FasTouch Absorbable Fixation System

K181668 · Via Surgical , Ltd. · GDW · Mar 13, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K181668
• Device Name: FasTouch Absorbable Fixation System
• Applicant: Via Surgical , Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Mar 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Disposable, sterile, single-use system for delivering absorbable fasteners to secure prosthetic mesh to soft tissue during general surgery (e.g., hernia repair). Device inserted via 5mm+ laparoscopic port; features spring-loaded firing mechanism. Fasteners (PLGA 8218) lock in tissue to form closed loops. Used in hospitals, sub-acute care institutions, and surgery centers by trained surgeons. Provides secure mesh fixation; absorbable material eliminates long-term foreign body presence associated with non-absorbable fasteners.

Clinical Evidence

Animal study conducted at the Institute of Animal Research (Kibbutz Lahav, Israel) compared subject device to predicate and reference devices. Evaluated functionality, usability, and histopathology up to 3 months. No adverse events reported; devices performed as intended to user satisfaction. Bench testing included fixation strength, mesh compatibility/integrity, and performance evaluation, all meeting predefined acceptance criteria.

Technological Characteristics

Disposable, single-use, spring-loaded delivery system. Shaft length 35.7cm; penetration depth 6.1mm. Fasteners made of PURASORB PLG 8218 (copolymer of L-lactide and Glycolide, 82/18 molar ratio) dyed with D&C violet No. 2. Sterilization via EtO per ISO 11135-1. Biocompatibility testing per ISO 10993 series.

Indications for Use

Indicated for individuals undergoing surgical procedures requiring prosthetic mesh fixation to soft tissues, including minimally invasive and open hernia repairs. Use restricted to trained surgeons under physician order.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Via Surgical FasTouch Fixation System (K162252, K132698)

Reference Devices

• Optifix Absorbable Fixation System (K132134)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><div style="display:inline-block; vertical-align:middle;"> <input checked="true" type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Research Use (Part 21 CFR 601.21; Subpart B)</div></td></tr><tr><td><div style="display:inline-block; vertical-align:middle;"> <input type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Over-The-Counter Use (21 CFR 201.66)</div></td></tr></table> | <div style="display:inline-block; vertical-align:middle;"> <input checked="true" type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Research Use (Part 21 CFR 601.21; Subpart B)</div> | <div style="display:inline-block; vertical-align:middle;"> <input type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Over-The-Counter Use (21 CFR 201.66)</div> |
| <div style="display:inline-block; vertical-align:middle;"> <input checked="true" type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Research Use (Part 21 CFR 601.21; Subpart B)</div> | | |
| <div style="display:inline-block; vertical-align:middle;"> <input type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Over-The-Counter Use (21 CFR 201.66)</div> | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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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: [phone] Fax: [phone]

## 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 [e-mail]

## and/or

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: [phone] Fax: [phone] 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

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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

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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<br>Fixation System | FasTouch Fixation<br>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 &<br>Indications for<br>Use | The FasTouch Absorbable<br>Fixation System is intended<br>for fixation of prosthetic<br>material to soft tissues in<br>various minimally invasive<br>and open surgical procedures<br>such as hernia repairs. | The FasTouch Fixation<br>Device is intended for<br>fixation of prosthetic<br>material to soft tissues in<br>various minimally<br>invasive and open<br>surgical procedures such<br>as hernia repairs | Same |
| Environments<br>of Use | Hospitals, sub-acute care<br>institutions and surgery<br>center | Hospitals, sub-acute care<br>institutions and surgery<br>center | Same |
| Patient<br>Population | Individuals undergoing<br>surgical procedure in which<br>prosthetic mesh is being<br>implanted | Individuals undergoing<br>surgical procedure in<br>which prosthetic mesh is<br>being implanted | Same |
| Delivery Device | Handles with trigger<br>"piston" grip | Handles with trigger<br>"piston" grip | Same |
| Loading | Cartridge can be loaded in<br>OR | Cartridge can be loaded<br>in OR | Same |

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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<br>Fixation System | FasTouch Fixation<br>System | SE Justification |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Shaft Length | 35.7cm | 35.7cm | Same |
| Firing<br>Mechanism | Spring-load | Spring-load | Same |
| Penetration<br>Depth | 6.1mm | 6.1mm | Same |
| Number of<br>Fasteners | 25 | 25 | Same |
| Fastener<br>Material | PLGA8218 dyed with D&C 2<br>colorant 0.05% (a copolymer<br>of L-lactide and Glycolide in<br>a 82/18 molar ratio) | Non - absorbable polymer<br>(PCU) | Same as the<br>reference device<br>Optifix<br>Absorbable<br>Fixation System<br>cleared under<br>K132134 |
| Fastener Design | Strap - suture like | Strap - suture like | Same |
| Single Patient<br>Use, Disposable | Yes | Yes | Same |
| Sterilization | Sterile for single use EtO | Sterile for single use EtO | Same |
| Prescription Use | The device should be used<br>only by trained surgeon under<br>a physician order. | The device should be<br>used only by trained<br>surgeon under a physician<br>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<br>Method | ISO 10993-5: 2009 |

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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<br>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.

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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.