The NobleStich EL is indicated for use in the placement of sutures for soft tissue approximation in cardiovascular procedures. The NobleStitch EL is not intended for blind vascular closure.

Device Description

The NobleStich EL device is a single-use surgical device, indicated for use in direct contact within the vascular and cardiovascular system. The NobleStitch EL device may be used by insertion through an access device (e.g. trocar, sheath or cannula), already in place following diagnostic or interventional procedures.

AI/ML Overview

Based on the provided text, the device in question is the NobleStitch EL Suturing Device, a non-AI/ML device. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study for an AI/ML diagnostic tool.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, sample sizes for training/test sets, and MRMC studies cannot be extracted from this document as it pertains to a traditional medical device clearance process, not an AI/ML device approval.

The document discusses "Non-Clinical Test Summary" which details bench testing and clinical simulations, but these are for the physical device's functionality and performance, not for an AI/ML algorithm's diagnostic or predictive capabilities.

Summary of what can be extracted/inferred from the document regarding the device's testing, not related to AI/ML device performance:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit - demonstrated through testing): The device functions as intended and is as safe and effective as the predicate device (K113494).
Reported Device Performance (as summarized):
- Functional Tests: Passed visual inspection and operation.
- Performance Tests: Actuation and verification of preloaded formed suture.
- Clinical Simulation Tests: Actuated using a clinical simulation porcine model.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified in terms of numerical quantity for the tests. It mentions "a clinical simulation porcine model" but doesn't quantify how many uses or simulations were performed.
Data Provenance: The "clinical simulation porcine model" suggests animal data, likely controlled laboratory conditions inherent to non-clinical bench testing. Country of origin not specified. These are non-clinical, likely prospective tests for the device's function.

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):

Not applicable / Not mentioned. This document describes testing for a physical suturing device, not an AI/ML algorithm requiring expert interpretation of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not mentioned. Adjudication methods are typically for resolving discrepancies in expert interpretations in AI/ML performance studies.

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:

Not applicable. This document is not about an AI/ML device requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML algorithm. The device itself is a standalone physical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical tests, the "ground truth" would be the successful mechanical function of the device, proper suture deployment, and usability in the porcine model as defined by predetermined engineering and functional specifications. It's not a medical "diagnosis" ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that undergoes "training."

9. How the ground truth for the training set was established:

Not applicable.

Conclusion: The provided text is a 510(k) clearance document for a physical medical device (suturing device), not an AI/ML diagnostic or therapeutic system. Therefore, the questions specifically pertaining to AI/ML device performance evaluation methods (e.g., training/test sets, expert adjudication, MRMC studies, ground truth for AI algorithms) are not addressed in this document. The "Non-Clinical Test Summary" describes traditional bench and simulation testing for the physical device's functionality.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2017

Nobles Medical Technologies II, Inc. Mr. Jason Lyon Director Regulatory Affairs 17074 Newhope St. Fountain Valley, California 92708

Re: K162617

Trade/Device Name: Noblestitch El Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: March 8, 2017 Received: March 15, 2017

Dear Mr. Lyon:

This letter corrects our letter of April 6, 2017.

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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

1. The safety and effectiveness of this device in percutaneous cardiac procedures such as closure of septal defects (e.g. patent foramen ovale, atrial septal defects and ventricular septal defects), closure of the left atrial appendage, and heart valve repair has not been established.

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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

William H. Maisel -S

William H. Maisel, M.D., M.P.H. Director, Office of Device Evaluation (Acting) Deputy Center Director for Science Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K162617

Device Name NobleStitch™ EL

Indications for Use (Describe)

The NobleStich EL is indicated for use in the placement of sutures for soft tissue approximation in cardiovascular procedures. The NobleStitch EL is not intended for blind vascular closure.

Type of Use (Select one or both, as applicable)

☑Prescription Use (Part 21 CFR 801 Subpart D)
☐Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Per 21 CFR §807.92

Submitters Name andAddress	Nobles Medical Technologies II, Inc.17074 Newhope StreetFountain Valley, CA 92708
Contact Name andInformation	Jason K. LyonDirector Regulatory Affairs(Tel.) 714-427-6348 x225(Fax) 714-427-6343
Date Prepared	April 04, 2017
Proprietary Name	NobleStitch EL Suturing Device
Common Name	NobleStitch EL
Product Code	GAW
Classification of Device	Class II
Predicate Device	Nobles Medical Technologies,Inc.NobleStitch EL, MR, and TAK113494GAW 21CFR878.5010	Teleflex Medical, Inc.DEKLENE II, DEKLENE MAX IIK153076GAT21 CFR878.5000
DeviceDescription	The NobleStitch EL device is a single-use surgical device, indicated foruse in direct contact within the vascular and cardiovascular system. TheNobleStitch EL device may be used by insertion through an accessdevice (e.g. trocar, sheath or cannula), already in place followingdiagnostic or interventional procedures.
Intended Use ofDevice	The NobleStitch EL is indicated for use in the placement of sutures forsoft tissue approximation in cardiovascular procedures. The NobleStitchEL is not intended for blind vascular closure.
TechnologicalCharacteristics	NobleStitch EL is composed of three components (primary, secondary,and Kwiknot). The primary and secondary handles each contain theoperating mechanism, and a multi-lumen shaft containing a preloadedsuture, a needle, a retractable arm, each of which is pre-loaded with oneend of a suture. Upon placement, the Kwiknot is deployed to secure thesuture.
Non-Clinical TestSummary	Non-clinical testing was performed to demonstrate substantialequivalency to the predicate device, K113494. Bench test dataconsisted of:
	Functional Tests	Visual inspection and operationof the device.
	Performance tests	Actuation andverification of preloaded formedsuture
	Clinical Simulation Tests	Actuated using a clinicalsimulation porcine model
Conclusion	Based on safety and performance testing, technological characteristicsand the indications for use. The NobleStitch EL is substantiallyequivalent to and as safe and effective as the predicate device(K113494)

Regulation Number and Section

§ 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.