(121 days)
No
The description focuses on the mechanical and fluid dispensing aspects of the device, with no mention of AI or ML capabilities. The performance studies are also related to physical properties and safety, not algorithmic performance.
No
Explanation: The device is used to dispense liquid nutrients, not to treat or diagnose a disease or condition. It acts as an administration set for feeding solutions.
No
The device is described as an enteral feeding set, which is used to dispense liquid nutrients. Its function relates to delivery of sustenance, not to the identification or analysis of a medical condition.
No
The device description and performance studies clearly indicate a physical medical device (enteral feeding sets) with hardware components and associated testing (bond strength, leak testing, dimensional analysis, etc.). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate." This describes a device used for delivering substances into the body, not for examining specimens from the body to diagnose conditions.
- Device Description: The description focuses on the physical components and how the device interfaces with a feeding tube and feeding solution containers. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic purposes, measuring analytes, or providing information for diagnosis, monitoring, or prognosis.
The device is clearly described as an enteral feeding set, which is used for delivering nutrition directly into the gastrointestinal tract. This falls under the category of medical devices used for patient care and treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.
Product codes
PIF, PIO
Device Description
These enteral feeding sets are designed to be used with or without an enteral feeding pump, (pump is not in scope for this 510k) model specific. Refer to diagrams below for explanation of components. The enteral sets terminate in a bonded conical connector, the ENFit connector; that is designed to be incompatible with ISO 594-1/2 and other non-enteral feeding connections. The ENFit connector is a new connector and it is anticipated that not all patient feeding tubes will be compatible with it, so the administration sets include an adapter that connects to the ENFit connector on one end while providing the traditional "Christmas Tree" shaped transitional stepped connector on the other.
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)
The following testing has been performed to support substantial equivalence:
- Bond Strength - Passed
- Leak Testing - Passed
- Volumetric accuracy testing Passed ●
- Biocompatibility - Passed
- Misconnection assessment - Passed
- Dimensional analysis — Passed
- Enteral Connector Risk Management Report Acceptable ●
- Human Factors Testing – Acceptable
- Failure Modes and Effects Analysis (FMEA) – Acceptable
- Accelerated Aging - Passed
- ISO 80369-3 Testing as follows:
- . Falling drop positive pressure liquid leakage - Passed
- Stress cracking - Passed
- Resistance to separation from axial load – Passed
- Resistance to unscrewing – Passed
- Resistance to overriding - Passed
- Disconnection by unscrewing - Passed
- Falling drop positive pressure liquid leakage after 20 cycles of connection and separation - Passed
The Enteral Feeding Sets meets all the requirements for overall design, functionality, biocompatibility, and confirms that the output meets the design inputs and specifications. The Enteral Feeding Sets passed all testing stated above as shown by the acceptable results obtained.
The Enteral Feeding Sets along with the ENFit connector and adapter complies with the applicable voluntary standards for biocompatibility. The devices passed all the testing in accordance with national and international standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
Zevex, Inc. Dianne Batch Director, RA/QA 4314 Zevex Park Lane Salt Lake City, UT 84123
Re: K142539
Trade/Device Name: Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: PIF, PIO Dated: November 28, 2014 Received: November 28, 2014
Dear Dianne Batch,
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. 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
1
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,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -A" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
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
Indications for Use
510(k) Number (if known) K142539
Device Name
Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set
Indications for Use (Describe)
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
for
Enteral Feeding Sets
1. Submission Sponsor
Zevex, Inc. 4314 Zevex Park Lane Salt Lake City, Utah 84123 USA Phone: 801.201.6928 Fax: 801.264.1051 Contact: Dianne Batch, Director, RA/QA
2. Date Prepared
September 5, 2014
3. Device Identification
| Trade/Proprietary Name: | EnteraLite Infinity Enteral Pump Delivery Sets | |
|---|---|---|
| 1200 mL Enteral Feeding Delivery Set | ||
| Common/Usual Name: | Enteral Feeding Sets | |
| Classification Name: | Gastrointestinal Tubes and Accessories | |
| Classification Regulation: | 876.5980 | |
| Feeding Set Product Code: PIF | ||
| Transition Connector | ||
| Product Code: | PIO | |
| Device Class: | Class II | |
| Classification Panel: | Gastroenterology/Urology |
4. Legally Marketed Predicate Device(s)
K012147, Zevex, Inc., Enteral Feeding Sets for Gravity and Pump Use
5. Device Description
These enteral feeding sets are designed to be used with or without an enteral feeding pump, (pump is not in scope for this 510k) model specific. Refer to diagrams below for explanation of components. The enteral sets terminate in a bonded conical connector, the ENFit connector; that is designed to be incompatible with ISO 594-1/2 and other non-enteral feeding connections. The ENFit connector is a new connector and it is anticipated that not all patient feeding tubes will be compatible with it, so the administration sets include an adapter that connects to the ENFit connector on one end while providing the traditional "Christmas Tree" shaped transitional stepped connector on the other.
6.
Indication for Use Statement
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with
4
the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.
7. Substantial Equivalence Discussion
The following table compares the Enteral Feeding Sets to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
In the 'Significant Differences' column of the table, list the differences between the device and the predicate and briefly justify why these differences do not raise safety and effectiveness concerns.
| Manufacturer | Moog Medical Devices | Moog Medical Devices | Significant |
|---|---|---|---|
| Group | Group | Differences | |
| Trade Name | Enteral Feeding Sets | Zevex, Inc., Enteral | |
| Feeding Sets For Gravity | |||
| And Pump Use | |||
| 510(k) Number | K142539 | K012147 | N/A |
| Product Code | PIF, PIO | KNT | Updated Codes from FDA |
| Regulation | 876.5980 | 876.5980 | Same |
| Number | |||
| Regulation Name | Gastrointestinal Tubes | Tubes, Gastrointestinal | Same |
| and Accessories | (and Accessories) | ||
| Indications for | The devices in this | The devices in this product | The difference is in the |
| Use | product family are used | family are used to | distal (or patient) end of |
| to dispense liquid | dispense liquid nutrients | the device. Where the | |
| nutrients (feeding | (feeding solution) at a | predicate terminates | |
| solution) at a | preprogrammed pump or | only in a traditional | |
| preprogrammed pump or | user controlled rate. | stepped connector, the | |
| user controlled rate. | These enteral feeding sets | proposed device | |
| These enteral feeding | interface with the | terminates in a bonded | |
| sets interface with the | patient's feeding tube and | ENFit connector which is | |
| patient's feeding tube | may use gravity or an | designed to be | |
| and may use gravity or an | enteral feeding pump to | incompatible with all | |
| enteral feeding pump to | dispense feeding solution. | other defined connectors | |
| dispense feeding | The devices may include a | available. The ENFit | |
| solution. The devices | bag to contain the feeding | connector is designed to | |
| may include a bag to | solution and/or a spike to | comply with ISO 80369-3. | |
| contain the feeding | connect to a prefilled | GI Tubes that are | |
| solution and/or a spike to | container. | compatible with the ISO | |
| connect to a prefilled | 80369-3 compliant | ||
| container. | design will be able to | ||
| Manufacturer | Moog Medical Devices | ||
| Group | Moog Medical Devices | ||
| Group | Significant | ||
| Differences | |||
| Trade Name | Enteral Feeding Sets | Zevex, Inc., Enteral | |
| Feeding Sets For Gravity | |||
| And Pump Use | |||
| connect directly to the | |||
| ENFit connector. Non | |||
| ISO 80369-3 compliant GI | |||
| tubes will be able to | |||
| connect to the | |||
| transitional stepped | |||
| connector which is | |||
| designed to adapt to the | |||
| ENFit connector. | |||
| Material | Non-DEHP PVC tubing, | ||
| extruded film (bags), inlet | |||
| port and outlet port; | |||
| Polyethylene inlet port | |||
| cap; polycarbonate | |||
| connector/pump | |||
| interface (cassette); | |||
| silicone pump tubing | |||
| segment; ABS distal | |||
| (stepped) connector. | Non-DEHP PVC tubing, | ||
| extruded film (bags), inlet | |||
| port and outlet port; | |||
| Polyethylene inlet port | |||
| cap; polycarbonate | |||
| connector/pump interface | |||
| (cassette); silicone pump | |||
| tubing segment; ABS distal | |||
| (stepped) connector. | Similar; the differences | ||
| between them are that | |||
| the ABS formulation (HF |
- and color of the
ENFit connector (purple,
Remofin Violet
PE43076356-ZT)) are
different from the ABS
formulation (CYCOLAC
HMG47MD 6H3C106,
pre-colored) used in the
current stepped adapter. |
| Sterile | Non-sterile | Non-sterile | Same |
| Overall Design | | | |
| Length | Set length varies, tubing
lengths same as
predicate; connector is
slightly shorter (~ 0.82"
vs. ~2.0") than the
current stepped adapter,
but with the adapter
(~1.74") the overall set
length will be less than
1/4" different. | Set length varies
depending on
configuration. | Same
The EnFit connector has a
slightly larger ID, which
has shown no negative
impact on flow rates. |
| Diameter | EnFit connector ID is
0.116". | Distal connector ID is
0.10". | |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 1 yr. | 1 yr. (minimum) | Same |
| Manufacturer | Moog Medical Devices | Moog Medical Devices | Significant |
| | Group | Group | Differences |
| Trade Name | Enteral Feeding Sets | Zevex, Inc., Enteral | |
| | | Feeding Sets For Gravity | |
| | | And Pump Use | |
| Latex Free | Yes | Yes | Same |
| Complies with ISO | Yes | Yes | Same |
| 10993-1 | | | |
Table 5A – Comparison of Characteristics
5
6
8. Non-Clinical Performance Data
The following testing has been performed to support substantial equivalence:
- Bond Strength - Passed
- Leak Testing - Passed
- Volumetric accuracy testing Passed ●
- Biocompatibility - Passed
- Misconnection assessment - Passed
- Dimensional analysis — Passed
- Enteral Connector Risk Management Report Acceptable ●
- Human Factors Testing – Acceptable
- Failure Modes and Effects Analysis (FMEA) – Acceptable
- Accelerated Aging - Passed
- ISO 80369-3 Testing as follows:
- . Falling drop positive pressure liquid leakage - Passed
- Stress cracking - Passed
- Resistance to separation from axial load – Passed
- Resistance to separation from unscrewing – Passed
- Resistance to overriding - Passed
- Disconnection by unscrewing - Passed
- Falling drop positive pressure liquid leakage after 20 cycles of connection and separation - Passed
As part of demonstrating safety and effectiveness of Enteral Feeding Sets and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Zevex completed a number of tests. The Enteral Feeding Sets meets all the requirements for overall design, functionality, biocompatibility, and confirms that the output meets the design inputs and specifications. The Enteral Feeding Sets passed all testing stated above as shown by the acceptable results obtained.
The Enteral Feeding Sets along with the ENFit connector and adapter complies with the applicable voluntary standards for biocompatibility. The devices passed all the testing in accordance with national and international standards.
9. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
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10. Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the difference between the Enteral Feeding Sets and the predicate devices do not raise any questions regarding its safety and effectiveness. The Enteral Feeding Sets, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.