(445 days)
No
The device description and performance studies focus on mechanical fixation and material properties, with no mention of AI/ML or data-driven functionalities.
No.
The device is used for surgical fixation of mesh to tissues, specifically in procedures like hernia repair, which is a structural or mechanical support function rather than a therapeutic treatment for disease.
No
The device is described as an "Absorbable Fixation System" designed to approximate surgical mesh to tissues during surgical procedures, not to diagnose a condition.
No
The device description clearly outlines a physical deployment device with a handle, trigger, shaft, and tip, preloaded with absorbable fasteners. This indicates a hardware-based medical device, not a software-only one.
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 "approximation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is described as a system for delivering an absorbable fastener for tissue fixation. This is a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Surgimatix Absorbable Fixation System does not fit this description.
N/A
Intended Use / Indications for Use
The Surgimatix Absorbable Fixation System is indicated for the approximation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Surgimatix Absorbable Fastener System is designed to deliver an absorbable fastener for tissue-to-tissue fixation or mesh-to-tissue fixation during surgical procedures. The deployment device consists of an ergonomic handle with trigger, shaft and tip. The shaft is 38 cm long, and can be utilized for laparoscopic or open surgical procedures. The device is preloaded with 20 polydioxanone absorbable fasteners. During deployment into soft tissue or mesh the absorbable fastener is formed into a helical configuration to establish fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Mechanical, biocompatibility, and preclinical data confirmed that the Surgimatix Absorbable Fixation System performs as intended and that no new issues of safety and effectiveness are introduced. The Surgimatix Absorbable Fasteners were tested in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Davol Absorbable Fastener System 510(k) #: K082396
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
The SorbaFix Absorbable Fixation System (K111153), and the Surgimatix Proxifast Absorbable Staple (K132669)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
October 1, 2021
Surgimatix, Inc. Dorene Markwiese Director of Regulatory Affairs 1539 Jarvis Ave Elk Grove Village, Illinois 60007
Re: K201934
Trade/Device Name: Surgimatix Absorbable Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: September 1, 2021 Received: September 2, 2021
Dear Dorene Markwiese:
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
1
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,
Deborah Fellhauer Acting 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
2
Indications for Use
510(k) Number (if known) K201934
Device Name Surgimatix Absorbable Fixation System
Indications for Use (Describe)
The Surgimatix Absorbable Fixation System is indicated for the approximation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Type of Use (Select one or both, as applicable)
| Production Use (Part 21 CFR 607 Subpart D) |
|---|
| Study, Teaching, or Research Use (21 CFR 58) |
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."
3
SECTION 5: 510(k) SUMMARY STATEMENT
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
1. General Information
Date of Submission: June 29, 2020
| Submitted By: | Surgimatix, Inc. |
|---|---|
| 1539 Jarvis Street | |
| Elk Grove Village, IL 60007 |
| Contact Person: | Dorene Markwiese |
|---|---|
| Director of Regulatory Affairs | |
| Phone 847-400-2546 | |
| Fax 847-258-3326 | |
| dmarkwiese@surgimatix.com |
2. Trade/Proprietary Name of Device:
| Trade Name: | Surgimatix Absorbable Fixation System |
|---|---|
| Common Name: | Staple, Implantable |
| Regulation Number | 878.4750 |
| Product Code: | GDW |
| Device Panel: | General and Plastic Surgery |
| Device Classification: | Class II |
3. Legally Marketed Predicate Devices for Claimed Equivalence:
Name: Davol Absorbable Fastener System 510(k) #: K082396
The SorbaFix Absorbable Fixation System (K111153) and the Surgimatix Proxifast Absorbable Staple (K132669) are reference devices for this submission.
4. Device Description
The Surgimatix Absorbable Fastener System is designed to deliver an absorbable fastener for tissue-to-tissue fixation or mesh-to-tissue fixation during surgical procedures. The deployment device consists of an ergonomic handle with trigger, shaft and tip. The shaft is 38 cm long, and can be utilized for laparoscopic or open surgical procedures. The device is preloaded with 20 polydioxanone absorbable fasteners. During deployment into soft tissue or mesh the absorbable fastener is formed into a helical configuration to establish fixation.
4
5. Indications for Use Statement
The Surgimatix Absorbable Fixation System is intended for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
6. Substantial Equivalence Comparison
Indications for Use:
Substantial equivalence for the Surgimatix Absorbable Fixation System is supported by the predicate device listed in this submission, which has an identical indications statement.
Technological Characteristics:
Key technological characteristics of the Surgimatix Absorbable Fixation System are similar to the predicate device. Both devices have the same basic components including a handle and shaft designed to deliver a fastener. Both devices use similar fixation technology to deliver a fastener by activating a trigger. The Surgimatix absorbable fasteners are manufactured from polydiaxonone, whereas the predicate absorbable fasteners are manufactured from poly (D.L.) lactide. The materials are both commonly used for implantable sutures or fasteners. The Surgimatix absorbable fastener material is identical to the material utilized for the Surgimatix Proxifast Absorbable Staple (K132669), referenced within this submission.
The proposed device and the predicate device differ in the details of the device design. The proposed device utilizes opposing needles at the tip to deliver the fastener into a helical configuration in the soft tissue or mesh. The predicate device has fasteners that are screw like which are driven into the tissue or mesh using a needle. The functional result of each device is equivalent as the end effect is to effectively place a fastener into tissue and/or mesh for fixation. Mechanical, biocompatibility, and preclinical data confirmed that the Surgimatix Absorbable Fixation System performs as intended and that no new issues of safety and effectiveness are introduced. The Surgimatix Absorbable Fasteners were tested in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device.
7. Conclusion
The Surgimatix Absorbable Fixation System is substantially equivalent to the predicate device currently marketed in accordance with the Federal Food, Drug and Cosmetic Act.