(90 days)
The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.
The Next Generation Salem Sump is a dual lumen Naso Gastric tube with a multiport connector/valve to facilitate switching among the various function of the device.
The provided text is a 510(k) summary for the "Next Generation Salem Sump," which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as one might find for a novel, higher-risk device.
Therefore, the information typically requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable or not available in this type of document because the device is a re-engineered version of an existing device and the "studies" are primarily non-clinical comparisons to predicate devices and industry standards.
Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not present:
Acceptance Criteria and Device Performance Study for Next Generation Salem Sump (K040388)
This submission is a 510(k) Premarket Notification for a Class II medical device (Gastrointestinal tube and accessories). The device, the "Next Generation Salem Sump," is intended for gastric decompression and fluid delivery. The primary method of demonstrating its suitability for market clearance is by proving substantial equivalence to legally marketed predicate devices, rather than through extensive clinical efficacy trials against pre-defined acceptance criteria for performance. The "study" here refers to non-clinical testing to demonstrate equivalence or adherence to industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from EN1615:2000 or equivalence to predicate) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices (Kendall Salem Sump K935781/A, Bard (Davol) NasoGastric Sump K960176, ICU Medical Lopez Valve K915171, ICU Medical Lopez Valve with NG tube K921104) in technological characteristics. | Stated as having "the same technological characteristics as the predicate devices." |
| Meeting industry accepted criteria for such devices, as defined in EN1615:2000. | Nonclinical testing was "conducted to demonstrate that the design of the proposed device... met the industry accepted criteria for such devices, as defined in EN1615:2000." (Specific test results or quantitative metrics are not provided in this summary.) |
| Function: Gastric decompression and delivery of fluids (irrigation, nutritional supplements, medication). | Stated to perform these functions, "The proposed device has the same technological characteristics as the predicate devices," and its "construction... is based upon a dual lumen PVC nasogastric tube." |
| Mechanism to prevent gastric reflux from the vent lumen. | "Both the proposed device and the predicate devices are equipped with a mechanism to prevent gastric reflux from the vent lumen of the device." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "Nonclinical Testing" which likely involves specific device prototypes or components, but the number of units tested is not detailed in this summary.
- Data Provenance: Not specified, but given it's non-clinical testing performed by the manufacturer (The Kendall Company / Tyco Healthcare Group), it would be proprietary testing. Contextually, such testing is generally performed in a controlled laboratory setting, not with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a device like a nasogastric tube undergoing non-clinical testing for substantial equivalence, "ground truth" and "experts" in the context of clinical interpretation (e.g., radiologists interpreting images) are not relevant. The "ground truth" here would be adherence to engineering specifications and performance standards as determined by test methods.
4. Adjudication method for the test set
- Not Applicable. No human interpretation or adjudication in the clinical sense is described. Non-clinical testing follows predefined protocols and acceptance criteria based on engineering and material science principles.
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. This is a physical medical device (nasogastric tube), not an AI/software-as-a-medical-device (SaMD) or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used
- Not Applicable / Engineering Specifications and Standards. For this type of submission, "ground truth" refers to the established engineering specifications for the device components and performance metrics derived from industry standards (EN1615:2000) or direct comparison to the predicate devices. It is not clinical data like pathology reports, expert consensus of images, or patient outcomes.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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K040388
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15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 * (508) 261-8000
| MAY 1 7 2004 | 510(k) Premarket NotificationNext Generation Salem Sump |
|---|---|
| Section H - 510(K) Summary | |
| Date SummaryWas Prepared: | February 12, 2004 |
| Submitter'sInformation: | The Kendall CompanyDivision of Tyco Healthcare Group, LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-8461 |
| Contact: | Jim WelshDirector, Regulatory AffairsThe Kendall CompanyDivision of Tyco Healthcare Group, LPTelephone: 508-261-8532Fax: 508-261-8461 |
| Device TradeName: | Next Generation Salem Sump |
| Device CommonName: | Tube, double lumen for intestinal decompression and/or intubation |
Classification Panel: Gastroenterology
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Kendall Salem Sump (naso gastric) tube with Anti-Reflux Valve, 510(k) number K935781/A, u cleared on January 10, 1995.
- Bard (Davol) NasoGastric Sump tube with PreVent Anti-Reflux filter, 510(k) number K960176, cleared on July 24, 1996.
- ICU Medical Lopez Valve, 510(k) number K915171, cleared February 7, 1992
- . ICU Medical Lopez Valve with NG tube, 510(k) number K921104, cleared on October 26, 1992.
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510(k) Premarket Notification Next Generation Salem Sump
Section H - 510(K) Summary
Device Description: The Next Generation Salem Sump is a dual lumen Naso Gastric tube with a multiport connector/valve to facilitate switching among the various function of the device.
Intended Use: The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.
Product Comparison: The proposed device has the same technological characteristics as the predicate devices. Both the proposed device and the predicate devices are intended to be used for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication. The construction of both the proposed and predicate devices is based upon a dual lumen PVC nasogastric tube, with external connection ports suitable for connection with commonly available devices such as vacuum adaptors, feeding sets, and irrigation syringes. Both the proposed device and the predicate devices are equipped with a mechanism to prevent gastric reflux from the vent lumen of the device.
Nonclinical Testing: Testing was conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the industry accepted criteria for such devices, as defined in EN1615:2000.
James E. Clark
alm Welsh Director, Regulatory Affairs Tyco Healthcare/Kendall
2-12-04
Date
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle with three stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2004
Mr. James Welsh Director, Regulatory Affairs The Kendall Company Tyco Healthcare Group, LP 15 Hampshire Street MANSFIELD MA 02048
Re: K040388
Trade/Device Name: Next Generation Salem Sump Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 FEG Dated: February 12, 2004 Received: February 17, 2004
Dear Mr. Welsh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have 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 for ass bated in the 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). and Ocometer for , roy the 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.
If your device is classified (see above) into either class II (Spccial 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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This letter will allow you to begin marketing your device in your Section 510(k)
. I alleging to begin of the first of also to tick answelesses of your device to a logally This letter will allow you to ocgli marketing of substantial equivalence of your device to a legally premarket nothication. The PDA intonty of submands of Erray of thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice to your device on our lasting of the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the promotion to , please note the regulation entitled, "Misbranding Office of Compliance at (301) 574 1059. Fab 1.97.97) you may obtain. Other general by reference to premarket notification (21 or Fr x are events and from the Division of Small information on your responsionalities uncer assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consuminent in associaded damamain huml Manufacturers, International and Collisamer Assisterial Assisted on the Contracted on the Collection of the Collection of the Internet
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000
510(k) Premarket Notification Next Generation Salem Sump
Appendix 1
Indications for Use Statement
Device Name:
Next Generation Salem Sump
Indications for Use:
The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, The Next Generation Oalch Outlip is internable for gast on, during the time period that gastric decompression is required.
Please Do Not Write Below This Line – Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancic Brogdon
(Division Sign-Off)
Division of Reproductive, Abo and Radiological Devic
510(k) Number K040388
§ 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.