(103 days)
Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
Novosyn is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn suture will be offered undyed or dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3206. The Novosyn suture will be offered in diameters ranging from USP size 8-0 through 2 and will be available in a variety of cut lengths with or without needles attached.
The Aesculap Novosyn Absorbable Suture, a synthetic absorbable braided surgical suture, was tested to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | USP 34 (Diameter, Tensile Strength, Needle Attachment) | All specifications met for tensile strength and needle attachment. Diameter specifications were not met. |
| Biocompatibility | ISO 10993-1 | Passed: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Genotoxicity (Chromosomal Aberration and Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation), and Muscle Implantation (12-week). |
| In-vitro Resorption | Not explicitly stated but implied to show equivalence to predicate devices | Performed and used to demonstrate substantial equivalence. |
| In-vivo Resorption | Not explicitly stated but implied to show equivalence to predicate devices | Performed and used to demonstrate substantial equivalence. |
Note on Diameter: The document explicitly states "All specifications were met apart from diameter." However, despite this deviation, the FDA determined the device to be substantially equivalent overall. It is not specified if the deviation was deemed clinically insignificant or if additional information not provided in this summary mitigated the concern.
2. Sample Size and Data Provenance for Test Set
The document does not specify the exact sample sizes used for each individual test (e.g., number of sutures tested for tensile strength, number of animals for in-vivo tests). The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). However, the testing was performed to support a 510(k) submission to the FDA, implying common laboratory testing standards for medical devices.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This study does not involve human readers for diagnostic interpretation or a ground truth established by experts in the context of medical imaging or clinical assessment. The "ground truth" for this device's performance is based on established scientific and regulatory standards as outlined in USP 34 and ISO 10993-1.
4. Adjudication Method (Test Set)
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is assessed against predefined quantitative and qualitative standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a study evaluating the physical and biological characteristics of a surgical suture, not a diagnostic imaging device requiring human reader interpretation. Therefore, no MRMC study was conducted, and no effect size for human readers improving with AI assistance is relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an algorithm or AI-based device.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Established Standards: Mechanical properties evaluated against the United States Pharmacopeia (USP 34) standards for surgical sutures.
- Biocompatibility Standards: Evaluated against international standards (ISO 10993-1) for biological evaluation of medical devices.
- Comparative Performance: The overall assessment of "substantial equivalence" is the ground truth, determined by comparing its technological characteristics (design, intended use, material composition, function, range of sizes) and performance data (mechanical, biocompatibility, resorption) to legally marketed predicate devices.
8. Sample Size for Training Set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How Ground Truth for Training Set Was Established
Not applicable.
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DEC 1 8 2012
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap® Novosyn Absorbable Suture December 5, 2012
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com |
| TRADE NAME: | Aesculap® Novosyn Absorbable Suture |
| COMMON NAME: | Synthetic Polyglycolic Absorbable Suture |
| CLASSIFICATION NAME: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| REGULATION NUMBER: | 878.4493 |
| PRODUCT CODE: | GAM |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Novosyn Absorbable Suture is substantially equivalent to:
- Safil Synthetic Absorbable Surgical Suture, Aesculap Inc. (K980704) t
- Coated Vicryl (Polyglactin 910) Suture, Ethicon Inc. (K022269) .
DEVICE DESCRIPTION
Novosyn is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn suture will be offered undyed or dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3206. The Novosyn suture will be offered in diameters ranging from USP size 8-0 through 2 and will be available in a variety of cut lengths with or without needles attached.
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INDICATIONS FOR USE
Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
As established in this submission, the Aesculap Novosyn suture is a synthetic absorbable braided surgical suture offered undyed or dyed in the same range of diameters and cut lengths that are substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.
PERFORMANCE DATA
As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 34. biocompatibility testing in accordance to ISO 10993-1, and in-vitro as well as in-vivo resorption testing has been performed to demonstrate that the Novosyn Absorable Suture is substantial equivalent to other predicate devices.
Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met apart from diameter. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Genotoxicity - Chromosomal Aberration and Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week).
Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.
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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 consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 18, 2012
Aesculap, Inc. % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K122734
Trade/Device Name: Aesculap® Novosyn Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: December 05, 2012 Received: December 06, 2012
Dear Ms. Racosky:
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 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
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Page 2 - Ms. Kathy A. Racosky
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 http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please 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 regulation (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 its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT A.
510(k) Number: K122734
Device Name: Aesculap® Novosyn Absorbable Suture
Indications for Use:
Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122734
§ 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.