(86 days)
Not Found
No
The document describes a surgical suture with an antibacterial agent and does not mention any AI or ML components or functionalities.
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 device for surgical procedures but not directly a therapeutic treatment in itself.
No
This device is a surgical suture used for tissue approximation and ligation, not for diagnosing conditions or diseases.
No
The device description clearly indicates it is a physical surgical suture made from a copolymer, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a surgical suture used for "general soft tissue approximation and/or ligation." This is a physical device used in vivo (within the living body) during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing of samples.
Therefore, the MONOCRYL* Plus Antibacterial suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MONOCRYL* Plus Antibacterial sutures are indicated for use in general soft tissue approximation and/or !igation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAM, GAN
Device Description
MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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)
Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed.
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.
0
K050845$_{1/2}$
JUN 2 9 2005
JMP-2005-008
Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Jennifer M. Paine Sr. Project Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville. NJ 08876
Name/Classification of Device:
Class II in 21 CFR § 878.4493, Absorbable poly(glycolide/l-lactide) surgical suture (GAM) and § 878.4830, Absorbable surgical gut suture (GAN)
Trade Name:
MONOCRYL * Plus (Poliglecaprone 25) Antibacterial Suture
Predicate Devices:
MONOCRYL* (poliglecaprone 25) Suture (K960653 and K964072) VICRYL* Plus Antibacterial Suture (K032420)
Statement of Intended Use:
MONOCRYL* Plus Antibacterial sutures are indicated for use in general soft tissue approximation and/or !igation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Device Description:
MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified device has similar technological characteristics as the predicate devices. Like currently marketed MONOCRYL* Suture, it is a sterile, monofilament synthetic absorbable suture that conforms to the USP
1
K05afYS$_{2/2}$
ﻳﺔ ﺍﻟ
Monograph for absorbable surgical sutures, except for diameter. Like the Monograph is aboutsation VICRYL Plus Antibacterial suture, the modified ourrently manologiaane** MP, an antibacterial agent.
Performance Data:
Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed.
Conclusions:
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act.
- Trademark of Ethicon, Inc.
**Trademark of Ciba Specialty Chemicals Corporation.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Ms. Jennifer M. Paine Senior Project Manager, Regulatory Affairs Ethicon Incorporated Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K050845
Trade/Device Name: MONOCRYL* Plus Antibacterial (Poliglecaprone 25) Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L- lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: April 1, 2005 Received: April 4, 2005
Dear Ms. Paine:
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.
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Page 2- Ms. Jennifer M. Paine
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 (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kosofys
Indications for Use
510(k) Number (if known): _____________
Device Name: MONOCRYL* Plus Antibacterial (Poliglecaprone 25) Suture
Indications for Use:
MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
ivision Sign-Can Division of Gerenal, Restorative and Neurological Devices
Number K050845