(79 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and USP standards of a nonabsorbable suture, with no mention of AI or ML.
No.
The device is a non-absorbable suture used for closing wounds and ligating tissues, which is a structural component for repairing injuries rather than directly treating a disease or therapeutic condition.
No
Explanation: The device is a nonabsorbable suture used for tissue approximation and ligation, which are therapeutic and surgical procedures, not diagnostic ones.
No
The device description clearly states it is a nonabsorbable suture made of nylon yarns, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures." This describes a surgical device used in vivo (within the body) for physical repair.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, this device is a surgical suture, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nonabsorbable synthetic polvamide suture manufactured by Aurolab is indicated for use in general soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAR
Device Description
This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications.
Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.
The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, ophthalmic, neurological
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)
To establish the technical equivalency of Non absorbable sutures manufactured by Aurolab with the predicate devices, tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture- needle attachment.
The test results show that Aurolab devices tested meet USP standards and are technically equivalent to the predicate devices tested.
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.
Not Found
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
Page 3 of 23 Phone : +91 - 452 - 535573 or 537580 : +91 - 452 - 535274 or 530984 Fax E-mail : aurolab@aurolab.com
510(K) Summary
K$\phi$24049$,\phi$ (1 of 2)
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
The assigned 510 (k) number is:
Applicant:
FEB 2 8 2003
Aurolab. Aravind Eye Hospital, LAICO Building, 72 KK Salai, Gandhi Nagar, Madurai – 625020, India.
Tel: 91 - 452 - 535573 Fax: 91 - 452 - 535274 Email: aurolab@aurolab.com bala@aurolab.com
Contact Person:
| In India | In United States |
|---|---|
| Dr.P.Balakrishnan, | |
| Managing Director, | |
| Aurolab, | |
| Aravind Eye Hospital | |
| LAICO Building | |
| 72 KK Salai, | |
| Gandhi Nagar, | |
| Madurai - 625020, | |
| India. | U.S.Representative: |
Michael G. Price
President,
Visionary Medical Supplies, Inc.
6441 Enterprise Lane, Suite 214
Madison, WI 53719 |
| Tel: 91 - 452 - 535573 | Phone: 608-270-3880 |
| Fax: 91 - 452 - 535274 | Fax: 608-270-3882 |
| Email: aurolab@aurolab.com
bala@aurolab.com | Email: visionarymedical@earthlink.net |
Date of 510 (k) summary preparation: November 11, 2002
Factory : Aravind Eye Hospital, LAICO Building, 72 KK Salai, Gandhi Nagar, Madurai 625 020. India
Image /page/0/Picture/14 description: The image shows a logo with the letters "UL" inside a circle, with the words "REGISTERED FIRM" surrounding the top half of the circle. Below the logo, the word "aurolab" is printed in a smaller font size. Underneath "aurolab", the text "ISO 9002" is printed in bold. Finally, the text "File No. A6187" is printed at the bottom of the image.
For Intraocular Lens
and Suture Needle
Divisions only
For Intraocu
CE
0543
"A not-for-profit organisation dedicated to
1
Trade name: ------
K$\phi$2 4$\psi$q$\phi$ (P. 2 of 2)
Common name: Suture, nonabsorbable, synthetic polyamide
Predicate devices:
Nonabsorbable synthetic polyamide sutures manufactured by Aurolab are equivalent to Ethicon nonabsorbable synthetic polyamide sutures.
Device description:
This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications.
Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.
The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.
Intended use:
Nonabsorbable synthetic polvamide suture manufactured by Aurolab is indicated for use in general soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Performance tests to demonstrate substanital equivalency:
To establish the technical equivalency of Non absorbable sutures manufactured by Aurolab with the predicate devices, tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture- needle attachment.
The test results show that Aurolab devices tested meet USP standards and are technically equivalent to the predicate devices tested.
Balein
Dr.P.Balakrishnan, M.D., Aurolab
Date :November 11, 2002
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or other winged creature, with three distinct head profiles visible, suggesting a sense of community or collaboration.
FEB 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aurolab c/o Visionary Medical Supplies Michael G. Price President 6441 Enterprise Lane, Suite 214 Madison, Wisconsin 53719
Re: K024090
Trade/Device Name: Nylon Suture Regulation Number: 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR Dated: December 6, 2002 Received: December 11, 2002
Dear Mr.Price:
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.
3
Page 2 – Mr. Michael G. Price
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). Other general information on your responsibilities under the Act may be obtained 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
4
Statement of Indications for Use
Page 1 of 1
510(k) Number (if known): K924494
Device Name: Suture, nonabsorbable, synthetic polyamide
------------------Nylon Suture:
Suture, nonabsorbable, synthetic polyamide Common name:
Instructions for Use:
Aurolab nonabsorbable, synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE) . ·
uriam C. Provost
Division Sign-Of (Division of General. Restorative Division Neurological vices
(Optional Format 3-10-98)
510(k) Number Kc24090