THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751

K082241 · Dale Medical Products, Inc. · KNT · Oct 30, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082241
• Device Name: THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
• Applicant: Dale Medical Products, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The Dale® ACE* (* Access Controller for Enteral) Connector is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.

Device Story

The Dale® ACE Connector is an inline device inserted between an enteral tube and fluid administration/drainage tubing. It functions as an access controller, allowing for formula delivery, irrigation, and medication administration without requiring repeated disconnection of the enteral tube. By maintaining a closed system, it prevents accidental exposure of healthcare workers to gastric fluids. The device is intended for use in clinical settings where enteral access is managed. It benefits patients and staff by reducing the frequency of line breaks, thereby minimizing contamination risks and simplifying the administration process.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Inline enteral tube connector; closed system design; facilitates fluid flow, irrigation, and medication delivery; 30-day usage duration. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring enteral feeding or medication delivery via medical tubes. Facilitates fluid flow control, formula delivery, syringe irrigation, and liquid medication administration without breaking lines for up to 30 days. Protects healthcare workers from gastric fluid exposure.

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

• Lopez Valve (K915171)

Submission Summary (Full Text)

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K082241
142

510(k) Summary for the Dale® Medical Products, Inc. The Dale® ACE* Connector (*Access Controller for Enteral) (per 21 CFR 807.92)

OCT 3 0 2008

#### 1. SUBMITTER/510(K) HOLDER

Dale® Medical Products, Inc. 7 Cross Street Plainville, MA 02762

Contact Person: Malcolm Card Telephone: [phone]

Date Prepared: August 6, 2008

#### 2. DEVICE NAME

| Proprietary Name: | The Dale® ACE (*Access Controller for Enteral) Connector |
|----------------------|----------------------------------------------------------|
| Common/Usual Name: | GI tube connector |
| Classification Name: | Gastrointestinal tubes and accessories |

#### 3. PREDICATE DEVICES

- . Lopez Valve, K915171
#### 4. DEVICE DESCRIPTION

The Dale® ACE* Connector is a device that is inserted between the enteral tube and the fluid administration tubing or drain receptacle. It is designed to reduce the need for repeated and regular disconnection of the enteral tube from the associated tubing.

#### INTENDED USE 5.

The Dale® ACE* (* Access Controller for Enteral) Connector is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.

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### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Dale® Medical Products, Inc. claims substantial equivalence of the Dale® ACE* Connector to the predicate device based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of the Dale® ACE* Connector and the cited predicate device is included in the 510(k).

#### 7. PERFORMANCE TESTING

Testing of the Dale® ACE* Connector demonstrates that the device meets design and performance specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

NOV 20 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dale® Medical Products, Inc. c/o Rosina Robinson, R.N., MEd., RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K082241

Trade/Device Name: Dale® Medical Products, Inc. Dale® ACE* Connector (*Access Controller for Enteral) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 4, 2008 Received: November 4, 2008

Dear Ms. Robinson:

This letter corrects our substantially equivalent letter of October 30, 2008.

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 (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.

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 mav 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

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## Page 2 - Ms. Rosina Robinson

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hubert Leuner

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure - New Indications for Use Form

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# Indications for Use

510(k) Number (if known): K082241

Dale® Medical Products, Inc. Dale® ACE* Connector (*Access Device Name: Controller for Enteral)

Indications for Use:

The Dale® ACE* Connector (*Access Controller for Enteral) is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines for up to 30 days. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Leuner

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number