(442 days)
Filbloc sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
Filbloc (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is: -(0-CH2-CH2-O-CH2-CO-CH2-CO)n- Filbloc sutures are undyed or dyed with D&C Violet No. 2 (21CFR§ 74.3602). 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 provided text describes the 510(k) premarket notification for the "Filbloc" absorbable polydioxanone surgical suture. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a novel AI/software device and proving its performance through a study of that nature.
Therefore, the information required to answer the prompt is not present in the provided text. The document outlines a regulatory submission for a physical medical device (surgical sutures), detailing its material, design, intended use, and comparison to existing predicate devices. It describes physical and biocompatibility testing, but not a study designed to meet specific acceptance criteria for a device's "performance" in the way an AI/software device would be evaluated (e.g., sensitivity, specificity, AUC).
Here's why the required information is missing:
- Acceptance Criteria & Reported Device Performance (Table): The document doesn't define quantitative performance metrics such as sensitivity, specificity, accuracy, or any thresholds related to diagnostic or analytical performance. It discusses tensile strength and absorption time in comparison to a predicate, but these are material properties, not software performance.
- Sample Size (Test Set) & Data Provenance: Not applicable in the context of an absorbable suture device. The "testing" refers to physical and biocompatibility tests on the suture material itself, not a dataset of medical images or patient records.
- Number of Experts & Qualifications: Not applicable. There's no interpretive task that would require expert adjudication of a test set.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is irrelevant for a surgical suture.
- Standalone Performance: While the "device" (suture) is a standalone physical product, the concept of "standalone performance" in the context of AI refers to the algorithm's performance without human intervention, which isn't relevant here.
- Type of Ground Truth: Not applicable in the AI/software sense. The "ground truth" for a suture would be its physical properties and biological absorption characteristics, confirmed through laboratory and animal testing.
- Sample Size (Training Set) & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/machine learning device.
In summary, the provided document is a 510(k) submission for a physical medical device (surgical sutures), outlining its characteristics and demonstrating substantial equivalence to a predicate device through physical and biocompatibility testing. It does not contain the type of information typically found in a study proving the acceptance criteria for an AI/software-based medical device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting hair or clothing. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Assut Europe Ms. Rhonda Alexander, M.S., M.P.A. Registrar Corp. 144 Research Drive Hampton, VA 23666
Re: K150553
Trade/Device Name: Filbloc Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: April 12, 2016 Received: April 14, 2016
Dear Ms. Alexander:
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 (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. 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.
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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 17
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (If known) | K150553 |
|---|---|
| Device Name | Filbloc |
| Indications for Use (Describe) | Filbloc sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. |
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of Information. Send comments regarding this burden estimate or any other aspect
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K150553, pg. 1 of 3
510(k) Summary
I. SUBMITTER
| Assut Europe SpA |
|---|
| ------------------ |
| Registered office: | Via G.Gregoraci, 1200173 Roma - Italy |
|---|---|
| Manufacturing plant: | Zona Industriale67062 Magliano dei Marsi (AQ) - Italy |
| Telephone: | +39-06-72677348 |
| Fax Number: | +39-06-72675380 |
| Contact Person: | Gloria Aggio |
| Date Prepared: | May 17, 2016 |
II. DEVICE
| Name of Device: | Filbloc |
|---|---|
| Common or Usual Name: | Suture, Surgical, Absorbable, Polydioxanone |
| Classification Name: | Absorbable Polydioxanone Surgical Suture |
| Regulatory Class: | II |
| Product Code: | NEW |
| Regulation Number: | 21 CFR 878.4840 |
III. PREDICATE DEVICE
| Name: | Stratafix Symmetric PDS Plus Knotless Tissue Control |
|---|---|
| Manufacturer: | Ethicon, Inc. |
| K Number: | K141776 |
| Name: | PDS II |
| Manufacturer: | Ethicon, Inc. |
| K Number: | N18331 |
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Filbloc (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is:
-(0-CH2-CH2-O-CH2-CO-CH2-CO)n-
Filbloc sutures are undyed or dyed with D&C Violet No. 2 (21CFR§ 74.3602).
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.
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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.
V. INDICATIONS FOR USE
Filbloc sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
VI. COMPARISON WITH THE PREDICATE DEVICE - SUMMARY
TECHNOLOGICAL CHARACTERISTICS a.
| New device | Predicate device | |
|---|---|---|
| Parameter | FilBloc smooth or barbed | Stratafix SymmetricPDS Plus KnotlessTissue Control |
| Chemical | Poly(p-dioxanone) | Poly(p-dioxanone) |
| USP sizes | 4-0 to 2 | 3-0 to 1 |
| Approx. TensileStrength Residual atTime: | 4 weeks 71.7%8 weeks 16.5% | 2 weeks ~75%4 weeks ~65%6 weeks ~ 55% |
| Absorption | ~ 180-210 dayspost-implantation | ~ 120-180 dayspost-implantation |
b. INTENDED USE
| New device | Predicate device | |
|---|---|---|
| Filbloc smooth or barbed | Stratafix Symmetric PDS PlusKnotless Tissue Control | |
| Indication for use | Filbloc is indicated for use in softtissue approximation where the useof absorbable suture is appropriate | Stratafix device is indicated for use in softtissue approximation where the use ofabsorbable suture is appropriate |
| Precaution orcontroindication | It is therefore recommended thatthe surgeon will consider thepossible use of non absorbablesutures for the closure of tissueswhich may undergo distension orstretching or requiring additionalsupport. This suture kind may beinappropriate in elderly,malnourished or weakened patientsor in patients suffering fromconditions which may delay woundhealing process | The Stratafix device is not to be used whereprolonged (beyond six weeks)approximation of tissues under stress isrequired and is not to be used in conjunctionwith or for fixation of prosthetic devicesthat are nonabsorbable |
| Sterility | Ethylene Oxide gas | Ethylene Oxide gas |
The new device, Filbloc, has similar technological characteristics as the predicate device; it conforms to the USP Monograph for absorbable surgical sutures, and has the same intended use as the predicate device.
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Differences between Filbloc and the predicate device are:
- Stratafix device is available in four USP sizes (USP 3-0, USP 2-0, USP 0, USP 1), whereas 1. Filbloc device is available in six USP sizes (USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1, USP 2)
-
- Stratafix device is available only barbed, whereas Filbloc device is available barbed or smooth
VII. PERFORMANCE DATA
Physical testing was performed on poly(p-dioxanone) synthetic absorbable suture, to USP 29, including <861> suture diameter, <871> suture attachment, <881>tensile strength. Animal testing was performed for conformance to ISO 10993 for Biocompatibility.
Rabbit Implantation Tests in accordance with ISO 10993-6: 2007 were conducted with determinations of tensile strength.
Biocompatibility Testing
- Test for in vitro cytotoxicity (ISO 10993-5:2009) -
- Irritation tests animal intracutaneous (intradermal) reactivity test (ISO 10993-10:2010) -
- Skin sensitization tests guinea pig maximization test (GPMT), extracted in sesame oil -(ISO 10993-10:2010)
- -Skin sensitization tests - guinea pig maximization test (GPMT), extracted in sterile solution of sodium chloride (ISO 10993-10:2010)
- -Acute systemic toxicity (ISO 10993-11:2006)
- Rabbit subchronic systemic toxicity (ISO 10993-11:2006) -
- -Test of local effects after implantation (ISO 10993-6:2007)
- Genotoxicity Test Mouse Lymphoma Assay, extracted in Modified Eagle Medium without serum (ISO 10993-3:2003)
- Genotoxicity Test Mouse Lymphoma Assay, extracted in ethanol/water solution (ISO -10993-3:2003)
The subject device is considered an implant device with contact duration of over 30 days.
VII. CONCLUSION
Filbloc in PDO sutures have the same intended use and same indication for use as the predicate devices "Stratafix". The nonclinical and clinical data support a finding of substantial equivalence, since they demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
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§ 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.