(340 days)
Not Found
Not Found
No
The summary describes a preformed surgical mesh device and does not mention any AI or ML capabilities.
Yes
The device is described as "supporting the endopelvic fascia in bladder neck surgery for stress incontinence" and "indicated for correction of pelvic floor relaxation or herniation at the bladder neck level," which directly addresses a medical condition and aims to restore normal function or alleviate symptoms.
No
This device is a surgical mesh for correction of pelvic floor relaxation or herniation, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it is a "preformed surgical mesh device with sutures woven along the edges," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "preformed surgical mesh device with sutures woven along the edges" intended for "supporting the endopelvic fascia in bladder neck surgery for stress incontinence" and "correction of pelvic floor relaxation or herniation at the bladder neck level." This describes a surgical implant used within the body during a procedure, not a test performed on a sample outside the body.
The information provided aligns with a surgical device used for structural support within the body, which is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
A preformed surgical mesh device with sutures woven along the edges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder neck
pelvic floor
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)
Not Found
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.
Marlex polypropylene mesh
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
§ 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.
0
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
1
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
2
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
3
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