(244 days)
Not Found
Error: The K/DEN number for the listed predicate device is not provided in the text.
No
The summary describes a physical medical device kit for gastrostomy tube placement and does not mention any software, algorithms, or AI/ML capabilities.
No.
This device is designed for feeding and decompression, not for treating a disease or condition. It is a long-term gastrostomy feeding and decompression device that is placed percutaneously, not a therapeutic device.
No
The device is described as a replacement gastrostomy tube kit for feeding and decompression, and its function is to create a pathway for enteral feeding, not to diagnose a condition.
No
The device description clearly states it is a "collection of medical devices" and a "kit" containing physical items for a medical procedure, indicating it is a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is designed for the placement of a gastrostomy tube for feeding and decompression. This is a surgical/procedural device used in vivo (within the body).
- Device Description: The description details a kit of medical devices used for a percutaneous procedure. It does not mention any components or processes related to testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely procedural and related to providing a means for enteral feeding and decompression.
N/A
Intended Use / Indications for Use
The device is a low profile replacement gastrostomy tube kit designed for percutaneous insertion through an established stoma tract.
The device is indicated for percutaneous placement of a low-profile long term gastrostomy feeding and decompression device through an established stoma.
Product codes
KNT
Device Description
The Low Profile Gastrostomy Tube Kit is a collection of medical devices that are assembled for the convenience of the health care professional for the purpose of creating a percutaneous gastrostomy through which an enteral feeding tube is placed. The Kit contains items that are commonly used in this type of procedure and which otherwise would be procured through the facility's central supply system. The units are packaged in a kit form with related feeding components and is ethylene oxide sterilized. It is packaged in a preformed plastic tray, and is sealed with a 1073B tyvek lid containing a description of the kit components. This packaging is similar to the predicate unit and is a system commonly used in the medical device industry.
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
health care professional
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)
Bard Button Replacement Gastrostomy Device
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
·
.
| JAN 2 2 1998 | 510(K) SUMMARY
(as required by 807.92(c)) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689 |
| Phone: | 813-942-3908 |
| Fax: | 813-942-3828 |
| Contact Person: | Ed Ransom or Pat Lamb |
| Date of Summary: | May 23, 1997 |
| Trade Name: | Radius Low Profile Gastrostomy Tube Kit |
| Classification Name: | Tube, Gastro-Intenstinal |
| Predicate Device: | Bard Button Replacement Gastrostomy Device |
| Device Description/
Comparison: | The Low Profile Gastrostomy Tube Kit is a collection of
medical devices that are assembled for the convenience of
the health care professional for the purpose of creating a
percutaneous gastrostomy through which an enteral feeding
tube is placed. The Kit contains items that are commonly
used in this type of procedure and which otherwise would be
procured through the facility's central supply system.
The units are packaged in a kit form with related feeding
components and is ethylene oxide sterilized. It is packaged
in a preformed plastic tray, and is sealed with a 1073B tyvek
lid containing a description of the kit components. This
packaging is similar to the predicate unit and is a system
commonly used in the medical device industry. |
| Intended Use: | The device is a low profile replacement gastrostomy tube kit
designed for percutaneous insertion through an established
stoma tract. |
(
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1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Radius International, Inc. c/o Edward H. Ransom Consultant Regulatory and Marketing Services P. O. Box 1108 Elfers, Florida 34680
Re: K971901 Radius Low Profile Gastrostomy Tube Kit Regulatory Class: II Product Code: 78 KNT Dated: October 24, 1997 Received: October 27, 1997
Dear Mr. Ransom:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
2
Page - 2 - Mr. Edward H. Ransom
This letter will allow you to begin marketing your device as described in your 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 the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Roker R. Sathing/
Sa
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): К 971901
Device Name:
Indications For Use:
The device is indicated for percutaneous placement of a low-profile long term gastrostomy feeding and decompression device through an established stoma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Ratliff /
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K971901 510(k) Number
Prescription Use ﺳﮯ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)