(101 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a balloon dilator and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is designed to treat a medical condition (strictures of the biliary tree and major duodenal papilla) by dilating them, which is a therapeutic intervention.
No
The device is described as a "single use balloon dilator" used for "dilating strictures of the biliary tree and the major duodenal papilla." Its function is to exert radial force to dilate narrow duct segments, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines a physical, triple lumen catheter with a balloon, and the performance studies focus on physical characteristics like insertion/withdrawal forces, balloon properties, and tensile strength, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 is a physical tool (a balloon dilator) used directly within the body during an endoscopic procedure to mechanically dilate strictures. It does not analyze biological samples.
The description clearly outlines a device used for a therapeutic procedure within the body, not for in vitro analysis of specimens.
N/A
Intended Use / Indications for Use
Single use balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major duodenal papilla during endoscopic applications.
Product codes
FGE
Device Description
The subject device is a single use biliary balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of biliary tree and the major duodenal papilla during endoscopic applications.
The subject device is a triple lumen catheter with a balloon mounted to the distal end of the catheter. Balloon dilators are used to exert radial force to dilate narrow duct segments. The balloon at the distal end of the subject device is inserted to the stricture of biliary tree or the major duodenal papilla. And the balloon is inflated by injection of inflation fluid from the balloon lumen hub. The stricture of biliary tree or the major duodenal papilla is dilated by the inflated balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree, major duodenal papilla
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)
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- Insertion/withdrawal forces from endoscope
- Advance/retreat forces of the guidewire
- Balloon diameter
- Balloon deflation time
- Balloon formation after deflation
- Tensile testing
- Balloon and tube shaft burst pressure
- Packaging validation
- Shelf life testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".
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
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2015
OLYMPUS MEDICAL SYSTEMS CORP. % Sheri L. Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610
Re: K143303
Trade/Device Name: Single Use Biliary Balloon Dilator Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 12, 2015 Received: February 13, 2015
Dear Sheri L. Musgnung,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143303
Device Name Single Use Biliary Balloon Dilator
Indications for Use (Describe)
Single use balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major duodenal papilla during endoscopic applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) SUMMARY Single Use Biliary Balloon Dilation
February 27, 2015
5.1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507
Establishment Registration No: 8010047 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Sheri L. Musgnung
Manager, Regulatory Affairs
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-3147
FAX: 484-896-7128
Email: sheri.musgnung@olympus.com |
| ■ Manufacturer: | OLYMPUS MEDICAL SYSTEMS CORP.
34-3 Hirai, Hinode-machi,
Tokyo, Japan 190-0182
Establishment Registration No.: 3003637092 |
5.2 Device Identification
| ■ Device Trade Name: | Single Use Biliary Balloon Dilator |
|---|---|
| ■ Common Name: | Balloon Dilation Catheter |
| ■ Regulation Number: | 876.5010 |
| ■ Regulation Name: | Biliary catheter and accessories |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Gastroenterology and urology |
| ■ Product Code: | FGE |
Section 5 510(k) Summary Page 1 of 3
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5.3 Predicate Device Information
| ■ Device Name: | Single use balloon dilator MaxPass™ |
|---|---|
| ■ Common Name: | Balloon Dilation Catheter |
| ■ Applicant | Olympus Winter & Ibe, GmbH |
| ■ 510(k) No | K050502 |
5.4 Device Description
The subject device is a single use biliary balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of biliary tree and the major duodenal papilla during endoscopic applications.
The subject device is a triple lumen catheter with a balloon mounted to the distal end of the catheter. Balloon dilators are used to exert radial force to dilate narrow duct segments. The balloon at the distal end of the subject device is inserted to the stricture of biliary tree or the major duodenal papilla. And the balloon is inflated by injection of inflation fluid from the balloon lumen hub. The stricture of biliary tree or the major duodenal papilla is dilated by the inflated balloon.
5.5 Indications for Use
Single use balloon dilator to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major duodenal papilla during endoscopic applications.
Comparison of Technological Characteristics 5.6
Compared to the predicate device, the proposed subject device; Single Use Biliary Balloon Dilator, has similar technological characteristics. There is no significant difference that affects the safety or effectiveness of the subject device.
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Image /page/5/Picture/0 description: The image contains the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, gold line is underneath the word. Below the line, the text "Your Vision, Our Future" is written in a smaller font.
5.7 Summary of non-clinical testing
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- · Insertion/withdrawal forces from endoscope
- · Advance/retreat forces of the guidewire
- · Balloon diameter
- · Balloon deflation time
- · Balloon formation after deflation
- · Tensile testing
- · Balloon and tube shaft burst pressure
- ·Packaging validation
- · Shelf life testing
· Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
· Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".
The following standards have been applied to the Single Use Biliary Balloon Dilator.
- · ISO 10993-1 ·ISO 10993-5 · ISO 10993-10 ·ISO 11135 ·ISO 14971 · ASTM F-1980-07
5.8 Conclusion
When compared to the predicate device, the Single Use Biliary Balloon Dilator 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.