(90 days)
The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.
A surgically implantable polypropylene mesh bolster with monofilament sutures.
The provided text is a 510(k) summary for the Island Biosurgical Bladder Neck Suspension Bolster. It explicitly states:
"Performance testing: Performance testing was not included in this 510 (k)."
Therefore, based on the provided document, there is no information available regarding acceptance criteria, device performance against such criteria, or any study that proves the device meets acceptance criteria.
As a result, I cannot provide the requested information. This device received substantial equivalence without requiring performance testing to demonstrate its safety and effectiveness.
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SEP 8 1998
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15922042
Bladder Neck Suspension Bolster Island Biosurgical, Inc. 510(k) Notification
510(k) SUMMARY
Contact Person: Hunter A. McKay, M.D. Date: June 4, 1998 Trade Name: Island Biosurgical Bladder Neck Suspension Bolster #2
Common Name: Bladder Neck Suspension Bolster Classification Name: None available
Predicate device: Island Biosurgical Bladder Neck Suspension Bolster
Substantial Equivalence: Island Biosurgical Bladder Neck Suspension Bolster
Description: A surgically implantable polypropylene mesh bolster with monofilament sutures.
Intended use: The Island Biosurgical Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.
Technological characteristics: This implantable bolster is composed of polypropylene mesh and monofilament suture material.
Performance testing: Performance testing was not included in this 510 (k).
Ref: \A\P\FDA\BQlster\980604\Summary. 022
1-800-858-5359
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Hunter A. McKay, M.D. President Island Biosurgical, Inc. 18 Meadow Lane MERCER ISLAND WA 98040
K982042 Re:
Trade/Device Name: Island Biosurgical, Inc. Bladder Neck Suspension Bolster Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: June 4, 1998 Received: June 10, 1998
Dear Dr. McKay:
This letter corrects our substantially equivalent letter of September 8, 1998.
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 (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.
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. You must
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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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Sincerely yours,
Benjamin R. Perkins
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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Sep-02-98 12:44P colvin/bovard Sep-01-98 19:21 IsTand Biosurgical
541-345-5431 206 232 6239
P.03 P.01
Bladder Neck Suspension Bolster Island Biosurgical, Inc. 510(k) Notification
APPENDIX C
INDICATIONS POR USE STATEMENT
The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.
Ref: \A\P\PDA\Bolstar\980604\Sec2C.013 (Modified)
Aocoeeto
ﻌﻬﺪ ﺍﻟﻤ
(Division Sign-Off) Division of General Restorative Devices 1982047 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.