(110 days)
No
The summary describes a standard enteral feeding set with mechanical components and no mention of AI/ML or related concepts.
No.
The device is described as an "Enteral Feeding Set" intended to deliver liquid nutrition formulas. It does not perform any therapeutic function like treating, curing, mitigating, or preventing a disease.
No
The device is described as an enteral feeding set, intended to deliver liquid nutrition formulas. It does not perform any diagnostic function such as identifying, confirming, or monitoring medical conditions.
No
The device description explicitly lists physical components such as bags, tubing, shut-off devices, sight chambers, cassette technology, and adapters, indicating it is a hardware device.
Based on the provided information, the HOSPIRA ® Enteral Feeding Sets is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver liquid nutrition formulas to a feeding tube. This is a direct interaction with the patient's body for therapeutic purposes (providing nutrition), not for testing or analyzing samples taken from the body.
- Device Description: The components described are for fluid delivery and control, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic testing or providing information about a patient's health status based on sample analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HOSPIRA ® Enteral Feeding Sets does not fit this description.
N/A
Intended Use / Indications for Use
The HOSPIRA * Enteral Feeding Sets is intended to deliver, via gravity or a pamp, liquid nuttition formulas to an enteral access device (a feeding tube):
Product codes
80-KNT
Device Description
The HOSPIRA * Enteral Feeding Sets will consist of variations of the following components: non-DETIP Enteral feeding bags, non-DEHP plasticized polyvinyl tubing, fluid shut off devices, non-DEHP sight chambers, cassette technology and adapters for enteral feeding catheters.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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K06 1432
1 of 2
SEP 1 1 2006
510(k) Summary
HOSPIRA. Incorporated Name of Submitter: 275 North Field Drive Lake Forest, Illinois 60045 Owner/Operator #: 9063339
Manufacturer and Establishment Registration Number:
Manufacturer:
HOSPIRA LTD. Carretera Sanchez, km 18 1/2 Parque Industrial Itabo, S.A. Haina, San Cristobal, Dominican Republic
Establishment Registration #: 9613251
Proprietary or Trade Name of Proposed Device: Hospira® Enteral Feeding Sets
Common Name: Enteral Bag w/Pump Set
Device Classification, Pancode and ProCode: Class II, 80-KNT
Performance Standards: No performance standards have been established under Section 514 of the Food. Drag and Cosmetic Act for Infusion pumps. Tubes, gastrointestinal (and accessories) are regulated withm 21 CFR 880.5860.
Intended Use / Indications for Use:
The HOSPIRA * Enteral Feeding Sets is intended to deliver, via gravity or a pamp, liquid nuttition formulas to an enteral access device (a feeding tube):
Proposed Device Description:
The HOSPIRA * Enteral Feeding Sets will consist of variations of the following components: non-DETIP Enteral feeding bags, non-DEHP plasticized polyvinyl tubing, fluid shut off devices, non-DEHP sight chambers, cassette technology and adapters for enteral feeding catheters.
Summary of Substantial Equivalence
The HOSPIRA " Enteral Feeding Sets as described in this substantially equivalent to the primary predicate device Enteral Pump Set with Integral Container (K810996 & K052052) with respect to the following:
Similarities:
- Both devices are mended to temporarily hold and deliver nutritional fluids from a container to a 】 patient's enteral access site
- The operating principles are the same for both devices 2)
- Both primary labeling and device bags clearly state not for I.V. or Epidural Use 3)
1
Difference:
- The HOSPIRA * Enteral Feeding Sets will be comprised of all non-DEHP materials. 1) The HOSPIRA® Enteral Feeding Sets will contain a non-PVC enteral feeding bag.
The HOSPIRA® Enteral Feeding Sets as described in this substantially equivalent to the I he HUSFINA Timeral Pecaling Bets as assette (K865059 & K052059 & K052052) with respect to the following:
Similarities:
-
- Both use the same infusion cassette technology
- The operating principles are the same for both devices.
Difference:
- I ) The predicate is cleared for I.V. use, the subject is for enteral use
- The HOSPIRA® Enteral Feeding Sets will contain a non-PVC enteral feeding bag.
r) The HOSPIRA® Enteral Feeding Sets will contain a non-PVC enteral feeding bag.
4) The HOSPIRA® Enteral Feeding Sets will be comprised of all non-DEHP materials.
Statement of Safety and Effectiveness
The HOSPIRA " Enteral Feeding Sets meets the functional claims and intended use as described in the I he IrOST trent - Enterate and effective in terms of substantial equivalence as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 1 2006
Ms. Diane Rennpferd Sr. Associate, Global Regulatory Affairs - Devices Hospira, Inc. Department 0389, Bldg. H2 275 North Field Drive LAKE FOREST IL 60045
K061432 Re:
Trade/Device Name: HOSPIRA® Enteral Feeding Sets Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: July 20, 2006 Received: July 21, 2006
Dear Ms. Rennpferd:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The logo has the letters FDA in a bold font in the center with the word Centennial underneath. There are three stars below the word Centennial.
oting Public
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Page 2 -
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
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)
HOSPIRA® Enteral Feeding Sets Device Name:
Indications for Use:
The Hospira® Enteral Feeding Sets is intended to deliver, via gravity or a pump, liquid nutrition formulas to an enteral access device (a feeding tube).
Prescription Use X (Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use (Part 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)
David Le. Byrom
(Division S Division of and Radiol 510(k) Num Page 1 of 1