(339 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical suture, with no mention of AI or ML capabilities.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a supportive role in healing rather than directly treating a disease or condition.
No
The device, ADVANTIME® sutures, is explicitly stated to be intended for "general soft tissue approximation and/or ligation," which are therapeutic procedures. Diagnostic devices are used to identify or characterize a disease or condition, an application not described for this product.
No
The device is a physical surgical suture made of a synthetic bioabsorbable thread, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation" during surgery. This is a direct surgical intervention on the body.
- Device Description: The device is a "synthetic absorbable surgical suture" used for "suturing and/or tissue ligation in open or laparoscopic surgery." This describes a physical tool used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. There is no mention of analyzing specimens or providing diagnostic information in the provided text.
The device is clearly a surgical tool used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.
Product codes
GAM
Device Description
ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment.
ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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
As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures.
Testing included:
- Diameter following USP 43
- Tensile strength following USP 43
- Needle attachment following USP 43
- Length following USP 43- Absorbable surgical suture
- Extractable color following USP 43- Absorbable surgical suture
Resorption profiles have been evaluated for each material. Resorption data in-vitro was provided for ADVANTIME® and DemeCaprone.
Stability testing has been completed.
Results of USP performance and resorption testing demonstrate that the subject device meets USP performance requirements for absorbable sutures with the exception of minor variations in diameter (with FDA guidance allowance) from USP and is substantially equivalent to the predicate device listed.
The biological evaluation of ADVANTIME® was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission:
- Cytotoxicity
- Sensitization
- Irritation
- Material mediated pyrogenicity
- Acute Systemic Toxicity
- Sub-acute/sub-chronic/chronic toxicity
- Genotoxicity
- Carcinogenicity
- Chemical characterization and toxicological risk assessment
- Implantation
- Degradation
- Sterilization residue testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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
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July 12, 2024
Peters Surgical % Marie Compagnon Riobé Chief Sustainability and Regulatory Officer Peter Surgical 119 North Road Deerfield, New Hampshire 03037
Re: K232372
Trade/Device Name: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: June 3, 2024 Received: June 3, 2024
Dear Marie Compagnon Riobé:
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.
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).
1
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.
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.
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: 2024.07.12 13:49:55 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
Indications for Use (Describe)
| ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue |
|---|
| approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic |
| surgery, and neurological tissue. |
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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3
510(k) Summary-K232372
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of ADVANTIME® Device.
1. Applicant
PETERS SURGICAL Immeuble Aurélium 1 Cours de l'Ile Seguin 92100 Boulogne Billancourt France
-
- Official Correspondent
Marie Compagnon Riobé Immeuble Aurélium 1 cours de l'Ile Seguin 92100 Boulogne-Billancourt, France Phone: +33 1 48 10 62 23 Email: m.compagnon-riobe@peters-surgical.com
- Official Correspondent
-
- Regulatory Correspondent/ 510(k) Submission Contact
Vikram Verma Global Regulatory Compliance 240 Annette Ave, Woonsocket, RI 02895 Email: vikver2000@yahoo.com Phone: 978-602-6239
- Regulatory Correspondent/ 510(k) Submission Contact
-
- Date Prepared: July 12, 2024
-
- Device Information
Device: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) Panel: General and Plastic Surgery Regulatory Number: 21 CFR 878.4493 Product Code: GAM Device Class: Class II
-
- Predicate Device
DemeCaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (K130083)
- Predicate Device
4
7. Device Description
ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment.
ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
8. Indications for Use
ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.
9. Comparison of Technological Characteristics
The ADVANTIME® device is substantially equivalent in intended use, design, performance, and principle of operation to the predicate device - DemeCaprone (K130083). Both devices include similar components of thread that are attached with needles. The ADVANTIME® and the predicated device consist of the same technological characteristics and are available in similar configurations and materials. Below the comparison table specifies substantial equivalence comparison between proposed device and predicated device. Any differences between ADVANTIME® and DemeCaprone sutures and needles are insignificant and do not raise any issues regarding safety or performance of the ADVANTIME® device.
Below is a comparison table that provides a top-level overview of the substantial equivalent comparison between proposed and predicate devices.
| Comparative
| Characteristics | Proposed Device: ADVANTIME® | Predicate Device: DemeCaprone |
|---|---|---|
| General Information | ||
| 510(k) Number | K232372 | K130083 |
| Classification | General and Plastic Surgery | General and Plastic Surgery |
| Device | ||
| Description | ADVANTIME® suture is a synthetic | |
| monofilament absorbable surgical | ||
| sutures composed of Poly(glycolic- | ||
| co-caprolactone) copolymer | ||
| (PGCL) and is supplied undyed and | DemeCaprone (Poliglecaprone 25) | |
| suture is a synthetic monofilament | ||
| absorbable surgical suture | ||
| composed of Poly (glycolic-co- | ||
| caprolactone) copolymer (PGCL) and | ||
| dyed with D&C Violet #2 below 0.1% | is supplied un-dyed and dyed with D&C Violet #2 below 0.1% | |
| Product Code | GAM | GAM |
| Indication for Use/Intended Use | ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue. | DemeCaprone (Poliglecaprone 25) Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular, surgery, microsurgery, ophthalmic surgery, and neurological tissue. |
| Regulation Number | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Regulatory Class | Class II | Class II |
| Surgical approach | In open or laparoscopic surgery | In open or laparoscopic surgery |
| Principle Device Components (Sterile, Disposable and Single Use) | Thread with attached needle | Thread with or without attached needle |
| Type of Device (Material Used) | Absorbable Poly(glycolic-co-caprolactone) sutures | Absorbable Poly(glycolic-co-caprolactone) sutures |
| Biocompatibility requirements | ISO 10993 | ISO 10993 |
| Sterilization methods | Ethylene Oxide method | Ethylene Oxide method |
| Technical Features/Design | ||
| Thread material | Poly(glycolide-co-caprolactone) | Poly(glycolide-co-caprolactone) |
| Dyed of thread | Dyed or Undyed | Dyed or Undyed |
| Thread coating | No coating | No coating |
| Thread size (diameter) | USP 6/0 to USP 1 | USP 6/0 to USP 1 |
| Thread length | 45 cm to 110 cm | 45 cm to 150 cm |
| Dyeing of thread | Undyed, Dyed (D&C Violet #2 below 0.1%) | Undyed, Dyed (D&C Violet #2 below 0.1%) |
| Needle material | Stainless steel | Stainless steel |
| Needle coating | Silicone coating | Information not available |
| Needle curvatures | ½, 3/8, 5/8, and straight | ½, 3/8, 5/8, and straight |
| Needle points | Cutting, taper cutting, taper and extracut | Reverse cutting, taper cutting, curved cutting, round bodied, and blunt point |
| Needle length | 10 mm to 60 mm | 11 mm to 70 mm |
| Absorption time | Between 90 to 120 days | Between 90 to 120 days |
| Shelf-life | 5 years | Information not available |
| Ideal storage | Must be stored in its original packaging, at a temperature below 25°C, in a dry place | Must be stored at room temperature |
5
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10. Summary of Testing
As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures.
Testing included:
- Diameter following USP 43
- Tensile strength following USP 43
- Needle attachment following USP 43
- •Length following USP 43- Absorbable surgical suture
- Extractable color following USP 43- Absorbable surgical suture
Resorption profiles have been evaluated for each material. Resorption data in-vitro was provided for ADVANTIME® and DemeCaprone.
Stability testing has been completed.
Results of USP performance and resorption testing demonstrate that the subject device meets USP performance requirements for absorbable sutures with the exception of minor variations in diameter (with FDA guidance allowance) from USP and is substantially equivalent to the predicate device listed.
The biological evaluation of ADVANTIME® was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission:
- Cytotoxicity
- Sensitization
- Irritation
- Material mediated pyrogenicity
- Acute Systemic Toxicity
- Sub-acute/sub-chronic/chronic toxicity
- Genotoxicity
- Carcinogenicity
- Chemical characterization and toxicological risk assessment
- Implantation
- Degradation
- Sterilization residue testing
7
11. Conclusion:
Based on the information provided within this 510(k) submission, Peters Surgical concludes that the Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is substantially equivalent to the predicate device, DemeCaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (K130083).