(28 days)
Not Found
No
The provided text describes a mechanical suture applicator system and explicitly states that it does not mention AI, DNN, or ML. Its performance is evaluated through physical testing against USP criteria, not through computational models.
No
The device is a suture applicator and a pre-mounted suture, used for closing the abdominal wall after surgery. This is a surgical tool, not a device intended to treat or prevent a disease or condition in a therapeutic manner.
No
The device is a suture applicator used for closing abdominal wall after surgery, which is a therapeutic function, not a diagnostic one.
No
The device is a physical medical device (suture applicator and pre-mounted suture) and does not involve any software components for its intended use or operation. The description details physical materials, manufacturing, and mechanical testing, all indicative of a hardware product.
No
The device is a surgical tool used for abdominal wall closure, which is an invasive procedure and does not involve in vitro examination of specimens derived from the human body.
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 (comma separated list FDA assigned to the subject device)
NEW, GAB
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: -(O-CH2-CH2-O-CH2-CO)n-. The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602).
The Suture-TOOL System includes the following:
• Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture PDO USP 0 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
• 6-417 USP 41-NF36:2018 Sutures - Needle Attachment
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.
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.
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.
Not Found
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
§ 878.4840 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.
FDA 510(k) Clearance Letter - Suture-TOOL System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 28, 2025
Suturion AB
℅ Adam Harris
Senior Director, Regulatory and Strategic Development
Target Health
110 West 40th Street, 8th Floor
New York, New York 10018
Re: K250977
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, GAB
Dated: March 28, 2025
Received: March 31, 2025
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 (the 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.
April 28, 2025
Suturion AB
℅ Adam Harris
Senior Director, Regulatory and Strategic Development
Target Health
110 West 40th Street, 8th Floor
New York, New York 10018
Re: K250977
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, GAB
Dated: March 28, 2025
Received: March 31, 2025
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 (the 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.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K250977 - Adam Harris Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250977 - Adam Harris Page 3
assistance/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,
TEK N. LAMICHHANE -S
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250977
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)
☒ 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."
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 07/31/2026 |
Indications for Use
See PRA Statement below.
510(k) Number (if known): K250977
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)
☒ 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 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
Suture-TOOL System-K250977 Suturion AB
510(k) Summary (K250977)
1. APPLICANT/CONTACT
Suturion AB
Contact Person
Adam Harris, MM, RAC
Senior Director, Regulatory and Strategic Development
Target Health
110 West 40th Street, 8th Floor
New York, NY 10018
Telephone: (646) 479-2437
aharris@targethealth.com
Date of Summary: April 28, 2025
2. DEVICE
| Device Proprietary Name | 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
| Predicate Device | K242835 Suture-TOOL System Absorbable polydioxanone surgical suture |
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:
-(O-CH2-CH2-O-CH2-CO)n-
Page 6
Suture-TOOL System-K250977 Suturion AB
The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602).
The Suture-TOOL System includes the following:
• Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 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.
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 DEVICE - SUMMARY
The Subject and Predicate devices are identical. The Subject device adds the size USP 0 suture which has the same material, design, intended use and technological characteristics as the predicate device K242835. The Subject and Predicate devices both provide sterile, single-use applicators with the same manufacturing process. The device characteristics comparing the Subject device to the Predicate device are summarized below.
Table 1: REGULATORY INFORMATION COMPARISON
| Predicate Device | Subject Device | |
|---|---|---|
| K242835 Suture-TOOL System | K250977 Suture-TOOL System | |
| Absorbable polydioxanone surgical suture | Same | |
| NEW | Same | |
| 21 CFR 878.4840 | Same | |
| Class II | Same | |
| General & Plastic Surgery | Same |
Page 7
Suture-TOOL System-K250977 Suturion AB
Table 2: OVERALL SUBSTANTIAL EQUIVALENCE COMPARISON
| Subject Device | Predicate Device | |
|---|---|---|
| Suture-TOOL System (Suture and Applicator) | Suture-TOOL System (Suture and Applicator) | |
| Manufacturer | Suturion, AB | Suturion, AB |
| 510(k) Number | K250977 | K242835 |
| Absorbable polydioxanone surgical suture | Same | |
| Product Code | NEW | Same |
| Regulation | 21 CFR 878.4840 | Same |
| Device Class | II | Same |
| Suture applicator | Same | |
| Product Code | GAB | Same |
| Regulation | 21 CFR 878.4800 | Same |
| Device Class | Class 1 | Same |
| Intended Use | The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older. | Same |
| 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:
- Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 1020S (Suture&Needle) and2)
- 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 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 |
Page 8
Suture-TOOL System-K250977 Suturion AB
Table 2: OVERALL SUBSTANTIAL EQUIVALENCE COMPARISON
| Subject Device | Predicate Device | |
|---|---|---|
| Suture-TOOL System (Suture and Applicator) | Suture-TOOL System (Suture and Applicator) | |
| Suture material | Resorbable | Same |
| Chemical | Poly(p-dioxanone) | Same |
| USP sizes | 2-0, 0 | 2-0 |
| Approx. Tensile strength residual at time: | 4 weeks 71.7% | |
| 8 weeks 16.5% | Same | |
| Absorption | ~ 180-210 days post-implantation | Same |
| Needle | Double-pointed AISI 316 L | Same |
| Sterility | Ethylene Oxide gas | Same |
7. PERFORMANCE TESTING
Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture PDO USP 0 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
• 6-417 USP 41-NF36:2018 Sutures - Needle Attachment
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.
Page 9
Suture-TOOL System-K250977 Suturion AB
8. CONCLUSION
The Subject and Predicate devices are identical, that is, as there are no differences in technological characteristics or performance characteristics between the Subject and Predicate devices. 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.