(84 days)
No
The summary describes a mechanical connector for enteral tubes and does not mention any AI/ML components or functionalities.
No.
The device is described as controlling fluid flow into and out of medical tubes for delivery of formula, irrigation, and medication, which is a functional role in fluid management, not directly therapeutic toward a disease or condition.
No
The device is described as controlling fluid flow and reducing disconnections in enteral feeding systems. There is no mention of analysis, measurement, or detection of a disease or condition.
No
The device description clearly indicates a physical connector inserted between tubes, which is a hardware component.
Based on the provided information, the Dale® ACE* Connector is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes controlling fluid flow into and out of medical tubes for enteral feeding, irrigation, and medication delivery. This is a function related to patient care and fluid management within the body, not the examination of specimens taken from the body.
- Device Description: The device is described as being inserted between enteral tubes and administration/drainage tubing. This further reinforces its role in managing fluids within the patient's system.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVDs are specifically designed to perform tests on samples taken from the human body. The Dale® ACE* Connector's function is entirely external to the analysis of such samples.
N/A
Intended Use / Indications for 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.
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.
Product codes
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare worker
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Dale® ACE* Connector demonstrates that the device meets design and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Lopez Valve, K915171
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
1
Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The top line reads 'K082241/'. The second line reads '282'. The text is written in a bold, somewhat stylized font, with some characters slightly overlapping or connected.
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
4
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