(15 days)
The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Ross Embrace Enteral Pump". This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and does not contain the detailed study information requested in your prompt.
Therefore, I cannot extract the following information from the provided text:
- Acceptance Criteria and Reported Device Performance: This document does not specify performance acceptance criteria or report device performance against them.
- Sample size used for the test set and data provenance: No information about a test set or its data provenance is present.
- Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
- Adjudication method for the test set: No adjudication method is mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: This is not relevant for an enteral pump.
- Type of ground truth_ used: No ground truth is discussed.
- Sample size for the training set: No training set is mentioned as this device is not an AI/ML product.
- How the ground truth for the training set was established: Not relevant as no training set is discussed.
In summary, the provided FDA clearance letter focuses on regulatory approval based on substantial equivalence and does not include the detailed technical study information that would be found in a clinical trial report or a more comprehensive technical submission.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Mr. Daniel Hamilton Manager, Device Regulatory Affairs Ross Products Division-Abbott Laboratories 625 Cleveland Avenue Columbus, Ohio 43215-1724
Re: K031407
Trade/Device Name: Ross Embrace Enteral Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZH Dated: May 2, 2003 Received: May 5, 2003
Dear Mr. Hamilton:
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.
{1}------------------------------------------------
Page 2 - Mr. Hamilton
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 (OS) 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 vour 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Susan Runre
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
VIII. INDICATIONS FOR USE
The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.
7
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use
(Per 21 CFR 801.109)
Patricio Cucurella
OR
General Hospital,
510(k) Number: KD3/407
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).