(83 days)
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.
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 provided text describes a 510(k) premarket notification for the TissueTak device, which is an implantable staple used for fixation of prosthetic or biologic material to soft tissues. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (FasTouch Absorbable Fixation System), rather than establishing de novo clinical efficacy through a comprehensive clinical trial with pre-defined acceptance criteria for diagnostic performance (such as those typically seen for AI/ML devices). This is because the core technology (an implantable staple) is well-established, and the modification is minor (clarification of intended use wording).
Therefore, the information you've requested about acceptance criteria, clinical study design, expert involvement, and statistical analyses (like MRMC studies or standalone algorithm performance) for a diagnostic AI/ML enabled device is not applicable to this 510(k) submission.
The "study" here is a performance test to ensure the modified device functions equivalently to the predicate, focusing on mechanical properties rather than diagnostic accuracy.
Here's a breakdown of why this information isn't present in the provided document, and what is presented instead:
1. A table of acceptance criteria and the reported device performance:
- Not applicable in the context of diagnostic AI/ML thresholds.
- Instead, the document focuses on "Substantial Equivalence" criteria, which are:
- Same Intended Use & Indications for Use (with a minor clarification for rotator cuff repair)
- Same Environments of Use
- Same Patient Population
- Same Delivery Device Design
- Same Loading Mechanism
- Same Shaft Length
- Same Firing Mechanism
- Same Penetration Depth
- Same Number of Fasteners
- Same Fastener Material
- Same Fastener Design
- Same Single Patient Use, Disposable
- Same Sterilization Method
- Same Prescription Use requirement
- Reported Device Performance (for this type of device): "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. In all instances, the modified TissueTak device functioned as intended and demonstrated equivalent performance to its predicate."
- Note: The specific quantitative results of this fixation strength test (e.g., in Newtons or PSI, with a defined acceptance range) are not provided in this summary document, but would have been part of the full submission to the FDA. The summary simply states that equivalence was demonstrated.
2. Sample size used for the test set and the data provenance:
- Not applicable for a "test set" in the diagnostic AI/ML sense.
- The "test set" here refers to the samples of devices used in the mechanical performance tests. The specific number of devices tested for fixation strength is not mentioned in this summary but would have been defined by engineering test protocols.
- Data Provenance: Not relevant for a mechanical device test; it's performed in a lab setting, likely by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for an AI/ML diagnostic algorithm (e.g., image annotation by radiologists) is not relevant here. The ground truth for a mechanical fixation device is its physical properties (e.g., force required to detach the staple).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to expert consensus in AI/ML model validation. Mechanical tests have predefined pass/fail criteria based on engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This pertains to diagnostic AI/ML where human interpretation is involved. This device is a surgical staple, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This also pertains to diagnostic AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the diagnostic sense. For this device, the "ground truth" for its performance would be the results of mechanical and functional tests (e.g., tensile strength, securement force, deployment reliability), compared against pre-defined engineering specifications and bench-top performance of the predicate device.
8. The sample size for the training set:
- Not applicable. This relates to AI/ML model training, which is not relevant for a mechanical surgical device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary: The provided FDA 510(k) summary for the TissueTak device is for a mechanical surgical implantable staple, not a diagnostic AI/ML device. Consequently, the performance criteria and study details are focused on demonstrating substantial equivalence to a predicate device through mechanical performance testing and comparison of device characteristics, rather than clinical efficacy or diagnostic accuracy studies typically associated with AI/ML systems.
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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 FixationSystem | 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 FixationSystem | TissueTak device | SE | |
| Intended Use &Indications forUse | The FasTouch AbsorbableFixation Device is intendedfor fixation of prostheticmaterial to soft tissues invarious minimally invasiveand open surgical proceduressuch as hernia repairs. | The TissueTak device isintended for fixation ofprosthetic or biologic materialto soft tissues in variousminimally invasive and opensurgical procedures such ashernia or rotator cuff repairs. | SameThe addition ofthe rotator cuff asexplanation of theword "various"does not changethe intended usenor impact safetyor effectiveness. |
| Environmentsof Use | Hospitals, sub-acute careinstitutions and surgery center | Hospitals, sub-acute careinstitutions and surgery center | Same |
| PatientPopulation | Individuals undergoingsurgical procedure in whichprosthetic mesh is beingimplanted | Individuals undergoingsurgical procedure in whichprosthetic mesh is beingimplanted | Same |
| Delivery DeviceDesign | 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 |
| FiringMechanism | Spring-load | Spring-load | Same |
| PenetrationDepth | 6.1mm | 6.1mm | Same |
| Number ofFasteners | 25 | 25 | Same |
| FastenerMaterial | PLGA8218 dyed with D&C 2colorant 0.05% (a copolymerof L-lactide and Glycolide in a82/18 molar ratio) | PLGA8218 dyed with D&C 2colorant 0.05% (a copolymerof L-lactide and Glycolide in a82/18 molar ratio) | Same |
| Fastener Design | Strap - suture like | Strap - suture like | Same |
| Single PatientUse, Disposable | Yes | Yes | Same |
| Sterilization | Sterile for single use EtO | Sterile for single use EtO | Same |
| FasTouch Absorbable FixationSystem | TissueTak device | SE | |
| Prescription Use | The device should be used onlyby trained surgeon under aphysician order. | The device should be used onlyby trained surgeon under aphysician 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.
§ 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.