(151 days)
The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
New standard ISO-80369-1 is pushing feeding tube manufacturers to transition current extension set designs to incorporate enteral only connectors. Most enteral feeding devices currently on the market utilize luer slip or catheter tip connectors to connect enteral giving sets and syringes to enteral receiving sets. Standard luer slip and catheter tip connectors raise risk levels for patients as devices outside of the enteral market use similar connections, including IVs. Therefore, the ISO/IEC 80369 series was developed to help reduce the possibility of misconnections across different medical fields.
The FDA recently cleared an updated AMT enteral extension set in 510(k) K142989. This extension set remains identical to our previously marketed device, but includes Enfit connectors. However, launching a enteral extension sets with Enfit connectors will not be simultaneous across all manufacturers and distributors. Therefore, transition adapters are necessary for a limited time.
As the new Enfit connectors are not backwards compatible with current luer and bolus connections currently used for enteral products, AMT has designed several transition adapter configurations to help users make the switch to the new connections. AMT estimates that there will be a time of at least a year and possibly up to three years where users and distributors will still have access to enteral devices with luer / bolus connectors. The transition adapters AMT has designed in this 510(k) will allow users to use their old giving/receiving sets until the market is flushed of old inventory.
The AMT Enteral Transition Adapters come in 5 configurations and are made up of 5 separate components. The five configurations include:
• Male Enfit to Male Luer Adapter
• Female Enfit to Female Luer Adapter
• Female Enfit to Y-Port (Bolus/Luer) Adapter
• Female Enfit to Bolus Adapter
• Male Enfit to Christmas-tree Adapter
These 5 transition adapter configurations will allow AMT to offer users with options for all of the common enteral connectors currently on the market. All components and materials have been previously cleared in 510(k)s for similar use. It is planned to include these transition adapters kitted with enteral devices previously cleared through the 510(k) process, as well as selling the adapters as stand-alone items.
This document is a 510(k) summary for the AMT Enteral Transition Adapters, which is a medical device subject to FDA review. The focus of this document is on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical or AI-based context.
Therefore, much of the requested information regarding acceptance criteria, study design for performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details (which are typically relevant for AI/algorithm-driven devices or clinical trials) is not applicable to this type of regulatory submission for a physical medical device.
However, I can extract the relevant performance testing information and present it in the requested format where possible, noting the limitations of the document's scope.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance values for each criterion. Instead, it lists the types of performance tests conducted. The "Conclusions" section states that the device is "substantially equivalent ... in testing criteria," implying that the device met the criteria for these tests, likely aligned with the predicate device or relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Tensile strength | Met (Device is substantially equivalent in testing criteria) |
| Fluid leakage | Met (Device is substantially equivalent in testing criteria) |
| Stress cracking | Met (Device is substantially equivalent in testing criteria) |
| Resistance to separation from axial load | Met (Device is substantially equivalent in testing criteria) |
| Resistance to separation from unscrewing | Met (Device is substantially equivalent in testing criteria) |
| Resistance to overriding | Met (Device is substantially equivalent in testing criteria) |
| Disconnection from unscrewing | Met (Device is substantially equivalent in testing criteria) |
| Flow testing | Met (Device is substantially equivalent in testing criteria) |
| Incompatibility with other connectors (ISO 80369-1) | Met (Enfit connectors will not misconnect to other connectors in the 80369 series) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "various performance tests on all components," but does not provide specific sample quantities for each test.
- Data Provenance: Not specified, but given it's a 510(k) submission for a physical device, testing would typically be conducted in a laboratory setting by the manufacturer (Applied Medical Technology, Inc.) in the USA (Brecksville, OH). The tests would be prospective in nature, performed on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical adapter, not an AI or diagnostic imaging device that requires expert-established ground truth for its performance evaluation (e.g., diagnosis, abnormality detection). The performance tests listed are engineering and mechanical evaluations.
4. Adjudication method for the test set
- Not Applicable. As per point 3, this is not a clinical or AI performance study requiring adjudication of expert interpretations.
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, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- For the performance tests listed (tensile strength, fluid leakage, etc.), the "ground truth" would be established by engineering specifications, material science standards, and mechanical test methods defined by ISO or other relevant industry standards (e.g., ISO 80369-1 for connector incompatibility). Test results are compared against predefined pass/fail criteria from these standards.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device, not an AI system.
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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 an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2015
Applied Medical Technology, Inc. Joshua D. Meinke OA/Regulatory Supervisor 8006 Katherine Boulevard Brecksville, OH 44141
Re: K150034
Trade/Device Name: AMT Enteral Transition Adapters Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIO Dated: March 16. 2015 Received: March 18, 2015
Dear Joshua D. 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.
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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 vours.
Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a simple, sans-serif font. The text is black and appears to be the main focus of the image. The background is a light gray, and there is a faint watermark-like design behind the text.
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150034
Device Name AMT Enteral Transition Adapters
Indications for Use (Describe)
The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
|×| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION - 5
510(K) Summary
AMT Enteral Transition Adapters
| Date Prepared: | June 8, 2015 |
|---|---|
| Submitter: | Joshua D. MeinkeQA/Regulatory SupervisorApplied Medical Technology, Inc.8006 Katherine BoulevardBrecksville, OH 44141Phone: 440-717-4252Fax: 440-717-4200Email: Josh.Meinke@appliedmedical.netContact Person: Joshua Meinke |
| DeviceInformation: | Trade Name: AMT Enteral Transition AdaptersCommon Name: Enteral Transition AdapterClassification Name: Gastroenterology and Urology (21 CFR 876.5980)Regulatory Class: IIProduct Code: PIOFDA Identification: Facilitate enteral specific connections betweenAAMI/CN3(PS) compliant connectors and non ISO 80369-1compliant legacy enteral connectors. |
| PredicateDevice: | Enteral Specific Transition Connectors (Cedic S.R.L.)(cleared under K140581) |
| Indications forUse: | The AMT Enteral Transition Adapters are intended to facilitate enteral specificconnections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1compliant legacy enteral connectors. |
| DeviceDescription: | New standard ISO-80369-1 is pushing feeding tube manufacturers to transitioncurrent extension set designs to incorporate enteral only connectors. Most enteralfeeding devices currently on the market utilize luer slip or catheter tip connectors toconnect enteral giving sets and syringes to enteral receiving sets. Standard luer slipand catheter tip connectors raise risk levels for patients as devices outside of theenteral market use similar connections, including IVs. Therefore, the ISO/IEC 80369series was developed to help reduce the possibility of misconnections across differentmedical fields. |
| The FDA recently cleared an updated AMT enteral extension set in 510(k) K142989.This extension set remains identical to our previously marketed device, but includesEnfit connectors. However, launching a enteral extension sets with Enfit connectorswill not be simultaneous across all manufacturers and distributors. Therefore,transition adapters are necessary for a limited time. | |
| As the new Enfit connectors are not backwards compatible with current luer andbolus connections currently used for enteral products, AMT has designed severaltransition adapter configurations to help users make the switch to the newconnections. AMT estimates that there will be a time of at least a year and possiblyup to three years where users and distributors will still have access to enteral deviceswith luer / bolus connectors. The transition adapters AMT has designed in this510(k) will allow users to use their old giving/receiving sets until the market isflushed of old inventory. | |
| The AMT Enteral Transition Adapters come in 5 configurations and are made up of 5separate components. The five configurations include:• Male Enfit to Male Luer Adapter• Female Enfit to Female Luer Adapter• Female Enfit to Y-Port (Bolus/Luer) Adapter• Female Enfit to Bolus Adapter• Male Enfit to Christmas-tree Adapter | |
| These 5 transition adapter configurations will allow AMT to offer users with optionsfor all of the common enteral connectors currently on the market. All componentsand materials have been previously cleared in 510(k)s for similar use. It is planned toinclude these transition adapters kitted with enteral devices previously clearedthrough the 510(k) process, as well as selling the adapters as stand-alone items. | |
| TechnologicalCharacteristics: | The AMT Enteral Transition Adapters are provided non-sterile for single user useonly. They are made from DEHP and Latex free materials. The Enteral TransitionAdapters are provided in a number of configurations providing different connectionpossibilities to enteral devices currently on the market. Description of the fivedifferent transition adapters AMT will offer are listed below: |
| Transition Adapter Types:• Male Enfit to Male Luer Adapter (P/N: TRN101)• Female Enfit to Female Luer Adapter (P/N: TRN201)• Female Enfit to Y-Port (Bolus/Luer) Adapter ) (P/N: TRN203)• Female Enfit to Bolus Adapter (P/N: TRN202)• Male Enfit to Christmas-tree Adapter (P/N: TRN102) | |
| BiocompatibilityTesting: | No additional biocompatibility testing was performed for this submission. Thedevice and materials in finished form for the AMT Enteral Transition Adapters werepreviously tested under 510(k) K123716. All AMT Enteral Transition adapters havebeen tested for permanent (greater than 30 days) indirect mucosal contact, except forthe Male Enfit to Christmas-tree Adapter (P/N: TRN 102) which has been tested toprolonged (less than 29 days) indirect mucosal contact. |
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Applied Medical Technology, Inc. -510(k) Submission
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| PerformanceTesting: | AMT conducted various performance tests on all components contained within AMTEnteral Transition Adapters. 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 testingIncompatibility testing was conducted on the Enfit connectors as recommended in theISO 80369-1 standard. Although the Enfit connectors will not misconnect to otherconnectors in the 80369 series, misconnections with non ISO/IEC 80369 seriesconnectors may still occur. |
|---|---|
| Conclusions: | The AMT Enteral Transition Adapters are substantially equivalent to the predicatedevice cleared under K140581 in intended use, patient population, design,biocompatibility, testing criteria, and method of operation. |
§ 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.