(86 days)
Not Found
Not Found
No
The summary describes a manually operated suturing device with no mention of AI or ML capabilities, image processing, or data sets for training/testing.
No
The device is a suturing device used to perform vascular stitching during surgical procedures. Its purpose is to physically close wounds or approximate tissues, which is a restorative or supportive function rather than a direct therapeutic intervention for a disease or condition.
No
The device is described as a suturing device used for performing vascular stitching, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly outlines physical components like a hand-held suturing device, suture, guidewire, and accessories, indicating it is a hardware medical device.
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: The SuperStitch device is a surgical tool used for placing sutures in blood vessels during surgical procedures. It is a mechanical device that directly interacts with the patient's anatomy.
- Intended Use: The intended use clearly states it is for "performing vascular stitching in general surgery, including endoscopic procedures." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description focuses on the mechanical function of the device and its use in a surgical setting, which is characteristic of a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The SuperStitch 5F, 12F & EL sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL are not intended for blind vascular closure.
Product codes (comma separated list FDA assigned to the subject device)
GAW
Device Description
The SuperStitch 5F, 12F & EL versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a pre-loaded guidewire, a KnotPusher accessory for advancing the knot to the wound site, and a KwiKnot accessory.
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
physician / general surgery, endoscopic procedures
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.
Not Found
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
§ 878.5010 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.
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OCT 1 9 2006
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510(k) SUMMARY
Sutura, Inc.'s SuperStitch® 5F, 12F & EL
OCT 1 9 2006
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708
Phone: (714) 437-9801 Facsimile: (714) 437-9806
Contact Person: Anthony Nobles Date Prepared: July 19, 2006
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 5F, 12F & EL
Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708
Common or Usual Name
SuperStitch Guidewire Vascular Suture Delivery Device
1
Classification Name
Suture, Nonabsorbable, Synthetic, Polypropolene
Predicate Devices
Sutura's SuperStitchVascular Suturing Device
Intended Use/Indications for Use
The SuperStitch 5F, 12F & EL sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL are not intended for blind vascular closure.
Technological Characteristics
The SuperStitch 5F, 12F & EL versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a pre-loaded guidewire, a KnotPusher accessory for advancing the knot to the wound site, and a KwiKnot accessory.
Substantial Equivalence
The SuperStitch 5F, 12F & EL has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch, except that the SuperStitch 5F, 12F & EL provide the option of diameter or lengths for use by the physician. This minor modification to the SuperStitch does not raise any new questions of safety or effectiveness. Thus, the SuperStitch 5F, 12F & EL are substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2006
Sutura, Inc. % Hogan & Hartson, L.L.P. Mr. Gerard J. Prud'homme 555 Thirteenth Street. NW Washington, District of Columbia 20004
Re: K062125
Trade/Device Name: SuperStitch® 5F Vascular Suture Delivery Device SuperStitch® 12F Vascular Suture Deliver Device SuperStitch® Extended Length Vascular Suture Deliver Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: September 21, 2006 Received: September 21, 2006
Dear Mr. Prud'homme:
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
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Page 2 - Mr. Gerard J. Prud'homme
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.
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Feli Pedr
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: SuperStitch® 5F Vascular Suture Delivery Device SuperStitch® 12F Vascular Suture Delivery Device SuperStitch® Extended Length Vascular Suture Delivery Device
Indications for Use:
The SuperStitch 5F, 12F & EL is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL is not intended for blind vascular 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 PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pohm
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number
\\DC - 80169/0002 - 2336580 v1