PPD BALLOON DILATATION CATHETER

K020379 · Telemed Systems, Inc. · KNT · May 6, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020379
• Device Name: PPD BALLOON DILATATION CATHETER
• Applicant: Telemed Systems, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: May 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dilatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

Device Story

PPD Balloon Dilatation Catheter consists of polymer balloon mounted on plastic shaft. Device used by clinicians to dilate gastrointestinal strictures. Balloon inflated to multiple distinct diameters via proximal luer connectors using controlled inflation pressure. Guidewire passage supported. Device modification submitted via Special 510(k) to demonstrate substantial equivalence to existing GI balloon dilatation catheters. Performance verified through bench testing including balloon burst, pressure vs. diameter confirmation, and scope passage testing.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included balloon burst testing, pressure vs. diameter confirmation, and scope passage testing.

Technological Characteristics

Polymer balloon on plastic shaft. Proximal luer connectors for inflation and guidewire passage. Multi-diameter inflation capability at specific pressures. Class II device.

Indications for Use

Indicated for dilatation of gastrointestinal strictures (inflammatory, neoplastic, congenital, anastomotic) in esophagus, pylorus, biliary tract, sphincter of Oddi, and colon. For prescription use.

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

• GI balloon dilatation catheters marketed by TeleMed Systems and Boston Scientific

Submission Summary (Full Text)

{0}------------------------------------------------

## SPECIAL 510(k) PREMARKET NOTIFICATION: DEVICE MODIFICATIO

## 510k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, TeleMed Systems, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." TeleMed Systems chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

| Trade Name: | PPD™ Balloon Dilatation Catheter |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator: | TeleMed Systems, Inc.<br>8 Kane Industrial Drive<br>Hudson, MA 01749 |
| Manufacturing Site: | TeleMed Systems, Inc.<br>8 Kane Industrial Drive<br>Hudson, MA 01749 |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II, Performance<br>Standards (78KNQ). |
| Predicate Devices: | GI balloon dilatation catheters marketed by TeleMed Systems<br>and Boston Scientific |

## Product Description:

The PPD Balloon Dilatation Catheter consists of a polymer balloon mounted on a plastic shaft. The balloon can be inflated to different diameters depending on the inflation pressure; each balloon is capable of inflation to three or four distinct and progressively larger sized diameters at the recommended pressures. Proximal luer connectors are provided for balloon inflation and quidewire passage.

## Indications for Use:

The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dillatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

#### Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), TeleMed Systems, Inc. has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Performance testing conducted in support of this submission included balloon burst testing, pressure vs. diameter confirmation and scope passage testing.

## Conclusion:

Based on the indications for use, technological characteristics, performance testing results and comparison to predicate devices, the TeleMed Systems, Inc. PPD™ Balloon Dilatation Catheters have been shown to be safe and effective for their intended use.

TeleMed Systems, Inc.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 6 2002

Re: K020379

Trade/Device Name: PPDTM Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Product Code: 78 KNT Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Product Code: 78 FGE Regulatory Class: II Dated: April 4, 2002 Received: April 8, 2002

Dear Mr. Carroll:

Mr. Michael Carroll

TeleMed Systems, Inc.

8 Kane Industrial Drive HUDSON MA 01749

President & CEO

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 (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) that do not require approval of a premarket approval application (PMA). 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 (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.

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); 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.

{2}------------------------------------------------

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page 1 of of 1

510(k) Number (if known): _ K020379

TeleMed Systems, Inc. PPD*™ Balloon Dilatation Catheter Device Name:

Indications for Use:

The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dilatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, diffation of gastromotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------|----------------------|
| <img alt="Signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020379 |
| Prescription Use<br>(Per 21 CFR 801.109) | |
| OR | Over-the-Counter Use |

TeleMed Systems, Inc.

PPD™ Balloon Dilatation Catheter K020379/Amendment 1