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 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 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.

AI/ML Overview

This document describes the performance testing for the Pilling® Esophageal Bougies, focusing on demonstrating substantial equivalence to a predicate device rather than a standalone AI device study.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not directly applicable to an AI device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Tensile strength between bougie plug and casing shall be at least 10 lbs.	Pilling® Esophageal Bougies: Avg 20.49 lbs, Min 14.24 lbs, Max 22.76 lbs. Medovations® M-Flex™ Esophageal Bougies (Predicate): Avg 14.92 lbs, Min 10.83 lbs, Max 26.83 lbs.
All samples of both products met the pre-defined acceptance criteria.	All 30 samples of Pilling® Hurst Tungsten-filled Bougie (20Fr) passed. All 30 samples of Medovations® M-Flex™ Hurst Tungsten-filled Bougie (20Fr) passed.

2. Sample size used for the test set and the data provenance

Sample size: 30 samples of the Pilling® Esophageal Bougies and 30 samples of the predicate Medovations® M-Flex™ Esophageal Bougies were tested.
Data provenance: Not explicitly stated, but based on the context of 'bench testing' and 'Teleflex has performed', it is implied to be prospective data generated by the manufacturer for the purpose of this submission. The "country of origin of the data" is not specified but would typically be the location of the manufacturing and testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The study described is a bench test evaluating the physical properties (tensile strength) of mechanical devices, not a study involving medical images or clinical data requiring expert human interpretation for ground truth. The "ground truth" here is a predefined engineering specification (10 lbs tensile strength).

4. Adjudication method for the test set

This information is not applicable. As a bench test with objective physical measurements, there is no need for expert adjudication. The results are quantitative and directly measured against the acceptance criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission concerns a physical medical device (esophageal bougies) and is not an AI-powered diagnostic or therapeutic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a mechanical tool, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is a predefined engineering specification/acceptance criterion: a minimum tensile strength of 10 lbs. This is a technical standard rather than a medical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI device or a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable. As there is no AI or machine learning involved, there is no training set or ground truth establishment method for it.

Summary

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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: 919-433-4996

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

Teleflex Medical, Inc.

Page 5.1

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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

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™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

TechnologicalCharacteristics	Predicate Device,Medovations® M-Flex™ EsophagealBougies	Proposed Device, Pilling®Esophageal Bougies	Comparison
Indications forUse	For dilation of upperesophageal webs, loweresophageal rings, causticstrictures, peptic esophagealstrictures, and temporaryease of esophagealcarcinoma.	The Pilling® EsophagealBougies are indicated for thedilation of upper esophagealwebs, lower esophageal rings,caustic strictures, pepticesophageal strictures andtemporary ease of esophagealcarcinoma.	Same
Contraindications	Contraindications includethose specific to upper GIendoscopy.Contraindications todilation include, but are notlimited to: uncooperativepatient; asymptomaticstrictures; inability toadvance the bougie throughthe strictured area;coagulopathy; known orsuspected perforation;severe inflammation orscarring near the dilationsite, recent myocardialinfarction, active ulcer andsevere cervical arthritis.	Contraindications include thosespecific to upper GI endoscopy.Contraindications to dilationinclude, but are not limited to:asymptomatic strictures;coagulopathy; known orsuspected perforation; severeinflammation or scarring nearthe dilation site, recentmyocardial infarction, activeulcer and severe cervicalarthritis.	Upon carefulreview.TeleflexMedical, Inc.hasdeterminedthatuncooperativepatients andthe inabilityfor a physicianto advance thebougiethrough astrictured areaare nolcontraindications of theproposeddevice.
Tip Design	Maloney (tapered) andHurst (blunt)	Maloney (tapered) and Hurst(blunt)	Same
Material	Silicone	70 and 80 durometer basesilicone	Same
Bougie Colorant	Blue	Blue	Same
WeightingMechanism	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

Teleflex Medical, Inc.

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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.

ProductDescription	Quantity	Test Parameters	Results
Pilling® HurstTungsten-filled Bougie(20Fr)	30samples	The tensile strengthbetween the bougieplug and casing shallbe at least 10 lbs.	All 30 samples passed theperformance test. ThePilling® EsophagealBougies have a tensilestrength of at least 10 lbs.Avg 20.49 lbs.Min 14.24 lbs.Max 22.76 lbs.
Medovations® M-Flex™HurstTungsten-filled Bougie(20Fr)	30samples	The tensile strengthbetween the bougieplug and casing shallbe at least 10 lbs.	All 30 samples passed theperformance test. TheMedovations® M-Flex™Esophageal Bougies have atensile strength of at least10 lbs.Avg 14.92 lbs.Min 10.83 lbs.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 (800) 638-2041 or (301) 796-7100 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:

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'

Regulation Number and Section

§ 876.5365 Esophageal dilator.

(a)
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).(b)
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.