(133 days)
Not Found
No
The summary describes a mechanical, single-use fixation device with no mention of AI or ML capabilities in its function or design.
No
The device is used for fixation of prosthetic material to soft tissue during hernia repair, which is a structural or supportive function rather than a therapeutic/healing one.
No
This device is a surgical fixation device used to attach prosthetic material (like mesh) to soft tissue during hernia repair procedures. Its function is to physically secure materials, not to diagnose a condition or provide information about a disease state.
No
The device description clearly states it is a "single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft." It also mentions "Electrical safety testing per IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2," which are tests for hardware components. While software verification and validation are mentioned, the core of the device is a physical fixation device with absorbable tacks.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft." It's designed for introduction and use through a cannula during surgery.
- Mechanism of Action: The device physically attaches prosthetic material (like mesh) to soft tissue using tacks. This is a mechanical action within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (within the body) for a surgical fixation procedure.
N/A
Intended Use / Indications for Use
The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.
Product codes
OCW, GDW
Device Description
The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.
The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal wall (ventral & groin)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.
The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated.
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)
Non-clinical performance data - The following studies have been performed to demonstrate substantial equivalence to the predicate device. When possible, applicable FDA-recognized standards were considered:
- Stability/Shelf-Life study for the single use devices
- Performance testing that includes: ●
- Benchtop and ex-vivo testing o
- Reliability study performed to confirm the reliability of tack deployment and the functional O integrity of the mesh manipulation grip feature at the distal end of the device
- MaxTack™ in-vivo material strength study: MEDSD-2106 GLP Strength Loss Study of a O Hernia Fixation Tack in a Rat Model
- MaxTack™ in-vitro material strength correlation study o
- MaxTack™ in-vitro Mass Loss Study o
- Usability study performed to fulfil the primary objectives supporting design change following the ● FDA's quidance as well as IEC 62366-1
- Biocompatibility testing of the green tacks and delivery system conducted in accordance with the ● FDA's 2020 guidance and ISO 10993-1 for their intended patient contact profile and historical data on the safety of the green dye (D&C Green No. 6) has been reviewed and presented.
- Software verification & validation activities completed following the FDA's guidance documents . and IEC 62304
- Electrical safety testing per IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC ● 60601-1-2
- Cybersecurity Assessment following FDA's Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued October 2, 2014.
- Following ASTM D4169 and EN ISO 11607-1, the protection of the product during shipping and ● storage was evaluated using packaging & product integrity testing.
- Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility ● Assurance Level (SAL) of 10-6
Previously demonstrated compliance for the following aspects remain unimpacted:
- Biocompatibility evaluation of the violet tacks conducted for Predicate Device in accordance with ● the FDA's guidance and ISO 10993-1 for their intended patient contact profile.
- MR safety testing was performed on the Predicate device - K090470 and no change has been made to impact MR characteristics.
- Packaging stability of sterile barrier material was evaluated for representative material of sterile barrier, and requirements are met per EN ISO 11607-1:2020.
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 25, 2023
Covidien Megha Patel Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K231240
Trade/Device Name: MaxTack™ Motorized Fixation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, GDW, GDW
Dear Megha Patel:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 09/08/2023. Specifically, FDA is updating this SE Letter to correct the main product code to OCW and the regulation to 21 CFR 876.1500 - Endoscope and accessories to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, OHT4: Office of Surgical and Infection Control Devices, 301-796-5436, Mark.Trumbore@FDA.HHS.GOV.
Sincerely,
| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.10.25
11:28:30 -04'00' |
| --------------------- | --------------------------------------------------------------------------------- |
|---|
Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Covidien Megha Patel Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K231240
Trade/Device Name: MaxTack™ Motorized Fixation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Staple, Implantable Regulatory Class: Class II Product Code: OCW, GDW, GDW Dated: August 10, 2023 Received: August 10, 2023
Dear Megha Patel:
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
2
Page 2
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (QS) 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 medical devices and radiation-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,
Francisco Delgado -S 2023.09.08 16:45:11 -04'00'
for Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image contains the word "COVIDIEN" in a sans-serif font. The word is in all caps and is a dark blue color. To the left of the word is a blue square with a grid pattern inside of it.
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------|
| | Indications for Use | See PRA Statement below. | |
| 510(k) Number (if known) | | | |
| Device Name | MaxTack™ Motorized Fixation Device | | |
| Indications for Use (Describe) | The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures. | | |
| Type of Use (Select one or both, as applicable) | 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." | | |
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (300) 443-6740 | EP |
| CONFIDENTIAL | MaxTack™ Motorized Fixation Device
Traditional 510(k)
Covidien | | April 2023
Page 22 |
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510(k) Summary
DATE PREPARED:
April 28, 2023
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Megha Patel, MS-RA Sr. Requlatory Affairs Specialist Telephone: (917) 664-9611
IDENTIFICATION OF DEVICE:
| Proprietary/Trade Name: | MaxTack™ Motorized Fixation Device |
|---|---|
| Classification Name: | Endoscopic Tissue Approximation |
| Device; Staple, implantable | |
| Regulations Number: | 21 CFR 876.1500; 21 CFR 878.4750 |
| Device Class: | Class II |
| Product Codes: | OCW; GDW |
| Review Panel: | Gastroenterology/Urology; General and Plastic Surgery |
| Common Name: | Surgical Stapler |
PREDICATE DEVICE:
| Predicate | |
|---|---|
| 510(k) Number | K090470 |
| Proprietary/Trade Name | AbsorbaTack™ Absorbable Fixation Device (ABSTACK30) |
| Classification Name | Endoscopic Tissue Approximation Device and Staple, |
| Implantable | |
| Regulation Number | 21 CFR 876.1500; 21 CFR 878.4750 |
| Device Class | Class II |
| Product Code | OCW; GDW |
| Review Panel | Gastroenterology/Urology; General and Plastic Surgery |
| Common Name | Surgical Stapler |
DEVICE DESCRIPTION:
The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.
The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.
INDICATIONS FOR USE:
The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.
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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
MaxTack™ Motorized Fixation Device, as implied by the product name, is a motorized hernia fixation technology that can deploy up to 30 absorbable tacks. The advantages of the device, such as push-button operations and in-line handle, offer an ergonomic advantage, allowing for each tack to be deployed with equivalent force.
Following changes to the technological characteristics have been made compared to the predicate -K090470, AbsorbaTack™ Absorbable Fixation Device (ABSTACK30):
- . The tacks are delivered through a drive shaft assembly rotated by a motor that is controlled via software through a printed circuit board assembly (PCBA), housed in the handle. The device is powered bytwo 9V alkaline batteries in parallel.
- Change in tack design as compared to predicate, to maintain/increase current fixation strength atboth ● perpendicular and non-perpendicular tack firings. Also, the last five tacks that will be fired by the subject device are dyed with a different colorant (D&C Green No. 6) as an indicator of low tack count to the user.
- . The distal end of the shaft of the subject device will have a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.
The design differences were found to have no impact on safety or effectiveness. This was established through applicable design verification and validation activities that showed conformance to applicable technical design specifications and performance.
SUBSTANTIAL EQUIVALENCE:
The below table summarizes the similarities and differences between the subject and predicate devices.
| Feature | Subject Device (MAXTACK30) | Predicate Device (ABSTACK30 - K090470) |
|---|---|---|
| Indications for Use | The device is indicated for fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures. | The device is intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures. |
| Target Anatomy | Abdominal wall (ventral & groin) | Abdominal wall (ventral & groin) |
| Surgical Procedures | Minimally Invasive hernia repair | Minimally Invasive and Open surgical hernia repair |
| Classification | OCW, 21 CFR 876.1500 | |
| GDW, 21 CFR 878.4750 | OCW, 21 CFR 876.1500 | |
| GDW, 21 CFR 878.4750 | ||
| Operating Principle | Push-button motorized firing mechanism to deploy tacks | Manual power grip squeeze to deploy tacks |
| Description | Straight configuration: stand-alone preloaded shaft with 30 tacks | Straight configuration: stand-alone preloaded shaft with 30 tacks |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Biocompatibility | Evaluated per ISO 10993 series and FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and FDA 2016 biocompatibility guidance |
| Tack Shape | Screw-like, with modified features | Screw-like |
| Tack Material | PGLA (Poly Glycolic and Lactic Acid) | PGLA (Poly Glycolic and Lactic Acid) |
| Tack Color | Violet & Green (25 tacks & 5 tacks respectively) | Violet (30 tacks) |
| Tack Length | 7.0 mm | 5.1 mm |
| Shaft Length | 14 inches | 14 inches |
| Shaft | 304L Stainless Steel with laser etched logo and mesh manipulation/grip feature at distal end and | 304L Stainless steel with laser etched logo and no mesh manipulation/grip feature |
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Image /page/6/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a lighter blue and white design inside, followed by the word "COVIDIEN" in blue, sans-serif font. The wordmark is bold and appears to be a custom typeface.
SUMMARY OF STUDIES:
Non-clinical performance data - The following studies have been performed to demonstrate substantial equivalence to the predicate device. When possible, applicable FDA-recognized standards were considered:
- Stability/Shelf-Life study for the single use devices
- Performance testing that includes: ●
- Benchtop and ex-vivo testing o
- Reliability study performed to confirm the reliability of tack deployment and the functional O integrity of the mesh manipulation grip feature at the distal end of the device
- MaxTack™ in-vivo material strength study: MEDSD-2106 GLP Strength Loss Study of a O Hernia Fixation Tack in a Rat Model
- MaxTack™ in-vitro material strength correlation study o
- MaxTack™ in-vitro Mass Loss Study o
- Usability study performed to fulfil the primary objectives supporting design change following the ● FDA's quidance as well as IEC 62366-1
- Biocompatibility testing of the green tacks and delivery system conducted in accordance with the ● FDA's 2020 guidance and ISO 10993-1 for their intended patient contact profile and historical data on the safety of the green dye (D&C Green No. 6) has been reviewed and presented.
- Software verification & validation activities completed following the FDA's guidance documents . and IEC 62304
- Electrical safety testing per IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC ● 60601-1-2
- Cybersecurity Assessment following FDA's Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued October 2, 2014.
- Following ASTM D4169 and EN ISO 11607-1, the protection of the product during shipping and ● storage was evaluated using packaging & product integrity testing.
- Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility ● Assurance Level (SAL) of 10-6
Previously demonstrated compliance for the following aspects remain unimpacted:
- Biocompatibility evaluation of the violet tacks conducted for Predicate Device in accordance with ● the FDA's guidance and ISO 10993-1 for their intended patient contact profile.
- MR safety testing was performed on the Predicate device - K090470 and no change has been made to impact MR characteristics.
- Packaging stability of sterile barrier material was evaluated for representative material of sterile barrier, and requirements are met per EN ISO 11607-1:2020.
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
CONCLUSION:
Based upon the supporting data summarized above, we concluded that the MaxTack™ Motorized Fixation Device, is as safe and effective as the legally marketed predicate device and does not raise any additional questions of safety and effectiveness than the predicate device.