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.

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:

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, 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the DoubleCHEK DC-1001 device, which is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy) for the pH and CO2 indicators. Instead, it states that "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 performance tests conducted were primarily focused on demonstrating the device's functional capabilities and adherence to existing standards, rather than clinical efficacy against a gold standard.

Here's a summary of the non-clinical performance tests mentioned:

Acceptance Criteria Category/Test	Reported Device Performance
Biocompatibility	Evaluated per ISO 1093-1. (Implied acceptance if passed, but specific results not detailed in this summary.)
ISO 80369-3:2016 Tests (for connectors)	Positive Pressure Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing. (Implied acceptance if passed, as it supports substantial equivalence.)
Packaging Visual Inspection	Performed. (Implied successful completion.)
IFU Visual Inspection	Performed. (Implied successful completion.)
Device Visual Inspection	Performed. (Implied successful completion.)
Pressure Profile	Performed. (Implied successful characterization.)
pH Indicator Imprecision and Bias Studies	Performed. (Implied acceptable performance for intended function, though specific numeric outcomes are not provided.)
CO2 Indicator Imprecision and Bias Studies	Performed. (Implied acceptable performance for intended function, though specific numeric outcomes are not provided.)
Device Working Life	Repeated assessment of CO2 indication performance, Repeated assessment of pH indication performance, Reset performance, Device Integrity. (Implied successful demonstration of durability and consistent performance over time.)

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical performance testing was not required to demonstrate the performance of the DoubleCHEK DC-1001."

Therefore, there is no clinical test set, sample size for a test set, or data provenance from patient studies to report. The evaluation was based entirely on non-clinical (laboratory/bench) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical performance testing was conducted, there were no patient-derived ground truth determinations by medical experts. The performance was assessed against defined physical and chemical parameters in a laboratory setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set using human subjects was utilized for performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The DoubleCHEK DC-1001 is a diagnostic device that provides an indication (color change for pH and CO2 presence); it is not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the device's inherent physical and chemical detection capabilities. The "standalone" performance was effectively evaluated through the non-clinical tests described in point 1 (e.g., pH and CO2 indicator imprecision and bias studies). The device's function is to show a color change, and the accuracy of that color change in response to specific pH or CO2 levels was the subject of these non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" was established by controlled laboratory conditions and known chemical/physical parameters. For example:

For pH indication, the ground truth would be solutions with known pH values.
For CO2 indication, the ground truth would be gas mixtures with known CO2 concentrations.
For mechanical tests (e.g., leakage), the ground truth is the engineering specification for what constitutes a pass/fail.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model that requires a "training set." Its function is based on chemical indicators and mechanical design.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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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

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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

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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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510(k) Summary of Safety and Effectiveness

Submitter / 510(k) Holder

Company:	NasoGastric Feeding Solutions, Ltd. doing business as Enteral AccessTechnologies, Ltd.
Address:	131 Mount PleasantLiverpool L3 5TFGreat 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

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Device Description

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.

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Criteria for Comparison	Proposed Device Compared toPredicate 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

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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.

Regulation Number and Section

§ 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.