← Product Code [FPD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FPD) · K101214 # GUARDIAN CONNECTION (K101214) _Maulin Medical, LLC · FPD · Jul 23, 2010 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FPD/K101214 ## Device Facts - **Applicant:** Maulin Medical, LLC - **Product Code:** [FPD](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FPD.md) - **Decision Date:** Jul 23, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection. ## Device Story Guardian Connection is a non-sterile, reusable, U-shaped plastic clip. It functions as a mechanical accessory for adult enteric feeding systems. The device clips around the exterior of standard non-IV tapered male conical and female connectors. Its purpose is to provide a secure connection and prevent inadvertent disconnection caused by tensile forces. The device is designed to break away at approximately two pounds of force to protect the feeding tube and nutrient line. It is intended for use in clinical or home settings where enteral feeding is administered. ## Clinical Evidence Bench testing only. No clinical data provided. Testing demonstrated the device secures the connection and includes a breakaway feature at approximately two pounds of tensile force. ## Technological Characteristics Non-sterile, reusable, U-shaped plastic clip. Mechanical principle of operation; provides physical retention of tapered enteral feeding connectors. No electronic components or software. ## Regulatory 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 - Cedic Enteral Feeding Spike Adapter ([K072652](/device/K072652.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K101214 182 ## 510(k) Summary of Safety and Effectiveness | Submitter: | Maulin Medical LLC (Sara J. Owens)
486 E. Gentry Drive,
Pueblo West, CO 81007 USA | | JUL 2.3 2010 | |-------------------|-----------------------------------------------------------------------------------------|--|--------------| | Contact Person: | Sara J. Owens
719-647-2938 (phone)
Email: maulinmedical@q.com | | | | | Device Trade Name: Guardian Connection™ | | | | | Classification name: Gastrointestinal Tube and Accessories (21 CFR
876.5980) | | | | Predicate Device: | Cedic Enteral Feeding Spike Adapter (K072652) | | | ## Device Description: The Guardian Connection is a non-sterile, reusable, plastic "Ushaped" clip designed to hold the connectors of an enteric feeding tube and an enteric feeding set together to help prevent inadvertent disconnection. The product is specifically designed to accommodate the non-IV tapered male conical stepped connectors and mating non-IV tapered female connectors commonly found on standard adult enteric feeding tubes and sets. The Guardian Connection clips around the outside of these connectors, and helps to prevent them from being pulled apart by tensile force. ## Intended Use: The Guardian Connection™ is designed for use with standard adult tapered feeding tube connectors to secure the connection. ### Technological Characteristics and Comparison to Predicate Device: The Guardian Connection is similar to the predicate device in that both are gastrointestinal tube accessories that connect enteral feeding systems. The following table compares the technological characteristics of the two devices: Maulin Medical LLC 510(k) #K101214 {1}------------------------------------------------ | Parameter | Guardian Connection™
(This submission) | Cedic Enteral Feeding
Spike Adapter (K072652) | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Intended Use | For securing the connection
between the standard peg
connector of an enteric
feeding tube and the inline
connector of a nutrient
delivery set. | For connecting a universal
enteral spike set to a feeding
container having a SpikeRight
connection port. | | Accessory to an
enteric feeding
system | Yes | Yes | | Food pathway or
patient contact | No | Yes | | Principle of
Operation | Secures the connection
between an enteric feeding
tube and the nutrient delivery
set by clipping around the
interconnection | Connects an enteric feeding
container and an enteric
feeding tube | | Sterile | No | Yes | | Usage | Single Use | Single Use | ## Testing Performed: Bench testing was performed on the Guardian Connector to show that the device performs as intended. No clinical testing was performed on this device. The Guardian Connection will break away at a tensile force of approximately two pounds, and thus it can help protect the feeding tube/nutrient line from disconnection due to low-level forces that can cause the failure of this connection.. ## Statement of Substantial Equivalence: The Guardian Connector is substantially equivalent to the Cedic Enteral Feeding Spike Adaptor, in that both are accessories to an enteric feeding system and both are intended to provide a secure connection in this system. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized depiction of an eagle or bird-like figure with three wing-like extensions. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 # JUL 2 3 2010 Ms. Sara J. Owens Maulin Medical LLC 486 E. Gentry Drive PUEBLO WEST CO 81007 Re: K101214 Trade/Device Name: Guardian Connection™ Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product code: FPD Dated: April 20, 2010 Received: April 30, 2010 Dear Ms. Owens: 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 10 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 CFK Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related {3}------------------------------------------------ ## Page 2 - 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K10/2/4 16/ # Indications for Use Statement 1214 510(k) Number (if known): Guardian Connection™ Device Name: Indications for Use: The GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Helio Romeu (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FPD/K101214](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FPD/K101214) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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