(97 days)
Not Found
No
The 510(k) summary describes a simple enteral feeding tube and does not mention any AI or ML components or functionalities.
No
The device is used for introducing fluids and medication, which is a supportive function, not a direct therapeutic treatment of a disease or condition.
No
Explanation: The device is an enteral feeding tube used for introducing fluids and/or oral medication, not for diagnosing a condition.
No
The device description clearly states it is a physical tube made of polyurethane or PVC, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of fluids and/or oral medication into the stomach. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a tube for physical delivery of substances. It does not involve testing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MPS Acacia Enteral Feeding Tube is intended to be placed into the stomach, nasogastrically or orogastrically, for the introduction of fluids and/or oral medication. The Enteral Feeding Tube is disposable and single use only. Not intended for intravascular or intravenous use.
Product codes
KNT
Device Description
The MPS Acacia Enteral Feeding Tube is a polyurethane or polyvinyl chloride (PVC) tube of various French sizes and lengths. A rigid female oral connector is attached to the proximal end of the Enteral Feeding Tube and accepts all male oral connectors such as those found on oral syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach, nasogastrically or orogastrically
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical test summary: The Kendall Polyurethane and PVC Feeding Tubes are legally marketed devices in the United States. The attachment of MPS Acacia's oral female connector does not require additional clinical testing since no changes in the common clinical use or intended use of the device is being made.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Page 1 of 2
510(k) Summary
| 1. | Submitter: | MPS Acacia
785 Challenger Street
Brea, CA 92821
Tel: 714-257-0470
Fax: 714-257-0513 | MAY 14 2008 |
|----|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------|
| 2. | Contact: | Fergie F. Ferguson, Quality Systems Manager
MPS Acacia | |
| 3. | Date prepared: | February 6, 2008 | |
| 4. | Device trade name: | MPS Acacia Enteral Feeding Tube | |
| | Common name: | Feeding Tube | |
| 5. | Predicate device:
510(k) number:
Marketed by: | Argyle Indwell Polyurethane Feeding Tube
K820442
Kendall
15 Hampshire Street
Mansfield, MA 02048 | |
| | Predicate device:
510(k) number:
Marketed by: | Argyle PVC Feeding Tube
K820441
Kendall
15 Hampshire Street
Mansfield, MA 02048 | |
6. Description:
The MPS Acacia Enteral Feeding Tube is a polyurethane or polyvinyl chloride (PVC) tube of various French sizes and lengths. A rigid female oral connector is attached to the proximal end of the Enteral Feeding Tube and accepts all male oral connectors such as those found on oral syringes.
7. Intended Use:
- 7.1 The MPS Acacia Enteral Feeding Tube is intended to be placed into the stomach, nasogastrically or orogastrically, for the introduction of fluids and/or oral medication.
- 7.2 The Enteral Feeding Tube is disposable and single use only.
- 7.3 Not intended for intravascular or intravenous use.
- Technological comparison to predicate device: 8.
MPS Acacia's Enteral Feeding Tube utilizes the Kendall's Feeding tube with MPS Acacia's rigid female oral connector attached in the place of Kendall's soft boot female connector. MPS Acacia's oral female connector can only accept an oral male connector such as those found on oral syringes.
There are no other technological differences between the proposed MPS Acacia Enteral Feeding Tube and the predicate devices marketed by Kendall.
1
510(k) Summary
-
Non-clinical test summary: ത
The Kendall Polyurethane and PVC Feeding Tubes are legally marketed devices in the United States. The attachment of MPS Acacia's oral female connector does not require additional clinical testing since no changes in the common clinical use or intended use of the device is being made. -
- Conclusion:
The MPS Acacia Enteral Feeding Tube utilizes the Kendall Feeding Tube and MPS Acacia's rigid female oral connector. All standard male oral connectors, such as those found on oral syringes, can connect with the rigid female oral connector.
- Conclusion:
MPS Acacia Enteral Feeding Tube is substantially equivalent to the predicate devices marketed by Kendall since there are no technological or intended use differences between the two devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a staff with a serpent entwined around it, but in this case, it is a more abstract, wave-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Mr. Fergie F. Ferguson Quality Systems Manager MPS Acacia 785 Challenger St. BREA CA 92821
Re: K080328
Trade/Device Name: MPS Acacia Enteral Feeding Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 25, 2008 Received: March 26, 2008
Dear Mr. Ferguson:
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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 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 begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K080328
Device Name: MPS Acacia Enteral Feeding Tube
Indications for Use:
-
- The MPS Acacia Enteral Feeding Tube is intended to be placed into the stomach, nasogastrically or orogastrically, for the introduction of fluids and/or oral medication.
-
- The Enteral Feeding Tube is disposable and single use only.
-
- Not intended for intravascular or intravenous use.
Prescription Use 2 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page | of
(Posted November 13, 2003)
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(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number