The Ballard Medical Products® Faciletome™ Bow String Papillotome(s) is intended to be used for patients requiring transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

Device Description

The bow string papillotome is one of the most commonly used E.R.C.P. (Endoscopic Retrograde Colangio-Pancreatography) devices and has been established in the industry for several years. It has evolved into several variations on one general theme, facilitating entrance into the biliary tree. It performs this by housing a stainless steel mono-filament or stranded wire that is to be the active wire when monopolar, surgical power is introduced into the device handle connection. A sheath runs the length of the wire and allows only that portion of the wire that is needed to cut be exposed and insulates the remainder from the patient. The bow geometry and wire tension aid in cutting the tissue at the precise location. The wire is attached to a handle, that when manipulated, allows the operator to apply tension forming a " bow" at the distal end.

The Ballard Medical Products® Faciletome™ Bow String Papillotome is placed under direct vision of a duodenscope, with or without fluoroscopic aid. The single lumen, double lumen and triple lumen designs have a variety of cutting wire lengths as well as a variety of precurved tip configurations in the precurved model type.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary Statement for the Ballard Medical Products® Faciletome™ Bow String Papillotome. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format of specific quantitative metrics for a clinical study. Instead, it lists non-clinical (in vitro) tests performed to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Non-Clinical Data)
Electrical safety: High Frequency Leakage Current	Test performed
Electrical safety: Capacitive Coupling between device and guidewire	Test performed
Electrical signal integrity: Verification of Frequency and Voltage	Test performed (800V p-p @ 1MHz)
Electrical safety: Dielectric Withstand Test	Test performed

The conclusion states that based on indications for use, technological characteristics, and performance testing, the device is "safe and effective for its intended use" and "substantially equivalent" to the predicate device. This implies that the device met the acceptance criteria for these non-clinical tests.

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

The document refers to "in vitro tests" and does not describe a clinical test set involving human patients or data with specific provenance (e.g., country of origin). The testing was non-clinical.

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

Not applicable. The tests performed were non-clinical (in vitro) and would not involve experts establishing ground truth in the context of clinical outcomes.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and non-clinical testing.

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

Not applicable. This is a medical device (papillotome), not an AI algorithm. Its performance is inherent to its physical and electrical properties, and its use involves human application.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by objective physical and electrical measurements against predefined engineering specifications or industry standards for similar devices. There was no clinical ground truth (e.g., pathology, outcomes data) used in this submission summarized in the provided text.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI or machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As noted above, there is no training set mentioned for this medical device.

Summary

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5/3/99

Image /page/0/Picture/1 description: The image shows the logo for "POLLARD Medical Products". The word "POLLARD" is in large, bold, sans-serif font, with a registered trademark symbol to the right of the word. Below "POLLARD" is the phrase "Medical Products" in a smaller, bold, sans-serif font. There are horizontal lines above and below the phrase "Medical Products".

12050 Lone Peak Park Draper, Utah 84020 (801) 572-6800 FAX (801) 572-6999

K 990376
pg 1 of 2

Appendix F Attachment 1.0 Summary Statement

510(k) Premarket Notification Summary Statement

Ballard Medical Products® Faciletome™ Bow String Papillotome

Friday, February 05, 1999

Submitter Information per 807.92(a)(1):

E. Martin Chamberlain Ballard Medical Products 12050 Lone Peak Parkway Draper, UT., 84020 Tel. (801) 572 - 6800 Fax. (801 572 - 6869

Proprietary Name per 807.92(a)(2):

The Ballard Medical Products® Faciletome™ Bow String Papillotome

Common Name per 807.92(a)(2):

Biliary Bow String Papillotome or Sphincterotome

Classification per 807.92(a)(2):

The Ballard Medical Products® Faciletome™ Bow String Papillotome has been classified a Class II device through the Gastrointestinal -- Urology Panel per 21 CFR Part 876.4300. Classification name is: Unit, Electrosurgical, Endoscopic (With or Without Accessories). Product Code 78KNS.

Legally marketed equivalent(s) per 807.92(a)(3):

The Ballard Medical Products® Faciletome™ Bow String Papillotome device is substantially equivalent to the Wiltek Medical, Inc. papillotomes; the subject of 510(k) #K894861, marketed under the trade names of Accuratome TM, Accuratome™, and Double Lumen™ Papillotome.

Description of the device 807.92(a)(4):

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Image /page/1/Picture/0 description: The image shows the logo for "POLLARD Medical Products". The word "POLLARD" is in large, bold, sans-serif font, with a registered trademark symbol to the right of the "D". Below "POLLARD" is the phrase "Medical Products" in a smaller, sans-serif font. There are horizontal lines above and below the text.

12050 Lone Peak Parkway Draper, Utah 84020 (801) 572-6800 FAX (801) 572-6999

Intended Use per 807.92(a)(5):

Technological Characteristics (equivalence to predicate devices) per 807.92(a)(6):

The Ballard Medical Products® Faciletome™ Bow String Papillotome(s) are substantially equivalent to the Wiltek Medical, Inc. papillotomes; K894861, marketed under the trade names of Accuratome3m, Accuratome™, and Double Lumen™ Papillotome.

The general design characteristics and functionality are similar in that they are all one piece construction which include: single or multiple lumen shafts, a one piece handle system, multiple cutting wire lengths and construction with precurved tips in multiple lengths.

The above devices may be advanced with or without employing a 0.035 inch guidewire through the biopsy channel of a duodenoscope with optional use of fluoroscopy.

In all the devices, current is applied through the cutting wire to incise the Papilla of Vater or Sphincter of Oddi. A Touhy Borst may be attached to the guidewire lumens of the multiple lumen devices to assist in placement, and minimize contrast leakage.

Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1):

The following in vitto tests were performed on the proposed Ballard Medical Products® FaciletomeTM Bow String Papillotome:

A) High Frequency Leakage Current
B) Capacitive Coupling between device active wire and recommended guidewire(s).
C) Verification of Frequency and Voltage Signal (800V p-p @ 1MHz)
D) Dielectric Withstand Test

Conclusions from non-clinical data per 807.92(b)(3):

Based on the indications for use, technological characteristics, and performance testing, the Ballard Medical Products® Faciletome™ Bow String Papillotome has been shown to be safe and effective for its intended use.

990376

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1030 MAY

Mr. E. Martin Chamberlain V.P. Regulatory Affairs Ballard Medical Products 12050 Lone Peak Parkway Draper, UT 84020

Re: K990376 Ballard Medical Products®Faciletome™ Bow String Papillotome Dated: February 5, 1999 Received: February 8, 1999 Regulatory Class: II 21 CFR 876.4300/Procode: 78KNS

Dear Mr. Chamberlain:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (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 requirements, as set forth in the Quality System Regulation (QS) 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 requlatory 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 the Electronic Product 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting 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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APPENDIX A ATTACHMENT 3.0 INTENDED USE STATEMENT

Ballard Medical Products® Faciletome™ Bow String Papillotome

INTENDED USE STATEMENT

Prescription

Over-the-counter.

(Division Sign-
Division of Re ctive, Abdominal, ENT,
and Radiologi vices
510(k) Numbe. K990376

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12050 Lone Peak Parkv Draper, Utah 84020 (801) 572-6800 FAX (801) 572-6999

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).