(86 days)
, SuperStitch® Vascular Suturing Device
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 used to perform vascular stitching, which is a surgical procedure to close wounds or connect tissues, not for treating a disease or condition itself.
No
Explanation: The device is indicated for performing vascular stitching, which is a therapeutic rather than diagnostic procedure. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a hand-held, manually operated suturing device with physical components like a suture delivery device, suture, and accessory. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the SRM-Stitch™ 8F is a "hand-held and manually operated suturing device" used for "performing vascular stitching." This is a surgical tool used directly on the patient's body, not for analyzing samples taken from the body.
- Intended Use: The intended use is for "performing vascular stitching in general surgery." This is a surgical procedure, not a diagnostic test performed on a sample.
The device's function is to physically manipulate tissue (suture) within the body, which is the opposite of how an IVD operates.
N/A
Intended Use / Indications for Use
The SRM-Stitch™ 8F version is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.
Product codes
GAW
Device Description
The SRM-Stitch™ 8F version is 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, and a KwiKnot™ accessory. The optional KnotPusher™ accessory has been eliminated from current packaging configuration of SRM-Stitch™ 8F.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
SuperStitch® Vascular Suturing Device
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
MAR 1 6 2012
510(k) SUMMARY
Nobles Medical Technologies II, Inc.'s SRM-Stitch™ 8F
Submitter's Name. Address. Telephone Number, Contact Person and Date Prepared
Nobles Medical Technologies II, Inc. 17080 Newhope St. Fountain Valley, California 92708
(714) 427-0398 Phone: Facsimile: (714) 427-0399
Maria Hategan, Director of RA/QMS Contact Person:
Date Prepared: December 12, 2011
Name of Device and Name/Address of Sponsor
SRM-Stitch™ 8F
Nobles Medical Technologies II, Inc. 17080 Newhope St. Fountain Valley, California 92708
Common or Usual Name
SRM-Stitch™ Vascular Suturing Device
Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Predicate Devices
SuperStitch® Vascular Suturing Device
Intended Use/Indications for Use
The SRM-Stitch™ 8F version is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.
KII 3763
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Technological Characteristics
The SRM-Stitch™ 8F version is 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, and a KwiKnot™ accessory. The optional KnotPusher™ accessory has been eliminated from current packaging configuration of SRM-Stitch™ 8F.
Substantial Equivalence
The SRM-Stitch™ 8F has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the cleared SuperStitch®, except that the SRM-Stitch™ 8F has a reconfigured suture sleeve and a refined guidewire port. The minor modifications to the SRM-Stitch™ do not raise any new questions of safety or effectiveness. Thus, the SRM-Stitch™ 8F is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol on the right, which is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Nobles Medical Technologies II, Inc. % Ms. Maria Hategan Director, of RA/QMS 17080 Newhope Street Fountain Valley, California 92708
.Re: K113763
Trade/Device Name: SRM-Stitch™ 8F, Vascular Suturing Device SRM-Stitch™ 8F with guidewire, Vascular Suturing Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: February 03, 2012 Received: February 15, 2012
Dear Ms. Hategan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Ms. Maria Hategan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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" (21CFR 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 vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KI13763
Indications for Use Statement
510(k) Number: (if known)
Device Name:
SRM-Stitch™ 8F, Vascular Suturing Device SRM-Stitch™ 8F with guidewire, Vascular Suturing Device
Indications for Use: The SRM-Stitch™ 8F is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.
Prescription Use _ X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Production Sign-Ori)
Division of Surgical, Orthopedic, and Restorative Devices
510(k)
L 113763