(340 days)
Supporting the endopelvic fascia in bladder neck surgery for stress incontinence.
The Island Biosurgical Bolster is indicated for correction of pelvic floor relaxation or herniation at the bladder neck level.
A preformed surgical mesh device with sutures woven along the edges.
This submission is a 510(k) premarket notification for a medical device and therefore does not contain details about acceptance criteria, device performance studies, or ground truth establishment in the way a clinical trial report or a comprehensive performance study would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or performance against specific metrics through new clinical data.
Based on the provided text, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and intended use matching a predicate device (Marlex polypropylene mesh), rather than specific performance metrics against pre-defined acceptance criteria for a novel device.
2. Sample size used for the test set and data provenance:
This information is not provided. As this is a 510(k) seeking substantial equivalence to a predicate device, it likely did not involve a specific "test set" or clinical study with patient samples. The basis for substantial equivalence is primarily through comparison of materials, design, and intended use with the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Ground truth establishment for a test set is typically part of a clinical trial or performance study, which is not detailed in this 510(k) summary.
4. Adjudication method for the test set:
This information is not provided. Adjudication methods are relevant for studies involving human assessment of outcomes, which are not described in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. This device is a surgical bolster, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a passive surgical implant, not an algorithm.
7. The type of ground truth used:
This information is not provided. Since there's no mention of a performance study with a "test set," there's no ground truth concept applied in this context. Substantial equivalence relies on comparing the new device's characteristics to a predicate, not against an objective clinical ground truth derived from patient data for performance evaluation.
8. The sample size for the training set:
This information is not applicable and not provided. This device is a physical surgical mesh, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As mentioned above, there is no "training set" for this type of device.
Summary based on the provided text:
The submission for the Island Biosurgical Bolster is a 510(k) premarket notification. The core of a 510(k) is to demonstrate substantial equivalence to a predicate device already on the market (in this case, Marlex polypropylene mesh). This means showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness.
Therefore, the document focuses on:
- Trade Name: Island Biosurgical Bolster
- Common Name: Surgical Bolster
- Classification Name: Mesh, Surgical, Polymeric
- Intended Use: Supporting the endopelvic fascia in bladder neck surgery for stress incontinence.
- Technological Characteristics: "No differences from the legally marketed polypropylene mesh."
- Predicate Device: Marlex polypropylene mesh
The absence of the requested details about acceptance criteria, performance studies, sample sizes, and ground truth establishment is typical for a 510(k) submission, especially one that claims "no differences from the legally marketed polypropylene mesh" in technological characteristics. These types of studies are more common for novel devices or those seeking PMA approval.
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ID BIOSURGICAL INC
DEC 1 6 1996
Feb 21, 1996
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Blvd Rockville, MD 20850
Re: 510 (k) Summary of Safety and Effectiveness
Island Biosurgical Establishment Registration No .: 9009464 K960101
Attention: Document Mail Clerk
The following is a summary of the information submitted in the complete 510(k) for the Island Biosurgical bolster.
Trade Name: Island Biosurgical Bolster Common Name: Surgical Bolster Classification Name: Mesh, Surgical, Polymeric
Substantial Equivalence: Marlex polypropylene mesh
Description: A preformed surgical mesh device with sutures woven along the edges.
Intended use: Supporting the endopelvic fascia in bladder neck surgery for stress incontinence.
Technological characteristics: No differences from the legally marketed polypropylene mesh.
18 Meadow Lane Mercer Island, WA 98040-5340
FAX 206/656-5002
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 depiction of an eagle or bird with outstretched wings, rendered in black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird, also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 28 2012
Hunter A. McKay, M.D. President Island Biosurgical, Inc. 18 Meadow Lane MERCER ISLAND WA 98040
Re: K960101 Trade/Device Name: Island Biosurgical Bolster Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 5, 1996 Received: November 13, 1996
Dear Dr. McKay:
This letter corrects our substantially equivalent letter of December 16. 1996.
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 (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/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely, Yari,
Benjamin R. Weeks
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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Image /page/3/Picture/0 description: The image shows the text "ISLAND BIOSURGICAL, INC." The text is in all caps and appears to be a company name. The font is simple and easy to read. The background is plain and does not distract from the text.
November 5, 1996
ﺰ..ﺗ
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Blvd Rockville, MD 20850
Re: 510 (k) Response to inquiry of Oct 30, 1996 Island Biosurgical Establishment Registration No. : 9009464 K960101
Attention: Document Mail Clerk
The following is a response to your recent inquiry (copy attached for reference) :
INDICATION FOR USE
The Island Biosurgical Bolster is indicated for correction of pelvic floor relaxation or herniation at the bladder neck level .
Sincerely yours,
Hunter A. McKay, M.D. President
to coello de
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use X
(Per 21 CFR 801.109)
B. 1 mar or the - Over-the-Counter Use_
1-800-858-5359
18 Meadow Lane Mercer Island, WA UNKETUNUMBO
FAX 206/656-5002
§ 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.