Salem Sump Dual Lumen Stomach Tube with Multi-functional Port

K150711 · Covidien · PIF · Oct 8, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150711
• Device Name: Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
• Applicant: Covidien
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Oct 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The device is intended for patients with age of two-year and older.

Device Story

Double lumen gastric sump tube; utilizes multi-functional port for alternating gastric decompression or fluid delivery. Input: suction source for decompression; syringe or feeding set for fluid delivery. Output: gastric drainage or delivered fluids/meds. Used in clinical settings by healthcare providers. Features male ENFit connector compliant with AAMI/CN3:2014 to prevent misconnections. Benefits patient by enabling safe, standardized enteral access and decompression while reducing risk of tubing misconnections.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), stability testing, usability/human factors testing, and physical/functional performance testing of the ENFit connector (leakage, stress cracking, axial load, unscrewing, and misconnection assessment).

Technological Characteristics

Double lumen sump tube; PVC construction with barium sulfate and print ink. Multi-functional port uses polycarbonate, polyethylene, polypropylene, cyanoacrylate adhesive, silicone rubber/lubricant, and copolyester. Features male ENFit connector (AAMI/CN3:2014). Sizes 10Fr–18Fr; lengths 36–48 inches. Sterilization via gamma irradiation and ethylene oxide.

Indications for Use

Indicated for gastric decompression and delivery of fluids (irrigation, nutritional supplements, medication) in patients aged two years and older requiring gastric decompression.

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

• Next Generation Salem Sump (K040388)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three heads, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2015

Covidien Wei Zhao, M.D. Senior Director, Regulatory Affairs 15 Hampshire Street Mansfiled. MA 02048

Re: K150711

> Trade/Device Name: Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port Regulation Number: 21 CFR\$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, FEG Dated: September 3, 2015 Received: September 4, 2015

Dear Wei Zhao,

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. 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.

{1}------------------------------------------------

Page 2 - Wei Zhao, M.D.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K150711

#### Device Name

Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port

Indications for Use (Describe)

Intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The device is intended for patients with age of two-year 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)

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 2.0 510(k) Summary

Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port

In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:

Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: January 18, 2015

#### a. Contact Person

Wei Zhao Senior Director, Regulatory Affairs Covidien Telephone: [phone] Fax: [phone]

#### b. Name of Medical Device

Common Name: Tube, double lumen for intestinal decompression and/or intubation

U.S. FDA Classification Product Code: FEG, PIF

U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980

Proprietary / Trade Name: Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port

## c. Identification of Legally Marketed Device(s)

Next Generation Salem Sump, K040388

{4}------------------------------------------------

# d. Device comparison summary

| Device Comparison Summary | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | Proposed Device | |
| Device Name | Next Generation Salem<br>Sump with Multi-port<br>Connector | Salem Sump™ Dual Lumen<br>Stomach Tube with Multi-<br>Functional Port (with ENFit<br>connector) |
| Intended use | Intended for gastric<br>decompression and delivery of<br>fluids, including irrigation,<br>nutritional supplements, and<br>medication during the time<br>period that gastric<br>decompression is required. | Intended for gastric<br>decompression and delivery of<br>fluids, including irrigation,<br>nutritional supplements, and<br>medication during the time<br>period that gastric<br>decompression is required. The<br>device is intended for patients<br>with age of two-year and older. |
| Sterility | Sterile by gamma irradiation | Sterile by gamma irradiation<br>and ethylene oxide |
| Technological Characteristics | The device is a gastric sump<br>tube which utilizes a<br>multifunctional port to allow<br>alternating use for gastric<br>decompression or delivery of<br>fluids, including irrigation,<br>nutritional supplements, and<br>medication. The connection<br>for delivery of fluids<br>supports multiple types of<br>devices and connectors. | The device is a gastric sump<br>tube which utilizes a<br>multifunctional port to allow<br>alternating use for gastric<br>decompression or delivery of<br>fluids, including irrigation,<br>nutritional supplements, and<br>medication. The connection<br>for delivery of fluids is via a<br>male ENFit connector. |
| Design | The product is a double<br>lumen sump tube available in<br>5 sizes, 10Fr – 18Fr, and<br>lengths of 36 – 48 inches.<br>The device is equipped with<br>a Multi-functional port to<br>allow alternating use for<br>gastric decompression (via a<br>suction connector) or<br>delivery of fluids, including<br>irrigation, nutritional<br>supplements, and medication<br>via a catheter tip syringe or a<br>feeding set with a step<br>connector. | The product is a double<br>lumen sump tube available in<br>5 sizes, 10Fr – 18Fr, and<br>lengths of 36 – 48 inches.<br>The device is equipped with<br>a Multi-functional port to<br>allow alternating use for<br>gastric decompression (via a<br>suction connector) or<br>delivery of fluids, including<br>irrigation, nutritional<br>supplements, and medication<br>via a syringe or feeding set<br>equipped with a female<br>ENFit connector. |
| Materials / Chemical<br>Composition | Sump Tube<br>● Polyvinyl chloride | Sump Tube<br>● Polyvinyl chloride |
| | | |
| (PVC)<br>• Barium Sulfate<br>• print ink | (PVC)<br>• Barium Sulfate<br>• print ink | |
| Multi-functional port<br>• Polycarbonate<br>• Polyethylene<br>• Polypropylene<br>• Cyanoacrylate adhesive<br>• Silicone rubber<br>• Silicone lubricant<br>• Print ink | Multi-functional port<br>• Polycarbonate<br>• Polyethylene<br>• Polypropylene<br>• Cyanoacrylate adhesive<br>• Silicone rubber<br>• Silicone lubricant<br>• Print ink<br>• Copolyester | |

{5}------------------------------------------------

#### Discussion of technological differences e.

The Salem Sump™ Dual Lumen Stomach Tube with Multi-functional Port are intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The primary technological difference is the incorporation of the new ENFit connector which is compliant to AAMI/CN3:2014 (PS) Part 3. This connector is part of an industry wide effort to address misconnections by adopting a uniform connector that has been engineered to meet the objective of AAMI/ANSI/ISO 80369-1, small-bore connectors for liquids and gases in healthcare applications - part 1: general requirements. The additional changes implemented in manufacturing technologies are incidental to the primary change, and do not alter device performance.

- f. Discussion of Nonclinical testing
- The following risk management activities were executed to identify the potential hazards, evaluate their risks and develop the risk mitigation methods:
- ENFit connector: Risk management report o
- Proposed device: Design Failure Modes and Effects Analysis (FMEA) and risk o analysis.
- Biocompatibility testing in accordance with ISO 10993-1:2009. Biological Evaluation of ● medical Devices- Part 1: Evaluation and Testing has demonstrated the biological safety of parts of the medical device which may indirectly contact the patient, and is consistent with FDA "Draft Guidance for Industry and FDA staff, Use of international Standard ISO 10993 'Biological Evaluation of medical Devices Part 1: Evaluation and Testing,"' issued on April 23, 2013. Similar testing had been conducted for the predicate device.

{6}------------------------------------------------

- Stability testing of the proposed device evaluated the key performance properties of the feeding set after accelerated aging in support of the expiration date which will be applied to the device.
- Usability and human factors testing was conducted as part of the design of the ENFit . connector.
- Device tensile properties were evaluated for its durability.
- . The following tests were performed to demonstrate the physical and functional performance of the ENFit connector:
- fluid leakage o
- stress cracking о
- resistance to separation from axial load O
- resistance to separation from unscrewing O
- resistance to overriding о
- disconnection from unscrewing O
- dimensional analysis o
- Misconnection assessment of ENFit connector and suctioning port was conducted to . prove the incompatibility of the ENFIt small bore connector to other medical devices to reduce the risk of misconnection.
- g. Clinical testing

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

#### h. Conclusions

This information provided within this pre-market notification demonstrates that the modified Salem Sump™ Dual Lumen Stomach Tube with Multi-Functional Port with ENFit Connectors is as safe, as effective, and performs as well as or better than the legally marketed device, therefore I find the subject device to be substantially equivalent to the predicate device. The addition of the ENFit connector, which is compliant with AAMI/CN3:2014 (PS) Part 3 is intended to improve device performance by addressing the risk of misconnections.

End of Summary