(96 days)
Not Found
No
The description details a manual surgical instrument for mechanical fixation and does not mention any computational or data-driven components.
No.
The device is a surgical instrument for fixation of prosthetic material, not a therapeutic device designed to treat or cure a disease.
No
The device is described as a surgical instrument for fixation of prosthetic material, not for diagnosing medical conditions.
No
The device description clearly states it is a "manual laparoscopic surgical instrument" and a "disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description clearly states it's a "manual laparoscopic surgical instrument" designed to "deliver a permanent fastener into tissue or prosthesis." This is a mechanical device for surgical intervention.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the FasTouch™ Fixation System does not involve any testing of biological samples.
Therefore, the FasTouch™ Fixation System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FasTouch™ Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
Product codes
GDW
Device Description
The FasTouch™ Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate hernia mesh delivery and placement in laparoscopic or open ventral hernia repair. The FasTouch™ Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair.
The Via Surgical's FasTouch™ Fixation System is designed to be inserted through a laparoscopic port sleeve. The FasTouch™ Fixation System is packaged in its unloaded state and contains a handle and a cartridge.
The FasTouch™ Fixation System is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues (for hernia repairs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Minimally invasive and open surgical procedures. User is likely a surgeon given the context.
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)
The following tests were performed and are the same as those performed and submitted in the original submission using the same acceptance criteria:
- Risk analysis per ISO 14971:2012 .
- Performance Evaluation (BT-114)
- Device Cartridge loading and replacement (BT-111)
- Fixation strength evaluation (BT 112)
- Mesh compatibility and Integrity following fixation with the Fas Touch Device (BT-113)
- Usability/Clinical Utility testing BT-WWH16
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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2016
Via Surgical Ltd. % Mr. Leo Basta CEO Northstar Biomedical Associates 93 Benefit Street Providence, Rhode Island 02904
Re: K162252
Trade/Device Name: Fastouch™ Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: October 20, 2016 Received: October 21, 2016
Dear Mr. Basta:
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 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162252
Device Name FasTouch™ Fixation System
Indications for Use (Describe)
The FasTouch™ Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
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 ViaSurgical's FasTouch™ Fixation System
I. SUBMITTER
Via Surgical Ltd. Mitzpe Kineret Street 22/1 Moshav Amirim, 20115, Israel
Tel: +972-52-639-5765 Fax: +972-153-77-500-8214
Date Prepared: August 6, 2016
Contact Person:
Leo Basta NorthStar Biomedical Associates for PolyTouch Medical Ltd. 755 Westminster Street Unit 120 Providence, RI 02903 617.834.9866 (phone) 401.454.1733 lbasta@northstarbiomedical.com
Or
Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com
II. DEVICE
| Name of Device: | FasTouch™ Fixation System |
|---|---|
| Common or Usual Name: | FasTouch™ Fixation System |
| Classification Name: | Staple Implantable (21 CFR 878.4750) |
| Regulatory Class: | II |
| Product Code: | GDW |
| Panel: | General & Plastic Surgery |
III. PREDICATE DEVICE
The predicate device is the FasTouch™ Fixation System, cleared under K132698.
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510(k) Summary - K162252
IV. DEVICE DESCRIPTION
The FasTouch™ Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate hernia mesh delivery and placement in laparoscopic or open ventral hernia repair. The FasTouch™ Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair.
The Via Surgical's FasTouch™ Fixation System is designed to be inserted through a laparoscopic port sleeve. The FasTouch™ Fixation System is packaged in its unloaded state and contains a handle and a cartridge.
The FasTouch™ Fixation System is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
V. INDICATIONS FOR USE
The FasTouch™ Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modified FasTouch™ Fixation System has the same intended use, principles of operation, and technological characteristics as the cleared FasTouch™ Fixation System. The minor differences in the handle design and in the clip do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified FasTouch™ Fixation System is as safe and effective as the FasTouch™ Fixation System. Thus, the FasTouch™ Fixation System is substantially equivalent to its predicate device.
VII. PERFORMANCE DATA
The following tests were performed and are the same as those performed and submitted in the original submission using the same acceptance criteria:
- Risk analysis per ISO 14971:2012 .
- · Performance Evaluation (BT-114)
- · Device Cartridge loading and replacement (BT-111)
- · Fixation strength evaluation (BT 112)
- · Mesh compatibility and Integrity following fixation with the Fas Touch Device (BT-113)
- · Usability/Clinical Utility testing BT-WWH16
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510(k) Summary - K162252
VIII. CONCLUSIONS
The modified FasTouch™ Fixation System device has the same intended use compared to the predicate device. The principal features of the device that were described show that the minor differences in device characteristics between the subject and predicate device do not raise any new questions of safety and effectiveness.
Performance data has been provided, establishing that the FasTouch™ Fixation System device performs as intended and in a manner that is substantially equivalent to the predicate. Therefore, the device may be found substantially equivalent.