(79 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and USP standards of a traditional surgical suture, with no mention of AI or ML.
No.
The device is a surgical suture used for approximation and ligation of tissues, not for treating a disease or condition.
No
The device description states that the silk suture is "indicated for use in general soft tissue approximation and/or ligation." This describes a surgical tool used for treatment, not for identifying a medical condition or disease.
No
The device is a physical surgical suture made of silk, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "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) to physically join or tie off tissues.
- Device Description: The description details a surgical suture made of silk, used for stitching. This is a physical implant/device, not a reagent or instrument used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This silk suture does not fit that description.
N/A
Intended Use / Indications for Use
Aurolab nonabsorbable Silk suture 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)
GAP
Device Description
This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.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.
This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.
This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular system, eye, neurological system
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 shows 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.
Ethicon silk nonabsorbable sutures.
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
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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
Aravind Eye Hospital 1 Anna Nagar Madurai - 625 020, India
Page 3 of 22 Phone : +91 - 452 - 535573 or 537580 : +91 - 452 - 535274 or 530984 Fax E-mail : aurolab@aurolab.com
024e91 (R 1 of 2)
510(K) Summary
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:_
FEB 2 8 2003
Applicant:
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, | U.S.Representative: |
| Managing Director, | |
| Aurolab, | Michael G. Price |
| Aravind Eye Hospital | President, |
| LAICO Building | Visionary Medical Supplies, Inc. |
| 72 KK Salai, | 6441 Enterprise Lane, Suite 214 |
| Gandhi Nagar, | Madison, WI 53719 |
| Madurai - 625020, | |
| India. | Phone: 608-270-3880 |
| Tel: 91 - 452 - 535573 | |
| Fax: 91 - 452 - 535274 | |
| Email: aurolab@aurolab.com | |
| bala@aurolab.com | Phone: 608-270-3880 |
| Fax: 608-270-3882 | |
| 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 word "REGISTERED" around it. To the right of the logo, the text reads "For Intraocular Lens and Suture Needle Divisions only". Below the logo, the text "aurolab ISO 9002 File No A6187" is present, followed by the partial text "A note".
For Intrancular Needles only
Image /page/0/Picture/16 description: The image shows the CE marking, a symbol indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Below the CE marking is the number 0543, which is likely a notified body identification number. This number indicates that a third-party organization has been involved in assessing the product's compliance with the relevant CE marking directives.
"A not-for-profit organisation dedicated to supply nroducts and services to eve care provid
1
Page 4 of 22
K02 4091 (P. 20f2)
Trade name: ------
Common name: Suture, nonabsorbable, Silk
Predicate devices:
Nonabsorbable Silk sutures manufactured by Aurolab are equivalent to Ethicon silk nonabsorbable sutures.
Device description:
This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.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.
This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.
This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.
Intended use:
Nonabsorbable Silk 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 shows that Aurolab devices tested meet USP standards and are technically equivalent to the predicate devices tested.
Bolin
Dr.P.Balakrishnan, M.D., Aurolab
November 11, 2002, Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2003
Aurolab c/o Visionary Medical Supplies Michael G. Price President 6441 Enterprise Lane, Suite 214 Madison, Wisconsin 53719
Re: K024091 Trade/Device Name: Silk Sutures Regulation Number: 878.5030 Regulation Name: Nonabsorbable silk surgical suture Regulatory Class: Class II Product Code: GAP 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
لها 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
Page 21 of 22
Statement of Indications for Use
Page 1 of 1
510(k) Number (if known): K024691
Device Name: Suture, nonabsorbable, Silk
Trade name: ----------------
Common name: Suture, nonabsorbable, Silk
Instructions for Use:
Aurolab nonabsorbable Silk 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)
(Optional Format 3-10-98)
Miriam C. Provost
Division Sign Division of General Restorative and Neurological revices
510(k) Number K024091