Predicate Devices

K0333333

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical balloon catheter and does not mention any AI/ML terms or capabilities.

Therapeutic

Yes
The device is intended to remove stones and bile sludge from the biliary system, which are therapeutic actions.

Diagnostic

No
The device is described as a balloon catheter used for the endoscopic removal of stones and bile sludge, and to facilitate the injection of contrast medium. These are interventional/therapeutic uses, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a balloon catheter, which is a physical hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used within the body (endoscopically) to remove stones and facilitate injection of contrast medium. This is an in vivo procedure.
Device Description: The device is a balloon catheter designed for use with endoscopes, further confirming its use within the body.
Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, or tissue. IVDs are used to diagnose conditions by examining these types of samples.

Therefore, this device falls under the category of a medical device used for therapeutic and diagnostic procedures performed directly on the patient, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FGE, LQR, KOG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

biliary system (pancreatic and common bile duct)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K0333333

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K063677

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

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

II

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

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.

	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 port
structure	Over the
wire type	Over the
wire type	Over the
wire type	Over the
wire type	Distal
Wireguided
type	Distal
Wireguided
type	Distal
Wireguided
type	Distal
Wireguided
type
Injection outlet
location type	Above the
balloon	Below the
balloon	Above the
balloon	Below the
balloon	Above the
balloon	Below the
balloon	Above the
balloon	Below the
balloon
Maximum
diameter of the
balloon (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

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

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-A
B-V233P-B | B-V433P-A
B-V433P-B | PD: #K033333
B233Q-A B-233Q-B |
|--------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------|
| Maximum diameter of
the balloon | $\phi$ 15mm | $\phi$ 20mm | $\phi$ 15mm
( $\phi$ 20mm is cleared a 510(k) in
#K063677) |
| Maximum outer
diameter of the sheath | $\phi$ 2.7mm | $\phi$ 3.2mm | $\phi$ 2.55mm |
| Compatible channel
diameter | $\phi$ 2.8mm or larger | $\phi$ 3.2mm or
larger | $\phi$ 2.8mm or larger |
| Working length | 1900mm | | 1950mm |
| Structure for attaching
to endoscope (Hook) | Provided | | Not provided |
| Guidewire port
structure | Over the wire type | | Over the wire type |
| Pre-measured
syringes in different
sizes 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-A
B-V243Q-B | B-V443Q-A
B-V443Q-B | PD: #K033333
B233Q-A B-233Q-B |
|--------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------|
| Maximum diameter of
the balloon | $\phi$ 15mm | $\phi$ 20mm | $\phi$ 15mm
( $\phi$ 20mm is cleared a 510(k) in
#K063677) |
| Maximum outer
diameter of the sheath | $\phi$ 2.9mm | $\phi$ 3.2mm | $\phi$ 2.55mm |
| Compatible channel
diameter | $\phi$ 3.2mm or larger | | $\phi$ 2.8mm or larger |
| Working length | 1950mm | | 1950mm |
| Structure for attaching
to endoscope (Hook) | Provided | | Not provided |
| Guidewire port
structure | Monorail type | | Over the wire type |
| Pre-measured
syringes in different
sizes 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

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:

... .. . . . .

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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.

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• 4/4

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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:

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.

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