(146 days)
Not Found
Not Found
No
The summary describes a manually operated suturing device with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
This device is a suturing device used in general surgery for vascular stitching, which directly treats or manages a condition (vascular closure).
No
The device description indicates it is a suturing device used for performing vascular stitching, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "hand-held and manually operated suturing device" and lists physical components like a "suture delivery device," "monofilament polypropylene suture," and accessories like a "KnotPusher™" and "KwiKnot™." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The NobleStitch™ is a surgical suturing device. It is used within the body to perform vascular stitching.
- Intended Use: The intended use is for "performing vascular stitching in general surgery, including endoscopic procedures." This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical tool used for a therapeutic purpose (stitching blood vessels), not a device used for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The NobleStitch™ EL, MR, and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA are not intended for blind vascular closure.
Product codes (comma separated list FDA assigned to the subject device)
GAW
Device Description
The NobleStitch™ EL, MR. and TA 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 KnotPusher™ accessory for advancing the knot to the wound site, and/or a KwiKnot™ accessory.
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
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): 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.
SuperStitch® Vascular Suturing Device
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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510(k) SUMMARY
Nobles Medical Technologies II, Inc.'s NobleStitch™ EL, MR, and TA
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Nobles Medical Technologies II, Inc. 17080 Newhope St. Fountain Valley, California 92708
Phone: (714) 427-0398 Facsimile: (714) 427-0399
Contact Person: Anthony Nobles Date Prepared: November 11, 2011
Alternate Contact: Maria Hategan
Name of Device and Name/Address of Sponsor
NobleStitch™ EL, MR, and TA
Nobles Medical Technologies II, Inc. 17080 Newhope St. Fountain Valley, California 92708
Common or Usual Name
NobleStitch™ Vascular Suturing Device
Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Predicate Devices
SuperStitch® Vascular Suturing Device
Intended Use/Indications for Use
The NobleStitch™ EL, MR, and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA are not intended for blind vascular closure.
1
Technological Characteristics
The NobleStitch™ EL, MR. and TA 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 KnotPusher™ accessory for advancing the knot to the wound site, and/or a KwiKnot™ accessory.
KI13494
2/2
Substantial Equivalence
The NobleStitch™ EL, MR, and TA has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the cleared SuperStitch®, except that the NobleStitch™ EL, MR, and TA provide the option of different diameters or lengths with improved handle ergonomics for use by the physician. The minor modifications to the NobleStitch™ do not raise any new questions of safety or effectiveness. Thus, the NobleStitch™ EL, MR, and TA are substantially equivalent.
2
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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2012
Nobles Medical Technologies, Inc. % Mr. Anthony Nobles 17080 Newhope Street Fountain Valley, California 92708
Re: K113494
Trade/Device Name: NobleStitch™ EL, Vascular Suturing Device NobleStitch™ MR. Vascular Suturing Device NobleStitch™ TA, Vascular Suturing Device Regulation Number: 21 CFR 878.5010
Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: March 14, 2012
Received: March 22, 2012
Dear Mr. Nobles:
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.
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
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Page 2 - Mr. Anthony Nobles
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 A. Milliman
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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Indications for Use Statement
510(k) Number: (if known)
Device Name:
NobleStitch™ EL, Vascular Suturing Device NobleStitch™ MR, Vascular Suturing Device NobleStitch™ TA, Vascular Suturing Device
Indications for Use:
Indications for Use: The NobleStitch™ EL, MR, and TA is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA is not intended for blind vascular closure.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Daniel Keane for MKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113494