(51 days)
No
The device description explicitly states it is "nonelectronic" and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is described as an enteral feeding system intended to deliver liquid nutrition formula, which is a supportive function rather than a direct therapeutic intervention for a disease or condition. While essential for nutrition, it doesn't directly treat or mitigate a disease.
No
The device is intended to deliver liquid nutrition formula, not to diagnose a condition.
No
The device description explicitly states it is a "portable, lightweight, nonelectronic, disposable enteral feeding system" with physical components (food pouch, filling set, giving set), indicating it is a hardware device, not software-only.
Based on the provided information, the Mobility+ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver liquid nutrition formula, to an enteral access device (feeding tube)". This is a delivery mechanism for nutrition, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a system for delivering liquid nutrition, consisting of a pouch and sets for filling and giving. This aligns with a medical device for administering treatment or support, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Mobility+ device does not fit this description.
N/A
Intended Use / Indications for Use
Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.
Product codes (comma separated list FDA assigned to the subject device)
PIF, KNT
Device Description
The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period.
The System has three primary components; food pouch, filling set and giving set.
Food Pouch: The Food Pouch serves as the Mobility+ System's combined reservoir and pump. The pouch consists of a foil container with an internal elastomeric pouch. The Food Pouch can hold up to 500 ml of feed.
Filling Set: The Filling Set is tubing that connects to commercially available nutritional feed from its packaging to the Food Pouch using ENFit connectors. The Filling Set is used to transfer feed from the feed packaging into the Food Pouch, using a syringe.
Giving Set: The Giving Set is tubing that connects the Food Pouch to the implanted feeding tube's ENFit connector. The Giving Sets will be available in a variety of lengths to give a range of feed flow rates.
All connectors in the Mobility+ system comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3).
The Mobility+ may be worn in a bag of choice that can fit the system without kinking the tubing and without squeezing the pouch. The Instructions for use guide the user to place the spout of the pouch within 15cm (6 inches) above or below the stoma when feeding.
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
2 years and over.
Intended User / Care Setting
clinical or home care settings.
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)
Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding Set as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2022
Rockfield Medical Orla Connaughton Director of Regulatory Affairs iHub GMIT, Dublin Road Galway, Galway H91 DCH9 IRELAND
Re: K222678
Trade/Device Name: Mobility+ Enteral Feeding System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF, KNT Dated: August 25, 2022 Received: September 6, 2022
Dear Orla Connaughton:
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/cdrl/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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21
1
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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222678
Device Name Mobility+ Eternal Feeding System
Indications for Use (Describe)
Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Premarket Notification Submission: Rockfield Medical Mobility+ Enteral Feeding Device
510(k) Summary
General Information
| Date: | 25 August 2022 |
|---|---|
| Classification: | Class II, 21 CFR 876.5980 Gastrointestinal tube and accessories |
| Product Code: | PIF, KNT |
| Trade Name: | Mobility+ Enteral Feeding System |
| Common Name: | Enteral Feeding System |
| Model Number(s): | MOB1-440 Mobility+ with 440mm Giving Set |
| MOB1-700 Mobility+ with 700mm Giving Set | |
| MOB1-1000 Mobility+ with 1000mm Giving Set | |
| MOB1-1900 Mobility+ with 1900mm Giving Set | |
| 510(k) Owner: | Rockfield Medical |
| GMIT Innovation Hub | |
| Dublin Road | |
| Galway | |
| H91 DCH9 | |
| Ireland | |
| Regulatory Contact: | Orla Connaughton |
| Regulatory Affairs | |
| Rockfield Medical | GMIT Innovation Hub |
| Dublin Road | |
| Galway | |
| H91 DCH9 | |
| Ireland | |
| Tel: + 353 91 763 000 | |
| Email: orla@rockfieldmd.com |
Intended Use
Mobility+ is intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over.
4
Page 2 of 5
Traditional 510(k) Premarket Notification Submission: Rockfield Medical Mobility+ Enteral Feeding Device
Predicate Device
- . Medline Enteral Feeding Sets, K150286
Reference Device
- SMARTez Elastomeric Infusion Pump, K151650
Device Description
The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period.
The System has three primary components; food pouch, filling set and giving set.
Food Pouch: The Food Pouch serves as the Mobility+ System's combined reservoir and pump. The pouch consists of a foil container with an internal elastomeric pouch. The Food Pouch can hold up to 500 ml of feed.
Filling Set: The Filling Set is tubing that connects to commercially available nutritional feed from its packaging to the Food Pouch using ENFit connectors. The Filling Set is used to transfer feed from the feed packaging into the Food Pouch, using a syringe.
Giving Set: The Giving Set is tubing that connects the Food Pouch to the implanted feeding tube's ENFit connector. The Giving Sets will be available in a variety of lengths to give a range of feed flow rates.
All connectors in the Mobility+ system comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3).
The Mobility+ may be worn in a bag of choice that can fit the system without kinking the tubing and without squeezing the pouch. The Instructions for use guide the user to place the spout of the pouch within 15cm (6 inches) above or below the stoma when feeding.
5
Materials
The Mobility+ Enteral Feeding Device is comprised of materials that are commonly used in medical device applications. The biological safety tests performed in accordance with ISO 10993-1 (Biological evaluation of medical devices -- Part 1: Evaluation and testing), for a device which has been categorized as prolonged and indirect contact with the mucosal membrane, demonstrate that the device is biocompatible for its intended use.
The tests performed to demonstrate the biocompatibility of the device were:
- 0 Physical and Chemical Characterization
- Cytotoxicity
- Sensitization
- Irritation / Intracutaneous Reactivity
- . Material Mediated Pyrogenicity
- Acute Toxicity
- Subacute Toxicity
Comparison of Technological Characteristics of Mobility+ Enteral Feeding System compared to the Predicate Device (Medline Enteral Feeding System)
The Mobility+ Enteral Feeding Set and the equivalent commercialized predicate device Medline Enteral Feeding Set were evaluated for substantial equivalence. No significant difference in clinical, technical and biological parameters was identified between the Mobility+ Enteral Feeding Set and the predicate device. Both devices have the same intended patient and user populations and intended use; to deliver liquid nutrition formula to an enteral access device (feeding tube). The relevant technological specifications and characteristics are extremely similar, the differences relating to the principle of operation of each device. The Mobility+ Enteral Feeding System is equivalent to the 510(k) cleared SMARTeZ Elastomeric Infusion Pump for the principle of operation (the constriction of the elastomeric fluid reservoir drives the feed solution through the tubing at a flowrate calculated using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe). The material and biological equivalence is demonstrated via reference to the material used in each device and the technical
6
ae 4 of 5
Traditional 510(k) Premarket Notification Submission: Rockfield Medical Mobility+ Enteral Feeding Device and biocompatibility testing which demonstrates equivalence between the devices. Via the comparative analysis and engineering data, the Mobility+ Enteral Feeding System has been shown to be substantially equivalent to the commercialized Medline Enteral Feeding System.
Non Clinical Information
| Design Verification Tests | |
|---|---|
| System Fill | Tube kink resistance |
| Connector dimensional and functional | Foil seal strength |
| Pouch valve seal pressure | Spout neck seal |
| On/Off Clamp functionality | Bond strength |
| Flowrate under nominal, minimum and overfill | Leak test |
| conditions | |
| Residual Feed remaining in system | Drop test |
| Multiple use within 24 hour period | Ancillary device compatibility |
| Temperature performance | Packaging seal strength |
| Device height relative to stoma | Removal of product from Packaging |
| Shelf-life testing | Labeling requirements (maintain integrity, adhesion, legible) |
| IFU requirements (maintain integrity, legible) | UDI (legible) |
Table 5-1: List of Design Verification Tests
Table 5-2: List of Design Validation Tests Design Validation Tes
| Design validation Tests | |
|---|---|
| Removal of Product from Packaging | Ability to fill |
| Ability to feed | Ability to flush |
| Ability to use while mobile | IFU requirements - (easy to understand, language) |
| Labelling requirements – (easy to understand, language, legible) |
The test results demonstrate that the Mobility+ Enteral Feeding System meets the requirements in the applicable standards and specifications and is substantially equivalent to legally marketed predicate device.
Clinical Information
Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding Set as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device.
7
Traditional 510(k) Premarket Notification Submission: Rockfield Medical Mobility+ Enteral Feeding Device
Summary of Substantial Equivalence
Rockfield Medical believes Mobility+ Enteral Feeding System is substantially equivalent to the predicate device, Medline Enteral Feeding Sets, based on the non-clinical literature review as discussed above.