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.

AI/ML Overview

The provided FDA 510(k) summary for the Guardian Connection™ device focuses on its substantial equivalence to a predicate device based on technological characteristics and bench testing. It does not contain information about acceptance criteria and a study in the context of diagnostic performance metrics like sensitivity, specificity, or AUC, as it is a physical medical device (a clip for feeding tubes), not a diagnostic algorithm.

Therefore, many of the requested categories are not applicable to this particular device submission.

Here's a breakdown of the relevant information from the document in relation to your request, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from testing description):

The device should secure the connection between an enteric feeding tube and a nutrient delivery set.
The device should "break away" at a tensile force of approximately two pounds.

Reported Device Performance:

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Connection Security	Device should secure the connection between an enteric feeding tube and a nutrient delivery set, preventing inadvertent disconnection due to low-level forces.	"helps to prevent them [connectors] from being pulled apart by tensile force."
Breakaway Force	The device should break away at a tensile force of approximately two pounds.	"The Guardian Connection will break away at a tensile force of approximately two pounds."

Regarding the study proving the device meets the acceptance criteria:

The document states: "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 following questions are not applicable to this 510(k) submission as it is for a physical medical device (a clip) and not an AI/diagnostic algorithm:

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Summary

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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. Owens719-647-2938 (phone)Email: maulinmedical@q.com
	Device Trade Name: Guardian Connection™
	Classification name: Gastrointestinal Tube and Accessories (21 CFR876.5980)
Predicate Device:	Cedic Enteral Feeding Spike Adapter (K072652)

Device Description:

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

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Parameter	Guardian Connection™(This submission)	Cedic Enteral FeedingSpike Adapter (K072652)
Intended Use	For securing the connectionbetween the standard pegconnector of an entericfeeding tube and the inlineconnector of a nutrientdelivery set.	For connecting a universalenteral spike set to a feedingcontainer having a SpikeRightconnection port.
Accessory to anenteric feedingsystem	Yes	Yes
Food pathway orpatient contact	No	Yes
Principle ofOperation	Secures the connectionbetween an enteric feedingtube and the nutrient deliveryset by clipping around theinterconnection	Connects an enteric feedingcontainer and an entericfeeding 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.

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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

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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

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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

Regulation Number and Section

§ 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.