(147 days)
Not Found
No
The 510(k) summary describes a standard surgical suture and its physical properties and testing against USP standards. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
A therapeutic device is one that treats a disease or condition. This device is a surgical suture used for tissue approximation and ligation, which is a supportive tool in a procedure rather than a direct therapeutic agent.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid, which is a physical, 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 "general soft tissue approximation and / or ligation in ophthalmic procedures." This describes a surgical procedure performed directly on a patient's tissue.
- Device Description: The device is a "sterile, surgical suture composed of monofilaments and braids of polyglycolic acid." This is a physical implant used during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Being used in a laboratory setting
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used in the body during a procedure.
N/A
Intended Use / Indications for Use
Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0.
The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0:
- t Sutures - Diameter
- Sutures Needle Attachment .
- Tensile Strength t
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, ophthalmic
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 the Sutrazorb Sutures manufactured for Visionary Medical Supplies, tests were conducted for diameter, tensile strength, and suture-needle attachment according to methods presented in United States Pharmacopoeia (USP) Monograph for absorbable surgical sutures.
Absorption profile and shelf life tests were also performed. The test results shows that Sutrazorb Sutures 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.
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.
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VISIONARY MEDICAL SUPPLIES, INC.
OPHTHALMIC SUTURES, IOL S AND MORE
6441 Enterprise Lane, Madison, Wisconsin 53719 USA Ph: 608 270-3880 Fax: 608 270-3882 www.visionarymedicalsupplies.com
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:
Applicant:
Visionary Medical Supplies, Inc. 6441 Enterprise Lane Madison, WI 53719 Phone: 608-270-3880 Fax: 608-270-3882 Email: morice@visionarymedicalsupplies.com
Contact Person:
Michael G. Price, President Visionary Medical Supplies, Inc. 6441 Enterprise Lane Madison, WI 53719 Phone: 608-270-3880 Fax: 608-270-3882 Email: mprice@visionarymedicalsupplies.com
Date of 510(k) summary preparation: September 3, 2010
Trade name: Sutrazorb Absorbable PGA Sutures
Common name: Absorbable Poly(glycolide/I-lactide) Surgical Suture
Predicate devices:
Trade Name: DEXON II Manufacture: Davis & Geck PMA Number: K951352
Trade Name: Surgisorb Manufacture: Samyang Corporation 510(k) Number: K984374
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1.0 Device description:
The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0.
The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0:
- t Sutures - Diameter
- Sutures Needle Attachment .
- Tensile Strength t
2.0 Intended use:
Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.
3.0 Performance tests to demonstrate substantial equivalency:
To establish the technical equivalency of the Sutrazorb Sutures manufactured for Visionary Medical Supplies, tests were conducted for diameter, tensile strength, and suture-needle attachment according to methods presented in United States Pharmacopoeia (USP) Monograph for absorbable surgical sutures.
Absorption profile and shelf life tests were also performed. The test results shows that Sutrazorb Sutures meet USP standards and are technically equivalent to the predicate devices tested.
4.0 Conclusions
The intended use, technology and materials of the Visionary Medical Supplies Sutrazorb Sutures are the equivalent to the predicate device. No new questions of safety or effectiveness are raised.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Visionary Medical Supplies, Inc. % Quality and Regulatory Associates, LLC Mr. Gary Syring 800 Levanger Lane Stoughton. Wisconsin 53589
FEB - 3 201
Re: K102592
Trade/Device Name: Sutrazorb Absorbable PGA Sutures Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: January 18, 2011 Received: January 21, 2011
Dear Mr. Syring:
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
and the country of the country of the county of
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Page 2 - Mr. Gary Syring
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to hillp://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, nease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regultiven (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 Small Manufacturers, International and Consumer Assistance at is coll free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K 102592
Device Name: Sutrazorb Absorbable PGA Sutures
Indications for Use:
Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kume for Mxing
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102592