(105 days)
No
The device description and performance studies focus on the physical components, materials, and mechanical performance of an enteral extension set. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an enteral extension set used for administering feeding, medications, and decompression, which are supportive functions rather than direct therapeutic treatments.
No
The device is an enteral extension set used for administering feeding, medications, and decompression, not for diagnosing conditions.
No
The device description clearly outlines physical components such as connectors, tubing, and clamps, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "administering feeding, medications, and decompression to compatible devices." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details the physical components and how they connect to other enteral feeding devices. It focuses on the mechanics of delivering substances to the patient's gastrointestinal tract.
- Lack of Diagnostic Language: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical integrity and functionality of the device (tensile strength, leakage, flow testing, misconnection testing), not on diagnostic accuracy or clinical performance related to a diagnostic test.
In summary, the Mini ONE® Enteral Extension Set is a medical device used for delivering substances into the body, which falls under the category of therapeutic or supportive devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Mini ONE® Enteral Extension Set is intended for use as an extension set for the Mini ONE® Gastrostomy Button, G-Jet Gastrojejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible enteral feeding devices. The extension set is for administering feeding, medications, and decompression to compatible devices.
Product codes
PIF
Device Description
The AMT Mini ONE® Enteral Extension Set is intended for use with the AMT Mini ONE® Gastrostomy Button, the AMT G-Jet Gastric-Jejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible feeding devices. The overall functionality and manufacturing methods remain similar to our original clearance of the Mini ONE Feeding Set in 510(K) K971757. The device materials and manufacturing methods were also recently cleared for use in our G-Jet Gastric-Jejunal Feeding Tube 510(K) Submissions K110804 and K123716. The main difference between our original Mini ONE Feeding Set Clearance (K971757) and this submission is the inclusion of new end connectors that are designed to the ISO/IEC 80369 series.
The extension set consists of several different assembled components and materials that make up the device. Each extension set consists of several common components: A Mini ONE® connector that is able to connect to a compatible enteral feeding tube, flexible tubing, a pinch clamp to block the tubing, and ENfit enteral connector(s) to connect to a compatible feeding bag or syringe.
There are two types of Mini ONE® connectors that are used for the extension set. The first type is a straight through connector that is used for bolus or gravity feedings/administration of medication. The second type of connector is a right angle connector that better directs the tubing around the patient for longer feedings/administration of medication. Both connectors are identical in material and in design along the connecting portion that fits with a compatible enteral device. The Mini ONE® connectors are also compatible with Kimberly Clark Mic-Key® Gastrostomy and enteral devices. Mic-Key® compatibility was cleared through the 510(K) process in K971757, K110804, and K123716.
The flexible tubing used with each device comes in two different diameters and several different lengths. The two diameter options are provided to accommodate different types of feeds and medications to the patient. The tubing may be provided as straight tubing or in a coiled configuration. The different lengths are supplied to provide different options for patient orientation and maneuvering and include lengths of 2-24" lengths. Each tubing length also has a pinch clamp included to allow the user to close off the tubing while not in use.
The enteral connectors in this submission are provided in two different configurations with the extension sets. The first configuration is a single ENFit connector assembled directly onto the tubing. The single port connection is typically used for bolus or gravity use. The second configuration is a Y-Port connection with two ENFit connections, each with a separate plug. The two port connection allows the user to administer medication and feed through the device at the same time.
The Mini ONE® Enteral Extension Set is provided non-sterile for single user use only. It is made from DEHP and Latex free materials. The Mini ONE® Enteral Extension Set is provided in a number of configurations providing different Mini ONE® adapter designs, lengths of tubing, diameters of tubing, and number of ENFit connectors. Description of each difference in design configurations is listed below:
Feeding Set Configurations:
Type of Mini ONE® Connector: Straight (bolus/gravity) or right angle (continuous/pump)
Number of ENFit connectors: One or Two
Tubing Diameter: 0.218" or 0.165"
Tubing Length: 2-24"
Part Number Scheme: 8-XXXX (where XXXX signifies tubing length, number of ENFit connectors, MiniONE® Connector Type, and tubing diameter)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
AMT conducted various performance tests on all components contained within the Mini ONE® Enteral Extension Set. A human factors study was also conducted to ensure that the new enteral connectors do not affect usability and intended use of the device. The study found that usability and intended use of our enteral extension set is not affected by the new ENFit connectors.
Bench tests have been carried out on samples of the AMT Mini ONE® Enteral Extension Sets with ENFit connectors. The tests carried out included:
- Tensile strength
- Fluid leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection from unscrewing
- Flow testing
Misconnection testing was conducted as recommended in the ISO 80369-1 standard. Connectors are made of rigid/semi rigid materials to reduce the risk of misconnection. Although the subject connector will not misconnect to other connectors in the 80369 series, misconnections with non ISO/IEC 80369 series connectors may still occur.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/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 a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
Applied Medical Technology, Inc. Joshua Meinke OA/Regulatory Supervisor 8000 Katherine Boulevard Brecksville, OH 44141
Re: K142989
Trade/Device Name: AMT Mini ONE® Enteral Extension Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: October 30, 2014 Received: November 3, 2014
Dear Joshua Meinke,
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
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
SECTION - 4
c. - INDICATIONS FOR USE STATEMENT
510(k) Number: K142989
Trade Name: AMT Mini ONE® Enteral Extension Set Common Name: Enteral Extension Set
Indications for Use:
The Mini ONE® Enteral Extension Set is intended for use as an extension set for the Mini ONE® Gastrostomy Button, G-Jet Gastrojejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible enteral feeding devices. The extension set is for administering feeding, medications, and decompression to compatible devices.
Prescription Use X (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)
3
SECTION – 5
510(K) Summary
AMT Mini ONE® Enteral Extension Set
| Date Prepared: | January 29, 2015 |
|---|---|
| Submitter: | Joshua D. Meinke |
| QA/Regulatory Supervisor | |
| Applied Medical Technology, Inc. | |
| 8006 Katherine Boulevard | |
| Brecksville, OH 44141 | |
| Phone: 440-717-4252 | |
| Fax: 440-717-4200 | |
| Email: Josh.Meinke@appliedmedical.net | |
| Contact Person: Joshua Meinke | |
| Device | |
| Information: | Trade Name: |
| AMT Mini ONE® Enteral Extension Set | |
| Common Name: | |
| Enteral Extension Set | |
| Classification Name: | |
| Gastroenterology and Urology (21 CFR 876.5980) | |
| Regulatory Class: | |
| II | |
| Product Code: | |
| PIF - Gastrointestinal Tubes with Enteral Specific Connectors | |
| Predicate | |
| Device: | AMT Low Profile Feeding Set Accessory (Applied Medical Technology, Inc.) |
| (cleared under K971757) | |
| Intended Use: | The Mini ONE® Enteral Extension Set is intended for use with compatible enteral |
| feeding devices for administration of feeding, medications, and decompression. | |
| Indications for | |
| Use: | The Mini ONE® Enteral Extension Set is intended for use as an extension set for the |
| Mini ONE® Gastrostomy Button, G-Jet Gastrojejunal Feeding Tube, Mic-Key® | |
| Secure-Lok® feeding devices, or other compatible enteral feeding devices. The | |
| extension set is for administering feeding, medications, and decompression to | |
| compatible devices. | |
| Device | |
| Description: | The AMT Mini ONE® Enteral Extension Set is intended for use with the AMT Mini |
| ONE® Gastrostomy Button, the AMT G-Jet Gastric-Jejunal Feeding Tube, Mic- | |
| Key® Secure-Lok® feeding devices, or other compatible feeding devices. The | |
| overall functionality and manufacturing methods remain similar to our original | |
| Technological | |
| Characteristics: | clearance of the Mini ONE Feeding Set in 510(K) K971757. The device materials and manufacturing methods were also recently cleared for use in our G-Jet Gastric- |
| Jejunal Feeding Tube 510(K) Submissions K110804 and K123716. The main difference between our original Mini ONE Feeding Set Clearance (K971757) and this submission is the inclusion of new end connectors that are designed to the ISO/IEC 80369 series. | |
| The extension set consists of several different assembled components and materials that make up the device. Each extension set consists of several common components: A Mini ONE® connector that is able to connect to a compatible enteral feeding tube, flexible tubing, a pinch clamp to block the tubing, and ENfit enteral connector(s) to connect to a compatible feeding bag or syringe. | |
| There are two types of Mini ONE® connectors that are used for the extension set. The first type is a straight through connector that is used for bolus or gravity feedings/administration of medication. The second type of connector is a right angle connector that better directs the tubing around the patient for longer feedings/administration of medication. Both connectors are identical in material and in design along the connecting portion that fits with a compatible enteral device. The Mini ONE® connectors are also compatible with Kimberly Clark Mic-Key® Gastrostomy and enteral devices. Mic-Key® compatibility was cleared through the 510(K) process in K971757, K110804, and K123716. | |
| The flexible tubing used with each device comes in two different diameters and several different lengths. The two diameter options are provided to accommodate different types of feeds and medications to the patient. The tubing may be provided as straight tubing or in a coiled configuration. The different lengths are supplied to provide different options for patient orientation and maneuvering and include lengths of 2-24" lengths. Each tubing length also has a pinch clamp included to allow the user to close off the tubing while not in use. | |
| The enteral connectors in this submission are provided in two different configurations with the extension sets. The first configuration is a single ENFit connector assembled directly onto the tubing. The single port connection is typically used for bolus or gravity use. The second configuration is a Y-Port connection with two ENFit connections, each with a separate plug. The two port connection allows the user to administer medication and feed through the device at the same time. | |
| The Mini ONE® Enteral Extension Set is provided non-sterile for single user use only. It is made from DEHP and Latex free materials. The Mini ONE® Enteral Extension Set is provided in a number of configurations providing different Mini ONE® adapter designs, lengths of tubing, diameters of tubing, and number of ENFit connectors. Description of each difference in design configurations is listed below: | |
| Feeding Set Configurations: Type of Mini ONE® Connector: Straight (bolus/gravity) or right angle (continuous/pump) Number of ENFit connectors: One or Two | |
| Tubing Diameter: 0.218" or 0.165" Tubing Length: 2-24" Part Number Scheme: 8-XXXX (where XXXX signifies tubing length, number of ENFit connectors, MiniONE® Connector Type, and tubing diameter) | |
| Biocompatibility | |
| Testing: | No additional Biocompatibility testing was performed for this submission. The device and materials in finished form for the Mini ONE® Enteral Extension Set were previously tested and cleared under 510(K) K123716 for permanent (greater than 30 days) skin contact. |
| Performance | |
| Testing: | AMT conducted various performance tests on all components contained within the Mini ONE® Enteral Extension Set. A human factors study was also conducted to ensure that the new enteral connectors do not affect usability and intended use of the device. The study found that usability and intended use of our enteral extension set is not affected by the new ENFit connectors. |
Bench tests have been carried out on samples of the AMT Mini ONE® Enteral Extension Sets with ENFit connectors. The tests carried out included: Tensile strength Fluid leakage Stress cracking Resistance to separation from axial load Resistance to separation from unscrewing Resistance to overriding Disconnection from unscrewing Flow testing Misconnection testing was conducted as recommended in the ISO 80369-1 standard. Connectors are made of rigid/semi rigid materials to reduce the risk of misconnection. Although the subject connector will not misconnect to other connectors in the 80369 series, misconnections with non ISO/IEC 80369 series connectors may still occur. |
| Conclusions: | The Mini ONE® Enteral Extension Set is substantially equivalent to the predicate device cleared under K971757 in intended use, patient population, design, biocompatibility and testing criteria, and method of operation. |
Applied Medical Technology, Inc. -510(k) Submission AMT Mini ONE® Enteral Extension Set
Section 5 — Page 5.1
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Applied Medical Technology, Inc. -510(k) Submission AMT Mini ONE® Enteral Extension Set
5