MyEllevate

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July 6, 2023 Cynosure, LLC Cynthia Aguirre Regulatory Affairs Specialist II 5 Carlisle Road Westford, Massachusetts 01886 Re: K230510 Trade/Device Name: MyEllevate Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: April 14, 2023 Received: April 17, 2023 Dear Cynthia Aguirre: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, Alexander Nquyen -S Digitally signed by Alexander Nquyen -S Date: 2023.07.06 16:23:26 -04'00' for Cynthia J. Chang, Ph.D. Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230510 Device Name MyEllevate Indications for Use (Describe) MyEllevate is indicated for use in soft tissue approximation of sub dermis and underlying muscle 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. 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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}------------------------------------------------ ### Section 5- 510(K) Summary {4}------------------------------------------------ Section 5 510(k) Summary #### 510(k) Summary for Cynosure MyEllevate A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. | 807.92(a)(1) Submitter Information | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | Cynosure, LLC | | Address | 5 Carlisle Road, Westford MA, 01886 | | Phone Number | 480-401-9884 | | Fax Number | N/A | | Establishment Registration Number | 1222993 | | Contact Person | Cynthia Aguirre | | Preparation Date | July 6, 2023 | | 807.92(a)(2) Name of Device | | | Trade or Proprietary Name | MyEllevate | | Common or Usual Name | Nonabsorbable Polyester Suture | | Classification Name | Nonabsorbable poly(ethylene terephthalate) surgical suture | | Classification Panel | General & Plastic Surgery | | Regulation | 21 CFR, §878.5000 | | Regulatory Class | II | | Product Code(s) | GAT | | 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | | | Predicate Devices | Implicitguide™ Surgical Suture System (K091061) TEVDEK ® Polyester Suture (K1001434, K021019) | | 807.92(a)(4) Device Description | | | The MyEllevate device consists of a Surgical Suture System consisting of synthetic non-absorbable, braided, polyester surgical suture, and a set of instruments designed to efficiently and accurately place the suture for the purpose of performing soft tissue approximation. MyEllevate contains a Skin Marking Tape, a Lancet, a Tunneling Rod, two stainless steel Suturods, and a Light Handle which contains an LED light source. Each Suturod™ has an internal fiber optic "light pipe" which, when connected to the Ligh Handle, illuminates the distal tip of the Suturod™ and permits visual verification of the location and depth of the Suturod™ as it is passed through the subcutaneous space. All components of MyEllevate are provided sterile and are intended for single use only. While the nonabsorbable suture is a Class II device as describes by 21CFR, §878.5000, the | | | remaining instruments are Class I devices exempt from 510(k) requirements. The Lancet, Clearing Device, and Tunneling Rod are manual surgical devices described by 21 CFR §878.4800. The Skin Marking Pen is described in 21 CFR §878.4660, and the fiber optic "light pipe" and Light Handle to illuminate surgical sites, is described in 21 CFR, §876.4530. | | | <b>807.92(a)(5) Intended Use of the Device</b> | | | The MyEllevate device is indicated for soft tissue approximation and elevation of sub dermis and underlying muscle. | | | <b>807.92(b)(1) Non-clinical tests submitted</b> | | | The following non- clinical tests have been included in this 510(k) submission in determination of substantial equivalence between the test device and the referenced predicates. | | | <b>Electromagnetic Compatibility and Electrical Safety</b><br>Performance testing was conducted for MyEllevate to demonstrate that the device satisfies electrical safety requirements of the following standards: | | | • | IEC 60601-1:2005/AMD1L2012 & AMD2:2020 Medical Electrical Equipment Part 1:<br>General requirements for basic safety and essential performance | | • | IEC 60601-1-2: Ed 4.1 Medical Electrical Equipment Part 1-2: General | {5}------------------------------------------------ Section 5 - IEC 60601 60601-1-2: Ed 4.1 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic Compatibility - Requirements and Tests - IEC 60601-1-6:2005/AMD1:2012 & AMD2:2020Medical Electrical Equipment Part ● 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62471: 2008 Photobiological safety of lamps and lamp system # 807.92(b)(2) Clinical tests submitted – N/A – No clinical tests submitted 807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted The results of our comparisons demonstrated the substantial equivalence of the subject device to the identified predicate devices. {6}------------------------------------------------ Cynosure MyEllevate 510(k) K230510 Page 4 of 5 Section 5 Cynosure, LLC 510(k) Summary | Device | MyEllevate<br>(K230510) | Implicitguide™ Surgical Suture<br>System<br>(K091061) | TEVDEK® II Suture<br>(K001434, K021019) | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------| | Indication for Use | The MyEllevate device is<br>indicated for soft tissue<br>approximation and elevation of<br>sub dermis and underlying muscle. | The Implicitguide™ Surgical<br>Suture System is indicated for use<br>in soft tissue approximation and<br>elevation of sub dermis and<br>underlying muscle | Soft tissue approximation | | Suture<br>Composition | Poly (Ethylene terephthalate) | Poly (Ethylene terephthalate) | Poly (Ethylene terephthalate) | | Suture<br>Construction | Braided | Braided | Braided | | Suture Color | Undyed (Natural)<br><br>Dyed (green) | Undyed (Natural)<br><br>Dyed (green) | Undyed (Natural)<br><br>Dyed (green) | | Suture Size | USP 4-0 | USP 4-0 | USP 4-0 | | USP Official<br>Monograph | Conforms | Conforms | Conforms | | <861> Suture<br>Diameter | Conforms | Conforms | Conforms | | <881> Tensile<br>Strength | Conforms | Conforms | Conforms | | Attached Needles | Yes | Yes | Yes | | Needle<br>Composition | Stainless Steel | Stainless Steel | Stainless Steel | | <871> Needle<br>attachment- Sutures | Conforms | Conforms | Conforms | {7}------------------------------------------------ | Manufacture | Cynosure, LLC. | ImplicitCare, LLC. | Teleflex | |---------------------------|-------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------| | How Supplied | Sterile; single- use | Sterile; single- use | Sterile; single- use | | Sterilization<br>Method | Ethylene oxide | Ethylene oxide | Ethylene oxide | | Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 | Meets ISO 10993-1 | | Additional<br>instruments | Manual surgical instruments per<br>§878.4800 supplied | Manual surgical instruments per<br>§878.4800 supplied | Manual surgical instruments per<br>§878.4800 supplied |