BARD BALLOON INFLATION SYSTEM

K991375 · C.R. Bard, Inc. · KNT · Sep 10, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991375
• Device Name: BARD BALLOON INFLATION SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The inflation system is recommended for use during esophageal, pyloric and colonic balloon dilatation to inflate and deflate balloon dilators and to monitor the pressure within the balloon.

Device Story

Bard Balloon Inflation System is a disposable, two-piece, 60cc plastic syringe with a cantilevered inflation/deflation lock and a distal-mounted manometer. Used in clinical settings for GI dilatation procedures; operated by clinicians. Device functions by infusing fluid into dilatation balloons to achieve inflation; pressure is monitored via the integrated manometer. Inflation/deflation is controlled by either pushing/pulling the plunger or rotating it clockwise/counter-clockwise. Provides controlled balloon expansion and pressure monitoring to assist in GI tract dilatation, potentially benefiting patients by facilitating safe and effective stricture management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by comparative bench testing and a history of safe and effective in vivo use since 1991.

Technological Characteristics

Hand-held, two-piece plastic 60cc syringe with integrated manometer. Features a cantilevered inflation/deflation lock. Mechanical operation via plunger push/pull or rotation. Non-powered, manual device.

Indications for Use

Indicated for patients undergoing esophageal, pyloric, or colonic balloon dilatation procedures requiring controlled inflation, deflation, and pressure monitoring of dilatation balloons.

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

• USCI Presto Disposable Inflation Device
• Quantum Inflation Device (Wilson-Cook Medical, Inc.)

Submission Summary (Full Text)

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K991375

Page 1 of 2

SEP 1 0 1999

Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989

1377 RID

## VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION

As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.

- A. Submitter Information Submitter's Name:

| Address: | 129 Con Billerica, |
|----------------------|--------------------|
| Phone: | 978 - 26 |
| Fax: | 978 - 26 |
| Contact Person: | Marion C |
| Date of Preparation: | June 14, |

Bard Interventional Products Division C.R. Bard, Inc. cord Road, Bldg. #3 , MA 01821 62 - 4867 62 - 4878 Gordon, R.A.C. 19999

- B. Device Name

| Trade Name: | B |
|----------------------|---|
| Common/Usual Name: | B |
| Classification Name: | 2 |

Bard® Balloon Inflation System Balloon inflation svringe 21 CFR 876.5980

- C. Predicate Device Names Trade Name:
USCI Presto Disposable Inflation Device Arterial Vascular Engineering, Inc (transferred ownership from C.R. Bard, Inc.)

Quantum Inflation Device Wilson-Cook Medical, Inc.

- D. Device Description:
The Bard" Inflation System is a disposable, two-piece, plastic 60cc syringe with a cantilevered inflation/deflation lock design and a manometer that is mounted on the distal tip of the syringe barrel.

- E. Intended Use:
The inflation system is recommended for use during esophageal, pyloric and colonic balloon dilatation to inflate and deflate balloon dilators and

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to monitor the pressure within the balloon.

- F. Technological Characteristics Summary:
The Bard Balloon Inflation System is a hand held device, which includes an inflation syringe and manometer for controlled inflation/deflation of balloons used in GI dilatation.

The Bard Balloon Inflation System is substantially equivalent to the USCI Presto Disposable Inflation Device and the Wilson-Cook Balloon Inflation Device. All of the manufacturers have designed their respective devices to function in a similar mechanical manner. These inflation systems are hand held devices that infuse fluid, in a controlled manner, to inflate dilatation balloons, and appropriately deflate the balloons post procedure. These designs include a syringe barrel and plunger with a manometer. Inflation/deflation can be achieved in either device by utilizing one of two techniques: (1) pushing/pulling the plunger or (2) turning the plunger in a clockwise/counter clockwise direction.

- G. Performance Data
Safe and effective in vivo use has been demonstrated with the Bard Balloon Inflation System since its initial commercialization in 1991.

Accepted scientific methods do exist for assuring the effects of the new characteristics among the Bard, Presto, and Wilson-Cook systems. Comparative bench testing has been evaluated and supports the use of a GI inflation device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three parallel lines that curve and flow together. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

Ms. Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator Bard Interventional Products Division C.R. Bard. Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031

Re: K991375 Bard® Balloon Inflation System Dated: June 14, 1999 Received: June 15, 1999 Regulatory Class: II 21 CFR §876.5980/Procode: 78 KNT

Dear Ms. Gordon:

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 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. 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 (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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.

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 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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): | TBD K991375 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Bard Balloon Inflation System |
| Indications For Use: | The inflation system is recommended for use during esophageal, pyloric and colonic balloon dilatation to inflate and deflate balloon dilators and to monitor the |

pressure within the balloon.

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| Prescription Use<br>(Per 21 CFR 801.109) | <span></span> |
|--------------------------------------------------------------------|---------------|
| Concurrence of CDRH, Office of Device Evaluation (ODE)<br>OR | <span></span> |
| Over-The-Counter Use<br>(Optional Format 1-2-96) | <span></span> |
| (Division Sign-Off) | <span></span> |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | <span></span> |
| 510(k) Number | K991375 |

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