(39 days)
Not Found
No
The description focuses on a mechanical spray catheter and its intended use for delivering fluids. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used to spray medicine (e.g., anesthetics) within the airway, which directly relates to treating or alleviating a condition, thus classifying it as therapeutic.
No
This device is described as a spray catheter used for washing and spraying contrast media or medicine, not for diagnosing conditions. Its function is interventional/therapeutic rather than diagnostic.
No
The device description clearly describes a physical catheter (PW-6C-1) and another physical component (MAI-929) used in combination with an endoscope. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for washing and spraying substances (contrast media, medicine) within the airway. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description confirms its use with an endoscope for direct application within the airway.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely different.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus endoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including tracheobronchial tree.
Product codes
EOO
Device Description
Spray Catheter PW-6C-1 has been designed to be used with an Olympus endoscope to perform washing, and spraying of contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobronchial tree. PW-6C-1 is used in combination with an way, mologing the spray fluid continuously. Both PW-6C-1 and MAI-929 are non-sterile, reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, including the 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)
Not Found
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
§ 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.
0
AUG 1 0 2001
$\cancel{K012703}$
SMDA 510(k) SUMMARY
A. Submitter's Name, Address, Phone and Fax Numbers
1. Manufacturer of the subject device
Name & Address of manufacturer:
Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division
Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishi-Shinjuku, Shinjyuku-ku Tokyo, Tokyo 163-0914 Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL 426-42-5177 FAX 426-46-5613
B. Name of Contact Person
Name: Address. Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: (631) 844-5688 FAX: (631) 844-5554
C. Device Name, Common Name, Classification Name and Predicate Devices
Trade Name:
Spray Catheter PW-6C-1, Injection Valve MAJ-929
Catheter / Valve
Bronchoscope and accessories 21 CFR 874.4680
Cannula PR-2 (K931154 EVIS-200 System Videobronchoscope & Accessories)
Common Name:
Classification:
Predicate Device:
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D. Description of the Device(s)
Spray Catheter PW-6C-1 has been designed to be used with an Olympus endoscope to perform washing, and spraying of contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobronchial tree. PW-6C-1 is used in combination with an way, mologing the spray fluid continuously. Both PW-6C-1 and MAI-929 are non-sterile, reusable.
E. Intended Use of the Device(s)
This instrument has been designed to be used with an Olympus endoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including tracheobronchial tree.
F. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, the subject device does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an emblem that resembles a stylized caduceus, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Olympus Optical Co., Ltd. c/o Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. 2 Corporate Center Dr. Melville, NY 11747-3157
Re: K012073
Trade/Device Name: Olympus Bronchoscopic Spray Catheter PW-6C-1 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: June 28, 2001 Received: July 2, 2001
Dear Ms. Tyler:
This letter corrects our substantially equivalent letter of August 10, 2001 regarding the Olympus Bronchoscopic Spray Catheter PW-6C-1. Our original letter incorrectly stated the 510(k) number as K012703. This letter corrects that error.
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). 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
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Page 2 - Laura Storms-Tyler
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 (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.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David A.M. Whizzle
of 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
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510(k) Number(if known):
Device Name: SPRAY CATHENER
Indications for Use:
This instrument has been designed to be used with an Olympus Brouchoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobroachial tree.
KO1 2073
itwister
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_KC i
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optoinal Format 1-2-96)
3