(83 days)
No
The description focuses on a mechanical device for tissue fixation and does not mention any AI/ML components or functions.
No
A therapeutic device is one that treats a disease or condition. This device is used to fasten prosthetic or biologic material to soft tissues during surgical procedures, which is a surgical tool, not a therapeutic device.
No
Explanation: The device is intended for the fixation of prosthetic or biologic material to soft tissues during surgical procedures. There is no mention of it being used for diagnosis or detection of a disease/condition.
No
The device description clearly describes a physical, disposable surgical system designed to deliver absorbable fasteners, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- TissueTak Function: The TissueTak device is a surgical tool used during a surgical procedure to physically attach prosthetic or biologic material to soft tissue. It is a mechanical device that performs a physical action within the body.
- Lack of Specimen Examination: The description of the TissueTak device does not involve the examination of any specimens (blood, tissue samples, etc.) outside of the body. It is used directly on the tissue during surgery.
- Purpose: Its purpose is to provide mechanical fixation, not to provide diagnostic information about a patient's physiological or pathological state.
The TissueTak device falls under the category of a surgical instrument or implantable device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
GDW
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues (such as in hernia or rotator cuff repairs)
Indicated Patient Age Range
Individuals undergoing surgical procedure in which prosthetic mesh is being implanted
Intended User / Care Setting
Prescription Use. The device should be used only by trained surgeon under a physician order.
Hospitals, sub-acute care institutions and surgery center
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)
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.
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma@gmail.com Date Prepared: January 5, 2021
Manufacturer
Via Surgical Ltd. Mitzpe Kineret Street 22/1 Amirim 2011500, Israel Tel: +972-52-639-5765 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
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
System | TissueTak device | SE |
| Intended Use &
Indications for
Use | The FasTouch Absorbable
Fixation Device is intended
for fixation of prosthetic
material to soft tissues in
various minimally invasive
and open surgical procedures
such as hernia repairs. | 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. | Same
The addition of
the rotator cuff as
explanation of the
word "various"
does not change
the intended use
nor impact safety
or effectiveness. |
| 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
Design | 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 |
| 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) | PLGA8218 dyed with D&C 2
colorant 0.05% (a copolymer
of L-lactide and Glycolide in a
82/18 molar ratio) | Same |
| 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 |
| FasTouch Absorbable Fixation
System | TissueTak device | SE | |
| 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 |
An SE Table is presented below:
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6
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.