(85 days)
Not Found
Not Found
No
The summary describes a mechanical surgical device for tissue fixation and does not mention any AI/ML terms or functionalities.
No.
Explanation: The device is intended for the fixation of sutures and surgical mesh, which is a structural and support function, not a direct therapeutic treatment of disease or condition by itself. Its predicate devices are classified as suture retention devices and soft tissue fasteners, which are not therapeutic devices.
No
Explanation: The device is described as a surgical system for fixation of sutures and mesh to soft tissue for the treatment of stress urinary incontinence. Its function is to provide physical support, not to diagnose a condition.
No
The device description explicitly states the system includes a surgical stainless steel retention anchor and a delivery device, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures involving the fixation of sutures and mesh to soft tissue for treating female stress urinary incontinence. This is a surgical implant and delivery system used in vivo (within the body).
- Device Description: The device is described as a surgical stainless steel anchor with suture and a delivery device. This aligns with a surgical implant and its associated tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting. This device is clearly designed for direct surgical use within a patient.
N/A
Intended Use / Indications for Use
For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Product codes
GAW
Device Description
The system includes a surgical stainless stcel retention anchor with attached polypropylene suture, and a delivery device for placement of the implant. The system may be supplied with legally marketed surgical mesh marketed for use in treating female stress urinary incontinence.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (pubourethral support and bladder neck support)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
AUG 2 8 2002
510(k) Premarket Notification: Sulure/ Mesh Fixation System K021384: Response I to FDA Email 8/21/02
III. Summary of Safety and Effectiveness
0 2 1 8 34
510(k) Summary for Suture Fixation System
A. Sponsor
MLE, Inc. 52 Commercial Wharf #1 Boston, MA 02110
B. Device Name
Suture/ Mesh Fixation System
C. Predicate Device(s)
21CFR 878.4930 Class I, KGS Suture retention device Devices Classified per 21CFR 878.5010 as Class II, procode GAW MBI, Soft tissue Fastener
D. Device Description
The system includes a surgical stainless stcel retention anchor with attached polypropylene suture, and a delivery device for placement of the implant. The system may be supplied with legally marketed surgical mesh marketed for use in treating female stress urinary incontinence.
1) Intended Use
For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
2) Technological Characteristics and Substantial Equivalence
The proposed device is substantially equivalent to the predicate devices currently marketed for use for fixation of soft tissuc in terms of intended use and functional characteristics tested.
1
Image /page/1/Picture/1 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 three heads in profile, facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
MLE, Inc. c/o Ms. Christine E. Nichols RCS Regulatory Consulting Services 10 Greenlawn Avenue S. Grafton, Massachusetts 01560
Re: K021834
Trade/Device Name: Suture Fixation Device and Mesh Fixation Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: May 29, 2002 Received: June 4, 2002
Dear Ms. Nichols:
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 application (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 such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR. 1000-1050.
2
Page 2 - Ms. Christine E. Nichols
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .
Sincerely yours,
Hypt. Ruckls
M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification: Suture/ Mesh Fixation System K021384: Response I to FDA Email 8/21/02
IV. Indications for Use Statement
510(k) Number (if Known);
K0218
Device Name: Suture/Mesh Fixation System
Indications For Use:
For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
(PLEASE DO NOT WRITF BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √ OR Over-The-Counter Use
(Optional Format 1-2-96)
Stupten Rhodes
. ...
Division of General, Restorative and Neurological Devices
1021834 510(k) Number.