(76 days)
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Not Found
No
The 510(k) summary describes a simple enteral feeding extension set and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
This device is an extension set used to deliver enteral formula; it does not directly treat a disease or condition.
No
The device is an enteral feeding extension set used to deliver formula, not to diagnose a condition.
No
The device description clearly identifies it as a physical "Enteral Feeding Extension Set," which is a hardware component used for delivering formula. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver enteral formula from a nutritional source to an enteral feeding device. This is a delivery mechanism for nutrition, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description is for an "Enteral Feeding Extension Set," which is consistent with a device used for delivering nutrition.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or assays
- Analysis of biomarkers
Therefore, the CORFLO Anti-IV Enteral Feeding Extension Set is a medical device used for delivering nutrition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
Product codes
FPD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Pediatric and neonatal use only.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three flowing lines representing the body and arms. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the circle's perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2009 MAR
Ms. Stephanie Wasielewski VP. Regulatory Affairs/Quality CORPAK MedSystems 100 Chaddick Drive WHEELING IL 60090
K083776 Re:
Trade/Device Name: CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories
Regulatory Class: II Product Code: FPD
Dated: December 18, 2008
Received: December 19, 2008
Dear Ms. Wasielewski:
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. Ilsting 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
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 os 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 892.xxx | (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 Biometrics' (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 Manufactures, 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.suppor/index.html.
Sincerely yours,
Lamme B. Merrel
anine M. Morri cting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k): K083776
Device Name: CORFLO Anit IV Enteral Feeding Set 20-1030AIV-LB-S
INDICATIONS FOR USE:
The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
Prescription Use (Per 21 CFR 801.109)
or Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number |
Prescription Use
(Per 21 CFR 801.109)
K083776