Mobility+ Enteral Feeding System OTC
Device Facts
| Record ID | K233034 |
|---|---|
| Device Name | Mobility+ Enteral Feeding System OTC |
| Applicant | Rockfield Medical |
| Product Code | PIF · Gastroenterology, Urology |
| Decision Date | Apr 12, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
Mobility+ Enteral Feeding System OTC is a portable, non-electronic, disposable enteral feeding system for clinical or home use. System components include a food pouch (reservoir/pump), filling set, and giving set. The food pouch consists of a foil container with an internal elastomeric pouch holding up to 500 ml of feed. The filling set transfers nutritional feed from packaging to the pouch via syringe and ENFit connectors. The giving set connects the pouch to the patient's implanted feeding tube. Flow rates are determined by the length of the giving set. The device is worn by the patient, with the pouch spout positioned within 15cm of the stoma. It is intended for single-patient use over a 24-hour period. The system provides a mechanical means for gravity-assisted or pressure-assisted enteral feeding, allowing patient mobility during administration.
Clinical Evidence
No clinical data. Substantial equivalence was demonstrated through bench testing and comparison to the predicate device.
Technological Characteristics
Non-electronic, gravity/pressure-fed enteral system. Components: foil container with internal elastomeric pouch, tubing, and ENFit connectors (ISO 80369-3, ISO 18250-3). Single-patient use, disposable, 24-hour duration. Biocompatibility per ISO 10993-1.
Indications for Use
Indicated for delivery of liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- Mobility+ Enteral Feeding System (K222678)
Submission Summary (Full Text)
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April 12, 2024
Rockfield Medical % Orla Connaughton CEO Aztec Medical Ltd iHub GMIT (ATU), Dublin Road Galway, Galway H91 DCH9 Ireland
Re: K233034
Trade/Device Name: Mobility+ Enteral Feeding System OTC Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIF, KNT Dated: March 12, 2024 Received: March 12, 2024
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
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Sincerely,
# Shanil P. Haugen -S
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
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# Indications for Use
510(k) Number (if known) K233034
Device Name Mobility + Enteral Feeding Systems OTC
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)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
## General Information
| Date: | 22 September 2022 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II, 21 CFR 876.5980 Gastrointestinal tube and accessories |
| Product Code: | PIF, KNT |
| Trade Name: | Mobility+ Enteral Feeding System OTC |
| Common Name: | Enteral Feeding System |
| Model Number(s): | MOB2-0440 Mobility+ with 440mm Giving Set<br>MOB2-0700 Mobility+ with 700mm Giving Set<br>MOB2-1000 Mobility+ with 1000mm Giving Set<br>MOB2-1900 Mobility+ with 1900mm Giving Set |
| 510(k) Owner: | Rockfield Medical<br>iHub GMIT (ATU),<br>Dublin Road<br>Galway<br>H91 DCH9<br>Ireland |
| Regulatory Contact: | Orla Connaughton<br>Regulatory Affairs |
| Rockfield Medical | iHub GMIT (ATU),<br>Dublin Road<br>Galway<br>H91 DCH9<br>Ireland<br>Tel: + 353 91 763 000<br>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.
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## Predicate Device
- Mobility+ Enteral Feeding System, K222678.
#### Device Description
The Mobility+ Enteral Feeding System OTC ("Mobility+ OTC" or the "System") is a portable, lightweight, non-electronic, 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 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+ Enteral Feeding System OTC 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 the Mobility+ food pouch to deliver 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+ Enteral Feeding System OTC comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3).
The Mobility+ Enteral Feeding System OTC 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.
#### Non-Clinical Information
The Mobility+ System OTC is the identical device as the predicate. Therefore, all technological characteristics (e.g., design, material, functionality) are identical and non-clinical performance data tests were not repeated. A list of the design verification and design validation test completed are in Table 3 List of Design Verification Tests and Table 4 List of Design Validation Tests.
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| 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<br>conditions | Leak test |
| 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 | Labelling requirements (maintain integrity,<br>adhesion, legible) |
| Biological Evaluation | UDI (legible) |
| IFU requirements (maintain integrity, legible) | |
#### Table 3 List of Design Verification Tests
#### Table 4 List of Design Validation Tests
| Design Validation Tests | |
|------------------------------------------------------------------|---------------------------------------------------|
| Removal of Product from Packaging | Ability to fill |
| Ability to feed | Ability to flush |
| Ability to use while mobile | |
| Labelling requirements – (easy to understand, language, legible) | IFU requirements – (easy to understand, language) |
The test results (K222678 – Volume 0007 Bench Testing) demonstrate that the Mobility+ Enteral Feeding System OTC, being identical to the predicate device, meets the requirements in the applicable standards.
The biological safety tests were performed on the predicate device in accordance with ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing). These tests were performed to demonstrate the biocompatibility of the device and are detailed in the predicate submission, K222768 – Volume 006 Biocompatibility.
## Clinical Information
Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding System OTC as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device.
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# Summary of Substantial Equivalence
Rockfield Medical believes Mobility+ Enteral Feeding System OTC is substantially equivalent to the predicate device, Mobility+ Enteral Feeding System (K222678).
