(235 days)
The device is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.
The device is described as a Percutaneous Endoscopic Gastrostomy tube. The device may be life supporting in tha it can be the primary source of nutrition for the patient. The indications, complications and contra-indications are identical to those of the predicate Bard device. The actual insertion and placement techniques are also identical. The bolster and connector systems perform the same functions as those performed by the Bard unit. The dilator tip is composed of the same medical grade polyethylene material that is used by Bard and is identical in design. The external bolster is a silicone friction fit as is the Bard. The internal bolster system is comparable to the Bard system in both retention and removal characteristics.
The provided text is a 510(k) summary for the "Radius Pull Percutaneous Endoscopic Gastrostomy Kit". This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more detailed technical submission.
The 510(k) summary is focused on establishing substantial equivalence, primarily by comparing the new device's design, materials, and intended use to a legally marketed predicate device (Bard Ponsky-Gauderer Silicone Peg Tray). This process generally doesn't require new clinical studies for devices similar in design and function to existing ones, especially for a relatively mature technology like gastrostomy tubes.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone algorithm performance) from the provided text because it simply isn't present in this type of regulatory document for this kind of device.
To answer your request based solely on the provided text, I must state that the information is not available.
Here's a breakdown of why each specific point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not present. The 510(k) focuses on equivalence of design and function, not on specific performance metrics with acceptance criteria.
- Sample size used for the test set and the data provenance: Not present. No "test set" or clinical study data is detailed. The comparison is based on device features and intended use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No clinical data requiring expert review is mentioned.
- Adjudication method for the test set: Not present. No clinical data or test set requiring adjudication is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a medical instrument (gastrostomy tube kit), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance are not applicable.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not present. This is not an algorithm or AI-driven device.
- The type of ground truth used: Not present. No clinical data requiring ground truth is detailed.
- The sample size for the training set: Not present. The device is not an AI/machine learning model, so there is no "training set."
- How the ground truth for the training set was established: Not present. Not applicable to this device.
In summary, the provided 510(k) document is a declaration of substantial equivalence for a medical device (a gastrostomy tube kit) based on comparison to a predicate device. It does not contain the kind of detailed study data, acceptance criteria, or performance metrics that would be found in a submission for a novel, higher-risk device, or an AI/software-as-a-medical-device (SaMD) product.
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K 472025
1 of 1
510(K) SUMMARY (as required by 807.92(c))
JAN 2 3 1998
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)40178 U.S. 19 NorthTarpon Springs, FL 34689 |
|---|---|
| Phone: 813-942-3908Fax: 813-942-3828 | |
| Contact Person: | Ed Ransom or Pat Lamb |
| Date of Summary: | May 30, 1997 |
| Trade Name: | Radius Pull Percutaneous Endoscopic Gastrostomy Kit |
| Classification Name: | Tube, Gastro-Intenstinal |
| Predicate Device: | Bard Ponsky-Gauderer Silicone Peg Tray |
| Device Description/Comparison: | The device is described as a Percutaneous EndoscopicGastrostomy tube. The device may be life supporting in thait can be the primary source of nutrition for the patient. Theindications, complications and contra-indications areidentical to those of the predicate Bard device. The actualinsertion and placement techniques are also identical. Thebolster and connector systems perform the same functionsas those performed by the Bard unit. The dilator tip iscomposed of the same medical grade polyethylene materialthat is used by Bard and is identical in design. The externalbolster is a silicone friction fit as is the Bard. The internalbolster system is comparable to the Bard system in bothretention and removal characteristics. |
| Intended Use: | The device is a low profile replacement gastrostomy tube kitdesigned for percutaneous insertion through an establishedstoma tract |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three faces in profile, one behind the other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Radius International, Inc. c/o Ed Ransom Consultant Requlatory and Marketing Services, Inc. P.O. Box 1108 Elfers, Florida 34680
Re: K972025 Radius International, Pull Percutaneous Endoscopic Gastrostomy Kit Requlatory 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class-H + =============================================================================================================== Controls) or class III (Premarket Approval) it may be subject to 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 Reqister.
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Page - 2 - Mr. Ed Ransom
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 requlations.
In addition, we have determined that your device kit contains Lidocaine, Povidone - iodine swabs, and Povidone - iodine ointment, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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 proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 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,
Robert R. Satherg/
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
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510(k) Number (if known):
Device Name: Radius Pull Percutaneous Endoscopic Gastrostomy Kit
Indications For Use:
The device is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.
(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 of Reproductive, Abdominal, ENT, and Radiological Devices 1197202 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
-OR-
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(Optional Format 1-2-96)
§ 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.