(13 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on a mechanical vascular stitching device.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is indicated for performing vascular stitching, which is a procedural function, not a treatment in itself. It is a surgical tool used during a therapeutic procedure, but it is not a therapeutic device by its sole function.
No
The device is described as performing vascular stitching for vascular closure, which is a therapeutic or surgical function, not a diagnostic one.
No
The device description and intended use clearly indicate a physical device ("vascular stitching," "vascular closure," "Suturing Device"). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "performing vascular stitching in general vascular closure." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description refers to "Models 06-15-04-GW; 08-15-04-GW," which are likely physical devices used in surgery.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SuperStitch GW is a surgical tool used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The SuperStitch GW is indicated for use in performing vascular stitching in general vascular closure. The SuperStitch GW is not intended for blind vascular closure.
Product codes
GAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular
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
Not Found
Key Metrics
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
DEC 2 7 2005
ಲ್ಲಿ 2
510(k) SUMMARY
Sutura, Inc.'s SuperStitch GW
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708
(714) 437-9801 Phone: Facsimile: (714) 437-9806
Anthony Nobles Contact Person: December 14, 2005 Date Prepared:
Alternate Contact:
Gerard J. Prud'homme Hogan & Hartson L.L.P. 555 Thirteenth St. NW Washington D.C., 20004 Phone: (202) 637-5600
Name of Device and Name/Address of Sponsor
SuperStitch GW
Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708
Common or Usual Name
SuperStitch Guidewire Vascular Suture Delivery Device
Classification Name
Suture, Nonabsorbable, Synthetic, Polypropolene
Predicate Devices
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text on the first line reads "K053482". The text on the second line reads "page 2 of 2".
Sutura's SuperStitchVascular Suturing Device
Intended Use
The SuperStitch GW is indicated for use in performing vasular stitching in general
. All is and many min a many and a gain l. CW is not intended for The SuperStich GW is matcaled for about portschills. While and intended for blind vascular closure.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
DEC 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sutura, Inc. % Mr. Gerard J. Prud'Homme, Esquire Hogan & Hartson L.L.P. 555 13th Street, NW Washington, DC 20004
Re: K053482
Trade/Device Name: Superstich GW Models 06-15-04-GW; 08-15-04-GW Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: December 14, 2005 Received: December 14, 2005
Dear Mr. Prud'Homme:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bookshow on (t) personalially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the enoredure) to wgmant date of the Medical Device Amendments, or to devices that provision that 20, 1978, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nave been rochassified and 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 therefore, mancer the detice, as joinements for annual registration, listing of devices, good vonufacturing 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 r your de fice is elasmod (tional controls. Existing major regulations affecting your device can be thay be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 r carates and regarments, 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 (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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w yours over finding of substantial equivalence of your device to a legally prematicated 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), please rryou desire specific arreliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other INISULANDING OF Telection on your responsibilities under the Act from the Division of Small Manufacturers, general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchud
TN
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1.
Indications for Use Statement
510(k) Number (if known): K053482
Device Name: SuperStitch Guide-wire Vascular Suture Delivery Device
Indications for Use:
The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.
Prescription Use __X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER
) -- CONTINUE BACK CONTEMENT PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Muchard
Division of General, Restorative, and Neurological Devices
510(k) Number K053452
. DC 8016940002 - 2203578 v1