Who is the manufacturer of Suture-TOOL System?

Suturion AB filed the 510(k) submission for Suture-TOOL System (K242835).

What is the FDA product code for Suture-TOOL System?

NEW. It is classified under 21 CFR 878.4840 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Suture-TOOL System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Suture-TOOL System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Suture-TOOL System

K242835 · Suturion AB · NEW · Jan 22, 2025 · General, Plastic Surgery

Device Facts

Record ID	K242835
Device Name	Suture-TOOL System
Applicant	Suturion AB
Product Code	NEW · General, Plastic Surgery
Decision Date	Jan 22, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4840
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

Device Story

Suture-TOOL System is a single-use, sterile suture applicator pre-loaded with a polydioxanone (PDO) monofilament absorbable suture on a needle. Used for abdominal wall closure following laparotomy; operated by surgeons in clinical settings. Device facilitates consistent suture placement; improves adherence to suture length/wound length (SL/WL) ratio ≥ 4 compared to manual suturing. Benefits include reduced risk of incisional hernia, surgical site infections, and needle stick injuries for clinicians. Healthcare providers use the applicator to place sutures; output is a closed abdominal incision. System components include the 1018S applicator and 1020S suture/needle assembly.

Clinical Evidence

Bench testing only. Physical testing performed per USP 29/41-NF36:2018 standards for suture diameter (<861>), needle attachment (<871>), and tensile strength (<881>). Biocompatibility testing conducted per ISO 10993-1:2018. Human factors/usability testing performed per 2016 FDA guidance. Literature review (Börner and Montgomery, 2020; Börner et al., 2022) indicates improved SL/WL ratio adherence compared to manual suturing.

Technological Characteristics

Single-use, sterile suture applicator. Suture material: Poly(p-dioxanone) (PDO), dyed with D&C Violet No. 2. Needle: Double-pointed AISI 316L stainless steel. Sterilization: Ethylene Oxide. Connectivity: None (mechanical).

Indications for Use

Indicated for abdominal wall closure after laparotomy in patients 18 years and older.

Regulatory Classification

Identification

An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

Filbloc (K150553)

Reference Devices

SafePath Suturing System (K180701)

Related Devices

K250977 — Suture-TOOL System · Suturion AB · Apr 28, 2025
K103412 — AXIOM FASCIAL CLOSURE SYSTEM · Axiom Technology Partners, LLC · Dec 30, 2010
K172666 — CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor · Sutureease, Inc. · Dec 1, 2017
K173917 — neoClose PDS · Neosurgical, Ltd. · Nov 8, 2018
K123280 — NEOCLOSE HASSON, NEOCLOSE UNIVERSAL · Neosurgical, Ltd. · Apr 18, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/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 & 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. January 22, 2025 Suturion AB % Adam Harris Senior Director, Regulatory and Strategic Development Target Health LLC 450 Commerce Boulevard Carlstadt, New Jersey 07072 Re: K242835 Trade/Device Name: Suture-TOOL System Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: December 20, 2024 Received: December 23, 2024 ### Dear Adam Harris: 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 (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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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, Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2025.01.22 15:36:00 -05'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242835 Device Name Suture-TOOL System Indications for Use (Describe) The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older. 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) #### 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." {4}------------------------------------------------ # 510(k) Summary ## 1. APPLICANT/CONTACT Suturion AB ### Contact Person Adam Harris, MM, RAC Senior Director, Regulatory and Strategic Development Target Health LLC 450 Commerce Boulevard Carlstadt, NJ 07072 Phone: (646) 479-2437 aharris(@targethealth.com ### Date of Summary: January 22, 2025 ### 2. DEVICE | Device Proprietary Name | K242835 Suture-TOOL System | |-------------------------|------------------------------------------| | Classification name | Absorbable polydioxanone surgical suture | | Product Code | NEW | | Regulation | 21 CFR 878.4840 | | Device Classification | Class II | | Review Panel | General & Plastic Surgery | ### 3. PREDICATE AND REFERENCE DEVICE | Predicate Device | K150553 Filbloc | |------------------|----------------------------------| | Reference Device | K180701 SafePath Suturing System | ## 4. DESCRIPTION OF DEVICE The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(0-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602) and are available in size 2. The Suture-TOOL System includes the following: - Polydioxanone resorbable suture pre-mounted on the needle -1020S (Suture&Needle). - Suture-TOOL 1018S (suture applicator) ● Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to {5}------------------------------------------------ the applicator. # 5. INDICATIONS FOR USE The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older. # 6. COMPARISON WITH THE PREDICATE AND REFERENCE DEVICES - SUMMARY | | Subject Device | Predicate Device | Reference Device | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | | Suture-TOOL System (Applicator and Suture) | Filbloc Smooth or Barbed (Suture) | SafePath Suturing System (Applicator and Suture) | | Manufacturer | Suturion, AB | Assut Europe SpA | SafePath Medical, Inc. | | 510(k) Number | K242835 | K150553 | K180701 | | | Absorbable polydioxanone surgical suture | Absorbable polydioxanone surgical suture | | | Product Code | NEW | NEW | | | Regulation | 21 CFR 878.4840 | 21 CFR 878.4840 | | | Device Class | II | II | | | | Suture applicator | | Suture applicator | | Product Code | GAB | | GAB | | Regulation | 21 CFR 878.4800 | | 21 CFR 878.4800 | | Device Class | Class 1 | | Class 1 | | Intended Use/ Indications for Use | The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older. | Filbloc sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. | The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues. | | Device Description | | | | | The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from the polyester, poly(p-dioxanone). The Suture-TOOL System includes the following: 1) the Suture-TOOL suture applicator (1018S), and 2) a polydioxanone resorbable suture pre- mounted on the needle (1020S). Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator. | Filbloc (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly(p dioxanone). The device is designed with unidirectional or bidirectional barbs, or with unidirectional barbs and final block in PDO. The barbs and the block design allow for tissue approximation, without need to tie surgical knot. The device is available in various lengths and diameter sizes 2 through 4/0 with various needles attached at one end or to both ends. | The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (8. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Sutur and is available in USP size 2- 0. The suture is provided as a 30 in. length, swaged on a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch. Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue. The System Includes: (2) Suturing Device Pre- loaded with one (1) 30 in. strand of USP size 2-0 black braided silk suture Swaged on a½ circle, 26 mm reverse cutting needle | | | Suture material | Resorbable | Resorbable | | | Chemical | Poly(p-dioxanone) | Poly(p-dioxanone) | | # Table 1: OVERALL SUBSTANTIAL EQUIVALENCE COMPARISON {6}------------------------------------------------ {7}------------------------------------------------ | USP sizes | 2-0 | 4-0 to 2 | | |-----------------------------------------------------|--------------------------------------|--------------------------------------|--| | Approx. Tensile strength residual at time: | 4 weeks 71.7% 8 weeks 16.5% | 4 weeks 71.7% 8 weeks 16.5% | | | Absorption | ~ 180-210 days post- implantation | ~ 180-210 days post- implantation | | | Needle | Double-pointed AISI 316 L | AISI 316 L | | | Sterility | Ethylene Oxide gas | Ethylene Oxide gas | | # Table 2: Comparison Summary | | Subject | Predicate | Reference | |-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------------| | Characteristics | Suture-TOOL System (Applicator and Suture) | Filbloc Smooth or Barbed (Suture) | SafePath Suturing System (Applicator and Suture) | | | K242835 | K150553 | K180701 | | Suturing system | Yes | No | Yes | | Includes suture applicator | Yes | N/A | Yes | | Product code GAB | Yes | N/A | Yes | | Regulation 21 CFR 878.4800 | Yes | N/A | Yes | | Applicator provided sterile for single-patient- use. | Yes | N/A | Yes | | Absorbable polydioxanone surgical suture | Yes | Yes | No | | Regulation 21 CFR 878.4840 | Yes | Yes | N/A | | Product code NEW | Yes | Yes | N/A | | Same suture manufacturer, materials, specifications, formulation, processing, sterilization and geometry | Yes | Yes | N/A | | Sutures are dyed with D&C Violet No. 2 | Yes | Yes | N/A | {8}------------------------------------------------ | Suture passes all required tests for USP absorbable suture material | Yes | Yes | N/A | |---------------------------------------------------------------------------------|-----|-----|-----| |---------------------------------------------------------------------------------|-----|-----|-----| # 7. PERFORMANCE TESTING Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture, to USP 29, including <861> suture diameter, <871> suture attachment, <881>tensile strength. - 6-415 USP 41-NF36:2018 <881> Tensile Strength ● - 6-416 USP 41-NF36:2018 <861> Sutures - Diameter . - <871> Sutures Needle Attachment 6-417 USP 41-NF36:2018 ● In all cases, the USP criteria were met or exceeded. ### Design Verification/Validation Verification testing performed with the Suture-TOOL System assessed design control to confirm the specification requirements established. The testing demonstrated that the Suture-TOOL System meets all specifications according to device requirements. ### Biocompatibility Testing Biocompatibility evaluations were performed for the Suture-TOOL System components and parts in accordance with the requirements set out in 10993-1:2018 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The Suture-TOOL system met the test criteria for each of the studies conducted. ### Human Factors Testing Usability/Human Factors testing was completed for the Suture-TOOL System in accordance with the Agency's Guidance for Industry, Applying Human Factors and Usability Engineering to Medical Devices 2016. Users in the study completed tasks successfully with favorable results regarding design, safety and documentation. ### Literature Two nonclinical performance studies, (Börner and Montgomery, 2020; and Börner et al., 2022) were completed with the subject device. Studies showed that the use of the subject device provided a much higher adherence to the SL/WL ratio ≥ 4 compared with manual NDS, reducing the risk for incisional hernia and site infections for patients, reducing the risk of needle stick injuries for surgeons. ### Comparison of Significant Features - . The Subject and Predicate devices provide identical absorbable polydioxanone surgical sutures using the same manufacturer, materials, specifications, formulation, processing, sterilization and geometry. - The Subject and Reference devices are both systems intended for {9}------------------------------------------------ the placement of sutures. - . The Subject and Reference devices both provide sterile, singleuse applicators with the same regulation and product code. ## 8. CONCLUSION The comparison tables, discussion and the testing provided all demonstrate that the Suture-TOOL System meets its specifications, fulfils its intended use, and is substantially equivalent to the Predicate device. Thus, the Sponsor has determined that the Suture-Tool System does not raise new questions of safety and effectiveness in comparison to the Predicate device and is substantially equivalent to the Predicate device.