PILLING ESOPHAGEAL BOUGIES

K133439 · Teleflexmedical, Inc. · FAT · Jun 16, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133439
• Device Name: PILLING ESOPHAGEAL BOUGIES
• Applicant: Teleflexmedical, Inc.
• Product Code: FAT · Gastroenterology, Urology
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.

Device Story

Pilling® Esophageal Bougies are weighted, cylindrical instruments used by clinicians to mechanically dilate esophageal strictures or clear blockages. The device consists of a silicone elastomer tube filled with tungsten for weighting, featuring either a tapered (Maloney) or rounded (Hurst) tip. Tips are impregnated with barium sulfate for radiopacity, and the tubing includes calibration marks. The clinician inserts the bougie through the patient's mouth into the esophagus to perform the dilation. The device is reusable and must be resterilized by the user between procedures. By mechanically pushing against strictures or blockages, the bougie restores esophageal patency, providing temporary relief for patients with esophageal conditions.

Clinical Evidence

Bench testing only. Tensile strength testing was performed on 30 samples of the Pilling® Hurst bougie (20Fr) and 30 samples of the predicate Medovations® M-Flex™ Hurst bougie (20Fr) to simulate manual removal from the esophagus. Both groups met the minimum 10 lbs tensile strength requirement. The Pilling® device showed an average tensile strength of 20.49 lbs (range 14.24–22.76 lbs), demonstrating performance equivalent to the predicate.

Technological Characteristics

Materials: 70 and 80 durometer silicone elastomer, tungsten-filled, barium sulfate for radiopacity. Dimensions: French sizes 20 to 60. Design: Cylindrical with Maloney (tapered) or Hurst (rounded) tips; includes depth markings. Energy: Manual/mechanical. Connectivity: None. Sterilization: Reusable/resterilizable by user. Compliance: Patient-contacting materials compliant with ISO 10993-1.

Indications for Use

Indicated for patients requiring dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures, or temporary ease of esophageal carcinoma. Contraindicated in patients with coagulopathy, known/suspected perforation, severe inflammation/scarring near dilation site, recent myocardial infarction, active ulcer, or severe cervical arthritis.

Regulatory Classification

Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Special Controls

*Classification.* Class II (special controls). 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.

Predicate Devices

• Medovations® M-Flex™ Esophageal Bougies (K972119)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

JUN 1 6 2014

# Pilling® Esophageal Bougies

### A. Name, Address, Phone, and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA 919-433-4918 Phone: Fax: [phone]

#### B. Contact Person

Holly Kornegay Regulatory Affairs Specialist

#### C. Date Prepared

April 11, 2014

#### D. Device Name

| Trade Name: | Pilling® Esophageal Bougies |
|----------------------------|-----------------------------|
| Common Name: | Esophageal Bougie |
| Classification Regulation: | CFR 876.5365 |
| Classification: | Class II |
| Panel: | Gastroenterology/Urology |
| Product Code: | FAT |
| Classification Name: | Esophageal Dilator, |

#### E. Device Description

Pilling® Esophageal Bougies are weighted, cylindrical instruments used for the dilation of the larynx and esophagus. They are designed to be reusable and resterilized by the user. Made from silicone elastomer and filled with tungsten, the bougies are marketed in French sizes 20 to 60. Pilling® Bougies have two tip styles; the Maloney bougie has a long tapered tip and the Hurst has a rounded tip. Both tips

Teleflex Medical, Inc.

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are impregnated with radio-opaque material (barium sulfate) and contain calibration marks along the tubing. By inserting the bougie through the patient's mouth and down the patient's esophagus, a clinician can mechanically push a blockage out of the esophagus or can mechanically dilate a stricture in the esophagus.

# F. Indications for Use

The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.

# G. Contraindications

Contraindications include those specific to upper GI endoscopy. Contraindications to dilation include, but are not limited to: asymptomatic strictures; coagulopathy; known or suspected perforation; severe inflammation or scarring near the dilation site, recent myocardial infarction, active ulcer and severe cervical arthritis.

## H. Substantial Equivalence

The proposed Pilling® Esophageal Bougies are substantially equivalent to the predicate reusable esophageal dilation devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|--------------------------------------------|-------------------|------------|--------------|
| Medovations® M-Flex™<br>Esophageal Bougies | Medovations, Inc. | K972119 | 02/02/1998 |

# I. Comparison to Predicate Devices

The proposed Pilling® Esophageal Bougies have the same technology, indications for use and functional characteristics as the predicate system that has been cleared under Medovations, Inc.

#### J. Materials

All patient contacting materials are in compliance with ISQ10993-1.

# K. Technological Characteristics

A comparison of the technological characteristics of the proposed Pilling® Esophageal Bougies and the predicate has been performed. The results of this comparison demonstrate that the esophageal bougies utilize the same technology as the predicate device. A summary of these comparisons is included in the table below. For a complete comparison chart, please refer to Section 16.

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#### K133439 Pilling® Esophageal Bougies Traditional 510(k) Refuse to Accept Response: Section 5 - 510(k) Summary

| Technological<br>Characteristics | Predicate Device,<br>Medovations® M-<br>Flex™ Esophageal<br>Bougies | Proposed Device, Pilling®<br>Esophageal Bougies | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | For dilation of upper<br>esophageal webs, lower<br>esophageal rings, caustic<br>strictures, peptic esophageal<br>strictures, and temporary<br>ease of esophageal<br>carcinoma. | The Pilling® Esophageal<br>Bougies are indicated for the<br>dilation of upper esophageal<br>webs, lower esophageal rings,<br>caustic strictures, peptic<br>esophageal strictures and<br>temporary ease of esophageal<br>carcinoma. | Same |
| Contraindications | Contraindications include<br>those specific to upper GI<br>endoscopy.<br>Contraindications to<br>dilation include, but are not<br>limited to: uncooperative<br>patient; asymptomatic<br>strictures; inability to<br>advance the bougie through<br>the strictured area;<br>coagulopathy; known or<br>suspected perforation;<br>severe inflammation or<br>scarring near the dilation<br>site, recent myocardial<br>infarction, active ulcer and<br>severe cervical arthritis. | Contraindications include those<br>specific to upper GI endoscopy.<br>Contraindications to dilation<br>include, but are not limited to:<br>asymptomatic strictures;<br>coagulopathy; known or<br>suspected perforation; severe<br>inflammation or scarring near<br>the dilation site, recent<br>myocardial infarction, active<br>ulcer and severe cervical<br>arthritis. | Upon careful<br>review.<br>Teleflex<br>Medical, Inc.<br>has<br>determined<br>that<br>uncooperative<br>patients and<br>the inability<br>for a physician<br>to advance the<br>bougie<br>through a<br>strictured area<br>are nol<br>contraindicati<br>ons of the<br>proposed<br>device. |
| Tip Design | Maloney (tapered) and<br>Hurst (blunt) | Maloney (tapered) and Hurst<br>(blunt) | Same |
| Material | Silicone | 70 and 80 durometer base<br>silicone | Same |
| Bougie Colorant | Blue | Blue | Same |
| Weighting<br>Mechanism | Tungsten-filled | Tungsten-filled | Same |
| Mercury-free | Yes | Yes | Same |
| Sizes (Diameter) | 20FR to 60FR | 20FR to 60FR | Same |
| Depth Markings | American and European | American and European | Same |

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# L. Performance Data

Teleflex has performed bench testing on both devices to verify that the performance of the proposed Pilling® Esophageal Bougies are substantially equivalent to that of the predicate bougies and that the Pilling® Esophageal Bougies are seamlessly interchangeable with the predicate bougies. Tensile tests were performed to simulate the process of the end-user manually removing the bougies from a patient's esophagus. All samples of both products met the pre-defined acceptance criteria, which supports the substantial equivalence claim that these two devices are functionally equivalent.

The test results, which are summarized below, conclude that the Pilling® Esophageal Bougies' performance is equivalent to the Medovations® M-Flex™ Esophageal Bougies' performance.

| Product<br>Description | Quantity | Test Parameters | Results |
|---------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pilling® Hurst<br>Tungsten-<br>filled Bougie<br>(20Fr) | 30<br>samples | The tensile strength<br>between the bougie<br>plug and casing shall<br>be at least 10 lbs. | All 30 samples passed the<br>performance test. The<br>Pilling® Esophageal<br>Bougies have a tensile<br>strength of at least 10 lbs.<br>Avg 20.49 lbs.<br>Min 14.24 lbs.<br>Max 22.76 lbs. |
| Medovations<br>® M-Flex™<br>Hurst<br>Tungsten-<br>filled Bougie<br>(20Fr) | 30<br>samples | The tensile strength<br>between the bougie<br>plug and casing shall<br>be at least 10 lbs. | All 30 samples passed the<br>performance test. The<br>Medovations® M-Flex™<br>Esophageal Bougies have a<br>tensile strength of at least<br>10 lbs.<br>Avg 14.92 lbs.<br>Min 10.83 lbs.<br>Max 26.83 lbs. |

# L. Conclusion

Based upon the comparative test results, the proposed Pilling® Esophageal Bougies are substantially equivalent in performance to the predicate devices cleared to market via 510(k) K972119. The new design of the Pilling® Esophageal Bougies does not introduce any new issues of safety and effectiveness.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2014

Teleflex Medical, Inc. Holly Kornegay Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

- Re: K133439
Trade/Device Name: Pilling® Esophageal Bougies Regulation Number: 21 CFR§ 876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: FAT Dated: April 11, 2014 Received: April 17, 2014

Dear Holly Kornegay,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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### Page 2 - Holly Kornegay

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 (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.

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/ReportalProblem/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin Fisher-S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Page i of i

510(k) Number:

K133439

Device Name:

Pilling® Esophageal Bougies

Indications for Use:

The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin 2014.06 -04'00'