(67 days)
None listed. However, the Boston Scientific Vesica Protogen Sling Kit is quite similar.
None
No
The device description and intended use are purely mechanical/surgical and there is no mention of AI/ML terms or image processing.
Yes
The device is used to surgically correct female stress urinary incontinence, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is a surgical kit intended for the surgical correction of stress urinary incontinence, which is a treatment rather than a diagnostic process.
No
The device description clearly lists multiple hardware components including suture carriers, catheter stylet, mesh bolsters, catheter, drapes, and bone anchors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to surgically correct female stress urinary incontinence. This is a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The components of the kit are surgical tools and implantable materials used during surgery. They are not reagents, instruments, or software designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any aspects related to testing, analyzing samples (blood, urine, tissue, etc.), or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a surgical intervention.
N/A
Intended Use / Indications for Use
The Island Biosurgical, Inc. Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.
Product codes
OTN
Device Description
A surgical kit including disposable surgical suture carriers and catheter stylet, implantable polypropylene mesh bolsters, a urethral Malecot catheter, surgical drapes, with bone anchors (Kit #2) or without bone anchors (Kit #1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating pelvic surgeons
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)
Performance testing was not included in this 510 (k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
None listed. However, the Boston Scientific Vesica Protogen Sling Kit is quite similar.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the text "ISLAND BIOSURGICAL, INC." in a simple, sans-serif font. The text is arranged on a single line, with each word clearly separated. The overall impression is clean and professional, suggesting a business or medical context.
Image /page/0/Picture/1 description: The image shows a black and white drawing of a sun setting over water. The sun is depicted as a semi-circle at the top of the image, and the water is represented by horizontal lines below the sun. The drawing is simple and stylized, with a focus on the contrast between the dark sun and the lighter water.
OCT 2 0 1997
Bladder Neck Suspension Kit Island Biosurgical, Inc. 510 (k) Notification
510 (k) SUMMARY
Contact Person: Hunter A. McKay, M.D. August 9, 1997 Date: Trade Name: Island Biosurgical Bladder Neck
Suspension Kit #1, and Kit #2.
Bladder Neck Suspension Kit Common Name: None available for the Kit Classification Name: Predicate device: None listed. However, the Boston Scientific Vesica Protogen Sling Kit is quite similar.
Substantial Equivalence: No predicate device is listed, so Substantial Equivalence claims are not possible.
Description: A surgical kit including disposable surgical suture carriers and catheter stylet, implantable polypropylene mesh bolsters, a urethral Malecot catheter, surgical drapes, with bone anchors (Kit #2) or without bone anchors (Kit #1) .
The Island Biosurgical, Inc. Intended use: Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.
Technological characteristics: Kit contains disposable surgical instruments (exempt-876.4730), implantable bolsters K960101, legally marketed surgical draping material, surgical bone anchors, and a calibrated Malecot urethral catheter.
Performance testing: Performance testing was not included in this 510 (k).
Ref: \A\P\FDA\Kit\SUMMARY.020
1-800-858-5359
18 Meader Island and Mercer Islan 98040-5340
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions, representing health and human services. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hunter A. McKay, M.D. President Island Biosurgical, Inc. 18 Meadow Lane MERCER ISLAND WA 98040
SEP 2 8 2012
Re: K973022
Trade/Device Name: Island Biosurgical Bladder Neck Suspension Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 9, 1997 Received: October 20, 1997
Dear Dr. McKay:
This letter corrects our substantially equivalent letter of October 20, 1997.
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/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 yours,
Benjamin R. Civiletti
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
Page | of |
510(k) Number (if known): K973022
Device Name: BLADDER NECK SUBBION (CNS) KIT (WITH AND WITHOUT CONE ANCHARS) Indications For Use:
INDICATIONS FOR USE STATEMENT
The Island Biosurgical, Inc. Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.
Ref: \ASSIST\P\FDA\KIT\Sec2C.001
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert D. Sathing/ (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973022 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ____ | |
|---|---|---|---|
| --------------------------------------- | ----------------------------------------------- | ---- | --------------------------- |
(Optional Format 1-2-96)