(47 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical aspects of the device, with no mention of AI or ML. The comparison to the predicate device highlights only a difference in balloon diameter offerings.
Yes
The device is designed for medical procedures (papillotomy, dilating to retrieve stones) to treat or alleviate a condition in the body, which aligns with the definition of a therapeutic device.
No.
The device is used for cutting tissue and dilating the papilla, which are therapeutic rather than diagnostic actions. While it is used with an endoscope (which can be used for imaging), the device itself is an interventional tool.
No
The device description clearly details physical components like a balloon, papillotomy knife, cutting wire, handle, and V-marking, and describes physical actions like cutting tissue and dilating the papilla. It also mentions hardware components it is used in combination with (endoscopes, A-Cord, electrosurgical unit, inflation device). This indicates it is a physical medical device, not software-only.
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/interventional procedure performed directly on the patient's body.
- Device Description: The device is described as a balloon and papillotomy knife used endoscopically to cut tissue and dilate the papilla. This is a therapeutic and procedural device, not a device used to examine specimens from the body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information for the diagnosis, treatment, or prevention of disease. This device is used in vivo (inside 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 (comma separated list FDA assigned to the subject device)
KNS, FGE
Device Description
The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy. The only difference from the predicate device which has been cleared under K150142 is the additional balloon diameter offerings. The intended use of the subject device is identical to the predicate device.
The subject device used in combination with compatible Olympus endoscopes, A-Cord (power cable), electrosurgical unit and compatible inflation device and the subject device is inserted endoscopically into the body cavity, and a tissue is cut by applying a high frequency current while the cutting wire is tightened. In addition, an inflation device is attached to a balloon port, and the inflation fluid is injected by utilizing an inflation device to dilate the papilla.
The insertion portion of this product has a V-marking, and the relative insertion length of this product into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope. The Hook provided on the handle is for attaching the subject device to an endoscope or an inflation device, which assists manipulation of the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
major papilla (biliary stones)
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 data were provided in support of the substantial equivalence determination:
- Electrical safety and electromagnetic compatibility (EMC) testing: The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
- Sterilization/Shelf-life testing: Conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test was conducted in accordance with ASTM F1980-16(2016). Three years real-time aging test will be performed.
- Biocompatibility testing: Conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff. Use of International Standard ISO 10993-1:2009. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Considered a surface-contacting device in contact with mucosal membranes, limited exposure (up to 24 hours).
- Performance testing - Bench: Conducted to ensure the subject device performs as intended and meet design specifications. Tests include Dimensional verification, Endoscopic compatibility, Knife operation, Papillotomy resistance, Tensile strength, Balloon deflation time, Balloon burst strength, Balloon fatigue, and Package integrity.
- Risk analysis: Conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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December 17, 2019
Olympus Medical Systems Corp. Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K193039
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: October 30, 2019 Received: October 31, 2019
Dear Sheri 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Daniel G. Walter, Jr. Assistant Director THT3A3: Obesity and Hepatobiliary Devices DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly stylized, with a modern and clean font. Underneath the word "OLYMPUS", there is a horizontal yellow bar that spans the length of the word. The overall design is simple and corporate, likely representing the logo of the Olympus Corporation.
October 30, 2019
K193039 Page 1 of 5
Section 5
510(k) Summary
5.1 GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Sheri L. Musgnung Contact Person: Olympus Corporation of the America 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
- Manufacturing site: Aomori Olympus Co., Ltd. 2-248-1 Okkonoki, Kuroishi-shi, Aomori 036-0357, Japan
5.2 DEVICE IDENTIFICATION
| ■ Device Name | Single Use Balloon Dilator V (with knife) |
|---|---|
| ■ Model Name | BD-VC431Q-1240-20 |
| BD-VC431Q-1240-25 | |
| BD-VC431Q-1240-30 | |
| ■ Common Name | Single Use Balloon Dilator (with knife) |
| ■ Regulation Number | 876.4300 |
| 876.5010 | |
| ■ Regulation Name | Endoscopic electrosurgical unit and accessories. |
| Biliary catheter and accessories. | |
| ■ Regulatory Class | II |
Section 5 510(k) Summary Page 1 of 5
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- Product Code KNS FGE
■ Classification Panel Gastroenterology/Urology
5.3 PREDICATE DEVICE
Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Single Use Balloon Dilator V (with knife) | OLYMPUS MEDICAL SYSTEMS CORP. | K150142 |
5.4 DEVICE DESCRIPTION
■ General Description of the subject device
The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy.
The only difference from the predicate device which has been cleared under K150142 is the additional balloon diameter offerings
The intended use of the subject device is identical to the predicate device.
Principle of Operation
There are no differences in composition and basic principle compared with the predicate.
The subject device used in combination with compatible Olympus endoscopes, A-Cord (power cable), electrosurgical unit and compatible inflation device and the subject device is inserted endoscopically into the body cavity, and a tissue is cut by applying a high frequency current while the cutting wire is tightened.
In addition, an inflation device is attached to a balloon port, and the inflation fluid is injected by utilizing an inflation device to dilate the papilla.
The insertion portion of this product has a V-marking, and the relative insertion length of this product into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope.
The Hook provided on the handle is for attaching the subject device to an endoscope or an inflation device, which assists manipulation of the subject device.
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K193039 Page 3 of 5
5.5 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.
5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The Single Use Balloon Dilator V (with knife) has the same technological characteristics and design as the predicate device except for the following new feature:
- । smaller balloon diameters
All other technological characteristics of both the subject and predicate device are identical.
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
| Comparison Table | ||
|---|---|---|
| Subject Device | Predicate Device | |
| Item | BD-VC431Q-1240-20/25/30 | BD-VC431Q-1840-20/25/30 |
| Distal tip diameter (mm) | ø1.5 mm | ø1.5 mm |
| Tip length (mm) | 7 mm | 7 mm |
| Knife length (mm) | 20 mm / 25 mm / 30 mm | 20 mm / 25 mm / 30 mm |
| Maximum insertion portion | ||
| diameter (mm) | ||
| (before inflating the | ||
| balloon) | ø 3.65 mm | ø 3.65 mm |
| Working length (mm) | 1950 mm | 1950 mm |
| Balloon diameter (mm (Fr)) | ||
| / Pressure (bar (atm)) | ø 8 mm(24Fr) / 0.5bar(0.5atm) | |
| ø 10mm(30Fr) / 2bar(2atm) | ||
| ø 12mm(36Fr) / 3.5bar(3.5atm) | ø 12 mm(36Fr) / 0.5bar(0.5atm) | |
| ø 15mm(45Fr) / 2bar(2atm) | ||
| ø 18mm(54Fr) / 3.5bar(3.5atm) | ||
| Balloon length (mm) | 40mm | 40mm |
| Maximum pressure (bar | ||
| (atm)) | 3.5 bar (3.5 atm) | 3.5 bar (3.5 atm) |
| Shape of the distal end | Pre-curved | Pre-curved |
| Knife wire diameter (mm) | ø 0.2 mm | ø 0.2 mm |
| Coated portion | Provided | Provided |
| Lumen type | 4-Lumen with C-channel | 4-Lumen with C-channel |
Comparison Table
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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced and appear to be a sans-serif font. A thin, horizontal gold bar is located beneath the word "OLYMPUS", adding a subtle visual element to the logo. The registered trademark symbol is located to the right of the letter "S".
K193039 Page 4 of 5
5.7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Single Use Balloon Dilator V (with knife). The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
2) Sterilization/Shelf-life testing
Sterilization/shelf-life testing for the Single Use Balloon Dilator V (with knife) was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Accelerated aging test for the Single Use Balloon Dilator V (with knife) was conducted in accordance with ASTM F1980-16(2016), the standard guide for accelerated aging of sterile barrier systems for medical devices. The three years real-time aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
3) Biocompatibility testing
Biocompatibility testing for the Single Use Balloon Dilator V (with knife) were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff. Use of International Standard ISO 10993-1:2009. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Contact classification:
The Single Use Balloon Dilator V (with knife) is considered a surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours).
4) Performance testing - Bench
Bench testing for the Single Use Balloon Dilator V (with knife) as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
Dimensional verification Endoscopic compatibility
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Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, creating a strong visual impact. Below the word, there is a horizontal yellow line that spans the width of the word. The overall design is simple and clean, with a focus on the brand name.
Traditional 510(k) Notification Single Use Balloon Dilator V (with knife) BD-VC431Q-1240
Knife operation Papillotomy resistance Tensile strength Balloon deflation time Balloon burst strength Balloon fatigue Package integrity
5) Risk analysis
Risk analysis for the Single Use Balloon Dilator V (with knife) was conducted 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.
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the Single Use Balloon Dilator V (with knife) raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.