These instruments have been designed to be used with Olympus endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones, to remove bile sludge from the biliary system and to facilitate injection of contrast medium into the biliary system.

Device Description

The Single Use 3-Lumen Extraction Balloon V, model B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B, B-V243Q-A, B-V243Q-B, B-V443Q-A and B-V443Q-B is a balloon catheter, included three kinds of premeasured syringe, to endoscopically remove stones such as calculi, pancreatic and common bile duct stones, to remove bile sludge from the biliary system and to facilitate injection of contrast medium into the biliary system.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Single Use 3-Lumen Extraction Balloon V". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study against specific acceptance criteria for a new device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in this type of submission.

However, I can extract the information that is present and highlight what is missing based on your request.

Analysis of the Provided Document:

The document describes a medical device seeking 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the new device is at least as safe and effective as a legally marketed predicate device (i.e., it is "substantially equivalent"). The emphasis is on comparing the new device's characteristics to a predicate, not on proving performance against predefined acceptance criteria from a clinical trial.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide specific quantitative acceptance criteria or a "reported device performance" table in the context of a clinical study. Instead, it demonstrates "substantial equivalence" by comparing the new device's specifications to a predicate device. The "performance" is implied by the similarity to the predicate and the lack of significant changes that would affect safety or effectiveness.

Characteristic Compared	Predicate Device (B-230Q-A, B-230Q-B from K033333, and K063677 for 20mm balloon)	Subject Device (B-V2xxP/Q, B-V4xxP/Q)	Implied "Acceptance" / Basis for Equivalence
Intended Use	Endoscopically remove stones, remove bile sludge, facilitate contrast injection into biliary system	Endoscopically remove stones, remove bile sludge, facilitate contrast injection into biliary system	Identical intended use. This is a primary criterion for substantial equivalence.
Method of Operation	Not explicitly detailed, but implied to be standard balloon catheter operation	Not explicitly detailed, but implied to be standard balloon catheter operation	"does not incorporate any significant changes in ... method of operation."
Materials	Not explicitly detailed	Not explicitly detailed	"does not incorporate any significant changes in ... material."
Design	Over-the-wire type guidewire port (for B-230Q-A/B)	Changes: - Guidewire port structure: "Over the wire type" (P-models), "Monorail type" (Q-models) - Maximum diameter of balloon: $\phi$ 15mm (P/B-V2xxQ models), $\phi$ 20mm (P/B-V4xxQ models). (Predicate had $\phi$ 15mm with $\phi$ 20mm cleared via K063677) - Max outer diameter of sheath: $\phi$ 2.7mm (B-V233P), $\phi$ 3.2mm (B-V433P), $\phi$ 2.9mm (B-V243Q), $\phi$ 3.2mm (B-V443Q) vs $\phi$ 2.55mm (Predicate) - Compatible channel diameter: $\phi$ 2.8mm or larger (B-V233P) / $\phi$ 3.2mm or larger (B-V433P/B-V243Q/B-V443Q) vs $\phi$ 2.8mm or larger (Predicate) - Working Length: 1900mm (P-models) vs 1950mm (Predicate) - Structure for attaching to endoscope (Hook): Provided (Subject) vs Not provided (Predicate) - Pre-measured syringes: Different volumes for inflation (listed in table)	"does not incorporate any significant changes in ... design that could affect the safety or effectiveness of the device." The identified changes in design (guidewire port, balloon diameter, sheath diameter, working length, hook) are considered not to impact safety or effectiveness such that new clinical data would be required. The larger balloon diameter was previously cleared for the predicate family.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not describe a clinical "test set" or a clinical study with a sample size for performance evaluation. The submission is based on engineering and performance testing to demonstrate substantial equivalence, not a clinical trial.
Data Provenance: Not applicable, as no clinical test set data from patients is presented.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the submission does not involve a clinical study requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided as no clinical test set or adjudication process is described in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

An MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. This type of study is typically for diagnostic imaging devices involving human interpretation, which is not the case for an extraction balloon catheter.

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

This question is not applicable to this device. An extraction balloon catheter does not have an "algorithm-only" or "standalone" performance in the way a diagnostic AI algorithm would. Its performance is mechanical and procedural when used by a human operator.

7. The Type of Ground Truth Used

This information is not provided as the submission relies on engineering design specifications, biocompatibility, sterilization validation, and non-clinical performance testing (e.g., burst pressure, force to fracture, dimensional accuracy) rather than clinical ground truth (pathology, expert consensus, outcomes data) derived from patient studies. The "ground truth" here is compliance with engineering standards and comparison to a legally marketed predicate.

8. The Sample Size for the Training Set

This information is not applicable. This is a medical device (catheter) and not an AI or machine learning algorithm that typically uses a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary of 510(k) Approach in this Document:

This 510(k) submission relies on a "traditional" substantial equivalence pathway. The manufacturer asserts that the new device shares the same intended use and fundamental scientific technology as the predicate device. Any differences in technological characteristics (e.g., guidewire port type, balloon diameter options, sheath diameter, working length, presence of a hook) are deemed not to raise different questions of safety and effectiveness, or that any questions raised are answered by existing scientific data or non-clinical performance testing (which would be referenced in the full 510(k) submission, though not detailed in this summary). The conclusion explicitly states that the new device "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This statement is the core "proof" of substantial equivalence from the manufacturer's perspective.

Summary

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

K 0914.95

Pg 1 of 4

510(k) SUMMARY

ngle Use 3-Lumen Extraction Balloon V 3P-A, B-V233P-B, B-V433P-A, B-V433P-B 243Q-A, B-V243Q-B, B-V443Q-A,B-V443Q-B

General Information ﻠﺴﻠﺴ

1 Applicant:

Official Correspondent: 1

Manufacturer

2 Device Identification

Device Trade Name
Common Name 물

Regulation Number 1

Regulation Name

Regulatory Class

Classification Panel

Product Code

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047

Stacv Abbatiello Kluesner, M.S., RAC Requlatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com

Aomori Olympus Co., Ltd. 2-248-1 Okkonoki, Kuroishi-sh I, Aomori, Japan, 036-0367 Establishment Registration No .: 9614641

Single Use 3-Lumen Extraction Balloon V B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B, B-V243Q-A, B-V243Q-B, B-V443Q-A, B-V443Q-B

3-Lumen Extraction Balloon

21 CFR 876. 5010

Biliary catheter and accessories

Catheter, Biliary, Diagnostic/Biliary Stone Dislodger Endoscope and/or Accessories

FGE/LQR/KOG

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

K0914.95

Pg 2 of 4

Predicate Device Information

• Device Name:	Single Use 3-Lumen Balloon Catheter B-230Q-A, B-230Q-B
• Common Name:	Balloon Catheter

Aomori Olympus Optical Co., Ltd. 1 Manufacturer:

510(k) No. K0333333 1

খ Device Description

	B-V233P	B-V233P	B-V433P	B-V433P	B-V243Q	B-V243Q	B-V443Q	B-V443Q
	-A	-B	-A	-B	-A	-B	-A	-B
Guidewire portstructure	Over thewire type	Over thewire type	Over thewire type	Over thewire type	DistalWireguidedtype	DistalWireguidedtype	DistalWireguidedtype	DistalWireguidedtype
Injection outletlocation type	Above theballoon	Below theballoon	Above theballoon	Below theballoon	Above theballoon	Below theballoon	Above theballoon	Below theballoon
Maximumdiameter of theballoon (mm)	$\phi$ 15	$\phi$ 15	$\phi$ 20	$\phi$ 20	$\phi$ 15	$\phi$ 15	$\phi$ 20	$\phi$ 20

The details of the line up of this subject devices are showed in the below.

5 Indications for Use

Comparison of Technological Characteristics 6

The Single Use 3-Lumen Extraction Balloon V, model B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B, B-V243Q-A, B-V243Q-B, B-V443Q-A and B-V443Q-B is identical to the predicate device in intended use, and similar in specifications except for the change of the guidewire port structure and expansion of the maximum diameter of the balloon. Comparison between the subject and predicate devices is shown in Table 1.

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

K09,495
pg 3 of 4

Table 1. Comparison of Specifications Subject Device: B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B B-V243Q-A, B-V243Q-B, B-V443Q-A, B-V443Q-B

.. /

: :

1.000

...

	B-V233P-AB-V233P-B	B-V433P-AB-V433P-B	PD: #K033333B233Q-A B-233Q-B
Maximum diameter ofthe balloon	$\phi$ 15mm	$\phi$ 20mm	$\phi$ 15mm( $\phi$ 20mm is cleared a 510(k) in#K063677)
Maximum outerdiameter of the sheath	$\phi$ 2.7mm	$\phi$ 3.2mm	$\phi$ 2.55mm
Compatible channeldiameter	$\phi$ 2.8mm or larger	$\phi$ 3.2mm orlarger	$\phi$ 2.8mm or larger
Working length	1900mm		1950mm
Structure for attachingto endoscope (Hook)	Provided		Not provided
Guidewire portstructure	Over the wire type		Over the wire type
Pre-measuredsyringes in differentsizes for inflation	1.1mL( $\phi$ 8.5mm)1.8mL( $\phi$ 11.5mm)3.4mL( $\phi$ 15mm)	2.4mL( $\phi$ 15mm)4.0mL( $\phi$ 18mm)5.6mL( $\phi$ 20mm)	1.2mL( $\phi$ 8.5mm)2.0mL( $\phi$ 11.5mm)3.8mL( $\phi$ 15mm)

	B-V243Q-AB-V243Q-B	B-V443Q-AB-V443Q-B	PD: #K033333B233Q-A B-233Q-B
Maximum diameter ofthe balloon	$\phi$ 15mm	$\phi$ 20mm	$\phi$ 15mm( $\phi$ 20mm is cleared a 510(k) in#K063677)
Maximum outerdiameter of the sheath	$\phi$ 2.9mm	$\phi$ 3.2mm	$\phi$ 2.55mm
Compatible channeldiameter	$\phi$ 3.2mm or larger		$\phi$ 2.8mm or larger
Working length	1950mm		1950mm
Structure for attachingto endoscope (Hook)	Provided		Not provided
Guidewire portstructure	Monorail type		Over the wire type
Pre-measuredsyringes in differentsizes for inflation	1.1mL( $\phi$ 8.5mm)1.8mL( $\phi$ 11.5mm)3.4mL( $\phi$ 15mm)	2.4mL( $\phi$ 15mm)4.0mL( $\phi$ 18mm)5.6mL( $\phi$ 20mm)	Unknown

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

Kog/495

pg 4 of 4

7 Conclusion

(

. .

... .. . . . .

. . .

management of the states

When compared to the predicate device, the single use 3-lumen extraction ball(1) { model When compared to the productions B-V433P-B, B-V243Q-A, B-V243Q-B, B-V443Q-A and B-V443Q-B does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

• 4/4

. .

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OLYMPUS MEDICAL SYSTEMS CORP. % Stacy Abbatiello Kluesner, M.S., RAC Project Manager Olympus America, Inc. 3500 Corporate Parkway CENTER VALLEY PA 18034-0610

SEP - 8 2009

Re: K091495

Trade/Device Name: Single Use 3-Lumen Extraction Balloon V Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: LQR & FGE Dated: July 31, 2009 Received: August 4, 2009

Dear Ms. Kluesner:

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); medical device reporting (reporting of medical

{5}------------------------------------------------

Page 2

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/cdrh/indr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ramsey Morris

Jarine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

K091495
K091459

510(k) Number (if known):

Device Name: Single Use 3-Lumen Extraction Balloon V B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B, B-V243Q-A, B-V243Q-B, B-V443Q-A, B-V443Q-B

Indications For Use:

Prescription Use (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)

Herlenn

Page 1 of 1

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

9 h09149

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.