(125 days)
The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.
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 the applicator.
The provided text describes the regulatory clearance of a medical device, the "Suture-TOOL System," and compares it to predicate and reference devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.
This document focuses on the substantial equivalence of a physical surgical device (suture and applicator) based on material properties, performance testing (tensile strength, diameter, needle attachment), biocompatibility, and human factors testing related to its physical use. It does not describe an AI medical device or a study involving human readers and AI assistance for diagnostic or interpretative tasks.
Therefore, I cannot provide the requested information from the given text. The text does not provide:
- A table of acceptance criteria and reported device performance: While it mentions USP criteria were met or exceeded for physical tests, it doesn't present these as specific acceptance criteria in a table format.
- Sample size, data provenance, number of experts, adjudication method, MRMC study effect size, standalone performance, type of ground truth, training set size, or how ground truth for training was established. These are all concepts relevant to AI/diagnostic studies, which are not described in this regulatory submission for a physical surgical device.
The study referenced ("Börner and Montgomery, 2020; and Börner et al., 2022") appears to be a nonclinical performance study related to the physical surgical technique (SL/WL ratio, reducing needle stick injuries), not an AI performance study measuring diagnostic accuracy.
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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.
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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.
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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
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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)
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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
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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 orBarbed (Suture) | SafePath Suturing System(Applicator and Suture) | |
| Manufacturer | Suturion, AB | Assut Europe SpA | SafePath Medical, Inc. |
| 510(k) Number | K242835 | K150553 | K180701 |
| Absorbablepolydioxanone surgicalsuture | Absorbablepolydioxanone surgicalsuture | ||
| 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 forUse | The Suture-TOOL Systemis intended for abdominalwall closure afterlaparotomy in patients 18years old and older. | Filbloc sutures areindicated for use ingeneral soft tissueapproximation whereuse of an absorbablesuture is appropriate. | The SafePath SuturingSystem is intended for use inplacement of a silk suture inthe skin and subcutaneoustissues. |
| DeviceDescription | |||
| The Suture-TOOL Systemis a single-use, sterile,suture applicator with apolydioxanone resorbablesuture pre-mounted to theneedle. The polydioxanonemonofilament syntheticabsorbable sutures areprepared from thepolyester,poly(p-dioxanone).The Suture-TOOL Systemincludes the following:1) the Suture-TOOLsuture applicator(1018S), and2) a polydioxanoneresorbable suture pre-mounted on the needle(1020S).Before use, the user mustfollow the instructions toattach the needle,preloaded with thesuture, to the applicator. | Filbloc (polydioxanone)monofilament syntheticabsorbable sutures areprepared from thepolyester, poly(pdioxanone). The device isdesigned withunidirectional orbidirectional barbs, orwith unidirectional barbsand final block in PDO.The barbs and the blockdesign allow for tissueapproximation, withoutneed to tie surgical knot.The device is available invarious lengths anddiameter sizes 2 through4/0 with various needlesattached at one end or toboth ends. | The silk suture provided withthe SafePath Suturing Systemis a nonabsorbable, sterile,surgical suture composed ofthe organic protein, fibroin.This protein is derived fromthe domesticated speciesBombyx mori (8. mori) of thefamily Bombycidae. The silksuture is silicone coated,braided and dyed (black) withlogwood extract. The silksuture meets all requirementsestablished by the UnitedStates Pharmacopeia (USP) forNonabsorbable Surgical Suturand is available in USP size 2-0. The suture is provided as a30 in. length, swaged on asingle-armed ½ circle, 26 mmreverse cutting needle.The suture is pre-loaded in ahand-held, manuallyoperated suturing device.When the suturing device isactuated a single stitch isplaced through the tissue andthe needle is automaticallycaptured and reset forplacement of an additionalstitch.Finished devices may bepackaged individually, or inmulti-unit cartons orprocedure packs. TheSafePath Suturing System isdesigned to place a suture inskin and subcutaneous tissue.The System Includes:(2) Suturing Device Pre-loaded with one (1)30 in. strand of USP size 2-0black braided silk sutureSwaged on a½ circle, 26 mmreverse cutting needle | |
| Suture material | Resorbable | Resorbable | |
| Chemical | Poly(p-dioxanone) | Poly(p-dioxanone) |
Table 1: OVERALL SUBSTANTIAL EQUIVALENCE COMPARISON
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| USP sizes | 2-0 | 4-0 to 2 | |
|---|---|---|---|
| Approx. Tensilestrengthresidual attime: | 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-TOOLSystem(Applicator andSuture) | Filbloc Smooth orBarbed (Suture) | SafePath SuturingSystem(Applicator andSuture) |
| K242835 | K150553 | K180701 | |
| Suturing system | Yes | No | Yes |
| Includes suture applicator | Yes | N/A | Yes |
| Product code GAB | Yes | N/A | Yes |
| Regulation 21 CFR878.4800 | Yes | N/A | Yes |
| Applicator providedsterile for single-patient-use. | Yes | N/A | Yes |
| Absorbablepolydioxanonesurgical suture | Yes | Yes | No |
| Regulation 21 CFR878.4840 | 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&CViolet No. 2 | Yes | Yes | N/A |
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| Suture passesall required testsfor USPabsorbablesuture 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
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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.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
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.(b)
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.