ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE

K972964 · Atrion Medical Products, Inc. · KOE · Oct 10, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972964
• Device Name: ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
• Applicant: Atrion Medical Products, Inc.
• Product Code: KOE · Gastroenterology, Urology
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

Device Story

Device is a manual, single-use balloon catheter inflation system. Components include a 20 cc plastic syringe, screw-type plunger, locking lever, rotating palm grip, manometer for pressure monitoring, and connecting tube. Operated by clinicians during balloon dilation procedures. User manually rotates palm grip to advance plunger, inflating balloon; manometer provides real-time pressure feedback (range: vacuum to 10-20 atm). Device facilitates controlled dilation of anatomical structures. No automated or electronic components.

Clinical Evidence

Bench testing only. Materials contacting contrast solution tested per USP guidelines; results indicate safety for intended use.

Technological Characteristics

Manual plastic syringe with screw-type plunger, locking lever, and rotating palm grip. Includes manometer and connecting tube. Fluid capacity: 20 cc. Operating pressure: vacuum to 10-20 atm. Single-use. No electronic or software components.

Indications for Use

Indicated for patients undergoing gastrointestinal (GI), gastrouterine (GU), or lacrimal duct balloon catheter dilation procedures requiring balloon inflation, pressure monitoring, and deflation.

Regulatory Classification

Identification

A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

Special Controls

*Classification.* (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device 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 for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Ryder International Urological Balloon Catheter (Bard® Eagle™) Inflation Device (K962611)

Submission Summary (Full Text)

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Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel [phone] Fax [phone]

K972964

OCT 10 1997

**Atrion**

#### SUMMARY OF SAFETY AND EFFECTIVENESS 12.

| Date of Preparation: | August 7, 1997 |
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| Device Name: | Atrion Medical Balloon Catheter Inflation Device |
| Classification Name: | Balloon Inflation/Deflation Device |
| Manufacturer: | Atrion Medical Products, Inc.<br>PO Box 564, 1426 Curt Francis Road<br>Arab, AL 35016 |
| Contact: | Mr. Dan Clark, Atrion Medical Products, Inc.<br>PO Box 564, 1426 Curt Francis Road<br>Arab, AL 35016<br>Telephone: [phone], Fax: [phone] |
| Predicate: | Ryder International Urological Balloon Catheter (Bard®<br>Eagle™) Inflation Device cleared under K962611 |

# Device Description/Intended Use:

The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger. a manometer to measure pressure and a connecting tube.

The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached.

The inflation device is intended for single use while performing balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

# Technological Characteristics:

The Atrion Medical Balloon Catheter Inflation Device has an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached, while the predicate device has a range of vacuum to 20 atm. The Atrion Medical Balloon Catheter Inflation Device has no stopcock, while the predicate device does. There are no other significant technological characteristics that distinguish the two devices, and no differences that should pose a risk to patient safety.

# Summary of Safety Testing:

The materials of the device which contact the contrast solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a series of flowing lines, possibly representing people or services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 0 1997

Mr. Dan Clark Vice President, Regulatory and Ouality Atrion Medical Products, Inc. 1426 Curt Francis Road P.O. Box 564 Arab, Alabama 35016

Re: K972964

Atrion Medical Balloon Catheter Inflation Device Dated: August 7. 1997 Received: August 11, 1997 Regulatory class: II and I 21 CFR 8876.5520/Product code: 78 KOE 21 CFR §886.4350/Product code: 86 HNW

Dear Mr. Clark:

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 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 (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/dsmamain.html".

Sincerely yours,

William Yu

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): K972964_____________________________________________________________________________________________________________________________________________

Device Name: Atrion Medical Balloon Catheter Inflation Device

Indications For Use:

The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K972964 | (Optional Format-1-2-96) |
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