Syringe Port: A male ENFit connector designed per ISO 80369-3:2016.
- The NG Tube (NGT) Port: A female ENFit connector designed per ISO 80369-3:2016.
- The Reservoir Interface: A 22 mm bung style connector. ●
To use the proposed device, the user attaches the reservoir to the reservoir interface, the naso/orogastric tube to the NGT Port and the syringe to the Syringe Port. The user then pumps the syringe (withdraws the plunger) to aspirate either liquid (stomach contents) or gas (exhalation gas). The gaseous aspirate will traverse the sample pathway to the CO2 indicator paper [5], where the presence or absence of CO2 can be detected via a color change in the paper. The liquid aspirate will traverse through the sample pathway to the pH paper, which will indicate pH level via a color change in the paper.
Indications for Use
Intended Use:
DoubleCHEK is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. The DoubleCHEK is NOT intended to confirm the location of the naso/oro gastric tube.
Indications for Use:
The DoubleCHEK is indicated for use with an initially placed or an in-situ naso/oro gatric tube. It is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. It is NOT intended to confirm the location of the naso/oro gastric tube. The device is intended to be used by Health Care Professionals on all patients within a health care setting. The device is intended to be used with a single patient for up to 24 hours.
Product Comparison Summary
The proposed and predicate devices are substantially equivalent.
5
| Criteria for Comparison | Proposed Device Compared to
Predicate Device |
|---------------------------------|----------------------------------------------------|
| Intended Use | |
| Indications | Similar and SE |
| Clinical Settings | Same |
| Target Population | Similar and SE |
| Design Characteristics | |
| Naso/orogastric Tube Connection | Similar and SE |
| Aspiration Device Connection | Similar and SE |
| Indicator Paper | Similar and SE |
| Materials | |
| Device | Different (unknown) |
| Performance | |
| Use/Human Factors | Same |
| Theory of Operation | Same |
| pH Detection | Different |
| CO2 Detection | Same as predicate device |
| Fluid administration prevention | Different (predicate device does not have feature) |
| Risk Assessment | Different (unknown) |
| Safety | |
| Mechanical | Similar and SE |
| Electrical | Same - not electrical devices |
| Radiation | Same - not radiation emitting devices |
Non-Clinical Performance Testing
Non-clinical performance testing was conducted to demonstrate that the proposed device, the DoubleCHEK DC-1001, is substantially equivalent to the predicate device and is safe and effective for its intended use.
The following tests were performed:
- . Biocompatibility evaluation per ISO 1093-1
- ISO 80369-3:2016 Tests .
- Positive Pressure Liquid Leakage o
- O Stress Cracking
- Resistance to Separation from Axial Load O
- O Resistance to Separation from Unscrewing
- O Resistance to Overriding
- Disconnection by Unscrewing о
- Packaging Visual Inspection
- IFU Visual Inspection
- Device Visual Inspection
- Pressure Profile
- pH Indicator Imprecision and Bias Studies
- CO2 Indicator Imprecision and Bias Studies
6
- Device Working Life, including: ●
- Repeated assessment of C02 indication performance O
- Repeated assessment of pH indication performance O
- Reset performance O
- O Device Integrity
Clinical Performance Testing
Clinical performance testing was not required to demonstrate the performance of the DoubleCHEK DC-1001. The DoubleCHEK DC-1001 performance has been adequately demonstrated by the completion of non-clinical performance testing.
Animal Testing
Animal testing was not required to demonstrate the performance of the DoubleCHEK DC-1001. The DoubleCHEK DC-1001 performance has been adequately demonstrated by the completion of non-clinical performance testing.
Conclusion
The results of the non-clinical performance testing demonstrate that the DoubleCHEK DC-1001 is as safe and effective as the predicate device. Therefore, the proposed device is substantially equivalent to the predicate device.