(145 days)
No
The summary describes a physical medical device (suture) and its materials, intended use, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a permanent suture used for general soft tissue approximation, which is a supportive rather than a therapeutic function.
No
The device, FilBloc Permanent sutures, is intended for general soft tissue approximation, which is a therapeutic rather than a diagnostic function. It is used to close wounds and remains attached to the patient, indicating a treatment purpose.
No
The device description clearly describes a physical suture made of material, with or without needles, and a physical "block" component. It also details physical performance testing and biocompatibility testing, which are not relevant to software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the FilBloc Permanent Sutures are intended for "general soft tissue approximation" and "contact the patient and remain attached to the patient". This indicates direct interaction with the patient's body for a therapeutic purpose (closing wounds), not for analyzing samples taken from the body.
- Intended Use: The intended use is for surgical procedures involving soft tissue, which is a direct medical intervention, not a diagnostic test performed on a sample.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and sterility, which are relevant for implantable medical devices, not IVDs.
Therefore, the FilBloc Permanent Suture is a surgical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
Product codes
GAW
Device Description
The Assut FilBloc Permanent Suture range of devices comprises a variety of gauge sizes and lengths, supplied with or without stainless steel needles, which are also available in a variety of different sizes and shapes. The sutures may have a 'block' at one end, which allows surgeons to close wounds quickly and securely without tying knots or changing suturing techniques. The block is made from the same material as the suture, and is used to anchor the suture.
Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods.
The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.
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
Physical testing was performed to establish compliance with USP 29, including suture diameter, suture attachment, tensile strength. Tests were also undertaken to establish sterility, shelf life and packaging integrity.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2017
Assut Europe S.p.A. % Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, 00153 Italy
Re: K171039
Trade/Device Name: Assut Filbloc Permanent Sutures Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: July 18, 2017 Received: July 20, 2017
Dear Mr. Gray:
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 device
1
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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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,
David Krause -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171039
Device Name Assut FilBloc Permanent sutures
Indications for Use (Describe)
FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
| ☑ 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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Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
| Device Name: | Assut FilBloc Permanent Sutures |
|---|---|
| Type of 510(k) submission: | Abbreviated |
| Date of submission: | 17 July 2017 |
| Manufacturer: | Assut Europe SpA |
| Zona Industriale | |
| 67062 Magliano dei Marsi (AQ) | |
| Italy | |
| Phone: | |
| Fax: | +39-06-72677348 |
| +39-06-72675380 | |
| FDA Registration Number: | 9617547 |
| 510(k) Owner and Submitter: | Assut Europe SpA |
| Via G.Gregoraci, 12 | |
| 00173 Rome | |
| Italy | |
| Owner/Operator Number: | 9044488 |
| 510(k) Application Correspondent: | Mr Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome | |
| Italy | |
| Phone: | |
| Fax: | |
| Email: | +39 06 578 2665 |
| +39 06 574 3786 | |
| rgray@donawa.com | |
| FDA Product Code: | GAW |
| FDA Regulation Number: | 21 CFR 878.5010 |
| FDA Classification Name: | Nonabsorbable Polypropylene Surgical Suture |
| Classification Panel: | General and Plastic Surgery |
| Common Name: | Nonabsorbable Polypropylene Surgical Suture |
| FDA Classification: | Class II |
| Submission Type: | 510(k) |
| Indication for Use: | FilBloc Permanent sutures are intended for general soft tissue |
| approximation, excluding closure of the epidermis, where use of | |
| a non-absorbable suture is appropriate. | |
| Predicate Device: | Quill Nonabsorbable Polypropylene barbed suture, K052373. |
| From information on the FDA website, there is no indication that | |
| this device has been subject to a design-related recall. |
4
Reference Device:
Assut FilBloc Absorbable Polydioxanone Surqical Suture, K150553. This device has not been subject to a design-related recall.
Device Description:
The Assut FilBloc Permanent Suture range of devices comprises a variety of gauge sizes and lengths, supplied with or without stainless steel needles, which are also available in a variety of different sizes and shapes. The sutures may have a 'block' at one end, which allows surgeons to close wounds quickly and securely without tying knots or changing suturing techniques. The block is made from the same material as the suture, and is used to anchor the suture.
Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods.
The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.
Technological Characteristics:
The sutures are manufactured in polypropylene monofilament thread, white natural (undyed) or dyed blue colour (phthalocyanine copper - C.I. 74160; 21 CFR§ 74.3045). The suture thread can be smooth or can have unidirectional or bidirectional barbs along the axis of the monofilament surface, either convergent or divergent.
The chemical formula of polypropylene is -(CH(CH3)-CH2)n. The chemical formula of the blue dye is C32H16CuN8. The suture content of the blue dye is below 0.5 wt%.
Assut FilBloc Permanent Sutures are available sterile (ethylene oxide, with SAL 10°) for single use in a wide range of lengths and in sizes from USP 2 to 4/0, (sizes USP 4/0, USP 3/0, USP 2/0, USP 0, USP 1, USP 2), with or without needles (single or double), with or without single-end blocks, and with or without barbs. The barbs can be unidirectional or bidirectional, and if bidirectional, the barbs can be opposing each other or not, at the purchaser's choice.
Performance Data:
Physical testing was performed to establish compliance with USP 29, including suture diameter, suture attachment, tensile strength. Tests were also undertaken to establish sterility, shelf life and packaging integrity.
Biocompatibility:
In accordance with the recommendations of ISO 10993-1 and FDA quidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', 16 June 2016, for devices described as implants in contact with tissuelbone for over 30 days, the following tests were carried out to establish the biocompatibility of the FilBloc Permanent Sutures:
- . Cytotoxicity (ISO 10993-5)
- . Sensitization (ISO 10993-10)
- Irritation or Intracutaneous Reactivity (ISO 10993-10) .
- Acute Systemic Toxicity (ISO 10993-11) ●
- . Subchronic Toxicity (ISO 10993-11)
- Genotoxicity (ISO 10993-3) ●
- Implantation (ISO 10993-6)
- . Material Mediated Pyrogenicity
Bacterial endotoxin testing (LAL test) is carried out on every batch of sutures.
5
Substantial Equivalence:
The features and characteristics of predicate device and reference device selected for an evaluation of substantial equivalence with the Filloc Permanent Sutures are provided in Table 1, together with a comparison with the same features and charcteristics of the subject device.
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Item | Predicate Device | Subject device | Similarity |
| Device name | Quill Nonabsorbable Polypropylene | ||
| Barbed Suture | FilBloc Permanent Sutures | N/A | |
| Device Manufacturer | Angiotech, Reading PA, US | Assut Europe, Italy | N/A |
| 510(k) Reference | K052373 | Not yet assigned | N/A |
| FDA Product Code | GAW | GAW | Same |
| FDA Classification | |||
| Name | Nonabsorbable polypropylene surgical | ||
| suture | Nonabsorbable polypropylene surgical | ||
| suture | Same | ||
| FDA Regulation | |||
| Number | 21 CFR 878.5010 | 21 CFR 878.5010 | Same |
| Device description | Nonabsorbable polypropylene surgical | ||
| suture in various thread sizes and needle | |||
| shapes/sizes, with bi-directional thread | |||
| barbs | Nonabsorbable polypropylene surgical | ||
| suture in various thread sizes with or | |||
| without unidirectional or bidirectional | |||
| barbs, and with or without various | |||
| needle shapes/sizes | Similar | ||
| Indications for Use / | |||
| Intended use | Quill® Nonabsorbable Polypropylene | ||
| Barbed Sutures are indicated for use in | |||
| soft tissue approximation excluding | |||
| closure of the epidermis. | FilBloc Permanent sutures are | ||
| intended for general soft tissue | |||
| approximation, excluding closure of | |||
| the epidermis, where use of a non- | |||
| absorbable suture is appropriate. | Equivalent to | ||
| predicate. Very | |||
| similar to | |||
| reference | |||
| device | |||
| Rx only? | Yes | Yes | Same |
| Monofilament? | Yes | Yes | Same |
| USP sizes | 4/0 to 2 | 4/0 to 1 | Different |
| Suture barbs | Bi-directional | None | |
| Bidirectional | |||
| Unidirectional | Different from | ||
| predicate but | |||
| same as | |||
| reference | |||
| device | |||
| Locking block? | Not available | Optional | Different from |
| predicate but | |||
| same as | |||
| reference | |||
| device | |||
| Thread color | White | ||
| Blue | |||
| Copper | White | ||
| Blue | Similar | ||
| Sterility | Sterile by EO, SAL 10-6 | Sterile by EO, SAL 10-6 | Same |
| Single use? | Yes | Yes | Same |
| Complies with | |||
| applicable USP | |||
| monographs? | Yes | Yes | Same |
6
| Table 1: Predicate device comparison table | ||||||
|---|---|---|---|---|---|---|
| Item | Predicate Device | Subject device | Similarity | |||
| Needles attached? | Yes | Yes | ||||
| Also available without needles | Different from | |||||
| predicate but | ||||||
| same as | ||||||
| reference | ||||||
| device | ||||||
| Needle shapes | 1/2 circle | |||||
| 3/8 circle | 1/2 circle | |||||
| 3/8 circle | ||||||
| 5/8 circle | ||||||
| "ski" needle | ||||||
| Straight | Different from | |||||
| predicate but | ||||||
| same as | ||||||
| reference | ||||||
| device | ||||||
| Needle cross- | ||||||
| section | Unknown | Cylindrical | ||||
| Triangular | ||||||
| Trapezoidal | Same as | |||||
| reference | ||||||
| device | ||||||
| Needle point | Taper | |||||
| Diamond | Cylindrical | |||||
| Triangular | ||||||
| Diamond (Taper-cut) | ||||||
| Blunt point | ||||||
| Spatula | Different from | |||||
| predicate but | ||||||
| same as | ||||||
| reference | ||||||
| device | ||||||
| Needle eye | Unknown | Open | ||||
| Closed | Same as | |||||
| reference | ||||||
| device | ||||||
| Needle materials | Surgical stainless steel: | |||||
| AISI 470 | Surgical stainless steel: | |||||
| AISI 470 | ||||||
| AISI 455 | ||||||
| AISI 301 | ||||||
| AISI 302 | ||||||
| AISI 304 | ||||||
| AISI 304L | ||||||
| AISI 316 | ||||||
| AISI 320 | ||||||
| AISI 321 | ||||||
| Cobalt chromium | Similar, same | |||||
| as reference | ||||||
| device | ||||||
| Needle coating | Siliconized | Siliconized | Same | |||
| Biocompatibility | Biocompatible | Biocompatible | Same |
The subject device and the predicate device have many identical or similar properties and features. In summary, the differencesare:
- USP sizes available: The subject device has one USP thread size less in its range. .
- Suture barb orientation: The predicate device has bidirectional barbs on all versions in the . range, whereas the subject device has options with or without barbs, and when barbs are included, these can be either bidirectional or unidirectional. The reference device has the same options of no barbs, bidirectional barbs and unidirectional barbs.
- Locking block: The predicate device does not offer a locking block option, whereas the subject device range does, which is the same as the reference device.
- . Needle sizes, shapes, points, etc: The subject device includes a wider variety of needle sizes, shapes, points, etc, than the predicate device. The reference device has a similarly wide range of needle sizes, shapes, points, etc.
7
Conclusion:
Based on the information contained within this submission, it is concluded that the FilBloc Permanent Sutures are substantially equivalent to the identified predicate device already in interstate commerce within the USA.