(175 days)
Not Found
No
The summary describes a physical filter for enteral feeding solutions and makes no mention of AI or ML technology.
No.
The device is intended to filter liquid feeding solutions to minimize the risk of tube occlusion, not to directly treat a disease or condition in a patient.
No
The device is an enteral in-line filter designed to filter liquid feeding solutions for patients, not to diagnose medical conditions.
No
The device description clearly states it is a physical filter made of biomaterials, intended to be inserted in-line with a feeding tube. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Y2K2 Enteral In-Line Filter is a physical filter designed to remove particulates from liquid feeding solutions before they enter the patient's body. It does not analyze or test any biological samples from the patient.
- Intended Use: The intended use is to prevent tube occlusion by filtering the feeding solution, not to diagnose or monitor a medical condition based on a biological sample.
The device is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The device will filter fluids to be delivered into a feeding tube to remove potentially obstructing particulates.
The Y2K2 Enteral In-Line Filter is intended for use to filter liquid feeding solutions prior to delivery into a patient's pre-inserted feeding tube, to minimize the risk of tube occusion by macro particulates.
This will be applicable to any size or length pediatric or adult feeding tube (e.g., nasogastric, nasoduodenal, nasojejunal, gastrostomy, jejunostomy, transgastric duodenal, or transgastic jejunal).
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The proposed and predicate devices are of essentially the same size, construction, and function. They are made of comparable (Re: Pall) or identical (Re: Cobe Cardiovascular) inert biomaterials. The Y2K2 Enteral In-Line Filter differs in having a larger pore size, to remove coarse (but not fine) particulates from enterally delivered fluids.
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
pediatric or adult
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV - 1 2005
510(k) SUMMARY INFORMATION
| APPLICANT NAME: | Moss Medical Products, Inc. |
|---|---|
| ADDRESS: | 4049 NY 150 |
| West Sand Lake, New York 12196 | |
| PHONE: | 518-674-0904 |
| FAX: | 914-684-1464 |
| E-MAIL: | mosstube@mossmed.com |
| ACTIVITY OF APPLICANT | Initial Distributor |
| CONTACT PERSON: | GERALD MOSS, Ph.D., M.D. |
| ADDRESS: | 1 Reynal Road |
| White Plains, New York 10605 | |
| PHONE: | 914-997-0392 |
| FAX: | 914-684-1464 |
| E-MAIL: | gerald_moss@mossmed.com |
| NAME OF DEVICE | |
| TRADE NAME: | Y2K2 Enteral Tube Fluid Filter |
| COMMON NAME: | In-Line Filter |
| CLASSIFICATION NAME: | {21 CFR 876.5980} |
| {Tubes, Gastrointestinal (and accessories) | |
| PRODUCT CODE: | {KNT} |
| MANUFACTURER: | Filtertek, Inc. |
| P.O. Box 310 | |
| 11411 Price Road | |
| Hebron, IL 60034-0310 | |
| PREDICATE DEVICES: | Pall PharmAssure Capsule Filter (K943127 |
I will maintain records to support a claim (TL, 15 to 127)
Cobe Cardiovascular Pre-bypass Filter (K850139)
INDICATIONS FOR USE: The device will filter fluids to be delivered into a feeding tube to remove potentially obstructing particulates.
TECHNICAL CHARACTERISTICS: The proposed and predicate devices are of essentially the same size, construction, and function. They are made of comparable (Re: Pall) or identical (Re: Cobe Cardiovascular) inert biomaterials. The Y2K2 Enteral In-Line Filter differs in having a larger pore size, to remove coarse (but not fine) particulates from enterally delivered fluids.
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Image /page/1/Picture/2 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The logo is encircled by text that reads 'Department of Health'. The text is arranged along the curve of the circle, with the bird figure positioned inside the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 2005
Moss Medical Products, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K051206
Trade/Device Name: Y2K2 Enteral In-Line Filter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 76 KNT Dated: October 15, 2005 Received: October 17, 2005
Dear Mr. Job:
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.
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.
2
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.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 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/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:_Y2K2 Enteral In-Line Filter
Indications For Use:
The Y2K2 Enteral In-Line Filter is intended for use to filter liquid feeding solutions prior to delivery into a patient's pre-inserted feeding tube, to minimize the risk of tube occusion by macro particulates.
This will be applicable to any size or length pediatric or adult feeding tube (e.g., nasogastric, nasoduodenal, nasojejunal, gastrostomy, jejunostomy, transgastric duodenal, or transgastic jejunal).
Prescription Use
X
(Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _