(154 days)
Not Found
No
The description focuses on the material composition and antibacterial properties of a surgical suture, with no mention of AI or ML.
No.
The device is a surgical suture used for approximation and ligation of soft tissues, which is a structural rather than a therapeutic function. While it has an antibacterial agent, its primary purpose is mechanical support during wound healing, not to treat a disease or condition.
No.
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device is a surgical suture, which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes tests performed on blood, urine, tissue, etc., outside of the body.
- Device Description and Intended Use: The provided text clearly describes a surgical suture used for in vivo (within the living body) soft tissue approximation and ligation. It is a physical material implanted into the body during surgery.
- Lack of Diagnostic Function: The device's function is to physically hold tissue together and provide an antibacterial effect to prevent infection at the surgical site. It does not analyze biological specimens to provide diagnostic information.
- Performance Studies: The performance studies mentioned are in vitro studies demonstrating the antibacterial effect of the suture itself, not diagnostic tests performed on patient samples.
Therefore, based on the provided information, the MONOCRYL™ Plus Antibacterial Suture is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MONOCRYL™ Plus Antibacterial Sutures 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.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
MONOCRYL™ Plus Antibacterial Suture is a sterile, monofilament, synthetic, absorbable surgical suture composed of a copolymer of glycolide and (epsilon) s-caprolactone. The empirical formula of the polymer is (C2H2O2)m (C6H102)n.
MONOCRYL™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2
MONOCRYL™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/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)
In vitro efficacy studies were conducted to demonstrate that bacteria will not colonize MONOCRYL™ Plus Antibacterial suture. The in vitro data indicated that MONOCRYL™ Plus suture provides an antibacterial effect sufficient to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-Resistant S. aureus, Methicillin-Resistant S. epidermidis, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2020
Ethicon Inc. Joice Pappan Regulatory Affairs Manager Route 22 West. P.O. Box 151 Somerville, New Jersey 08876
Re: K201996
Trade/Device Name: Monocryl Plus Antibacterial 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 11, 2020 Received: December 14, 2020
Dear Joice Pappan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201996
Device Name
MONOCRYL™ Plus Antibacterial Poliglecaprone - 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
Indications for Use (Describe)
MONOCRYL™ Plus Antibacterial Sutures 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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ETHICON,INC.
won Johnson company a Joh
510(k) Summary
| Submitter: | Ethicon, Inc., a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, New Jersey 08876-0151
USA |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joice Pappan
Regulatory Affairs Manager
Ethicon, Inc., a Johnson & Johnson company
Phone: (718) 419-1838
Fax: (908) 541-3868
E-mail: jpappan@its.jnj.com |
| Date Prepared: | July 17, 2020 |
| Device Trade Name: | MONOCRYL™ Plus Antibacterial Poliglecaprone - 25
(Monofilament), Sterile Synthetic Absorbable Surgical Suture |
| Device Common Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Class: | II |
| Classification Name: | Absorbable poly(glycolide/l-lactide) surgical suture
(21 CFR878.4493) |
| Product Code: | GAM |
Predicate Device:
| Predicate Device | 510(k) Number |
|---|---|
| MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 | K050845 |
| (Monofilament), Sterile Synthetic Absorbable Surgical Suture |
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Device Description:
MONOCRYL™ Plus Antibacterial Suture is a sterile, monofilament, synthetic, absorbable surgical suture composed of a copolymer of glycolide and (epsilon) s-caprolactone. The empirical formula of the polymer is (C2H2O2)m (C6H102)n.
MONOCRYL™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2
MONOCRYL™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m.
Indications for Use:
MONOCRYL™ Plus Antibacterial Sutures 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.
Summary of Technological Characteristics and Performance:
The modified MONOCRYL™ Plus Suture has the same technological characteristics as the predicate device. Like the currently marketed predicate device, it is a sterile, monofilament synthetic absorbable suture that complies with the requirements of the United States Pharmacopoeia (USP) for absorbable surgical sutures except for a slight oversize in diameter.
Like the current marketed MONOCRYL™ Plus Antibacterial Suture, the modified device will continue to be available as a suture product with Irgacare®† MP, an antibacterial agent.
In vitro efficacy studies were conducted to demonstrate that bacteria will not colonize MONOCRYL™ Plus Antibacterial suture. The in vitro data indicated that MONOCRYL™ Plus suture provides an antibacterial effect sufficient to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-Resistant S. aureus, Methicillin-Resistant S. epidermidis, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae.
Substantial Equivalence:
The modified device has the same intended use and indications for use as the predicate device. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed device. The modified device and currently marketed device differ only in the labeling (Instruction for Use and device box) which have been revised for updating invitro effectiveness against an additional microorganism and to include new descriptor and icon to allow customers to easily distinguish between Ethicon MONOCRYL™ suture and Ethicon MONOCRYL™ Plus suture.
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Conclusion:
Since there will be no physical or technological characteristic changes to the currently marketed predicate device, the proposed labeling changes has shown to be appropriate for its intended use. Therefore, the modified device is substantially equivalent to the predicate device.
- Trademark
IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"