(146 days)
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.
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.
This is a 510(k) premarket notification for the NobleStitch™ EL, MR, and TA vascular suturing devices. As such, the documentation provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance in the way you might expect for a typical study. This is common for predicate pathway 510(k) submissions, where the primary argument is that the new device is "substantially equivalent" to an already cleared device.
Instead of formal performance metrics against acceptance criteria, the submission makes the argument of equivalence based on:
- Intended Use/Indications for Use: Identical to the predicate device.
- Technological Characteristics: Essentially the same as the predicate, with minor modifications related to "different diameters or lengths with improved handle ergonomics."
- Principles of Operation: Identical to the predicate device.
The core assertion is that "The minor modifications to the NobleStitch™ do not raise any new questions of safety or effectiveness." This statement implies that the new device will perform equivalently to the predicate, and therefore, no new performance data or acceptance criteria are explicitly required beyond demonstrating that the modifications do not negatively impact safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any specific test set, sample size, or data provenance for a clinical study. The submission relies on the concept of substantial equivalence to a predicate device (SuperStitch® Vascular Suturing Device). This means that the safety and effectiveness are inferred from the predicate, and new clinical data typically isn't required unless the changes are significant enough to raise new questions of safety or effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not detailed in the provided document as there is no mention of a clinical study involving a test set that required expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or mentioned because no clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable or mentioned. The device is a manual vascular suturing device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable or mentioned. The device is a manually operated surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not detailed as no specific clinical study with ground truth data is described. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device.
8. The sample size for the training set
This information is not applicable or mentioned as the device is a manual surgical instrument and not an AI or algorithmic system that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable or mentioned for the same reason as point 8.
In summary:
This 510(k) submission is a "predicate pathway" submission, which means it seeks to demonstrate that the new device (NobleStitch™ EL, MR, and TA) is "substantially equivalent" to an already legally marketed device (SuperStitch® Vascular Suturing Device). For such submissions, the FDA typically does not require new comprehensive clinical studies with detailed acceptance criteria, sample sizes, and expert adjudications, unless the changes from the predicate raise new questions of safety or effectiveness. The core argument here is that minor ergonomic and diameter/length changes do not alter the fundamental safety or effectiveness demonstrated by the predicate device.
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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.
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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
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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.
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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 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
§ 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.