(88 days)
The B5-2Q/B5-2LA and B7-2Q/B7-2LA Balloon Catheters are to be used for biliary or pancreatic stone removal and dye injection associated with ERCP.
The balloon catheter is designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through an instrument channel of an endoscope. The Balloon Catheter is constructed of an inflatable balloon, catheter, branch, irrigation port, air feed cap, and stopcock. The B5 series Catheters are 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloons are 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. They are available in two different lengths for the specific needs, which the final letter designates as follow: Q is 1950 mm and LA is 3500 mm.
This 510(k) summary for the Olympus B5/B7 Balloon Catheters does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a premarket notification (510(k)) submission to the FDA, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Olympus B5/B7 Biliary Balloon Catheter K904669).
Therefore, I cannot provide the requested information from the provided text.
Here's a breakdown of why the information is missing:
- Acceptance Criteria/Performance Data: The 510(k) process for this type of device often relies on demonstrating that the new device is "substantially equivalent" to an existing device. This means showing that it has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device. It typically does not involve conducting new clinical studies with specific performance metrics defined as acceptance criteria, unless there are significant technological differences or new indications for use.
- Study Details: Since no new performance study is described, there's no mention of sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states: "the subject Olympus B5/B7 Series Balloon Catheters do not incorporate any significant change in the design, specifications, intended use, or method of operation that could affect the safety or efficacy of the subject devices."
In the context of the provided document, the "study" demonstrating the device meets "acceptance criteria" is implicitly the comparison to the predicate device, which is deemed to be safe and effective. The FDA's acceptance is based on this finding of substantial equivalence, not on a new, independently conducted performance study with measurable acceptance criteria.
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CT 25 1996
510 (k) SUMMARY
K 962925
p1072
OLYMPUS B5/B7 BALLOON Catheter
| Device Name: | Olympus B5/B7 Balloon Catheter |
|---|---|
| Common/Usual Name: | Balloon Catheter |
| Classification Name: | Endoscope and Accessories |
| Predicate Devices: | Olympus B5/B7 Biliary Balloon Catheter (K904669) |
| Submitted By:(Contact Person) | Mr. Barry SandsOlympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, New York 11747-3157(516) 844-5474 |
| Summary Preparation Date: | July 17, 1996 |
Statement of Intended Use
B5-2Q/B5-2LA Balloon Catheters (Color of Branch - Blue)
The B5-2Q/BS-2LA Balloon Catheters are designed to be used as an accessory to Olympus endoscopes with a minimum channel size of 2.0 mm.
B7-2Q/B7-2LA Balloon Catheters (Color of Branch - Yellow)
The B7-2Q/B7-2LA Balloon Catheters are designed to be used as an accessory to Olympus endoscopes with a minimum channel size of 2.8 mm.
Indications for Use:
B5-2Q/B5-2LA and B7-2Q/B7-2LA Balloon Catheters (Four Models)
The B5-2Q/B5-2LA and B7-2Q/B7-2LA Balloon Catheters are to be used for biliary or pancreatic stone removal and dye injection associated with ERCP.
Device Description
The balloon catheter is designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through an instrument channel of an endoscope.
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K962925
PL072
The Balloon Catheter is constructed of an inflatable balloon, catheter, branch, irrigation port, air feed cap, and stopcock. The B5 series Catheters are 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloons are 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. They are available in two different lengths for the specific needs, which the final letter designates as follow:
| Final Letter | Length |
|---|---|
| Q | 1950 mm |
| LA | 3500 mm |
General Safety
In conclusion, when compared with the predicate biliary balloon (K904669), the subject Olympus B5/B7 Series Balloon Catheters do not incorporate any significant change in the design, specifications, intended use, or method of operation that could affect the safety or efficacy of the subject devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/16 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is written in a simple, sans-serif font. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Public Health Service
OCT 2 5 1996
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Barry E. Sands Regulatory Affairs Manager Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157 Re:
K962925 Olympus B-5/B-7 Series Balloon Catheter Dated: July 23, 1996 Received: July 29, 1996 Regulatory Class: II 21 CFR 876.1500/Product Code: 78 FGE
Dear Mr. Sands:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that In uncroations of processions of 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 (Premarket Approval), in may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal subject to sublic additional concess in substantially equivalent determination assumes compliance with the Good Negulations: The Dr, a a 800 cal Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic MM inspections, the Food not Drug Administration (FDA) will verify such assumptions. Failure to comply with the OMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your Over Toganton may road in register. Pleaser notes to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA This rotes with and monderice 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Olympus B5/B7 Series Balloon Catheters
్
Not assigned yet.
Device Name:
Indications for Use:
B5-2Q/B5-2LA andB7-2Q/B7-2LABalloon Catheters (Four Models)
The B5-2Q/B5-2LA andB7-2Q/B7-2LA Balloon Catheters are to be used for biliary or pancreatic stone removal and dye injection associated with ERCP.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number R K962925 Over-the Counter Use
Rico Rathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (per 21CFR 801 109)
(Optional Format 1-2-96)
§ 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.