(259 days)
No
The summary describes a mechanical device (balloon and knife) for endoscopic procedures and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The changes described are related to the physical design of the guidewire lumen.
Yes
The device is used for papillotomy and dilating the major papilla to retrieve biliary stones, which are therapeutic interventions.
No
The device is described as an instrument for papillotomy and dilating the major papilla to retrieve biliary stones. These are interventional/therapeutic procedures, not diagnostic ones. The performance studies also focus on mechanical and operational aspects of the device, not its ability to diagnose.
No
The device description clearly outlines physical components (balloon, papillotomy knife, guidewire lumen) and the performance studies focus on physical characteristics and functionality, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for papillotomy and dilating the major papilla to retrieve biliary stones. This is a surgical or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical instrument (balloon and papillotomy knife) used directly within the body during an endoscopic procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information. The performance studies focus on the physical and functional aspects of the device itself, not on its ability to detect or measure substances in a sample.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is used in vivo (within the body) for a therapeutic procedure.
N/A
Intended Use / Indications for Use
These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.
Product codes
KNS, FGE
Device Description
The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed guidewire lumen, and the subject device consists of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
major 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
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device works as intended: Dimensional verification, Endoscope compatibility, Knife operation, Papillotomy resistance, Tensile strength, Balloon deflation time, Balloon burst strength, Balloon fatigue, and Package integrity. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2015
OLYMPUS MEDICAL SYSTEMS CORP. % Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus Corporation of the Americas 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610
Re: K150142
Trade/Device Name: Single Use Balloon Dilator V (with Knife) Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS. FGE Dated: August 27, 2015 Received: August 28, 2015
Dear Daphney Germain-Kolawole,
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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) K150142
Device Name Single Use Balloon Dilator V (with Knife)
Indications for Use (Describe)
These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY Single Use Balloon Dilator V (with Knife)
October 7, 2015
. General Information
- 1 Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- . Official Daphney Germain-Kolawole Correspondent: Regulatory Affairs Project Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128 Email: daphney.germain-kolawole@olympus.com
- 1 Manufacturer: Aomori Olympus Co., Ltd. 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0357 Establishment Registration No.: 9614641
- ll. Device Identification Single Use Balloon Dilator V (with Knife)
- . Device Trade Name: Single Use Balloon Dilator V (with Knife)
- I Common Name: Single Use Balloon Dilator (with Knife)
- . Regulation Number: 876.4300 876.5010
- . Regulation Name: Biliary catheter and accessories Endoscopic electrosurgical unit and accessories
- I Regulatory Class: ll
Product Code:
1
- . Classification Panel: Gastroenterology and urology
- KNS FGE Section 5 510(k) Summary Page 1 of 3
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| Single Use Balloon Dilator V (with Knife) | ||
|---|---|---|
| Primary Predicate Device | ||
| Model name | Applicant | 510(k) No. |
| Single use balloon dilator | ||
| MaxPassTM | Olympus Winter & Ibe, GmbH | K050502 |
| Additional Predicate Device1 | ||
| Model name | Applicant | 510(k) No. |
| CRE Dilatation Balloon | Boston Scientific Corporation | K112994 |
| Additional Predicate Device2 | ||
| Model name | Applicant | 510(k) No. |
| Single Use Preloaded | ||
| Sphincterotome V | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K122505 | |
| Reference Device | ||
| Model name | Applicant | 510(k) No. |
| Autotome RX Sphincterotome | Boston Scientific Corporation | K013153 |
| Single Use Biliary Balloon | ||
| Dilator | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K143303 |
III. Predicate Device and Reference Devices Information
IV. Device Description
The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed guidewire lumen, and the subject device consists of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added.
V. Indications for Use
These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.
VI. Comparison of Technological Characteristics
· Compared to the predicate devices, the subject device has three lumens and one C-channel.
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VII. 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 works as intended.
- · Dimensional verification
- · Endoscope compatibility
- · Knife operation
- · Papillotomy resistance
- · Tensile strength
- · Balloon deflation time
- · Balloon burst strength
- · Balloon fatigue
- · Package integrity
· 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.
The following standards have been applied to the Single Use Balloon Dilator V (with Knife).
- · IEC 60601-1
- · IEC 60601-1-2
- · IEC 60601-1-6
- · IEC 60601-2-2
- · IEC 60601-2-18
- · ISO 10993-1
- · ISO 10993-5
- · ISO 10993-7
- · ISO 10993-10
- · ISO 10993-11
- · ISO 11135
- · ISO 14971
- · ASTM F-1980-07
VIII. Conclusion
When compared to the predicate device, the Single Use Balloon Dilator V (with Knife) do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.