PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE

K103109 · C.R. Bard, Inc. · KNT · Dec 22, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K103109
• Device Name: PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
• Applicant: C.R. Bard, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for establishment of replacement gastrostomy through an existing healed stoma resulting from a previously placed gastrostomy tube.

Device Story

Ponsky Non-Balloon Replacement Gastrostomy Tube is a 20 French silicone tube with an internal retention dome and external bolster; includes dual port feeding adaptor. Device features a pocket in the dome to accommodate an obturator for placement through an established stoma. Used for long-term enteral nutrition and/or gastric decompression. Operated by clinicians in a clinical setting. Provides a pathway for nutrition and medication administration via feeding and medication ports. Benefits patient by providing a stable, non-balloon replacement for gastrostomy feeding.

Clinical Evidence

Bench testing only. Performance evaluated against AAMI/ANSI/ISO 10993-1, EN 1615, EN 1618, JIS T 3213, ASTM F 640, ISO 14971, AAMI/ANSI/ISO 11607-1, ANSI/AAMI/ISO 11135, and AAMI/ANSI/ISO 10993-7. Device met all pre-determined acceptance criteria.

Technological Characteristics

20 French silicone tube; internal retention dome; external bolster; dual port feeding adaptor. Sterilized via Ethylene Oxide (EO). Complies with ISO 10993 (biocompatibility), EN 1615/1618 (catheter properties), and ASTM F 640 (radiopacity).

Indications for Use

Indicated for percutaneous placement of a long-term replacement gastrostomy feeding and/or decompression device into an established stoma.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Bard Non-Balloon Replacement Gastrostomy System (K915837)

Submission Summary (Full Text)

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| Bard Access Systems | Ponsky" Non-Balloon Replacement Gastrostomy Tube | K103109<br>10f 2 | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Special 510(k) Premarket Notification | | | Page 1945 08 | |
| | | 510(k) Summary<br>21 CFR 807.92 | DEC 2 2 2010 | |
| | | Ponsky* Non-Balloon Replacement Gastrostomy Tube | | |
| | | Prepared October 19, 2010 | | |
| | Submitter of 510(k)<br>Premarket Notification: | Bard Access Systems, Inc.<br>[Subsidiary of C.R. Bard, Inc.]<br>Salt Lake City, Utah 84116<br>Phone: [phone]<br>[phone]<br>Fax: | | |
| General<br>Provisions | Contact Person: | Ji Hyun Kim | | |
| | Device Trade Name: | Ponsky* Non-Balloon Replacement Gastrostomy<br>Tube | | |
| | Device Generic Name: | Gastrointestinal tube and accessories | | |
| Subject Device | Trade Name: | Ponsky* Non-Balloon Replacement Gastrostomy<br>Tube | | |
| | Common Name: | Gastrointestinal tube and accessories | | |
| | Classification Name: | Gastrointestinal tube and accessories<br>(21 CFR 876. 5980, Product Code KNT), Class II | | |
| | Classification Panel: | Gastroenterology / Urology | | |
| | Trade Name: | Bard* Non-Balloon Replacement Gastrostomy<br>System | | |
| | Common Name: | Gastrointestinal tube and accessories | | |
| Predicate<br>Devica | Classification Name: | Gastrointestinal tube and accessories<br>(21 CFR 876. 5980, Product Code KNT), Class II | | |
| | Classification Panel: | Gastroenterology / Urology | | |
| | Premarket Notification: | K915837 {Concurrence Date: 03/23/1993} | | |
| Device<br>Description | The Ponsky* Non-Balloon Replacement Gastrostomy Tube is a 20 French<br>soft, silicone gastrostomy tube and internal retention dome with pre-attached<br>external bolster and dual port feeding adaptor, packaged sterile with<br>procedural aids. | | | |
| | The Ponsky* Non-Balloon Replacement Gastrostomy Tube has a pocket in the<br>dome that fits the obturator in order to assist in placement of the device through an<br>established stoma. The Ponsky* Non-Balloon Replacement Gastrostomy Tube<br>has a feeding port to administer nutrition, and a medication port. | | | |
| Indications for Use | For percutaneous placement of a long-term replacement gastrostomy feeding<br>and/or decompression device into an established stoma. | | | |
| Intended use | Intended for establishment of replacement gastrostomy through an existing healed<br>stoma resulting from a previously placed gastrostomy tube. | | | |
| Technological<br>Characteristics | The subject Ponsky* Non-Balloon Replacement Gastrostomy Tube has the same<br>Technological characteristics as the predicate device. There are no new questions<br>raised regarding safety or effectiveness of the device. | | | |
| | Design verification and validation have been performed in accordance with 21<br>CFR 820.30, Design controls. The following FDA recognized standards and<br>national standards were referenced to develop in-house test protocols to<br>determine appropriate methods for evaluating the performance of the subject device: | | | |
| Performance<br>Data<br>Assessment | AAMI / ANSI /<br>ISO 10993-1 | 2003 | Biological Evaluation of Medical Devices Part<br>1: Evaluation and Testing | |
| | EN 1615 | 2000 | Enteral Feeding Catheters and Enteral Giving<br>Sets for Single Use and Their Connectors | |
| | EN 1618 | 1997 | Catheters other than Intravascular Catheters<br>- Test Methods for Common Properties | |
| | JIS T 3213 | 2005 | Enteral Feeding Catheters and Enteral Giving<br>Sets | |
| | ASTM F 640 | 2007 | Standard Test Methods for Determining<br>Radiopacity for Medical Use | |
| | ISO 14971 | 2009 | Medical devices - Application of risk<br>management to medical devices | |
| | AAMI / ANSI /<br>ISO 11607-1 | 2006 | Packaging for terminally sterilized<br>medical devices - Part 1: Requirements for<br>materials, sterile barrier systems<br>and packaging systems, 3ed. (Sterility) | |
| | ANSI / AAMI /<br>ISO 11135 | 2007 | Medical Devices - Validation and Routine<br>Control of Ethylene Oxide Sterilization | |
| | AAMI / ANSI /<br>ISO 10993-7 | 1995<br>(R)<br>2001 | Biological Evaluation of<br>Medical Devices - Part 7: Ethylene Oxide<br>Sterilization Residuals | |
| | The subject device met all pre-determined acceptance criteria and<br>demonstrated substantial equivalence as compared to the predicate device. | | | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Ponsky* Non-Balloon Replacement<br>Gastrostomy Tube meets the pre-determined requirements under 21 CFR<br>820.30, Design controls, and demonstrates that the subject device is<br>substantially 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 [phone] or [phone] 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<br>(Part 21 CFR §801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR §801 Subpart C) |
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(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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