(212 days)
No
The device description and performance studies focus on the physical characteristics and functionality of a traditional medical tube, with no mention of AI/ML components or data processing.
No
A therapeutic device is one that treats or heals a disease or medical condition. This device is used for gastric decompression and administration of nutrition, fluids and medication, which are supportive functions rather than direct treatment for a disease.
No
This device is a stomach tube used for gastric decompression and administration of nutrition, fluids, and medication. It is a therapeutic and delivery device, not one that identifies or analyzes medical conditions.
No
The device description clearly states it is a "double-lumen tube made of PVC" and describes physical components and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "gastric decompression and administration of nutrition, fluids and medication." This involves direct interaction with the patient's body for therapeutic and supportive purposes.
- Device Description: The description details a tube inserted into the stomach for drainage and feeding. This is a medical device used for treatment and support, not for analyzing samples from the body to diagnose or monitor conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
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 codes (comma separated list FDA assigned to the subject device)
PIF, FEG
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric
Indicated Patient Age Range
patients with age of two and older.
Intended User / Care Setting
Prescription Use
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 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
- 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.
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.
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 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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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: 508.618.3727 Email: alexis.erazo@cardinalhealth.com
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- |
| 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™ |
| Polyurethane (PU) Neonatal and Pediatric Feeding Tubes | |
| 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
4
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
5
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).