(261 days)
No
The description focuses on a mechanical fixation system and does not mention any AI or ML components.
No
This device is for fixation of prosthetic material to soft tissues, such as during hernia repair, which is a surgical tool rather than a therapeutic device that treats or cures a condition.
No
The device is described as a fixation system intended for use in surgical procedures to attach prosthetic material to soft tissues. Its function is to deliver absorbable fasteners, not to diagnose conditions or diseases.
No
The device description clearly outlines a physical, disposable surgical system designed to deliver absorbable fasteners. It describes hardware components like a firing mechanism and fasteners made of specific materials. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures." This is a surgical tool used for mechanical fixation.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to be used in vitro (outside the living body) for diagnostic purposes. This device is used in vivo (within the living body) for a surgical procedure.
N/A
Intended Use / Indications for Use
The FasTouch Absorbable 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 Absorbable Fixation System is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia repair.
The Via Surgical FasTouch Absorbable Fixation System, is designed to be inserted through a 5mm or larger laparoscopic port sleeve.
The fasteners two ends are designed to be locked together in the tissue by the Fas Touch firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, sub-acute care institutions and surgery center
The device should be used only by trained surgeon under a physician order.
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)
- Risk analysis: per ISO 14971:2012
- Biocompatibility testing: An evaluation of biocompatibility was performed in compliance with ISO 10993-1. Biocompatibility evaluation included:
- Cytotoxicity Study Using the ISO Elution Method (ISO 10993-5: 2009)
- Irritation - ISO Intracutaneous Study (ISO 10993-10: 2010)
- Systemic Toxicity Study (ISO 10993:11:2010)
- ISO Maximization Sensitization Test (ISO 10993-10: 2010)
- Pyrogen Study - Material Mediated (ISO 10993-11:2010)
- Implantation/Toxicity (ISO 10993-6, ISO 10993-11)
*All tests were completed with passing results.
- Sterilization, Packaging and Shelf Life Testing: Sterilization validation testing of the FasTouch Absorbable Fixation System is performed to demonstrate compliance with ISO 11135-1. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
- Bench Testing:
- TEST # 1: Fixation Strength Evaluation (BT-212)
- TEST# 2: Mesh compatibility and Integrity following fixation with the FasTouch Absorbable Fixation System (BT-213)
- TEST# 3: Performance Evaluation (BT-214)
*All tests met the predefined acceptance criteria.
- Animal Study: Performed at the Institute of Animal Research in Kibbutz Lahav in Israel by several trained surgeons evaluating the subject device in comparison to the predicate and reference devices.
*Purpose: To assess the functionality and usability of the FasTouch Absorbable Fixation System.
*Key results: No adverse events occurred, devices performed well without malfunction to users' satisfaction. Users were able to perform the required tasks. Histopathology evaluation was also conducted at the preset intervals up to 3 months. The test met the predefined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue.
March 13, 2019
Via Surgical Ltd. % Mr. Leo Basta Owner Northstar Biomedical Associates 93 Benefit Street Providence. Rhode Island 02904
Re: K181668
Trade/Device Name: FasTouch Absorbable Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: June 22, 2018 Received: June 25, 2018
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name "Joseph Nielsen -S" in a large font. To the right of the name is a digital signature from Joseph Nielsen -S. The signature includes the date 2019.03.13 13:22:02 -04'00' and other information such as DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Joseph Nielsen -S, and 0.9.2342.19200300.100.1.1=20003675.
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K181668
Device Name FasTouch Absorbable Fixation System
Indications for Use (Describe)
The FasTouch Absorbable 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) | ||
|---|---|---|
| Research Use (Part 21 CFR 601.21; Subpart B) Over-The-Counter Use (21 CFR 201.66) | Research Use (Part 21 CFR 601.21; Subpart B) | Over-The-Counter Use (21 CFR 201.66) |
| Research Use (Part 21 CFR 601.21; Subpart B) | ||
| Over-The-Counter Use (21 CFR 201.66) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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 PRAStaff@fda.hhs.gov
"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
Image /page/3/Picture/1 description: The image shows the logo for Via Surgical. The logo features a stylized, abstract graphic to the left of the company name. The graphic is a gray triangle with a green arrow pointing upwards and to the right. The company name, "Via Surgical," is written in a sans-serif font, with "Via" in a slightly bolder font than "Surgical."
Traditional Premarket Notification Submission - 510(k) FasTouch Absorbable Fixation System
Date Prepared: June 19, 2018
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
Contact Person
Leo Basta Northstar Biomedical Associates for Via Surgical Ltd. 755 Westminster Street Unit 120 Providence, RI 02903 617.834.9866 (phone) 401.454.1733 lbasta@northstarbiomedical.com
and/or
Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma(@gmail.com
II. DEVICE
Name of Device: FasTouch Absorbable Fixation System
Common or Usual Name: FasTouch Absorbable Fixation System
Classification Name: Implantable staple, Regulation No. 878.4750 Regulatory Class: II
4
Image /page/4/Picture/1 description: The image shows the logo for Via Surgical. The logo features a stylized gray and green icon on the left, resembling a globe with a green arrow piercing through it. To the right of the icon, the text "Via Surgical" is written in a clean, sans-serif font, with the letters in a light gray color.
Product Code: GDW
III. PREDICATE DEVICE
Via Surgical Ltd. believes that the FasTouch Absorbable Fixation System is substantially equivalent to the following predicate device:
- Via Surgical FasTouch Fixation System cleared under ● K162252 and (product code GDW Regulation No. 878.4750) and K132698 (original submission).
In addition, the OptifixTM Absorbable Fixation System (C.R. BARD, Inc) cleared under K132134 (product code GDW, Regulation No. 878.4750) is being used as a reference device for its technological characteristics of the fastener used for the same clinical intended use.
IV. DEVICE DESCRIPTION
The FasTouch Absorbable Fixation System is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia repair.
The Via Surgical FasTouch Absorbable Fixation System, is designed to be inserted through a 5mm or larger laparoscopic port sleeve.
The fasteners two ends are designed to be locked together in the tissue by the Fas Touch firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.
V. INDICATIONS FOR USE
The FasTouch Absorbable 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 FasTouch Absorbable Fixation System has the same intended use as the predicate device. In addition, the subject device has the identical indications for use to that of the reference device. The dimensions of the FasTouch Absorbable Fixation System are identical to the predicate. Similar tests and test methods performed in accordance
5
Image /page/5/Picture/1 description: The image shows the logo for Via Surgical. The logo features a stylized letter "V" with a green arrow pointing upwards and to the right. The text "Via Surgical" is written in a sans-serif font to the right of the "V" symbol. The logo is simple and modern, and the green arrow suggests growth and progress.
with the same standards were used in both FasTouch Absorbable Fixation System and the predicate device to validate the design. The testing results showed that the minor differences in device characteristics between the subject devices and predicate devices do not raise any new questions of safety or effectiveness.
The FasTouch Absorbable Fixation System have the same technological characteristics as the predicate device and as the reference device as demonstrated in the SE table below:
Based on the above analysis, Via Surgical Ltd. believes that the FasTouch Absorbable Fixation System is substantially equivalent to the legally marketed predicate device.
| | FasTouch Absorbable
Fixation System | FasTouch Fixation
System | SE Justification |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 510(k) Number | Not yet known | K132698 and K162252 | |
| Manufacturer | Via Surgical Ltd. | Via Surgical Ltd. | Same |
| Product Code | GDW | GDW | Same |
| CFR | 878.4750 | 878.4750 | Same |
| Intended Use &
Indications for
Use | The FasTouch Absorbable
Fixation System is intended
for fixation of prosthetic
material to soft tissues in
various minimally invasive
and open surgical procedures
such as hernia repairs. | The FasTouch Fixation
Device is intended for
fixation of prosthetic
material to soft tissues in
various minimally
invasive and open
surgical procedures such
as hernia repairs | Same |
| Environments
of Use | Hospitals, sub-acute care
institutions and surgery
center | Hospitals, sub-acute care
institutions and surgery
center | Same |
| Patient
Population | Individuals undergoing
surgical procedure in which
prosthetic mesh is being
implanted | Individuals undergoing
surgical procedure in
which prosthetic mesh is
being implanted | Same |
| Delivery Device | Handles with trigger
"piston" grip | Handles with trigger
"piston" grip | Same |
| Loading | Cartridge can be loaded in
OR | Cartridge can be loaded
in OR | Same |
6
Image /page/6/Picture/1 description: The image shows the logo for Via Surgical. The logo consists of a stylized graphic on the left and the text "Via Surgical" on the right. The graphic features a gray shape with a green arrow pointing upwards. The text "Via Surgical" is in a sans-serif font and is gray in color.
| | FasTouch Absorbable
Fixation System | FasTouch Fixation
System | SE Justification |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Shaft Length | 35.7cm | 35.7cm | Same |
| Firing
Mechanism | Spring-load | Spring-load | Same |
| Penetration
Depth | 6.1mm | 6.1mm | Same |
| Number of
Fasteners | 25 | 25 | Same |
| Fastener
Material | PLGA8218 dyed with D&C 2
colorant 0.05% (a copolymer
of L-lactide and Glycolide in
a 82/18 molar ratio) | Non - absorbable polymer
(PCU) | Same as the
reference device
Optifix
Absorbable
Fixation System
cleared under
K132134 |
| Fastener Design | Strap - suture like | Strap - suture like | Same |
| Single Patient
Use, Disposable | Yes | Yes | Same |
| Sterilization | Sterile for single use EtO | Sterile for single use EtO | Same |
| Prescription Use | The device should be used
only by trained surgeon under
a physician order. | The device should be
used only by trained
surgeon under a physician
order. | Same |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- Risk analysis per ISO 14971:2012 -
- Biocompatibility testing -
An evaluation of biocompatibility was performed in compliance with ISO 10993-1. Biocompatibility evaluation included:
| # | Test | Standard |
|---|---|---|
| 1 | Cytotoxicity Study Using the ISO Elution | |
| Method | ISO 10993-5: 2009 |
7
Image /page/7/Picture/1 description: The image shows the logo for Via Surgical. The logo features a stylized, abstract shape in shades of gray and green on the left, resembling a mountain or a stylized letter "V". To the right of the shape, the words "Via Surgical" are written in a clean, sans-serif font, with "Via" slightly larger than "Surgical".
| # | Test | Standard |
|---|---|---|
| 2 | Irritation - ISO Intracutaneous Study | ISO 10993-10: 2010 |
| 3 | Systemic Toxicity Study | ISO 10993:11:2010 |
| 4 | ISO Maximization Sensitization Test | ISO 10993-10: 2010 |
| 5 | Pyrogen Study - Material Mediated | ISO 10993-11:2010 |
| 6 | Implantation/Toxicity | ISO 10993-6 |
| ISO 10993-11 |
All tests were completed with passing results.
Sterilization, Packaging and Shelf Life Testing
Sterilization validation testing of the FasTouch Absorbable Fixation System is performed to demonstrate compliance with ISO 11135-1. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
Bench Testing
Bench testing included the following: TEST # 1: Fixation Strength Evaluation (BT-212) TEST# 2: Mesh compatibility and Integrity following fixation with the FasTouch Absorbable Fixation System (BT-213) TEST# 3: Performance Evaluation (BT-214) All tests met the predefined acceptance criteria.
Animal Study
Animal Study was performed at the Institute of Animal Research in Kibbutz Lahav in Israel by several trained surgeons evaluating the subject device in comparison to the predicate and reference devices.
The purpose of the study was to assess the functionality and usability of the FasTouch Absorbable Fixation System.
No adverse events occurred, devices performed well without malfunction to users' satisfaction. Users were able to perform the required tasks. Histopathology evaluation was also conducted at the preset intervals up to 3 months. The test met the predefined acceptance criteria.
VIII. CONCLUSIONS
The FasTouch Absorbable Fixation System has the same intended use as the predicate device and the reference device. The principal features of the device that were described, as well as the testing provided, show that the minor differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
8
Image /page/8/Picture/1 description: The image shows the logo for Via Surgical. The logo features a stylized gray and green arrow pointing upwards and to the right. To the right of the arrow is the text "Via Surgical" in a sans-serif font, with "Via" in a slightly darker shade of gray than "Surgical".
Performance data and animal study have been provided using both the predicate and reference device as appropriate, establishing that the FasTouch Absorbable Fixation System performs as intended and in a manner that is substantially equivalent to the predicate. Therefore, the device is substantially equivalent.