(125 days)
No
The device description and performance studies focus on the mechanical and material properties of a suture applicator and suture, with no mention of AI or ML.
No.
The device is a surgical tool designed to close abdominal walls after laparotomy using sutures. It is used in a surgical context to perform a procedure rather than to provide therapy.
No
Explanation: The Suture-TOOL System is described as a suture applicator for abdominal wall closure, which is a therapeutic and surgical function, not a diagnostic one. It does not identify a disease, condition, or state of health.
No
The device description clearly states it is a "single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle," which are physical hardware components. The performance studies also focus on physical testing and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "abdominal wall closure after laparotomy." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "suture applicator with a polydioxanone resorbable suture." This is a surgical tool used to physically close a wound.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on the physical properties of the suture, the functionality of the applicator, biocompatibility, and usability in a surgical setting. They do not involve diagnostic accuracy metrics.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for a surgical procedure.
N/A
Intended Use / Indications for Use
The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.
Product codes
NEW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
Indicated Patient Age Range
18 years old and older.
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
Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture, to USP 29, including suture diameter, suture attachment, tensile strength.
- 6-415 USP 41-NF36:2018 Tensile Strength
- 6-416 USP 41-NF36:2018 Sutures - Diameter
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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:
-
the Suture-TOOL
suture applicator
(1018S), and -
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 suture diameter, suture attachment, tensile strength.
- 6-415 USP 41-NF36:2018 Tensile Strength ●
- 6-416 USP 41-NF36:2018 Sutures - Diameter .
- 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.