(125 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a surgical suture, with no mention of AI or ML technologies.
No
A surgical suture is used for approximation and/or ligation of soft tissue, which is a supportive function, not a therapeutic one. Therapeutic devices are typically those that treat or cure a disease or condition.
No
The device is a surgical suture intended for soft tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, braided surgical suture made of a specific material, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in general soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical suture," which is a material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: The description does not mention anything about:
- Analyzing samples (blood, urine, tissue, etc.) outside of the body.
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or other materials to perform a test.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
The Artimplant, Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.
Product codes (comma separated list FDA assigned to the subject device)
GAR
Device Description
Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.
The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
A collection of tests has been conducted and successfully completed including biocompatibility safety studies, diameter, tensile strength and properties such as pliability and handling in accordance to:
- ISO 10993 standards
- USP 26
- Guidance for surgical suture issued on: August 10, 2000
- Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K993998, K981582, K003000, K001173
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 1 7 2003
KO32160
page 1 of 3
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Artimplant AB's summary for the Artelon™ Surgical Suture
| SUBMITTER'S NAME: | Artimplant AB |
|---|---|
| ADDRESS: | Hulda Mellgrens gata 5, SE-421 32 Västra Frölunda, |
| Sweden | |
| CONTACT PERSON: | Britt Novén |
| TELEPHONE NUMBER: | +46 31 7465600 or +46 705 280255 |
| FAX NUMBER: | +46 31 7465660 |
| DATE OF SUBMISSION: | July 11, 2003 |
1. Identification of device
Proprietary Name: Artelon™ Surgical Suture Common Name: Nonabsorbable Nylon Surgical Suture Classification Status: Class II per regulations §878.5020 Product Codes: GAR- Surgical, Nonabsorbable, Synthetic, Polyamide
2. Equivalent devices
Artimplant AB believes the Artelon™ Surgical Suture is substantially equivalent to:
| K993998 | T.CAD International - Nylon |
|---|---|
| K981582 | Sherwood-Davis & Geck - Surgilon®, Ophtalon® and Dermalon® Non- |
| absorbable Surgical Suture | |
| K003000 | Grams American Suture, Inc. - Grams Nylon Nonabsorbable Suture |
| K001173 | C.P. Medical - Nylon Nonabsorbable Surgical Sutures |
Description of the Device 3.
Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.
The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.
1
4. Intended use
The Artimplant, Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.
Technological characteristics, comparison to predicate device. 5.
Like the predicate devices, the Artelon™ Surgical Suture is intended for general soft tissue approximation and/or ligation.
| Company | T.CAD | Sherwood-Davis
& Geck | Grams American
Suture, Inc. | C.P. Medical | Artimplant AB |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | International -
Nylon | Surgilon®,
Ophtalon® and
Dermalon®
Non-absorbable
Surgical Suture | Grams Nylon
Nonabsorbable
Suture | Nylon
Nonabsorbable
Surgical Sutures | Artelon™ Surgical
Suture |
| 510(k) Number | K993998 | K981582 | K003000 | K001173 | No number yet |
| Characteristic | | | | | |
| Intended use | General soft tissue
approximation
and/or ligation
Including use in
cardiovascular
ophthalmic and
neurological
procedures. | General soft tissue
approximation
and/or ligation
Including use in
cardiovascular
ophthalmic and
neural tissue. | General soft tissue
approximation
and/or ligation
Including use in
cardiovascular
ophthalmic and
neurological
procedures. | General soft tissue
approximation
and/or ligation
Including use in
cardiovascular
ophthalmic and
neurological
procedures. | General soft tissue
approximation and/or
ligation |
| Suture Material | Nylon 6 or Nylon
6,6 | Nylon 6 or Nylon
6,6 | Nylon 6 or Nylon
6,6 | Nylon 6 or Nylon
6,6 | Polycaprolactone
based poly(urethane
urea) |
| Suture
Characteristics | Not absorbed,
progressive
degradation of the
Nylon in vivo may
result in gradual
loss of all of the
suture's tensile
strength over time | Not absorbed,
progressive
hydrolysis of the
Nylon in vivo may
result in gradual
loss of all of the
suture's tensile
strength over time | Unknown | Unknown | Not absorbed,
progressive
degradation by
hydrolysis of the
poly(urethane urea) in
vivo will result in
gradual loss of all of
the suture's tensile
strength over time |
| Suture Diameter | Meet U.S.P.
Requirements | Unknown | U.S.P. 24 for
diameter 861 | U.S.P. 24 for
diameter 861 | U.S.P. 26 for diameter
861 |
| How supplied | Monofilament
thread, coated or
uncoated, undyed
or dyed with an
FDA listed color
additive. Sterile
and offered for
Single Use Only.
Available with or
without surgical
needle. | Braided and
monofilament
sutures available
in various lengths
and diameters
with or without
surgical needles. | Sterile, flexible,
monofilament
thread or braided
thread, dyed or
undyed, offered in
a variety of
lengths and a
range of diameters
with or without
needle. | Monofilament or
braided, coated
with silicone, or
wax, or uncoated,
dyed black or dyed
blue or undyed
white. | Braided, uncoated,
undyed without
surgical needle. |
| Packaging | Dry packaged in
Aluminum Foil
and Polyester tear
open packaging | Tyvek/Mylar
packaging | Unknown | Unknown | Double peel open
laminated aluminium-
plastic foil,
respectively coated
paper and
polyester/polyethylene
film. |
2
Discussion of performance testing. 6.
A collection of tests has been conducted and successfully completed including biocompatibility safety studies, diameter, tensile strength and properties such as pliability and handling in accordance to:
- ISO 10993 standards ●
- USP 26
- Guidance for surgical suture issued on: August 10, 2000
- Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003
7. Conclusion
Based on extensive performance testing and a comparison to the predicate devices, we believe that the Artelon™ Surgical Suture is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness. Additionally, the device has identical indications to the predicate devices and the labeling of the device is consistent both with FDA's guidance as well as current medical practice.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
NOV 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Artimplant AB c/o Mr. Russell P. Pagano, Ph.D. Vice President M Squared Associates, Inc. 719 A Street, NE Washington, D.C. 20002
Re: K032160
Trade/Device Name: Artimplant AB, Artelon™ Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polymide surgical suture Regulatory Class: II Product Code: GAR Dated: October 21, 2003 Received: October 22, 2003
Dear Dr. Pagano:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Mr. Russell P. Pagano, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
B. INDICATIONS FOR USE
K032160 510(k) Number: to be Assigned
Device Name: Artimplant AB, Artelon™ Surgical Suture
Indications for Use:
The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109)
OR
Over the Counter Use
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number 6 K632160