(123 days)
No
The 510(k) summary describes a mechanical connector for enteral feeding sets and mentions only mechanical and performance testing, with no indication of AI/ML technology.
No
The device is described as a connector for enteral feeding sets, delivering nutrition or water, which is a supportive function rather than a direct therapeutic intervention.
No
The device is a modified connector for enteral feeding sets, designed to deliver nutrition and water, not to diagnose a medical condition.
No
The device description clearly states it is a modified proximal connector for enteral feeding sets, which is a physical hardware component. The performance studies also focus on mechanical and biocompatibility testing of this hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver liquid nutrition formulas or water to an enteral access device (a feeding tube)." This describes a device used for delivering substances into the body for nutritional support, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description focuses on a connector for an enteral feeding set, which is part of a system for delivering nutrition. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Keywords: The text does not contain keywords commonly associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyze," "test," etc.
- Anatomical Site: The anatomical site is "Gastrointestinal," which aligns with the delivery of nutrition via a feeding tube, not with the collection or analysis of samples from the gastrointestinal tract for diagnostic purposes.
Therefore, the information provided clearly indicates that this device is intended for enteral feeding, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).
Product codes
KNT
Device Description
The subject of this 510(k) is a modified proximal connector for Abbott Nutrition enteral feeding sets. The proximal connector connects the tubing of the enteral feeding set to the source of the nutrition (i.e., the container of the enteral nutritional formula).
The modified design is the Safety Screw Connector and is compliant with the new AAMI/ISO Standard 80369-1 (Small-bore connectors for liguids and gases in healthcare applications – Part 1: General Requirements). This same design is being used for currently marketed competitive enteral nutrition sets.
This bundled 510(k) is a modification of the following three Class 2 nutrition devices:
- K943240 Flexiflo® Six Enteral Nutrition Pump Set: KNT, Class 2, 876.5980, . Gastroenterology/Urology (currently marketed as the Patrol® Pump Set with Piercing Pin).
- K915735 Flexiflo® Quantum Enteral Pump Sets and Enteral Nutrition Containers: KNT, . Class 2. 876.5980. Gastroenterology/Urology (currently marketed as two versions; Flexiflo@ Quantum Pump Set with Piercing Pin and the Flexiflo® Quantum Pump Set with Piercing Pin and Flush Bag)
- PREAMENDMENT Gravity Feeding Sets: KNT, Class 2, 876.5980, . Gastroenterology/Urology
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following tests were conducted in support of the substantial equivalence:
- Mechanical test for verifying non-interconnectable characteristics of Safety Screw t Connector and other connectors (ANSI/AAMI/ISO 80369-1:2010)
- Delivery accuracy and feeding system performance assessment testing of Safety Screw . Connector
- Biocompatibility testing for the Safety Screw Connector and the RTH Adapter Cap
- Tensile strength testing for the bond junction between the Safety Screw Connector and ● tubing
The risk analysis showed that the new connector does not raise new questions of safety and effectiveness. Performance testing showed that the new designs are equivalent to currently marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943240, K915735, PREAMENDMENT Gravity Feeding Sets
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K113719 Page 1 of
Abbott Nutrition · Abbott Laboratories 510(k) Premarket Notification
APR 2 0 2012
510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the Safety Screw Connector is provided below.
Device Common Name: Gastrointestinal tubes and accessories
Device Proprietary Name: Safety Screw Connector
510(k)#
Submitter:
Abbott Nutrition Abbott Laboratories 3300 Stelzer Road Columbus, OH 43219-3034
Contact:
Elizabeth M. Zola, PharmD Associate Director, Regulatory Affairs Abbott Nutrition Abbott Laboratories Phone: 614-624-3316 Fax: 614-727-3316 Email: elizabeth.zola@abbott.com
Classification Regulation:
21 CFR 876.5980
Panel:
Gastroenterology/Urology
Product Code:
KNT
Indication for Use:
The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).
CONFIDENTIAL INFORMATION
This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOIA response, contact the submitter (Abort Laboratories) for a pre-release review pursuant 21 CFR § 20.61.
Page 18
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KIJ3719
Page 2 of
Abbott Nutrition Abbott Laboratories 510(k) Premarket Notification
Device Description:
The subject of this 510(k) is a modified proximal connector for Abbott Nutrition enteral feeding sets. The proximal connector connects the tubing of the enteral feeding set to the source of the nutrition (i.e., the container of the enteral nutritional formula).
The modified design is the Safety Screw Connector and is compliant with the new AAMI/ISO Standard 80369-1 (Small-bore connectors for liguids and gases in healthcare applications – Part 1: General Requirements). This same design is being used for currently marketed competitive enteral nutrition sets.
This bundled 510(k) is a modification of the following three Class 2 nutrition devices:
- K943240 Flexiflo® Six Enteral Nutrition Pump Set: KNT, Class 2, 876.5980, . Gastroenterology/Urology (currently marketed as the Patrol® Pump Set with Piercing Pin).
- K915735 Flexiflo® Quantum Enteral Pump Sets and Enteral Nutrition Containers: KNT, . Class 2. 876.5980. Gastroenterology/Urology (currently marketed as two versions; Flexiflo@ Quantum Pump Set with Piercing Pin and the Flexiflo® Quantum Pump Set with Piercing Pin and Flush Bag)
- PREAMENDMENT Gravity Feeding Sets: KNT, Class 2, 876.5980, . Gastroenterology/Urology
Performance Data:
The following tests were conducted in support of the substantial equivalence:
- Mechanical test for verifying non-interconnectable characteristics of Safety Screw t Connector and other connectors (ANSI/AAMI/ISO 80369-1:2010)
- Delivery accuracy and feeding system performance assessment testing of Safety Screw . Connector
- Biocompatibility testing for the Safety Screw Connector and the RTH Adapter Cap �
- Tensile strength testing for the bond junction between the Safety Screw Connector and ● tubing
Substantial Equivalence:
The Abbott Nutrition enteral feeding devices with the Safety Screw Connector are substantially equivalent to commercially marketed Abbott Nutrition sets in terms of principle of operation and intended use. The new design reduces the risk of unintentional misconnection to another type of
CONFIDENTIAL INFORMATION
This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOLA response, contact the submitter (Abort Laboratories) for a pre-release review pursuant 21 CFR § 20.61.
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K113719 Pzgc 3of3
Abbott Nutrition Abbott Laboratories 510(k) Premarket Notification
tube. The risk analysis showed that the new connector does not raise new questions of safety and effectiveness. Performance testing showed that the new designs are equivalent to currently marketed devices.
CONFIDENTIAL INFORMATION
This document includes confidential and proprietary business information that is exempt from disclosure under the I his dobanient information Act (FOIA). Prior to any FOTA response, contact the submitter (Abort Laboratories) for a pre-release review pursuant 21 CFR § 20.61.
Page 20
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Elizabeth M. Zola, PharmD Associate Director, Regulatory Affairs Abbott Nutrition Abbott Laboratories 3300 Stelzer Road COLUMBUS OH 43219
APR 2 0 2012
Re: K113719
Trade/Device Name: Safety Screw Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 15, 2012 Received: March 16, 2012
Dear Dr. Zola:
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 Act. The Act. The Act. The Act. The A 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 requirements, including, but not limited to: registration and listing 0011); "Ital an 1001); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D.
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
5
Indications for Use Statement 4.0
510{k} Number (if known):
Device Name: Safety Screw Connector
Indications For Use: .
The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K113719 |
| Page 1 of | 1 |
CONFIDENTIAL INFORMATION
This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOIA response, contact the submitter (Abbott Laboratories) for a pre-release review pursuant 21 CFR § 20.61.
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