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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Dale® ACE* Connector, focusing on acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document (K082241) is a 510(k) summary for a medical device. In this context, "acceptance criteria" for performance refer to the specifications the device must meet to demonstrate substantial equivalence to a predicate device and ensure safety and effectiveness. The document states:

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

However, the specific quantitative acceptance criteria (e.g., maximum leak rate, force required for connection/disconnection, number of cycles) are not explicitly detailed in this summary document. Similarly, the reported numerical performance values are also not provided. The summary confirms that testing was done and that the device met these unstated specifications.

For a 510(k) submission, the "study" referred to is the performance testing conducted to show substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Not explicitly stated in summary	"meets design and performance specifications"

Note: The exact quantitative criteria and performance data would typically be found in the full 510(k) submission, which is not fully provided here, but are summarized as having been met.

Study Details Pertaining to Device Performance

Based on the provided K082241 510(k) summary, here's what can be inferred or explicitly stated:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary (e.g., country of origin, retrospective/prospective). However, such testing is generally conducted by the manufacturer (Dale® Medical Products, Inc.) or a contracted lab to support the 510(k) submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This device is a mechanical connector. Performance testing for such devices typically involves engineering and functional tests (e.g., leak tests, flow rate, durability) rather than human expert categorization of complex data where "ground truth" is established by medical experts for diagnostic purposes. The ground truth would be based on objective physical measurements against engineering standards.
Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, this type of device undergoes functional and engineering performance testing, not studies requiring adjudication of human-interpreted data.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done; If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not relevant for this type of mechanical device. This kind of study is specific to diagnostic aids, often involving AI or imaging interpretation, where human readers evaluate cases.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not a software algorithm. Performance is inherent to its physical design and function.
The Type of Ground Truth Used:
- Engineering Standards and Objective Measurements. For a mechanical device like the Dale® ACE* Connector, the "ground truth" for performance testing (e.g., fluid flow, leak prevention, durability, connection integrity) is established by adherence to predefined engineering specifications, industry standards, and reproducible physical measurements using calibrated equipment. This is distinct from ground truth derived from pathology, expert consensus on medical images, or patient outcomes data.
The Sample Size for the Training Set:
- Not Applicable. This is a hardware device; it does not involve machine learning or AI models that require a "training set" of data.
How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for this type of device, this question is not relevant.

Summary

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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: 208-695-9316

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

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

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a larger document or heading. The words are clearly legible and stand out against the background.

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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

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.