DoubleChek DC-1001

K212316 · Nasogastric Feeding Solutions, Ltd. · KNT · Sep 30, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K212316
• Device Name: DoubleChek DC-1001
• Applicant: Nasogastric Feeding Solutions, Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

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.

Device Story

Hand-held, non-powered, disposable device; utilizes CO2 and pH indicator papers to assess naso/oro gastric tube tip environment. User connects reservoir, naso/orogastric tube, and syringe to device ports. Syringe aspiration draws either liquid (stomach contents) or gas (exhalation) through sample pathways. Gaseous aspirate contacts CO2 indicator paper; liquid aspirate contacts pH indicator paper. Color changes on papers, compared against integrated color scale, indicate presence of CO2 or acidic environment. Used by healthcare professionals in clinical settings to assist in monitoring tube environment during or after initial placement. Does not confirm tube location; provides environmental data to support clinical decision-making.

Clinical Evidence

No clinical data. Performance demonstrated via non-clinical bench testing, including biocompatibility, ISO 80369-3:2016 mechanical testing, pressure profiling, and pH/CO2 indicator imprecision and bias studies.

Technological Characteristics

Non-powered, disposable, hand-held device. Features CO2 and pH indicator papers. Includes male and female ENFit connectors (ISO 80369-3:2016) and 22 mm reservoir interface. Ultrasonically welded chambers. No electrical or radiation components.

Indications for Use

Indicated for use with an initially placed or in-situ naso/oro gastric tube in all patients within a health care setting. Intended to indicate presence of acidic or CO2 environment at tube tip. Not intended to confirm tube location. Single-patient use for up to 24 hours.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Kendall CO₂nfirm NOW™ CO₂ Detector (K042572)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary of Safety and Effectiveness

# Submitter / 510(k) Holder

| Company: | NasoGastric Feeding Solutions, Ltd. doing business as Enteral Access<br>Technologies, Ltd. |
|-----------------|--------------------------------------------------------------------------------------------|
| Address: | 131 Mount Pleasant<br>Liverpool L3 5TF<br>Great Britain |
| Phone: | [phone] |
| 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

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.

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| Criteria for Comparison | Proposed Device Compared to<br>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

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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.