TissueTak device

K203117 · Via Surgical , Ltd. · GDW · Jan 7, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203117
• Device Name: TissueTak device
• Applicant: Via Surgical , Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jan 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.

Device Story

Disposable, sterile, single-use surgical instrument; delivers absorbable fasteners to secure prosthetic or biologic material to soft tissue. Operated by surgeons in hospitals, sub-acute care institutions, or surgery centers. Inserted via 5mm or larger laparoscopic port. Features spring-loaded firing mechanism; locks two ends of fastener together within tissue to form closed loop. Enables secure mesh/patch fixation during hernia or rotator cuff repairs. Benefits patient by providing reliable, absorbable fixation in minimally invasive or open procedures.

Clinical Evidence

Bench testing only. Performance data demonstrated that the modified TissueTak device provides equivalent fixation strength to the predicate FasTouch Absorbable Fixation System and reference device. Risk analysis concluded no additional risks were introduced.

Technological Characteristics

Disposable, single-use, spring-loaded delivery system. Fasteners made of PURASORB PLG 8218 (copolymer of L-lactide and Glycolide, 82/18 molar ratio) dyed with D&C violet No. 2. Shaft length 35.7cm; penetration depth 6.1mm. Sterilized via Ethylene Oxide (EtO).

Indications for Use

Indicated for individuals undergoing surgical procedures requiring fixation of prosthetic or biologic material to soft tissues, including hernia or rotator cuff repairs. Prescription use only.

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

• FasTouch Absorbable Fixation System (K181668)

Reference Devices

• Rotation Medical Soft Tissue Staple (RMST Staple) (K131637)

Submission Summary (Full Text)

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January 7, 2021

Via Surgical Ltd. % Orly Maor Company Consultant Orly Maor 25A Sirkin Street Kfar Saba, 4442156 Israel

Re: K203117

Trade/Device Name: TissueTak device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, Dated: October 10, 2020 Received: October 16, 2020

Dear Mr. Maor:

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. Although this letter refers to your product as a device, please be aware 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 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203117

Device Name TissueTak device

Indications for Use (Describe)

The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY

Via Surgical Ltd. TissueTak device K203117

# Contact Person

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: [phone] Fax: [phone] [e-mail] Date Prepared: January 5, 2021

## Manufacturer

Via Surgical Ltd. Mitzpe Kineret Street 22/1 Amirim 2011500, Israel Tel: [phone] Contact Person: Ofek Levin

#### Subject Device

Name of Device- TissueTak device Regulation Number- 21 CFR 878.4750 Regulation Name- Implantable staple Regulatory class- class II Product Code- GDW Classification Panel- General & Plastic Surgery

## Predicate Device

510(k) Number- K181668 Name of Device- FasTouch Absorbable Fixation System Regulation Number- 21 CFR 878.4750 Regulation Name- Implantable staple Regulatory class- class II Product Code- GDW Classification Panel- General & Plastic Surgery

## Reference Device

510(k) Number- K131637 Name of Device- Rotation Medical Soft Tissue Staple (RMST Staple) Regulation Number- 21 CFR 878.4750 Regulation Name- Implantable staple

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Regulatory class- class II Product Code- GDW

# Indications for Use

The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.

# Purpose of 510(k)

The purpose of this 510(k) is to describe the modifications made to the cleared FasTouch Absorbable Fixation System.

# Description

The TissueTak device is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia or rotator cuff repairs.

The Via Surgical TissueTak device, 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 TissueTak firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh/patch to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.

The only change in the TissueTak device from the cleared FasTouch Absorbable Fixation System include clarification of the intended use wording to include rotator cuff repair.

# Substantial Equivalence Discussion

The TissueTak device has the same intended use and indications for use, and similar principles of operation, and technological characteristics as the cleared device. The minor differences in the intended use words do not raise any new questions of safety or effectiveness. Performance data demonstrated that the modified TissueTak is as safe and effective as its predicate device. Thus, the modified TissueTak device is substantially equivalent to its predicate device.

| | FasTouch Absorbable Fixation<br>System | TissueTak device | SE |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181668 | K203117 | |
| Manufacturer | Via Surgical Ltd. | Via Surgical Ltd. | Same |
| Product Code | GDW | GDW | Same |
| CFR | 878.4750 | 878.4750 | Same |
| | FasTouch Absorbable Fixation<br>System | TissueTak device | SE |
| Intended Use &<br>Indications for<br>Use | The FasTouch Absorbable<br>Fixation Device 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 TissueTak device is<br>intended for fixation of<br>prosthetic or biologic material<br>to soft tissues in various<br>minimally invasive and open<br>surgical procedures such as<br>hernia or rotator cuff repairs. | Same<br>The addition of<br>the rotator cuff as<br>explanation of the<br>word "various"<br>does not change<br>the intended use<br>nor impact safety<br>or effectiveness. |
| Environments<br>of Use | Hospitals, sub-acute care<br>institutions and surgery center | Hospitals, sub-acute care<br>institutions and surgery 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 which<br>prosthetic mesh is being<br>implanted | Same |
| Delivery Device<br>Design | Handles with trigger<br>"piston" grip | Handles with trigger<br>"piston" grip | Same |
| Loading | Cartridge can be loaded in OR | Cartridge can be loaded in OR | Same |
| 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 a<br>82/18 molar ratio) | PLGA8218 dyed with D&C 2<br>colorant 0.05% (a copolymer<br>of L-lactide and Glycolide in a<br>82/18 molar ratio) | Same |
| 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 |
| FasTouch Absorbable Fixation<br>System | TissueTak device | SE | |
| Prescription Use | The device should be used only<br>by trained surgeon under a<br>physician order. | The device should be used only<br>by trained surgeon under a<br>physician order. | Same |

An SE Table is presented below:

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# Performance Data

Performance test was conducted in order to demonstrate that the fixation strength of the modified TissueTak device have equivalent performance to the FasTouch Absorbable Fixation System predicate and its refence device.

Risk analysis was performed and it was concluded that no additional risks were raised. In all instances, the modified TissueTak device functioned as intended and demonstrated equivalent performance to its predicate.

# Conclusions

The TissueTak device is substantially equivalent to the predicate device.