Salem Sump Dual Lumen Stomach Tube with ENFit Connection

K190923 · Cardinalhealth · PIF · Nov 7, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190923
• Device Name: Salem Sump Dual Lumen Stomach Tube with ENFit Connection
• Applicant: Cardinalhealth
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Nov 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids and medication. The device is intended for patients with age of two and older.

Device Story

Double-lumen PVC tube used for naso/orogastric drainage and feeding; larger lumen facilitates drainage and nutrition/medication delivery; smaller lumen draws in ambient air to moderate suction pressure at drainage eyes. Device incorporates ISO 80369-3 compliant ENFit connector for secure enteral access. Single-use, EO-sterilized device; intended for clinical use by healthcare professionals. Provides gastric decompression and enteral support; ENFit connection prevents misconnection with non-enteral systems, enhancing patient safety.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional verification, occlusion, leakage, patency, tensile strength, stress cracking, flow rate, simulated gastric indwell, and biocompatibility evaluation.

Technological Characteristics

Double-lumen PVC tube; sizes 6Fr to 18Fr. Features ISO 80369-3 compliant ENFit connector. Sterilized via EO. Complies with EN 1615:2000, EN 1618:1997, ISO 80369-1:2010, ISO 80369-3:2016, ISO 80369-20:2015, and ISO 10993-1:2009.

Indications for Use

Indicated for gastric decompression and administration of nutrition, fluids, and medication in patients aged two years and older.

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

• Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711)

Reference Devices

• Argyle Salem Sump Tube Anti-Reflex Valve Insertion Tray (K935781)
• Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (K150084)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 7, 2019

Cardinal Health Alexis Erazo Principal Regulatory Affairs Specialist 777 West Street Mansfield, MA 02048

Re: K190923

> Trade/Device Name: Salem Sump Dual Lumen Stomach Tube with ENFit Connection Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, FEG Dated: October 7, 2019 Received: October 8, 2019

Dear Alexis Erazo:

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.

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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 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 (QS) 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 medical devices and radiation-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.

for

Martha W. Betz, Ph.D. Acting 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) K190923

Device Name

Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection

Indications for Use (Describe)

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids and medication. The device is intended for patients with age of two and older.

| 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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K190923 Page 1 of 3

#### 510(k) Summary Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection

### Preparation date:

November 4, 2019

## Submitter Information:

Alexis Erazo Principal Regulatory Affairs Specialist Cardinal Health 777 West Street, Mansfield, MA 02048 Phone: [phone] Email: [e-mail]

### Name of Medical Device:

| Trade Name: | Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection |
|----------------------|------------------------------------------------------------|
| Common Name: | Tubes, gastrointestinal |
| Classification Name: | Gastrointestinal tube and accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Product Code: | PIF; FEG |
| Class: | II |

## Identification of Predicate Device:

| 510(k) Number | K150711 |
|--------------------|-------------------------------------------------------------------|
| Device Description | Salem Sump Dual Lumen Stomach Tube with Multi-<br>Functional Port |
| Submitter | Covidien |

## Identification of Reference Device:

| 510(k) Number | K935781 |
|--------------------|---------------------------------------------------------|
| Device Description | Argyle Salem Sump Tube Anti-Reflex Valve Insertion Tray |
| Submitter | Sherwood Medical Co. |

#### Identification of Reference Device:

| 510(k) Number | K150084 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™<br>Polyurethane (PU) Neonatal and Pediatric Feeding Tubes<br>with ENFit connector |
| Submitter | Covidien |

#### Device Description:

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is a double-lumen tube made of PVC used for naso/orogastric drainage and feeding. The larger (main) lumen is

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for feeding and drainage, while the smaller lumen draws in outside air to moderate the amount of suction at the drainage eyes. The device contains an ISO 80369-3 compliant ENFit connector which is inserted into the main lumen after decompression is no longer required to administer enteral fluids, including enteral nutrition, hydration and medication. It is a single use device which is provided sterilized via EO sterilization.

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is available in the following configurations:

- 6Fr x 24in ●
- . 8Fr x 24in
- 10Fr x 36in
- . 12Fr x 48in
- . 14Fr x 48in
- 16Fr x 48in ●
- 18Fr x 48in

## Intended Use/Indications for Use:

The Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids and medication. The device is intended for patients with age of two and older.

## Product Comparison Summary:

The proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection has the same intended use, indications for use and similar fundamental technological characteristics and as compared to the predicate Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711). Verification testing provided demonstrates that the technological characteristics differences to the Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection do not raise new questions of safety and efficacy than that of the predicate K150711. The test results demonstrate that the proposed device is as safe and effective as the legally marketed predicate device.

## Non-Clinical Performance Data:

Laboratory testing was completed to support substantial equivalence between the modified device and the current device. The modified device was evaluated to show compliance to the standards requirements (listed below) as well as performance characteristics related to the modification of the device.

- EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and ● their connectors - Design and testing
- EN 1618:1997 Catheters other than intravascular catheters. Test methods for . common properties
- . ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
- ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare . applications - Part 3: Connectors for enteral applications

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Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection Traditional 510(k) Pre-Market Notification

- . ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
- . ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

The following testing was conducted to demonstrate that the device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence.

- . Functional Verification
- Occlusion Verification ●
- Liquid/Fluid Leakage .
- Patency Verification .
- Tensile Strength
- Resistance to separation from axial load ●
- . Resistance to separation from unscrewing
- . Resistance to overriding
- . Disconnection by unscrewing
- . Stress Cracking
- Dimension verification ●
- Flow Rate ●
- Simulated Gastric Indwell ●
- Biocompatibility Evaluation ●
- Shelf Life (2 years) ●

The results of the testing show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence.

## Clinical Data:

Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.

## Conclusion:

The proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection has the same indications for use, intended use and similar fundamental technological characteristics and as compared to the predicate Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711). Verification testing demonstrates that the difference in technological characteristics between the K157011 predicate and the proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection do not raise new questions of safety and efficacy. In addition, test results demonstrate that the proposed device is as safe and effective as the legally marketed predicate device. Based on the above evaluation, the proposed Salem Sump™ Dual Lumen Stomach Tube with ENFit™ Connection is substantially equivalent to the predicate Salem Sump Dual Lumen Stomach Tube with Multi-Functional Port (K150711).