K Number

Device Name

EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

Manufacturer

OLYMPUS OPTICAL CO., LTD.

Date Cleared

2003-10-16

(10 days)

Product Code

EOQ

Regulation Number

874.4680

Intended Use

The EVIS Bronchofibervideoscope Olympus BF type XP160F has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Device Description

The subject device, EVIS EXERA Bronchofibervideoscope Olympus BF type XP100F is basically The Subject device, EVIC EXER & Bronchofiberscope Olympus BF type XP40 (BF-XP40) licentical to the predicate device, OEO Bronth hise copy othe control section. The fiber partners them except that the subject dovice to equipped with the control section, and the CCD changes them the insection tube transmite thay of the subject device is equivalent to the combination of the BF-XP40 to video Signals: In printiple, the stayss OVC-200. The CCD equipped with the subject device is and the OLO Video Onvortor Offinial Orympas Oronchovideoscope Olympus BF type 160 (BF-160). By licentical to that of the EVTO EXER & Erenonention tube diameter of the subject device Combining the OOD in the Boops o on comparison with the BF-XP40, the performance of is han ower than that of the essary to attach the video converter.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K023984, K931154

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bronchoscope and its components, focusing on optical and video technology. There is no mention of AI or ML in the intended use, device description, or dedicated sections for AI/ML information.

Therapeutic

Yes
The device is used for endoscopy and endoscopic surgery within the airways and tracheobronchial tree, indicating a therapeutic purpose. It also mentions the use of "endo-therapy accessories (such as a biopsy forceps)," which are used for therapeutic interventions.

Diagnostic

Explanation: The "Intended Use / Indications for Use" section describes the device as being used for endoscopy and endoscopic surgery, with mentions of "endo-therapy accessories (such as a biopsy forceps)". While it allows visualization, its primary stated purpose leans towards interventional procedures and observation, rather than solely diagnosis based on image analysis or specific medical condition detection. There is no explicit mention of diagnosis as an intended use.

SaMD (Software as a Medical Device)

The device description clearly describes a physical bronchoscope with a CCD and insertion tube, which are hardware components.

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 states the device is for "endoscopy and endoscopic surgery within the airways and tracheobronchial tree." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
Device Description: The description details a bronchoscope with a CCD for transmitting video signals. This is consistent with a device used for visualization and intervention within the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for direct visualization and intervention within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

EOQ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airways and tracheobronchial tree

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)

When compared to the predicate device, the BF type XP160F does not incorporate any significant vinen compared to the products do nother, material, or design that could affect safety and cifanges in the finendod ass, mot necessary for evaluation of safety and efficacy.

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

Not Found

Predicate Device(s)

#K023984, #K023984, #K931154

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.

Summary

K033225

SMDA 510(k) SUMMARY

10-16-03 August 22, 2003 Revised March 19, 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the This Summary of STO(K) Safety and 21CFR, Part 807, Subpart E, Section 807.92.

A. GENERAL INFORMATION

1. Applicant

Olympus Optical Co., Ltd. 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, 190-0182 Japan (Registration Number: 3003637092)

2. Submission Correspondent

Shiho Otsuki Olympus Optical Co., Ltd. 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, JAPAN TEL: +81-426-42-2891 FAX:+81-426-42-2291 (Registration Number: 8010047)

3. Official Correspondent

Tina Steffanie-Oak Senior R.A. Analyst Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 TEL: 631-844-5477 FAX: 631-844-5416 (Registration Number:2429304)

B. DEVICE IDENTIFICATION

1. Common/Usual Name

Bronchoscope, its accessories and ancillary equipment

2. Device Name

Device Name
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, its accessories and ancillary equipment

3. Classification Name

CFR Number	Classification Name	Class	Product Code
874. 4680	Bronchoscopes (flexible and rigid)
and accessories	II	EOQ

C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE

| Model | 510(k)# | Manufacturer | Class | Product
Code |
|-----------------------------------------------------|----------|---------------------------|-------|-----------------|
| OES Bronchofiberscope Olympus BF
type XP40 | #K023984 | Olympus Optical Co., Ltd. | II | EOQ |
| EVIS EXERA Bronchovideoscope
Olympus BF type 160 | #K023984 | Olympus Optical Co., Ltd. | II | EOQ |
| OES Video Converter Olympus
OVC-200 | #K931154 | Olympus Optical Co., Ltd. | II | EOQ |

D. DEVICE DESCRIPTION

1. Summarv

Summary
The subject device, EVIS EXERA Bronchofibervideoscope Olympus BF type XP100F is basically The Subject device, EVIC EXER & Bronchofiberscope Olympus BF type XP40 (BF-XP40) licentical to the predicate device, OEO Bronth hise copy othe control section. The fiber partners them except that the subject dovice to equipped with the control section, and the CCD changes them the insection tube transmite thay of the subject device is equivalent to the combination of the BF-XP40 to video Signals: In printiple, the stayss OVC-200. The CCD equipped with the subject device is and the OLO Video Onvortor Offinial Orympas Oronchovideoscope Olympus BF type 160 (BF-160). By licentical to that of the EVTO EXER & Erenonention tube diameter of the subject device Combining the OOD in the Boops o on comparison with the BF-XP40, the performance of is han ower than that of the essary to attach the video converter.

2. Design

Design rne EV10 EXETV Chononoorwith voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-1, IEC60601-1-2 and IEC60601-2-18.

3. Materials

Materials
All the patient contacting materials used in this endoscope and ancillary equipment are identical to All the patient oonlaoling material in the past 510(k) submissions. All materials have been confirmed with ISO 10993-1.

4. Intended Use of the device

This instrument has been designed to be used with the Olympus video system center, light source, i fills instrument has been dolgnod to be arountherapy accessories (such as a biopsy forceps) and documentation equipment, naos monton, one endoscopic surgery within the airways and tracheobronchial tree.

5. Summary including conclusion drawn from Non-clinical Tests

Contraindications

Hypersensitivity to darisocianer or to any of the excipients
Severe hepatic impairment
Severe renal impairment
Concomitant use of strong CYP3A4 inhibitors
Pregnancy and breastfeeding
Children and adolescents under the age of 18 years

1. Omprisons betwen the subject devices
  The interled use of the BF-XP (is , is ustartially instrument of the BF-XF40 and BF-100 and BF-100 and BF-100 and Bronning on the C

CHARACTERISTICS	Subject device	Predicate device (#K023984)
	BF-XP160F	BF-XP40	BF-160
Intended Use	Designed to be used with an Olympus
video system center, light source,
documentation equipment, video
monitor, endo-therapy accessories
(such as a biopsy forceps) and other
ancillary equipment for endoscopy and
endoscopic surgery within the airways
and tracheobronchial tree.	Designed to be used with an Olympus
light source, video
documentation equipment, display
monitor, endo-therapy accessories
and other ancillary equipment for
endoscopic diagnosis and treatment
within the airways and
tracheobronchial tree.	Designed to be used with an Olympus
video system center, light source,
documentation equipment, video
monitor, endo-therapy accessories
(such as a biopsy forceps) and other
ancillary equipment for endoscopy and
endoscopic surgery within the airways
and tracheobronchial tree.
Optical Characteristics
Field of view	90°	90°	120°
Depth of Field	2mm~50mm	2mm~50mm	3mm~100mm
Direction of view	0° Forward Viewing	0° Forward Viewing	0° Forward Viewing
Outer Diameter of Distal End	2.8mm	2.8mm	5.3mm
Outer Diameter of Insertion Tube	2.8mm	2.8mm	5.3mm
Angulation
UP/DOWN	180° /130°	180° /130°	180° /130°
Working Length-Insertion Tube	600mm	600mm	600mm
Instrument Channel-I.D.	1.2mm	1.2mm	2.0mm

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Olympus Optical Co., Ltd. c/o Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K033225

Trade/Device Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, its accessories and ancillary equipment Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: August 22, 2003 Received: October 6, 2003

Dear Mr. Devine:

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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Ned Devine

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Rakipi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

510(k) Number(if known): _

Device Name: EVIS EXERA BRONCHOEIBERVIDEOSCOPE OLYMPUS BE TYPE

_XP160F, its accessories and ancillary equipment.

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801,109)

(Division Sign-Off)
---------------------	--

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)