(62 days)
For percutaneous placement of a long-term replacement gastrostomy feeding and/or decompression device into an established stoma.
The Ponsky* Non-Balloon Replacement Gastrostomy Tube is a 20 French soft, silicone gastrostomy tube and internal retention dome with pre-attached external bolster and dual port feeding adaptor, packaged sterile with procedural aids. The Ponsky* Non-Balloon Replacement Gastrostomy Tube has a pocket in the dome that fits the obturator in order to assist in placement of the device through an established stoma. The Ponsky* Non-Balloon Replacement Gastrostomy Tube has a feeding port to administer nutrition, and a medication port.
The provided text describes a Special 510(k) Premarket Notification for the Ponsky Non-Balloon Replacement Gastrostomy Tube. This type of submission is for modifications to a legally marketed device that do not affect the intended use or alter fundamental scientific technology. Therefore, the study presented here focuses on demonstrating that the modified device meets specified performance criteria and remains substantially equivalent to the predicate device. It does not involve a comparative effectiveness study with human readers (MRMC) or a standalone AI algorithm performance study.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present specific quantitative acceptance criteria or a detailed table of device performance results for each criterion in the typical format of a clinical study. Instead, it references a series of recognized and national standards that were used to develop in-house test protocols. The general statement is that the device "met all pre-determined acceptance criteria."
| Acceptance Criteria (Referenced Standards) | Reported Device Performance |
|---|---|
| AAMI / ANSI / ISO 10993-1:2003 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding biological safety. |
| EN 1615:2000 (Enteral Feeding Catheters and Enteral Giving Sets for Single Use and Their Connectors) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding performance as an enteral feeding catheter. |
| EN 1618:1997 (Catheters other than Intravascular Catheters - Test Methods for Common Properties) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding common catheter properties. |
| JIS T 3213:2005 (Enteral Feeding Catheters and Enteral Giving Sets) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding performance as an enteral feeding catheter. |
| ASTM F 640:2007 (Standard Test Methods for Determining Radiopacity for Medical Use) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding radiopacity. |
| ISO 14971:2009 (Medical devices - Application of risk management to medical devices) | Risk management processes were applied, leading to the conclusion that no new questions regarding safety or effectiveness are raised. Device met all pre-determined acceptance criteria. |
| AAMI / ANSI / ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding packaging and maintenance of sterility. |
| ANSI / AAMI / ISO 11135:2007 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding sterilization efficacy and control. |
| AAMI / ANSI / ISO 10993-7:1995 (R) 2001 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding biocompatibility in relation to ethylene oxide residuals. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for particular tests. The tests performed are in-house design verification and validation activities, which would typically involve testing of device prototypes or production samples. The data provenance is "in-house test protocols" developed based on recognized standards. The country of origin of the data is implied to be within Bard Access Systems, Inc. (Salt Lake City, Utah, USA), given the submitter information. It is a retrospective analysis of device performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a device modification submission based on engineering and material performance standards rather than clinical evaluation, there's no mention of experts establishing a "ground truth" for a test set in the clinical sense (e.g., radiologists interpreting images). The "ground truth" for these engineering tests are the specifications and requirements defined by the referenced international and national standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and established standards, rather than expert interpretation requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a gastrostomy tube, not an AI-powered diagnostic tool, and the submission is for a device modification (Special 510(k)) that focuses on engineering and material performance, not clinical efficacy through human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for performance assessment is based on the requirements and specifications embedded within the referenced international and national consensus standards (e.g., ISO, AAMI, EN, JIS, ASTM). These standards define acceptable levels of biological safety, material properties, sterility, radiopacity, and other performance characteristics for medical devices of this type.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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| Bard Access Systems | Ponsky" Non-Balloon Replacement Gastrostomy Tube | K10310910f 2 | ||
|---|---|---|---|---|
| Special 510(k) Premarket Notification | Page 1945 08 | |||
| 510(k) Summary21 CFR 807.92 | DEC 2 2 2010 | |||
| Ponsky* Non-Balloon Replacement Gastrostomy Tube | ||||
| Prepared October 19, 2010 | ||||
| Submitter of 510(k)Premarket Notification: | Bard Access Systems, Inc.[Subsidiary of C.R. Bard, Inc.]Salt Lake City, Utah 84116Phone: (801) 522-5675(801) 522-5425Fax: | |||
| GeneralProvisions | Contact Person: | Ji Hyun Kim | ||
| Device Trade Name: | Ponsky* Non-Balloon Replacement GastrostomyTube | |||
| Device Generic Name: | Gastrointestinal tube and accessories | |||
| Subject Device | Trade Name: | Ponsky* Non-Balloon Replacement GastrostomyTube | ||
| Common Name: | Gastrointestinal tube and accessories | |||
| Classification Name: | Gastrointestinal tube and accessories(21 CFR 876. 5980, Product Code KNT), Class II | |||
| Classification Panel: | Gastroenterology / Urology | |||
| Trade Name: | Bard* Non-Balloon Replacement GastrostomySystem | |||
| Common Name: | Gastrointestinal tube and accessories | |||
| PredicateDevica | Classification Name: | Gastrointestinal tube and accessories(21 CFR 876. 5980, Product Code KNT), Class II | ||
| Classification Panel: | Gastroenterology / Urology | |||
| Premarket Notification: | K915837 {Concurrence Date: 03/23/1993} | |||
| DeviceDescription | The Ponsky* Non-Balloon Replacement Gastrostomy Tube is a 20 Frenchsoft, silicone gastrostomy tube and internal retention dome with pre-attachedexternal bolster and dual port feeding adaptor, packaged sterile withprocedural aids. | |||
| The Ponsky* Non-Balloon Replacement Gastrostomy Tube has a pocket in thedome that fits the obturator in order to assist in placement of the device through anestablished stoma. The Ponsky* Non-Balloon Replacement Gastrostomy Tubehas a feeding port to administer nutrition, and a medication port. | ||||
| Indications for Use | For percutaneous placement of a long-term replacement gastrostomy feedingand/or decompression device into an established stoma. | |||
| Intended use | Intended for establishment of replacement gastrostomy through an existing healedstoma resulting from a previously placed gastrostomy tube. | |||
| TechnologicalCharacteristics | The subject Ponsky* Non-Balloon Replacement Gastrostomy Tube has the sameTechnological characteristics as the predicate device. There are no new questionsraised regarding safety or effectiveness of the device. | |||
| Design verification and validation have been performed in accordance with 21CFR 820.30, Design controls. The following FDA recognized standards andnational standards were referenced to develop in-house test protocols todetermine appropriate methods for evaluating the performance of the subject device: | ||||
| PerformanceDataAssessment | AAMI / ANSI /ISO 10993-1 | 2003 | Biological Evaluation of Medical Devices Part1: Evaluation and Testing | |
| EN 1615 | 2000 | Enteral Feeding Catheters and Enteral GivingSets for Single Use and Their Connectors | ||
| EN 1618 | 1997 | Catheters other than Intravascular Catheters- Test Methods for Common Properties | ||
| JIS T 3213 | 2005 | Enteral Feeding Catheters and Enteral GivingSets | ||
| ASTM F 640 | 2007 | Standard Test Methods for DeterminingRadiopacity for Medical Use | ||
| ISO 14971 | 2009 | Medical devices - Application of riskmanagement to medical devices | ||
| AAMI / ANSI /ISO 11607-1 | 2006 | Packaging for terminally sterilizedmedical devices - Part 1: Requirements formaterials, sterile barrier systemsand packaging systems, 3ed. (Sterility) | ||
| ANSI / AAMI /ISO 11135 | 2007 | Medical Devices - Validation and RoutineControl of Ethylene Oxide Sterilization | ||
| AAMI / ANSI /ISO 10993-7 | 1995(R)2001 | Biological Evaluation ofMedical Devices - Part 7: Ethylene OxideSterilization Residuals | ||
| The subject device met all pre-determined acceptance criteria anddemonstrated substantial equivalence as compared to the predicate device. | ||||
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Ponsky* Non-Balloon ReplacementGastrostomy Tube meets the pre-determined requirements under 21 CFR820.30, Design controls, and demonstrates that the subject device issubstantially equivalent to the predicate device. |
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- Bard and Ponsky are trademarks and/or registered trademarks of C. R. Bard, Inc.
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- Bard and Ponsky are trademarks and/or registered trademarks of C. R. Bard, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, facing to the right. To the left of the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Dennis Salzmann, Ph.D. Director, Regulatory Affairs Bard Access Systems, Inc. C. R. Bard, Inc. 605 North 5600 West SALT LAKE CITY UT 84116
DEC 2 2 2 200
Re: K103109
Trade/Device Name: Ponsky* Non-Balloon Replacement Gastrostomy Tube Regulation Number: 21 CFR $876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 24, 2010 Received: November 26, 2010
Dear Dr. Salzmann:
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 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). 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 vour 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Dennis Salzmann
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Thurl L. Stolan.
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Bard Access Systems Ponsky* Non-Balloon Replacement Gastrostomy Tube Spacial 510(k) Premarket Notification
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| 510(k) Number (if known): | K103109 | DEC 22 2010 |
|---|---|---|
| Device Name: | Ponsky* Non-Balloon Replacement Gastrostomy Tube | |
| Indications for Use: | For percutaneous placement of a long-term replacement gastrostomy feeding and/or decompression device into an established stoma. |
| Prescription Use(Part 21 CFR §801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR §801 Subpart C) |
|---|---|---|
| -------------------------------------------------- | -------- | ------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
| 510(k) Number | K103109 |
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- Bard and Ponsky are trademarks and/or registered trademarks of C. R. Bard, Inc.
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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.