(202 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML.
No
The device, a surgical suture, is used for approximating or ligating soft tissue, which is a supportive rather than therapeutic function.
No
This device is a surgical suture used for tissue approximation and ligation, not for diagnosing conditions.
No
The device description clearly details a physical surgical suture made of Nylon 6,6, available in various sizes, colors, and with or without needles. It is a tangible, hardware medical device.
Based on the provided information, the Golnit Nylon Monofilament Suture is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a physical suture used to hold tissue together during surgery. This is a surgical tool, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, detect substances, or provide diagnostic information.
Therefore, the Golnit Nylon Monofilament Suture is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.
Product codes
GAR
Device Description
The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear).
The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm).
Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical or animal testing was conducted.
Testing that was performed demonstrate that the suture meets the requirements outlined in Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003. Testing in accordance with to the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength, was performed. This performance testing demonstrated that the Golnit Monofilament Suture meets the USP requirements for suture diameter, suture needle attachment, and tensile strength.
Real-time aging stability testing was performed to support shelf life of the Golnit Nylon Monofilament Suture, and this testing supported the shelf life of the device.
Biocompatibility testing was also performed per Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. This testing demonstrated that the device is biocompatible.
All testing demonstrated that the Golnit Nylon Monofilament Suture is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 31, 2022
Antarma LLC dba Golnit Sutures Armine Badalyan CEO 276 5th Ave., Suite 704 New York, New York 10001
Re: K212888
Trade/Device Name: Golnit Nylon Monofilament Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR Dated: September 9, 2021 Received: September 10, 2021
Dear Armine 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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic 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
510(k) Number (if known) K212888
Device Name Golnit Nylon Monofilament Suture
Indications for Use (Describe)
The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo is pink and features a stylized "G" inside a square on the left. To the right of the square is the word "GOLNIT" in large, bold letters, and below that is the word "SUTURES" in smaller letters.
510(k) Summary
In accordance with 21 CFR 807.92, the following summary of information is provided.
I. SUBMITTER
| Name: | Antarma LLC dba Golnit Sutures |
|---|---|
| Address: | 276 5th Avenue, Suite 704 |
| New York, NY 10001 | |
| Phone: | 718-219-0731 |
| Contact Person: | Armine Badalyan, Chief Executive Officer |
| Date Summary Prepared: | February 25, 2022 |
II. DEVICE
| Proprietary Name: | Golnit Nylon Monofilament Suture |
|---|---|
| Common Name: | Nonabsorbable polyamide surgical suture |
| Classification Name: | Suture, Nonabsorbable, Synthetic, Polyamide |
| Regulation: | 21 CFR 878.5020 |
| Regulatory Class: | II |
| Product Code: | GAR |
| Panel: | Surgical and Infection Control Devices (OHT4) / Infection Control and |
| Plastic Surgery Devices (DHT4B) |
III. PREDICATE DEVICE
The Golnit Nylon Monofilament Suture is being compared to the predicate device, REXLON, which was cleared under K161633 and manufactured by SM ENG CO., Ltd.
One reference device, the Golnit Non-Absorbable PTFE Surgical Suture, was used to support equivalence of the needle component and to support adoption into the product family for sterilization validation. The reference device was cleared under K163049.
Neither the predicate device nor the reference device has been the subject to a design-related recall.
IV. DEVICE DESCRIPTIONS
The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear).
The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm
4
to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm).
Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.
V. INTENDED USE / INDICATIONS FOR USE
The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| Attribute | Proposed Device - Golnit
Nylon Monofilament Suture | Predicate Device -
REXLON | Reference Device -
Golnit Non-
Absorbable PTFE
Surgical Suture |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GAR | GAR | NBY |
| Regulation | 21 CFR 878.5020 | 21 CFR 878.5020 | 21 CFR 878.5035 |
| Intended use | Soft tissue approximation
and/or ligation | Soft tissue approximation
and/or ligation | Soft tissue
approximation and/or
ligation |
| Indications for use | The Golnit Nylon
Monofilament Suture is
indicated for use in general
soft tissue approximation
and/or ligation, including use
in ophthalmic procedures, but
not for use in cardiovascular
or neurological procedures. | REXLON is indicated for use
in general soft tissue
approximation and/or
ligation, including use in
ophthalmic procedures, but
not for use in cardiovascular
or neural tissue. | The GOLNIT Non-
Absorbable PTFE
Surgical Suture is
indicated for use in all
types of soft tissue
approximation and/or
ligation, including
dental, cardiovascular
and general surgeries,
as well as repair of the
dura mater. The device
is not indicated for use
in ophthalmic surgery,
microsurgery and
peripheral neural tissue |
| How Supplied | Sterile monofilament thread
in various colors and sizes
with or without attached
needles | Sterile monofilament thread
in various colors and sizes
with or without attached
needles | Sterile monofilament
thread in various sizes
with or without attached
needles |
| Suture Specifications | | | |
| Material | Polyamide surgical suture
from long-chain aliphatic
polymers Nylon 6 and Nylon
6,6 | Polyamide surgical suture
from long-chain aliphatic
polymers Nylon 6 and Nylon
6,6 | Polytetrafluoroethylene
(ePTFE) polymer
(100%),
expanded and uncoated
monofilaments |
| Color (colorant) | Undyed (natural)
Black (Logwood extract) | Undyed (natural)
Black (Logwood extract) | Natural (undyed) |
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Image /page/5/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo is pink and features a stylized "G" in a square on the left. To the right of the "G" is the word "GOLNIT" in large, bold letters. Below "GOLNIT" is the word "SUTURES" in smaller letters.
| Attribute | Proposed Device – Golnit
Nylon Monofilament Suture | Predicate Device –
REXLON | Reference Device –
Golnit Non-
Absorbable PTFE
Surgical Suture |
|----------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Coating | Blue (FD&C Blue No. 2) | Blue (FD&C Blue No. 2) | None |
| | None | None | None |
| Nonabsorbable | Yes | Yes | Yes |
| Monofilament | Yes | Yes | Yes |
| Sizes | USP 10/0 to 2 | Black: USP 11/0 to 1
Blue: USP 8/0 to USP 2
Undyed: USP 8/0 to USP 1 | 2-0 to 6-0 |
| Length | 10 cm to 300 cm with 5 cm
intervals | 15 cm, 20 cm, 30 cm, 35 cm,
40 cm, 45 cm, 50 cm, 60 cm,
70 cm, 75 cm, 80 cm, 100
cm, 150 cm, 200 cm | 10 cm to 300 cm with 5
cm intervals |
| | | | |
| Needle | | | |
| Material | Stainless steel | Stainless steel | Stainless steel |
| Needle type | Taper, Cutting, Reverse-
cutting, Taper-cutting
(tapercut), Spatula, Diamond,
no needle | Reverse cutting, Taper point,
Spatula | Taper, Reverse Cutting,
Taper-Cutting |
| | | | |
| Performance Characteristics and Safety | | | |
| Packaging | Dry packaged in tear-open
double paper/PET/CPP
pouches | Dry packaged in tear-open
pouch | Dry packaged in tear-
open double
paper/PET/CPP
pouches |
| Suture Diameter per
USP | Meets requirements | Meets requirements | Meets requirements |
| Suture Needle
Attachment per USP
| Meets requirements | Meets requirements | Meets requirements |
| Tensile Strength per
USP | Meets requirements | Meets requirements | Meets requirements |
| Sterile | Yes | Yes | Yes |
| Method of Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Biocompatible | Yes | Yes | Yes |
The Golnit Non-Absorbable PTFE Surgical Suture was used as a reference device to support equivalence of the needle component and to support adoption into the product family for sterilization. Both the reference device and proposed device use the same stainless-steel needle from the same supplier and have the same sterilization parameters. The proposed device may be supplied with additional needle tip shapes.
VII. PERFORMANCE DATA
No clinical or animal testing was conducted.
Testing that was performed demonstrate that the suture meets the requirements outlined in Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003. Testing in accordance with to the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength, was performed. This performance testing demonstrated that the Golnit Monofilament Suture meets the USP requirements for suture diameter, suture needle attachment, and tensile strength.
6
Image /page/6/Picture/0 description: The image shows the logo for GOLNIT SUTURES. The logo is pink and features a stylized letter "G" on the left side. The word "GOLNIT" is written in large, bold letters above the word "SUTURES", which is written in smaller letters.
Real-time aging stability testing was performed to support shelf life of the Golnit Nylon Monofilament Suture, and this testing supported the shelf life of the device.
Biocompatibility testing was also performed per Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. This testing demonstrated that the device is biocompatible.
All testing demonstrated that the Golnit Nylon Monofilament Suture is as safe and effective as the predicate device.
VIII.CONCLUSIONS
Based on the performance data and comparison to the predicate device, the Golnit Nylon Monofilament Suture has been shown to be substantially equivalent to the legally marketed predicate device.