(216 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and function of a physical instrument for dilation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for dilation of various esophageal strictures and conditions, which is a therapeutic intervention.
No
Explanation: The device description states that the Pilling® Esophageal Bougies are "weighted, cylindrical instruments used for the dilation of the larynx and esophagus" and are used to "mechanically push a blockage out of the esophagus or can mechanically dilate a stricture." This indicates a therapeutic or interventional function, not a diagnostic one. There is no mention of the device being used to identify or characterize a medical condition.
No
The device description clearly states it is a physical, weighted instrument made of silicone elastomer and filled with tungsten, used for mechanical dilation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The Pilling® Esophageal Bougies are used directly within the patient's body to mechanically dilate or clear blockages in the esophagus. This is an in vivo procedure, not an in vitro test.
- Intended Use: The intended use clearly states dilation of esophageal strictures and temporary ease of esophageal carcinoma, which are physical interventions, not diagnostic tests performed on specimens.
The description and intended use clearly indicate that this is a surgical/interventional device used directly on the patient, not a device used for laboratory testing of biological samples.
N/A
Intended Use / 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.
Product codes
FAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, larynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed 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.
Sample size: 30 samples for Pilling® Hurst Tungsten-filled Bougie (20Fr), 30 samples for Medovations® M-Flex™ Hurst Tungsten-filled Bougie (20Fr).
Key Results: All 30 samples of both products met the pre-defined acceptance criteria (tensile strength between the bougie plug and casing shall be at least 10 lbs). The Pilling® Esophageal Bougies had an average tensile strength of 20.49 lbs (Min 14.24 lbs, Max 22.76 lbs). The Medovations® M-Flex™ Esophageal Bougies had an average tensile strength of 14.92 lbs (Min 10.83 lbs, Max 26.83 lbs). The test results conclude that the Pilling® Esophageal Bougies' performance is equivalent to the Medovations® M-Flex™ Esophageal Bougies' performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
Page 5.1
1
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™ | |||
| 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.
2
K133439 Pilling® Esophageal Bougies Traditional 510(k) Refuse to Accept Response: Section 5 - 510(k) Summary
| Technological
Characteristics | Predicate Device,
Medovations® M-
Flex™ Esophageal
Bougies | Proposed Device, Pilling®
Esophageal Bougies | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | For dilation of upper
esophageal webs, lower
esophageal rings, caustic
strictures, peptic esophageal
strictures, and temporary
ease of esophageal
carcinoma. | 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. | Same |
| Contraindications | Contraindications include
those specific to upper GI
endoscopy.
Contraindications to
dilation include, but are not
limited to: uncooperative
patient; asymptomatic
strictures; inability to
advance the bougie through
the strictured area;
coagulopathy; known or
suspected perforation;
severe inflammation or
scarring near the dilation
site, recent myocardial
infarction, active ulcer and
severe cervical arthritis. | 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. | Upon careful
review.
Teleflex
Medical, Inc.
has
determined
that
uncooperative
patients and
the inability
for a physician
to advance the
bougie
through a
strictured area
are nol
contraindicati
ons of the
proposed
device. |
| Tip Design | Maloney (tapered) and
Hurst (blunt) | Maloney (tapered) and Hurst
(blunt) | Same |
| Material | Silicone | 70 and 80 durometer base
silicone | Same |
| Bougie Colorant | Blue | Blue | Same |
| Weighting
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 |
Teleflex Medical, Inc.
Page 5.3
.
3
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
| Description | Quantity | Test Parameters | Results |
|---|---|---|---|
| Pilling® Hurst | |||
| Tungsten- | |||
| filled Bougie | |||
| (20Fr) | 30 | ||
| samples | The tensile strength | ||
| between the bougie | |||
| plug and casing shall | |||
| be at least 10 lbs. | All 30 samples passed the | ||
| performance test. The | |||
| Pilling® Esophageal | |||
| Bougies have a tensile | |||
| strength of at least 10 lbs. | |||
| Avg 20.49 lbs. | |||
| Min 14.24 lbs. | |||
| Max 22.76 lbs. | |||
| Medovations | |||
| ® M-Flex™ | |||
| Hurst | |||
| Tungsten- | |||
| filled Bougie | |||
| (20Fr) | 30 | ||
| samples | The tensile strength | ||
| between the bougie | |||
| plug and casing shall | |||
| be at least 10 lbs. | All 30 samples passed the | ||
| performance test. The | |||
| Medovations® M-Flex™ | |||
| Esophageal Bougies have a | |||
| tensile strength of at least | |||
| 10 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.
4
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.
5
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
6
Indications for Use
Page i of i
510(k) Number:
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'