VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 27, 2019 Ethicon, Inc. Ms. Stephanie Saati Sr. Regulatory Affairs Program Lead Route 22 West P.O. Box 151 Somerville, New Jersey 08876 Re: K183183 Trade/Device Name: VICRYL™ Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture PDSTM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, NEW Dated: May 23, 2019 Received: May 24, 2019 Dear Ms. Saati: 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. {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, For Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use #### 510(k) Number (if known) K183183 #### Device Name VICRYLTM (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture PDSTM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture #### Indications for Use (Describe) VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS™ II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable. PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Ethicon logo. The word "ETHICON" is in red, and below it is the phrase "a Johnson & Johnson company" in black cursive. The logo is simple and clean, with a focus on the company name. # 510(k) Summary | Submitter: | Ethicon, Inc. a Johnson & Johnson company<br>P.O. Box 151<br>Route 22 West<br>Somerville, NJ 08876-0151 | |-----------------|------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Stephanie Saati<br>Senior Regulatory Affairs Program Lead<br>Phone: 908-218-3318<br>Fax: 908-218-2595<br>Email: ssaati@its.jnj.com | Date Prepared: May 20, 2019 | Device Trade Name: | VICRYL TM (Polyglactin 910) Sterile Synthetic Absorbable<br>Surgical Suture | |----------------------------|-----------------------------------------------------------------------------------------| | Common Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid | | Regulatory Classification: | Absorbable poly(glycolide/l-lactide) surgical suture (21 CFR<br>878.4493 | | Class: | II | | Code: | GAM | | Panel: | General and Plastic Surgery Devices | | Device Trade Name: | PDS TM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | |----------------------------|------------------------------------------------------------------------| | Common Name: | Suture, Surgical, Absorbable, Polydioxanone | | Regulatory Classification: | Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840) | | Class: | II | | Product Code: | NEW | | Panel: | General and Plastic Surgery Devices | | Device Trade Name: | PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic<br>Absorbable Surgical Suture | |----------------------------|------------------------------------------------------------------------------------------| | Common Name: | Suture, Surgical, Absorbable, Polydioxanone | | Regulatory Classification: | Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840) | | Class: | II | | Product Code: | NEW | | Panel: | General and Plastic Surgery Devices | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font. Below it, in a smaller, cursive font, it says "a Johnson & Johnson company". The logo is simple and clean, with a focus on the company name. # Predicate Devices: | Device | Company | Product Code | 510(k)/ NDA Number | |----------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------|--------------------| | VICRYL™ (Polyglactin 910)<br>Braided Coated and Uncoated<br>Synthetic Absorbable Suture, Dyed<br>& Undyed, Braided and<br>Monofilament | Ethicon, Inc. | GAM | K946271 | | PDSTM II (Polydioxanone) Suture<br>Dyed & Undyed | Ethicon, Inc. | NEW | N18331 | | PDS™ Plus Antibacterial Suture | Ethicon, Inc. | NEW | K061037 | # Device Description: VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolymer made of 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. VICRYL™ Suture is available as a coated or an uncoated suture. VICRYL™ Suture is coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field. VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes. PDSTM II (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HoO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption. PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field. PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters. Below it, in a smaller, cursive font, it says "a Johnson & Johnson company". The logo is simple and clean, with a focus on the company name. PDSTM Plus Antibacterial (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture made from the polyester poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HaO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption. PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field. PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m. PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes. # Indications for Use: # VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture: VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation. including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. ### PDS™ II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture: PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDSTM II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable. ### PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture: PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable. ### Summary of Technological Characteristics: The technological characteristics of the subject devices are identical to the predicate devices and performance data are not necessary to establish substantial equivalence. ### Substantial Equivalence: The proposed devices are identical to the predicate devices with respect to functionality, technological characteristics and intended use. There is no material, device construction, {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is in large, red, sans-serif font. Below it, in a smaller, black, cursive font, it says "a Johnson & Johnson company." performance specification, packaging, sterilization or manufacturing process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which have been revised for clarification, standardization, and harmonization with the intent of creating Instructions for Use which can be supplied globally. There is no change to the intended use or to the patient population for these devices. The proposed devices do not raise new questions of safety or effectiveness as the predicate devices and are therefore substantially equivalent. # Conclusion: Based on the intended use, fundamental scientific technology, technological characteristics and the intended use, the following subject devices, VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture, PDSTM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture, and PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture are considered to be substantially equivalent to their predicated devices.