(435 days)
Not Found
No
The description focuses on the physical properties of the catheter and its function in transmitting electrical signals (Edi signals) to a ventilator. There is no mention of AI or ML being used to process or interpret these signals or to control the ventilator. The "Not Found" entries for mentions of AI/ML and descriptions of training/test sets further support this conclusion.
Yes.
The device administers nutrition, fluids, and medications; aspirates fluids; and detects diaphragm electrical activity to improve ventilator synchrony, all of which are therapeutic interventions aimed at maintaining or restoring health.
Yes
The device is described as carrying electrode rings that record diaphragm electrical activity (Edi signal), which is then transferred to a compatible ventilator system. This signal is used to improve synchrony between the patient and the ventilator, indicating it gathers data about a physiological state for clinical decision-making.
No
The device description clearly states it is a "sterile, single use nasogastric feeding tube that carries electrode rings" and is an "accessory" to a ventilator system. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Edi Catheter ENFit has two primary functions:
- Feeding Tube: Administering nutrition, fluids, and medications, and aspiration via the naso-gastro-enteric route. This is a direct intervention on the patient's body.
- Electrical Signal Transfer: Recording diaphragm electrical activity (Edi signals) and transferring them to a ventilator system. This signal is used to improve ventilator synchrony, which is a physiological measurement and not an in vitro test on a sample.
- Lack of In Vitro Testing: The description does not mention any testing performed on samples taken from the patient's body. The electrical signal is recorded directly from the diaphragm.
The device is a medical device used for direct patient care (feeding/aspiration) and physiological monitoring (Edi signal). It does not perform any diagnostic tests on samples outside of the body.
N/A
Intended Use / Indications for Use
The Edi catheter ENFit is intended for:
- . Administrating nutrition, fluids and medications via the naso-gastro-enteric route
- . Aspiration via the naso-gastroenteric route
- . Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available
Product codes (comma separated list FDA assigned to the subject device)
PIF, CBK
Device Description
The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that record diaphragm electrical activity (Edi signal). The Edi Catheter ENFit is an accessory to be used with patients in the range of neonates, infants, and adults together with the SERVO ventilator system. The Edi signal is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support in the ventilation modes NAVA and NIV NAVA.
As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere.
The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
naso-gastro-enteric route
Indicated Patient Age Range
Neonates, infants, and adults
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)
Non-clinical Testing:
- Biocompatibility testing in conformance to "ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and applicable sub-standards has demonstrated the biological safety of all parts of the proposed feeding tubes that have contact with the patient.
- Stability testing evaluated the properties of the proposed feeding tubes after accelerated aging in support of the product expiration date.
- The risks associated with the misconnection of the ENFit connector and feeding/aspiration have been assessed.
- Verification of the proposed ENFit Connector includes the tests listed below, in accordance with ISO 80369-3, Small- bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
- Fluid Leakage
- Stress Cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
- Evaluation of the Usability validation for the new ENFit connector.
Verification activities have been performed for all changes that have been updated due to the changes performed in this submission. The testing demonstrates that the proposed device conform to all requirements of the Edi Catheter ENFit.
Animal Testing: Animal testing was not relied upon for the determination of substantial equivalence to the predicate device.
Clinical Investigation: Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient data and functional performance information provided in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are designed with flowing lines, giving the impression of movement or wind. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Maquet Critical Care Ab % Mark Dinger Senior Regulatory Affairs Specialist Maquet Medical System USA 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K153688
Trade/Device Name: Edi Catheter ENFit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories. Regulatory Class: Class II Product Code: PIF, CBK Dated: January 30, 2017 Received: January 31, 2017
Dear Mark Dinger:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Lori A. Wiggins -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153688
Device Name Edi Catheter ENFit
Indications for Use (Describe)
The Edi catheter ENFit is intended for:
- . Administrating nutrition, fluids and medications via the naso-gastro-enteric route
- . Aspiration via the naso-gastroenteric route
- . Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY as required by section 21 CFR 807.92
Date prepared: March 1, 2017
Submitter Name & Address
Maquet Critical Care AB Röntgenvägen 2 SE-171 54 Solna, Sweden Tel: +46 10 335 73 00 Fax: +46 10 335 7838
Contact Persons for this submission:
Mirva Boothe Regulatory Affairs Manager Phone: +46 10 335 73 00 Email: mirva.boothe@getinge.com
Application Correspondent:
Mark Dinger Senior Regulatory Affairs Specialist Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470 USA Email: mark.dinger@getinge.com Phone: 973-709-7691 Fax: 973-909-9954
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Trade name
| Edi Catheter ENFit | |
|---|---|
Device Classification
| Common Name | Classification
Product Code | Class | Regulation Number |
|------------------------------------------------------------|--------------------------------|-------|-------------------|
| Gastrointestinal tubes with enteral
specific connectors | PIF | II | 21 CFR 876.5980 |
| Ventilator, continuous, facility use | CBK | II | 21 CFR 868.5895 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| SERVO-i Ventilator System | K123149 |
Device Description
The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that record diaphragm electrical activity (Edi signal). The Edi Catheter ENFit is an accessory to be used with patients in the range of neonates, infants, and adults together with the SERVO ventilator system. The Edi signal is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support in the ventilation modes NAVA and NIV NAVA.
As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere.
The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.
See table 1 below for a listing of the main components and characteristics of the device, compared to the predicate device.
| Predicate device | Current device | Comment | |
|---|---|---|---|
| Technology | |||
| Device type | Nasogastric feeding tube | Nasogastric feeding tube | Identical |
| Measurement method | Monitor electrical | ||
| signal from | |||
| diaphragm activity | |||
| (Edi) | Monitor electrical | ||
| signal from | |||
| diaphragm | |||
| activity (Edi) | Identical | ||
| Energy source | From NAVA | ||
| module in SERVO | |||
| Ventilator System | From NAVA | ||
| module in | |||
| SERVO | |||
| Ventilator System | Identical | ||
| Patient group | Neonatal to adult | Neonatal to adult | Identical |
| Components/Parts | |||
| Total number of electrodes | 10 | 10 | Identical |
| Electrodes | Material: Stainless | ||
| steel | Material: | ||
| Stainless steel | Identical | ||
| Electrical connector | 14 pole circular | ||
| connector | 14 pole circular | ||
| connector | Identical | ||
| Feeding tube | Material: PUR | Material: PUR | Identical |
| Feeding connector | Funnel type | ||
| Material: PVC | ENFit type | ||
| Material: ABS | New type of connector | ||
| and new material for | |||
| current device | |||
| Sump lumen | For 12 and 16 Fr | For 12 and 16 Fr | Identical |
| Catheter dimensions | Length: | ||
| 49-125 cm | |||
| Diameter: | |||
| 6 / 8 / 12 / 16 Fr | Length: | ||
| 49-125 cm | |||
| Diameter: | |||
| 6 / 8 / 12 / 16 Fr | Identical size range. | ||
| Additional feeding | |||
| holes and one new | |||
| design option for | |||
| current device: | |||
| 8 Fr 50 cm | |||
| Sterilization | |||
| Sterile barrier system | Preformed pouch | Preformed pouch | Identical |
| Sterilization | Gamma | ||
| sterilization | Gamma | ||
| sterilization | Identical | ||
| Accessories | |||
| Guidewire | For 6 Fr 49 and 50 | ||
| cm | |||
| For 8 Fr 100 cm | |||
| For 8 Fr 125 cm | For 6 Fr 49 and | ||
| 50 cm | |||
| For 8 Fr 100 cm | |||
| For 8 Fr 125 cm | Not part of device. | ||
| Guidewire cleared in | |||
| K153461, is not a | |||
| device component |
Table 1. Comparison with predicate device catheter
5
6
Indications for Use
The Edi catheter ENFit is intended for:
- . Administrating nutrition, fluids and medications via the naso-gastro-enteric route
- Aspiration via the naso-gastroenteric route
- Transfers electrical activity (Edi signals) to compatible SERVO ventilator ● systems on which NAVA and NAVA NIV are available
Comparison of Indications for Use
The Indications for Use for the subject device is comparable to the Indications for Use for the predicate device Edi Catheter PHT Free, which is an accessory within the ventilator system SERVO-i (K123149).
However, since the proposed device is submitted as a product of its own right instead of an accessory within the ventilator system, the Indications for Use is not the same as the Indications for Use for the entire ventilator system.
The predicate device Edi Catheter PHT Free has been cleared with the ventilators Indications for Use. The Indication for Use for the Edi catheter ENFit has been clarified compared to the Edi catheter PHT Free. The following information has been updated, which is also relevant for the predicate device Edi catheter PHT Free.
-
Added: ●
o Aspiration via the naso-gastroenteric route -
. Clarified:
- o Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available
7
Summary of Technological characteristics
The technological characteristics of the subject device Edi catheter ENFit with respect to design, material and energy source are similar to the Edi catheter PHT free included in the predicate device (K123149), see summary and comparison below. Note that the differences listed here are the only differences between the catheter variants.
Design
The design of the catheters and methodology used for fulfilling its intended use is the same between the subject and predicate device. The only differences include:
- A new male ENFit connector on the feeding tube, in order to avoid misconnections with other small-bore connectors used for other applications than enteral feeding. This update is done according to the Standard requirements, ISO 80369-3:2016: Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
- Addition of a new size option within the current size range (Edi Catheter -ENFit 8Fr/50cm). This particular size combination is new, although the predicate device includes catheters 8Fr/X cm and XFr/50 cm. The design of of the catheter is therefore considered the same.
- -Additional feeding holes to facilitate feeding and aspiration.
Material
The catheter material remains identical between the catheters, except from:
- The new ENFit connector contains a new material compared to the predicate device (ABS in ENFit connecter and PVC in predicate device). The new material has been tested for biocompatibility according to applicable sub-standards of ISO 10993-1:2009.
However, the material coming in direct contact with the patient is identical between the subject and predicate device.
Energy source
Identical. From NAVA module in SERVO Ventilator System.
8
Non-clinical Testing
- · Biocompatibility testing in conformance to "ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and applicable sub-standards has demonstrated the biological safety of all parts of the proposed feeding tubes that have contact with the patient.
- · Stability testing evaluated the properties of the proposed feeding tubes after accelerated aging in support of the product expiration date.
- · The risks associated with the misconnection of the ENFit connector and feeding/aspiration have been assessed.
- · Verification of the proposed ENFit Connector includes the tests listed below, in accordance with ISO 80369-3, Small- bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
- Fluid Leakage ●
- Stress Cracking
- . Resistance to separation from axial load
- Resistance to separation from unscrewing .
- . Resistance to overriding
- . Disconnection by unscrewing
- Evaluation of the Usability validation for the new ENFit connector. .
Verification activities have been performed for all changes that have been updated due to the changes performed in this submission. The testing demonstrates that the proposed device conform to all requirements of the Edi Catheter ENFit.
Animal Testing
Animal testing was not relied upon for the determination of substantial equivalence to the predicate device.
Clinical Investigation
Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient data and functional performance information provided in the submission.
9
Conclusion
There are no different questions regarding safety and effectiveness for the Edi Catheter ENFit compared to the predicate device Edi Catheter PHT Free within the SERVO-i ventilator system (K123149).
MAQUET has conducted the risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design input requirements and the appropriate product standards.
MAQUET has concluded that the subject device, Edi Catheter ENFit is substantially equivalent to the predicate device, Edi Catheter PHT Free which is an accessory within the SERVO-i ventilator system (K123149).