NobleStitch EL

K162617 · Nobles Medical Technologies Ii, Inc. · GAW · Apr 6, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162617
• Device Name: NobleStitch EL
• Applicant: Nobles Medical Technologies Ii, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Apr 6, 2017
• Decision: SESU
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobleStitch 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 Story

Single-use surgical device for suture placement in cardiovascular soft tissue; inserted via existing access devices (trocar, sheath, or cannula). Device comprises primary and secondary handles with operating mechanisms and a multi-lumen shaft containing preloaded suture, needle, and retractable arm. Operator deploys suture and secures it using a Kwiknot component. Used by clinicians in cardiovascular procedures to approximate tissue. Benefits include controlled suture placement for soft tissue repair.

Clinical Evidence

No clinical data. Evidence consists of bench testing including functional inspection, performance testing of suture actuation, and clinical simulation using a porcine model.

Technological Characteristics

Single-use device; three-component system (primary handle, secondary handle, Kwiknot). Features multi-lumen shaft, preloaded suture, needle, and retractable arm. Mechanical actuation. Non-powered.

Indications for Use

Indicated for soft tissue approximation in cardiovascular procedures. Not for blind vascular closure.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NobleStitch EL, MR, and TA (K113494)
• DEKLENE II, DEKLENE MAX II (K153076)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

### 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)

| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) Summary
Per 21 CFR §807.92

Per 21 CFR §807.92

| Submitters Name and<br>Address | Nobles Medical Technologies II, Inc.<br>17074 Newhope Street<br>Fountain Valley, CA 92708 | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Jason K. Lyon<br>Director Regulatory Affairs<br>(Tel.) 714-427-6348 x225<br>(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.<br>NobleStitch EL, MR, and TA<br>K113494<br>GAW 21<br>CFR<br>878.5010 | Teleflex Medical, Inc.<br>DEKLENE II, DEKLENE MAX II<br>K153076<br>GAT<br>21 CFR<br>878.5000 |
| Device<br>Description | The NobleStitch EL device is a single-use surgical device, indicated for<br>use in direct contact within the vascular and cardiovascular system. The<br>NobleStitch EL device may be used by insertion through an access<br>device (e.g. trocar, sheath or cannula), already in place following<br>diagnostic or interventional procedures. | |
| Intended Use of<br>Device | The NobleStitch EL is indicated for use in the placement of sutures for<br>soft tissue approximation in cardiovascular procedures. The NobleStitch<br>EL is not intended for blind vascular closure. | |
| Technological<br>Characteristics | NobleStitch EL is composed of three components (primary, secondary,<br>and Kwiknot). The primary and secondary handles each contain the<br>operating mechanism, and a multi-lumen shaft containing a preloaded<br>suture, a needle, a retractable arm, each of which is pre-loaded with one<br>end of a suture. Upon placement, the Kwiknot is deployed to secure the<br>suture. | |
| Non-Clinical Test<br>Summary | Non-clinical testing was performed to demonstrate substantial<br>equivalency to the predicate device, K113494. Bench test data<br>consisted of: | |
| | Functional Tests | Visual inspection and operation<br>of the device. |
| | Performance tests | Actuation and<br>verification of preloaded formed<br>suture |
| | Clinical Simulation Tests | Actuated using a clinical<br>simulation porcine model |
| Conclusion | Based on safety and performance testing, technological characteristics<br>and the indications for use. The NobleStitch EL is substantially<br>equivalent to and as safe and effective as the predicate device<br>(K113494) | |