← Product Code [NEW](/productcode/NEW) · K162366 # Omega VL (K162366) _Ov World Co., Ltd. · NEW · Mar 2, 2018 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K162366 ## Device Facts - **Applicant:** Ov World Co., Ltd. - **Product Code:** [NEW](/productcode/NEW.md) - **Decision Date:** Mar 2, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4840 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. ## Device Story Omega V L is a synthetic, absorbable, monofilament surgical suture composed of polydioxanone (PDO). The device features bi-directional barbs along the long axis of the monofilament to facilitate tissue anchoring. It is supplied without an attached needle. The device is intended for use by clinicians for soft tissue approximation. As an implantable device, it remains in the body for over 30 days while undergoing absorption. The device provides mechanical support to tissues during the healing process, eventually being absorbed by the body. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, acute systemic toxicity, irritation, pyrogenicity, genotoxicity, subchronic toxicity, implantation, hemolysis) and USP <85>. Performance testing included USP <861> diameter, USP <881> tensile strength, barb holding strength, and in vitro resorption/tensile strength testing. ## Technological Characteristics Synthetic absorbable monofilament suture made of polydioxanone (PDO). Features bi-directional barbs along the long axis. Supplied without needle. Sterilized via EO gas. Color additive: D&C Violet No.2. Implantable, duration >30 days. Complies with USP <861> and USP <881> standards. ## Regulatory Identification An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached. ## Special Controls *Classification.* Class II (special controls). The special control for the 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. ## Predicate Devices - MINT ([K130191](/device/K130191.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/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" arranged around the perimeter. 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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 2, 2018 Ov World Co., Ltd % Ho Dong Yang CEO Onbix Corporation #821 Samil Plaza, 837 -26 Yeuksam-dong Gangnam-gu, Seoul, South Korea 135-768 Re: K162366 Trade/Device Name: Omega V1 Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: December 20, 2017 Received: January 3, 2018 Dear Ho Dong Yang: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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. Sincerely, # David Krause -S for 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162366 Device Name Omega V L Indications for Use (Describe) Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. Type of Use (*Select one or both, as applicable*)X 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}------------------------------------------------ ## 510(k) SUMMARY This information is being submitted in accordance with the requirements of 21 CFR §807.92. | Submitter Information: | OV World Co., Ltd.
(Gasan-dong, Fomatec Bd.) A-202, 213 205-28
Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 14 Dogok-ro 1gil, 14
Gangnam-gu, Seoul, 06253, Korea
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: onbix@naver.com | | Date Summary Prepared: | Feb 15, 2018 | | Device Information: | | | Trade Name(s): | Omega V L | |----------------------|-----------------------------------| | Classification Name: | suture, absorbable, polydioxanone | | Panel: | general & plastic surgery | | Product code: | NEW | #### Predicate Device Information: K130191 MINT (Hansbiomed Corporation) #### Device Description: This device is made of polydioxanone and has bi-directional barbs along the long axis of the suture monofilament without needle attachment #### Indications for Use Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. #### Comparison to Predicate Device(s): This device is equivalent to the predicate devices in its intended use and technological characteristics, including: - * indications for use - * technological characteristics - * performance properties #### Summary of the technological characteristics compared to the predicate device The device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below. {4}------------------------------------------------ Comparison table is as follows: | Features | Omega V L | MINT | |-----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | 510(k) number | K162366 | K130191 | | Product
Classification | Absorbable polydioxanone
surgical | Absorbable polydioxanone
surgical suture | | Manufacturer | OV World Co., Ltd | Hansbiomed Corporation | | Intended use | general soft tissue approximation
where use of an absorbable
suture is appropriate | general soft tissue approximation
where use of an absorbable
suture is appropriate | | Sterilization | EO gas | EO gas | | Raw Material | PDO (supplier: Samyang) | PDO | | Suture
Characteristic | Synthetic Absorbable
Monofilament | Synthetic Absorbable
Monofilament | | Technique of
Deployment | Needles are not attached | Needles are not attached | | Technical
characteristic | Bi-directional barbs along the long
axis of the suture monofilament
without needle attachment | Bi-directional barbs along the long
axis of the suture monofilament
without needle attachment | | Absorbable | Absorbable | Absorbable | | Patient contact | Implant | Implant | | Duration contact | Over 30 days | Over 30 days | | Color additive | D&C Violet No.2 | D&C Violet No.2 | | Suture diameters
(USP) | 1 | 1 | | Tensile strength | USP 2-0 | USP 2-0 | ## Non-Clinical Study Performance 1) Biocompatibility testing | Test | Method | |-----------------------------------------|--------------| | Cytotoxicity | ISO 10993-5 | | Sensitization | ISO 10993-10 | | Acute Systemic Toxicity | ISO 10993-11 | | Irritation (Intracutaneous Reactivity) | ISO 10993-10 | | Material Mediated Pyrogenicity | ISO 10993-11 | | Mammalian Erythrocyte Micronucleus Test | ISO 10993-3 | | In Vitro Chromosomal Aberration Test | ISO 10993-3 | {5}------------------------------------------------ | Test | Method | |----------------------------------------|--------------| | Bacterial Reverse Mutation (Ames Test) | ISO 10993-3 | | Subchronic Systemic Toxicity | ISO 10993-11 | | Implantation | ISO 10993-6 | | Hemolysis | ISO 10993-4 | | LAL Endotoxin Test | USP <85> | 2) Bench (performance) testing | Test | |-------------------------------------| | Absorption Test (non-barbed suture) | | USP <861> Sutures—Diameter | | USP <881> Tensile Strength | | Barb Holding Strength | | In Vitro Resorption Rate Test | | In Vitro Tensile Strength Test | ## Conclusion Based on the information provided in this summary, we conclude that Omega V L is substantially equivalent to the predicate device K130191. --- **Source:** [https://fda.innolitics.com/device/K162366](https://fda.innolitics.com/device/K162366) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com