(55 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics testing of a simple connector, with no mention of AI/ML algorithms or data processing.
No.
The device is an adapter for connecting enteral feeding equipment, not a device that directly treats or prevents a disease.
No
The device description and performance studies indicate it is used for connecting enteral feeding systems to deliver nutritional fluids, not for diagnosing medical conditions.
No
The device description clearly outlines a physical adapter with components like a screw cap, ENPlus port, vent, and gasket. The performance studies focus on physical properties and testing of the hardware. There is no mention of software as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect enteral feeding sets to nutrition bottles/reservoirs for delivering nutritional fluids. This is a mechanical function related to administering substances to the body, not analyzing samples from the body to diagnose conditions.
- Device Description: The description details a physical adapter with a screw cap, ports, vent, and gasket. It facilitates the delivery of fluids.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances within biological samples.
- Providing information for the diagnosis, monitoring, or treatment of diseases or conditions based on sample analysis.
- Performance Studies: The performance studies focus on mechanical integrity, flow rate, leakage, and biocompatibility – all relevant to a device used for fluid delivery, not diagnostic testing.
In summary, the device is designed for the physical connection and delivery of enteral nutrition, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ENConnect 40 mm Screw Cap to ENPlus Adapter is intended to connect enteral giving sets, equipped with an ENPlus connector, to enteral nutrition crown cap bottles or wide neck reservoirs in order to deliver nutritional fluids.
Product codes
PIF
Device Description
The ENConnect 40 mm Screw Cap to ENPlus Adapter (the proposed device) is a non-sterile, single use device consisting of screw cap with a 40 mm thread, an ENPlus port, vent, and gasket. The proposed device is intended to connect enteral giving sets, equipped with an ENPlus connector, via the ENPlus port to wide neck reservoirs and/or crown cap bottles containing enteral nutrition.
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
Non-clinical performance testing was conducted to demonstrate that the ENConnect 40 mm Screw Cap to ENPlus Adapter is substantially equivalent to the predicate device and is safe and effective for its intended use. In addition, ENConnect 40 mm Screw Cap to ENPlus Adapters that underwent accelerated aging conditioning were tested to substantiate the product shelf life.
The following tests were performed:
- Biocompatibility testing per ISO 10993-1
- Flow Rate testing with Enteral Nutrition
- Fluid Leakage Testing
- ISO 18250-3 Evaluations:
- Dimension Evaluation
- Positive Pressure Liquid Leakage Test
- Sub-atmospheric Pressure Air Leakage Test
- Stress Cracking
- Resistance to Separation from Axial Load
- Resistance to Separation from Unscrewing
- Resistance to Overriding
- Disconnection by Unscrewing
- Tensile Testing
- Distribution Simulation
- Packaging Tests:
- Distribution Simulation
- Burst Test
- Peel Test
- Dye Penetration Test
Clinical performance testing was not required to demonstrate the performance of the ENConnect 40 mm Screw Cap to ENPlus Adapter. The ENConnect 40 mm Screw Cap to ENPlus Adapter performance has been adequately demonstrated by the completion of non-clinical performance testing.
Animal testing was not required to demonstrate the performance of the ENConnect 40 mm Screw Cap to ENPlus Adapter. The ENConnect 40 mm Screw Cap to ENPlus Adapter performance has been adequately demonstrated by the completion of non-clinical performance testing.
The results of the non-clinical performance testing demonstrate that the ENConnect 40 mm Screw Cap to ENPlus Adapter is as safe and effective as the predicate device. Therefore, the proposed device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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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April 9, 2019
Cedic S.r.1. % Crystal Koelper President Koelper Consulting, LLC 268 Biltmore Drive North Barrington, IL 60010
Re: K190327
Trade/Device Name: ENConnect 40 mm Screw Cap to ENPlus Adapter Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: February 12, 2019 Received: February 13, 2019
Dear Crystal Koelper:
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.
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.
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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
3
Section 5: 510(k) Summary of Safety and Effectiveness
Submitter / 510(k) Holder
| Company: | Cedic s.r.l. |
|---|---|
| Address: | Via Liberazione, 63/9 |
| 20068 Peschiera Borromeo (MI) | |
| Italy | |
| Phone: | +1-847-345-6920 |
| Contact Person: | Crystal Koelper |
| Date Prepared: | April 4, 2019 |
Device Name and Classification
| Trade Name: | ENConnect 40 mm Screw Cap to ENPlus Adapter |
|---|---|
| Model Number(s): | A520 |
| Classification Name: | Gastrointestinal Tube and Accessories (21 CFR 876.5980) |
| Product Code: | PIF |
| Class: | II |
| Predicate Device(s) |
U Deliver Bolink ENFit Enteral Feeding Sets (K170555)
Device Description
The ENConnect 40 mm Screw Cap to ENPlus Adapter (the proposed device) is a non-sterile, single use device consisting of screw cap with a 40 mm thread, an ENPlus port, vent, and gasket. The proposed device is intended to connect enteral giving sets, equipped with an ENPlus connector, via the ENPlus port to wide neck reservoirs and/or crown cap bottles containing enteral nutrition.
Indications for Use
The ENConnect 40 mm Screw Cap to ENPlus Adapter is intended to connect enteral giving sets, equipped with an ENPlus connector, to enteral nutrition crown cap bottles or wide neck reservoirs in order to deliver nutritional fluids.
4
Product Comparison Summary
The proposed and predicate enteral feeding devices are both intended to connect enteral nutrition reservoirs to enteral devices (enteral feeding tubes or sets). Both the proposed and predicate devices operate by providing a means of interconnecting enteral reservoirs to other enteral feeding devices (tubes and/or sets). The designs of both the proposed and predicate devices are different, but the differences do not impact the safety and effectiveness of the proposed device. A comparison of the proposed and predicate devices is summarized below:
| Criteria for Comparison | Proposed Device Compared to Predicate
Device |
|---------------------------------|-------------------------------------------------|
| Intended Use | |
| Indications | Similar and SE |
| Clinical Settings | Same |
| Target Population | Same |
| Design Characteristics | |
| Screw Cap (including
gasket) | Similar and SE. |
| Tubing | Different, proposed does not have tubing. |
| Distal Connector | Similar and SE. |
| Sterility | Same |
| Materials | |
| Screw Cap | Same |
| Gasket | Same |
| Vent | Different, predicate does not have a vent. |
| Tubing | Different, proposed does not have tubing. |
| Distal Connector | Different |
| Performance | |
| Use/Human Factors | Same |
| Theory of operation | Same |
| Risk assessment | Same |
| Safety | |
| Mechanical | Similar and SE |
| Electrical | Same - Not an electrical device. |
| Radiation | Same - Not a radiation emitting device. |
Non-Clinical Performance Testing
Non-clinical performance testing was conducted to demonstrate that the ENConnect 40 mm Screw Cap to ENPlus Adapter is substantially equivalent to the predicate device and is safe and effective for its intended use. In addition, ENConnect 40 mm Screw Cap to ENPlus Adapters that underwent accelerated aging conditioning were tested to substantiate the product shelf life.
The following tests were performed:
- Biocompatibility testing per ISO 10993-1
- Flow Rate testing with Enteral Nutrition
- Fluid Leakage Testing
5
K190327 Page 3 of 3
- ISO 18250-3 Evaluations: ●
- Dimension Evaluation O
- O Positive Pressure Liquid Leakage Test
- Sub-atmospheric Pressure Air Leakage Test O
- O Stress Cracking
- O Resistance to Separation from Axial Load
- Resistance to Separation from Unscrewing O
- Resistance to Overriding O
- Disconnection by Unscrewing O
- Tensile Testing
- Distribution Simulation
- Packaging Tests:
- o Distribution Simulation
- o Burst Test
- o Peel Test
- O Dye Penetration Test
Clinical Performance Testing
Clinical performance testing was not required to demonstrate the performance of the ENConnect 40 mm Screw Cap to ENPlus Adapter. The ENConnect 40 mm Screw Cap to ENPlus Adapter performance has been adequately demonstrated by the completion of non-clinical performance testing.
Animal Testing
Animal testing was not required to demonstrate the performance of the ENConnect 40 mm Screw Cap to ENPlus Adapter. The ENConnect 40 mm Screw Cap to ENPlus Adapter performance has been adequately demonstrated by the completion of non-clinical performance testing.
Conclusion
The results of the non-clinical performance testing demonstrate that the ENConnect 40 mm Screw Cap to ENPlus Adapter is as safe and effective as the predicate device. Therefore, the proposed device is substantially equivalent to the predicate device.