(133 days)
Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.
Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a 510(k) submission for an absorbable surgical gut suture and details its intended use, characteristics, materials, and performance data, but it does not specify acceptance criteria, study results in the format of a table, sample sizes for test or training sets, data provenance, expert qualifications, or details about MRMC studies. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study against specific acceptance criteria.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2015
Covidien Ms. Mary Mellows Senior Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K142656
Trade/Device Name: Absorbable Surgical Gut Suture Regulation Number: 21 CFR 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: Class II Product Code: GAL Dated: December 23, 2014 Received: December 30, 2014
Dear Ms. Mellows:
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
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142656
Device Name Absorbable Surgical Gut Suture
Indications for Use (Describe)
Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CEB 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
| SUBMITTER: | Covidien60 Middletown AvenueNorth Haven, CT 06473(203) 492-5284 (T) |
|---|---|
| CONTACT PERSON: | Mary MellowsSenior Specialist, Regulatory Affairs |
| DATE PREPARED: | September 17, 2014 |
| TRADE/PROPRIETRY NAME: | Surgical Gut Suture |
| COMMON/USUAL NAME: | Absorbable Surgical Gut Suture |
| CLASSIFICATION NAME: | Suture, Absorbable, Natural |
| FDA PANEL NUMBER: | 79 |
| PRODUCT CODE: | GAL |
| CLASS CODE: | Pursuant to 21 CFR 878.4830, absorbable surgical gutsuture is a Class II device |
| LEGALLY MARKETEDDEVICES TO WHICHEQUIVALENCY ISCLAIMED: | Surgical Gut Suture (K885018) |
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REASON FOR 510(K)
TECHNICAL
SUBMISSION: Obtain clearance for Covidien's surgical gut suture (plain, mild, and chromic) with a manufacturing process modification to include an additional sodium hydroxide (1N NaOH) bath or soaking step inactivate any potential viruses. to In addition, the Contraindications and Warning sections of the Instructions for Use are being modified to make them clearer for the user.
- DEVICE DESCRIPTION: Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.
- INTENDED USE: Plain, Chromic and Mild Chromic qut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.
- CHARACTERISTICS: The proposed surgical gut suture is substantially equivalent and its fundamental scientific technology has not been altered as compared to the predicate devices.
- MATERIALS: All components of the surgical gut suture are similar to the predicate surgical gut suture. All materials are similar and have been tested in accordance with ISO Standard 10993-1.
- PERFORMANCE DATA: Design verification and pre-clinical validation studies were conducted to demonstrate that the proposed surgical gut sutures are safe and effective and perform as intended. In vitro and in vivo testing to support the intended use of this device includes:
- . In Vitro
- Visual/Tactile o
- Suture Removal O
- Diameter O
- Knot Pull O
- Needle Attachment O
- In Vivo ●
- Strenath Loss O
- Mass Loss o
- Biocompatibility .
- . In Vitro
CONCLUSION:
The result of these tests demonstrates that the proposed surgical gut sutures are substantially equivalent to the predicate device and does not introduce additional risk to the patient.
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.