(198 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description points to a mechanical surgical tool.
No
The NobleStich EL is a surgical device used for placing sutures to approximate soft tissue. It is an operative tool rather than a device designed to deliver therapy for a disease or condition.
No
Explanation: The device is indicated for "placement of sutures for soft tissue approximation," which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states it is a "single-use surgical device" and a "surgical device," indicating it is a physical hardware device used in procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "placement of sutures for soft tissue approximation in cardiovascular procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description confirms it's a "single-use surgical device, indicated for use in direct contact within the vascular and cardiovascular system." This further reinforces its use in a surgical setting.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, the NobleStich EL is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GAW
Device Description
The NobleStitch 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular and cardiovascular system
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)
Non-clinical testing was performed to demonstrate substantial equivalency to the predicate device, K113494. Bench test data consisted of:
- Functional Tests: Visual inspection and operation of the device.
- Performance tests: Actuation and verification of preloaded formed suture
- Clinical Simulation Tests: Actuated using a clinical simulation porcine model
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.
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.
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:
-
- 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 (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
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)
| ☑Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary
Per 21 CFR §807.92
Per 21 CFR §807.92
| Submitters Name and
Address | Nobles Medical Technologies II, Inc.
17074 Newhope Street
Fountain Valley, CA 92708 | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Contact Name and
Information | Jason K. Lyon
Director 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 TA
K113494
GAW 21
CFR
878.5010 | Teleflex Medical, Inc.
DEKLENE II, DEKLENE MAX II
K153076
GAT
21 CFR
878.5000 |
| Device
Description | The NobleStitch 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. | |
| Intended Use of
Device | 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. | |
| Technological
Characteristics | NobleStitch EL is composed of three components (primary, secondary,
and Kwiknot). The primary and secondary handles each contain the
operating mechanism, and a multi-lumen shaft containing a preloaded
suture, a needle, a retractable arm, each of which is pre-loaded with one
end of a suture. Upon placement, the Kwiknot is deployed to secure the
suture. | |
| Non-Clinical Test
Summary | Non-clinical testing was performed to demonstrate substantial
equivalency to the predicate device, K113494. Bench test data
consisted of: | |
| | Functional Tests | Visual inspection and operation
of the device. |
| | Performance tests | Actuation and
verification of preloaded formed
suture |
| | Clinical Simulation Tests | Actuated using a clinical
simulation porcine model |
| Conclusion | Based on safety and performance testing, technological characteristics
and the indications for use. The NobleStitch EL is substantially
equivalent to and as safe and effective as the predicate device
(K113494) | |