(330 days)
Not Found
No
The summary describes a physical medical device (drainage tube and accessories) and its intended use with endoscopes, with no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is a Pancreatic Drainage Tube, which is used for Endoscopic Pancreatic Drainage to treat a medical condition, even if it's for short-term implantation.
No
The device, a Pancreatic Drainage Tube, is described as being used for "Endoscopic Pancreatic Drainage" and for "short-term implantation." Its function is to drain, which is a therapeutic intervention, not a diagnostic one. No mention of diagnostic capabilities is made in the text.
No
The device description explicitly mentions physical components like a Drainage Tube, Insertion Kit, and Guidewire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The description clearly states that this device is an instrument used with endoscopes for Endoscopic Pancreatic Drainage. This is a procedure performed within the body to drain fluid from the pancreas. It is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activities typically associated with IVD devices.
Therefore, this device falls under the category of a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation.
This instrument has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.
Product codes
78 FGE
Device Description
Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The instrument consists of the Drainage Tube, and Insertion Kit and Guidewire. The Drainage Tube is not intended to be permanently implanted in the patient. The drainage Tube is intended for short-term implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreas
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
APR 1 6 2003
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: | Pancreatic Drainage Tube |
|---|---|
| Common Name: | Stent |
| Classification: | 21CFR #876.5010 Biliary catheter and accessories |
| 21CFR #876.1500 Endoscope and accessories | |
| Predicate Device: | Olympus PBD Stents #K933200 |
| Zimmon Endoscopic Pancreatic Stent |
Zimmon Endoscopic Pancreatic Stent (K900923 Wilson-Cook Medical, Inc.)
1
D. Description of the Device(s)
Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The instrument consists of the Drainage Tube, and Insertion Kit and Guidewire. The Drainage Tube is not intended to be permanently implanted in the patient. The drainage Tube is intended for short-term implantation.
E. Intended Use of the Device(s)
Pancreatic Drainage Tube has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation.
F. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, the subject device does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
2
APR 1 6 2003
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina Steffanie-Oak Senior R.A. Analyst Olympus America Inc. 2 Corporate Center Drive MELVILLE NY 11747-3157
Re: K021672
Trade/Device Name: Pancreatic Drainage Tube Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 7, 2003 Received: March 11, 2003
Dear Ms. Steffanie-Oak:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
3
Page 2 -- Ms. Tina Steffanie-Oak
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 (21 CFR Part 807); 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 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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,
Omit be lyum
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number(if known):
Device Name: Pancreatic Drainage Tube
Indications for Use:
This instrument has been designed to be used with Olympus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Division Sign-Off) | (Optoinal Format 1-2-96) | |||
| Division of Reproductive, Abdominal, and Radiological Devices | ||||
| 510(k) Number | K021672 |