(232 days)
No
The device description and performance studies focus solely on the material properties and physical performance of a surgical suture, with no mention of AI or ML.
No.
The device is a surgical suture used for approximation and ligation of soft tissue, primarily serving a mechanical function rather than a therapeutic one (i.e., treating or preventing disease).
No.
The device is a surgical suture used for approximation and ligation of soft tissue, not for diagnosing conditions.
No
The device description clearly states it is a physical surgical suture made of PTFE polymer, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical suture," which is a physical material used to close wounds or hold tissues together during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are designed for testing samples in vitro (in glass or in a lab).
The description clearly indicates a device used in vivo (within a living organism) for surgical purposes.
N/A
Intended Use / Indications for Use
GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.
Product codes
NBY
Device Description
GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0.
The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple.
GOLNIT Non-Absorbable PTFE Surgical Suture is sterilized by ethylene oxide. The GOLNIT surgical suture is intended for single use only. The surgically invasive device is indicated to remain in the body for up to 30 days and is biocompatible.
GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes. The device is not intended for invasive procedures related to central nervous system and central circulatory system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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
Per FDA's Special Control Guidance Document Surgical Sutures, performance testing including testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed to further ensure substantial equivalence to the predicate devices. Biocompatibility testing performed on each suture material type for implantable material included Cytotoxicity, Irritation and Sensitiation, and Pyrogenicity.
All testing performed has demonstrated that the GOLNIT PTFE suture is as safe and effective as the predicate, meets current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and the sutures are substantially equivalent to the predicate devices.
Design verification testing (U.S.P. - Sutures - Needle Attachment; U.S.P. -Tensile Strength; U.S.P. -Sutures -Diameter) was conducted to demonstrate the performance of the subject devices to prove conformance to the requirements of U.S.P. standards except for suture diameter. Stability testing was performed to support the proposed shelf life.
The materials selected were based on known biocompatibility (per ISO 10993) and are substantially equivalent to the materials used in the predicate devices listed. Biocompatibility testing performed on each suture material type for implantable material. Testing included: Cytotoxicity, Irritation, Sensitization and Pyrogenicity. The PTFE sutures were non-cytotoxic, non-irritant and non-sensitizer material.
Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Non-Absorbable Surgical Sutures except for the variance in suture diameter. There are no new questions concerning the safety and effectiveness of the device. These results support the safety and effectiveness of the devices for their intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2017
Antarma dba GOLNIT Sutures Ms. Armine Badalyan Chief Executive Officer 1204 Avenue U, #2030 Brooklyn, New York 11229
Re: K163049
Trade/Device Name: GOLNIT Non-absorbable PTFE Surgical Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluoroethylene surgical suture Regulatory Class: Class II Product Code: NBY Dated: May 24, 2017 Received: May 31, 2017
Dear Ms. Badalyan:
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 devicerelated 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.
1
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/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 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
Indications for Use
510(k) Number (if known) K163049
Device Name
GOLNIT Non-Absorbable PTFE Surgical Suture
Indications for Use (Describe)
GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.
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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Image /page/3/Picture/0 description: The image shows the logo for Golnit Sutures. The logo is pink and features a stylized letter G on the left. To the right of the G is the word "GOLNIT" in large, bold letters, with the word "SUTURES" in smaller letters underneath.
5.1. 510(k) Summary
In accordance with 21 CFR 807.92, the following summary of information is provided.
| Date: | June 16, 2017 |
|---|---|
| Device Owner: | Antarma dba GOLNIT Sutures |
| Company Contact: | Armine Badalyan |
| Chief Executive Officer, Antarma LLC | |
| 1204 Avenue U, #2030 | |
| Brooklyn, NY 11229 | |
| 718-219-0731 | |
| armine@golnit.com | |
| Proprietary Name: | GOLNIT Non-Absorbable Surgical Suture |
| Common Names: | Non-absorbable Surgical Suture, Synthetic: |
| • Non-absorbable, Expanded, Polytetrafluoroethylene (PTFE) Suture | |
| Classification Names: | Suture, Surgical, Non-absorbable, Polytetrafluoroethylene |
| Regulation Numbers: | 21 CFR 878.5035 |
| Regulatory Class: | Class II |
| Product Codes: | NBY |
| Review Panel: | General & Plastic Surgery |
| 510 (k) Predicate Devices: | New Device |
|---|---|
| Osteogenics Biomedical, Inc. | GOLNIT Non-Absorbable PTFE |
| Cytoplast™ Sutures | Surgical Suture: |
| K003028 | • Non-absorbable, Expanded, |
| Polytetrafluoroethylene (PTFE) | |
| Surgical Suture |
5.2 Device Description
GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for
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Image /page/4/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo consists of a stylized letter "G" on the left, followed by the word "GOLNIT" in large, bold, pink letters. Below "GOLNIT" is the word "SUTURES" in smaller, pink letters.
diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0.
The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple.
GOLNIT Non-Absorbable PTFE Surgical Suture is sterilized by ethylene oxide. The GOLNIT surgical suture is intended for single use only. The surgically invasive device is indicated to remain in the body for up to 30 days and is biocompatible.
GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes. The device is not intended for invasive procedures related to central nervous system and central circulatory system.
5.3 Device Format
The GOLNIT Non-absorbable PTFE Surgical Suture is packaged into labelled two-pouch packaging system consisting of medical grade heat-sealable pouches for single use only. The pouches conform to the international product standards and norms: ISO 11607-1:2006. ISO 11607-2:2006, EN 868-5:2009.
The suture final configuration consists of specified length and diameters of PTFE monofilaments with attached standard, medical grade suture needles coiled in double pouches, sterilized by ethylene oxide, cartoned in labeled white board boxes and shipping containers.
5.4 Special Controls
FDA Guidance "'Class II. Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA was followed during the preparation of this submission.
5.5 Intended Use
GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.
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Image /page/5/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo consists of a stylized letter "G" in a square on the left, followed by the word "GOLNIT" in large, bold letters. Below "GOLNIT" is the word "SUTURES" in smaller letters. The entire logo is in a pink color.
5.6 Technological Characteristics
GOLNIT Non-absorbable Surgical PTFE Sutures have been designed to meet the requirements for tensile strength, and needle attachment strength as specified in current USP for non-absorbable sutures. Testing is performed on each lot of product to verify that these USP requirements have been met.
Sizing designations for GOLNIT Non-absorbable Surgical PTFE Suture does not follow the standard United States Pharmacopeia (USP) nomenclature used for many commercially available nonabsorbable sutures, differing in the diameter-strength relationship. The sutures in the current submission are oversized in diameter.
5.7. Subject Device vs. Predicate Device
The determination of substantial equivalence for the suture device compared to the predicate devices was based on a detailed device description, including intended use, color and materials composition, and sterilization. In addition, performance testing and conformance with voluntary performance standards, e.g. ANSVAAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP 29 - Non-Absorbable Surgical Sutures, and the FDA "Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA, December 19,2002 demonstrates compliance to U.S.P. Requirements.
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Image /page/6/Picture/0 description: The image shows the logo for Golnit Sutures. The logo is pink and features a stylized "G" on the left side, enclosed in a square. To the right of the "G" is the word "GOLNIT" in large, bold letters, with the word "SUTURES" underneath in smaller letters.
GOLNIT Non-Absorbable PTFE Surgical Suture 510 (k) Premarket Notification
| Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial Equivalence
| Comparison | |||
|---|---|---|---|
| Feature | New Device | Predicate Device | Discussion |
| Device Name | GOLNIT Non-absorbable PTFE Surgical Suture | Osteogenics Biomedical, Inc. CytoplastTM Sutures | New device vs Predicate device |
| FDA Device Premarket Notification | New device | K003028 | New device vs Predicate device |
| FDA Device Classification | Class II per 21 CFR 878.5035 | Same: | |
| Class II per 21 CFR 878.5035 | Same | ||
| Product Code | NBY | NBY | Same |
| Intended Use | GOLNIT Non-Absorbable PTFE | ||
| Surgical Suture is a | |||
| removable, non- | |||
| absorbable surgical | |||
| suture intended for use in | |||
| the approximation and | |||
| ligation of soft tissue in | |||
| the oral cavity including | |||
| fixation of barrier | |||
| membranes. | The CytoplastTM Suture is | ||
| intended for use in the | |||
| approximation and ligation | |||
| of soft tissue in the oral | |||
| cavity, including fixation | |||
| of barrier membrane. | The new device has the | ||
| same Intended Use as | |||
| Cytoplast Suture | |||
| (K003028) for oral cavity | |||
| suturing. | |||
| How Supplied | PTFE: Sterile | ||
| monofilament, thread, | |||
| undyed (natural) in | |||
| various sizes with | |||
| attached needles | |||
| Approximate U.S.P. | |||
| Sizes:2-0 to 6-0 | PTFE: Sterile | ||
| monofilament, thread, | |||
| undyed (natural) in various | |||
| sizes with attached needles | |||
| U.S.P. Sizes: 2-0 to 4-0 | The How Supplied for the | ||
| new device is comparable | |||
| to the predicate device, | |||
| CytoplastTM Sutures, in | |||
| terms of USP sizes (gauge) | |||
| and attachment of needles. | |||
| Use | Single Use Only | Single Use Only | Same |
| Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial Equivalence | |||
| Comparison | |||
| Feature | New Device | Predicate Device | Discussion |
| Color | Natural (undyed) | Natural (undyed) | Same |
| Material | |||
| Composition | Polytetrafluoroethylene | ||
| (ePTFE) polymer (100%), | |||
| expanded and uncoated | |||
| monofilaments | Polytetrafluoroethylene | ||
| (PTFE) polymer, | |||
| monofilament, uncoated, | |||
| high density monofilament | The polymer format of the | ||
| new device is expanded | |||
| whereas the Cytoplast™ | |||
| Suture polymer is extruded | |||
| as a high density PTFE | |||
| monofilament. | |||
| Needle Choices | Stainless steel: Needle tips: | ||
| Taper, Reverse Cutting, | |||
| Taper-Cutting, | |||
| Needle Curvature: $\frac{1}{2}$ , 3/8, | |||
| 5/8, $\frac{1}{4}$ , and straight | |||
| Length: various | Similar: Stainless steel | ||
| needles with various | |||
| needles points and needle | |||
| curvature | The types of GOLNIT | ||
| needle tips and shapes are | |||
| similar to the predicate | |||
| devices and provides a | |||
| range of eyeless suture | |||
| needle designs for user | |||
| convenience or preference. | |||
| Suture | |||
| Characteristics | Non-absorbable and does | ||
| not undergo any changes in | |||
| vivo. | Not absorbed and no | ||
| significant changes known | |||
| to occur in vivo. | The new device test results | ||
| indicate requirements met | |||
| for Biocompatibility per | |||
| ISO 10993 per FDA | |||
| Special Controls Guidance | |||
| Class II Special Controls | |||
| Guidance Document: | |||
| Surgical Sutures; Section |
- The sutures are
biocompatible for
implantation of short
duration less than 30 days. |
| Suture
Diameter,
Suture Length | Meets U.S.P. requirements
except for variance in | Meets U.S.P. requirements | New device with the
expanded PTFE |
| Predicate Devices vs. GOLNIT Non-absorbable PTFE Surgical Sutures - Substantial Equivalence Comparison | | | |
| Feature | New Device | Predicate Device | Discussion |
| Needle
Attachment,
Strength, Knot
Pull Tensile | diameters. | | monofilament (designated
as ePTFE) differs from
USP requirements for
diameter. |
| Packaging | Dry packaged in tear-open
double, paper/PET/CPP
pouches | Dry packaged in
paper/polyester-propylene
tear-open pouch | New device has same or
equivalent design to the
predicate devices. |
| Safety | Biocompatible per
ISO10993 for
cytotoxicity, maximum
sensitization and
irritation. | Biologically inert, non-
cytotoxic | New device has same or
equivalent biocompatibility
to the predicate devices
tested per ISO 10993-5 for
cytotoxicity and 10993-10
for maximum sensitization
and irritation. |
| | Non-pyrogenic | Not determined | The new device has been
tested to verify non-
pyrogenicity characteristic
per USP. There is no impact
on the product safety. |
| | Sterilization per ISO
11135 | Sterilized by Ethylene Oxide | Same |
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Image /page/7/Picture/0 description: The image shows the logo for Golnit Sutures. The logo is pink and features a stylized "G" on the left side of a square. To the right of the square, the word "GOLNIT" is written in large, bold letters. Below "GOLNIT", the word "SUTURES" is written in smaller letters.
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Image /page/8/Picture/0 description: The image is a logo for Golnit Sutures. The logo is pink and features a stylized letter G on the left side of the logo. To the right of the G is the word "GOLNIT" in large, bold letters, and below that is the word "SUTURES" in smaller letters.
GOLNIT Non-Absorbable PTFE Surgical Suture 510 (k) Premarket Notification
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Image /page/9/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo features a stylized letter "G" on the left, enclosed in a square. To the right of the "G" is the word "GOLNIT" in a bold, sans-serif font, with the word "SUTURES" underneath in a smaller font. The entire logo is in a pink color.
GOLNIT Non-Absorbable PTFE Surgical Suture 510 (k) Premarket Notification
5.8. Performance Data:
Per FDA's Special Control Guidance Document Surgical Sutures, performance testing including testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed to further ensure substantial equivalence to the predicate devices. Biocompatibility testing performed on each suture material type for implantable material included Cytotoxicity, Irritation and Sensitiation, and Pyrogenicity.
All testing performed has demonstrated that the GOLNIT PTFE suture is as safe and effective as the predicate, meets current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and the sutures are substantially equivalent to the predicate devices.
Design verification testing (U.S.P. - Sutures - Needle Attachment; U.S.P. -Tensile Strength; U.S.P. -Sutures -Diameter) was conducted to demonstrate the performance of the subject devices to prove conformance to the requirements of U.S.P. standards except for suture diameter. Stability testing was performed to support the proposed shelf life.
The materials selected were based on known biocompatibility (per ISO 10993) and are substantially equivalent to the materials used in the predicate devices listed. Biocompatibility testing performed on each suture material type for implantable material. Testing included: Cytotoxicity, Irritation, Sensitization and Pyrogenicity. The PTFE sutures were non-cytotoxic, non-irritant and non-sensitizer material.
6. Conclusion
Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Non-Absorbable Surgical Sutures except for the variance in suture diameter. There are no new questions concerning the safety and effectiveness of the device. These results support the safety and effectiveness of the devices for their intended use.
Based on the similarities to the predicate devices identified in this submission as well as the outcome of design verification, and that the new device has the same intended use, the same fundamental technology, and the same principle of operation, we conclude that the new device is substantially equivalent to the predicate devices.