(30 days)
The FastracTM Gastric Access Port System is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.
The FASTRAC™ Gastric Access Port device is a silicone balloon-type feeding Product designed for percutaneous initial endoscopic placement (via a Pull placement technique, or a Guidewire placement technique) of a long term initial feeding and/or decompression gastrostomy tube. The feeding tube is designed with soft thin silicone tubing, which is wire-reinforced to prevent kinking, and the with volster positions the device at a 90° angle against the abdomen.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Fastrac™ Gastric Access Port System. It details an application for marketing a medical device and its substantial equivalence to a predicate device, rather than a clinical study with acceptance criteria and performance data in the typical sense of a diagnostic or algorithmic device.
Therefore, many of the requested elements for a study proving acceptance criteria (such as sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission. This document focuses on demonstrating that the new device meets the same performance requirements and is as safe and effective as its predicate device through design verification, not through an independent clinical study establishing new performance metrics.
Here's a breakdown based on the provided information, addressing what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported device performance metrics in the way a diagnostic algorithm would. Instead, it states that the device meets the "same performance requirements" as the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same performance requirements as predicate device | "Design verification data demonstrated that the Fastrac™ Gastric Access Port System meets the same performance requirements and is as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "design verification data," which typically involves engineering tests, bench testing, and potentially limited animal or human use data from development, but not a formal clinical trial with a defined sample size for statistical evaluation of new performance.
- Data Provenance: Not specified. This would refer to the tests and verification activities performed by the manufacturer (C.R. Bard, Inc. in Billerica, MA).
- Retrospective/Prospective: Not specified, but "design verification" is inherently an integral part of prospective product development and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study focused on diagnostic accuracy or interpretation by experts. The "ground truth" for a device like this would be its physical and functional characteristics documented by engineers and testing personnel against design specifications, potentially with clinical input on requirements, but not expert adjudication of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" in the sense of cases requiring adjudication of results, as this is a device performance verification, not a diagnostic accuracy study.
5. 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 applicable. This is not an AI-assisted diagnostic device, nor is it a study involving human readers or comparative effectiveness in that context. It is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Its performance is inherent in its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be engineering specifications, material and mechanical test standards, and functional requirements. For example, "ground truth" might be that the silicone tubing must withstand a certain pressure without kinking, or that the bolster maintains a 90° angle, as measured by precise engineering tests, rather than a clinical outcome or expert diagnosis for individual patients.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.
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K033562
1 of 2
DEC 12 2003
BARD ENDOSCOPIC TECHNOLOGIES
TRATRID
C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- Submitter Information: A.
| Submitter's Name: | C.R. Bard, Inc.,Bard Endoscopic Technologies Division |
|---|---|
| Submitter's Address: | 129 Concord Road,Billerica MA 01821-7031 |
| Contact Person: | Thomas Hirte |
| Contact Person's Telephone Number: | (978) 262-4867 |
| Contact Person's FAX Number: | (978) 262-4878 |
-
Device Name: B.
Fastrac™ Gastric Access Port Pull Kit Fastrac™ Gastric Access Port Guidewire Kit Fastrac™ Gastric Access Port Pull Safety System Fastrac™ Gastric Access Port Guidewire Safety System -
C. Predicate Devices:
Fastrac™ Gastric Access Port Pull PEG System (K972025), Fastrac™ Gastric Access Port Guidewire PEG System (K972102) -
Device Description: D.
The FASTRAC™ Gastric Access Port device is a silicone balloon-type feeding Product designed for percutaneous initial endoscopic placement (via a Pull placement technique, or a Guidewire placement technique) of a long term initial feeding and/or decompression gastrostomy tube. The feeding tube is designed with soft thin silicone tubing, which is wire-reinforced to prevent kinking, and the with volster positions the device at a 90° angle against the abdomen.
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Bard Endoscopic Technologies
BARRID
C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989
-
E. Intended Use:
The Fastrac™ Gastric Access Port System is intended for percutaneous placement, and long term initial feeding and/or decompression gastrostomy. -
Technological Characteristics Summary: F.
The FASTRAC™ Gastric Access Port device is a silicone balloon-type feeding product designed with soft thin silicone tubing, which is wire-reinforced to prevent kinking. The external bolster positions the device at a 90° angle against the abdomen. -
Performance Data: G.
Design verification data demonstrated that the Fastrac™ Gastric Access Port System meets the same performance requirements and is as safe and effective as the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2003
Thomas Hirt, P.E. Senior Regulatory Affairs Specialist Bard Endoscopic Technologies C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 BILLERICA MA 01821-7031
Re: K033562
Trade/Device Name: Fastrac™ Gastric Access Port System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: November 10, 2003 Received: November 12, 2003
Dear Mr. Hirt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviews a your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass batter in 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 the kill nave ethior been 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found may of babyer to and 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);
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Page 2 - Mr. Thomas Hirt
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.
In addition, we have determined that your device kit contains 1% lidocaine HCL, lubricating jelly, m addition, we have actions indine 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 n ordevice 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 Section 510(k) I mis letter witification. The FDA finding of substantial equivalence of your device to a legally premaince noutheated evice 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, please contact the Office of n you ucure specific da 16016. Jobs, please note the regulation entitled, "Misbranding by reference Comphance at (301) 97 - 1010. Price Pat 807.97). You may obtain other general information on your to promibilities under the Act from the Division of Small Manufacturers, International and Topponsioner Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/dsma/dsmamain.html.
Sincerely yours.
Danielle Leppan
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 Statement
| 510(k) Number (if known): | TBD K033562 |
|---|---|
| Device Name: | FastracTM Gastric Access Port System |
| Indications For Use: | The FastracTM Gastric Access Port System is indicated forpercutaneous placement of a long term initial feedingand/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)
| Prescription Use(Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --------------------------------------------------------- |
OR
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K033562 |
|---|---|
| --------------- | --------- |
| Over-The-Counter Use(Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
016
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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.