Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a manual surgical suture system with instruments and a light source, with no mention of software, algorithms, or any technology typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".

Therapeutic

No
A therapeutic device is one that treats or manages a disease or condition. This device is used for "soft tissue approximation," which is a surgical procedure to bring tissues together, but it does not treat or manage a disease itself.

Diagnostic

No

The device is designed for surgical soft tissue approximation using sutures and instruments, not for diagnosing medical conditions. Its function is interventional, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly details multiple hardware components including sutures, instruments, a light handle with an LED, and fiber optic "light pipes". There is no mention of any software component.

IVD (In Vitro Diagnostic)

Based on the provided information, the MyEllevate device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "soft tissue approximation of sub dermis and underlying muscle." This is a surgical procedure performed directly on the patient's body.
Device Description: The device consists of surgical instruments and suture material used for physical manipulation of tissue.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The MyEllevate device does not perform any such analysis of specimens.
Regulatory Classifications: The listed regulatory classifications (e.g., 21 CFR §878.5000 for suture, 21 CFR §878.4800 for manual surgical devices) are for surgical and general hospital devices, not IVDs.

Therefore, MyEllevate is a surgical device used for tissue approximation, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MyEllevate is indicated for use in soft tissue approximation of sub dermis and underlying muscle

Product codes (comma separated list FDA assigned to the subject device)

GAT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue, sub dermis, underlying muscle

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 tests were conducted to demonstrate substantial equivalence. These include: Electromagnetic Compatibility and Electrical Safety testing to standards IEC 60601-1:2005/AMD1L2012 & AMD2:2020, IEC 60601-1-2: Ed 4.1, IEC 60601-1-6:2005/AMD1:2012 & AMD2:2020, and IEC 62471: 2008. The product also conforms to USP Official Monograph, Suture Diameter, Tensile Strength, and Needle attachment- Sutures. Biocompatibility meets ISO 10993-1. No clinical tests were submitted. The results of these comparisons demonstrated the substantial equivalence of the subject device to the identified predicate devices.

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.

Implicitguide™ Surgical Suture System (K091061), TEVDEK ® Polyester Suture (K1001434, K021019)

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

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.

Summary

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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)

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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.
807.92(a)(5) Intended Use of the Device
The MyEllevate device is indicated for soft tissue approximation and elevation of sub dermis and underlying muscle.
807.92(b)(1) Non-clinical tests submitted
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.
Electromagnetic Compatibility and Electrical Safety
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:
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.

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Cynosure MyEllevate 510(k)
K230510
Page 4 of 5 Section 5

Cynosure, LLC

510(k) Summary

| Device | MyEllevate
(K230510) | Implicitguide™ Surgical Suture
System
(K091061) | TEVDEK® II Suture
(K001434, K021019) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Indication for Use | The MyEllevate device is
indicated for soft tissue
approximation and elevation of
sub dermis and underlying muscle. | The Implicitguide™ Surgical
Suture System is indicated for use
in soft tissue approximation and
elevation of sub dermis and
underlying muscle | Soft tissue approximation |
| Suture
Composition | Poly (Ethylene terephthalate) | Poly (Ethylene terephthalate) | Poly (Ethylene terephthalate) |
| Suture
Construction | Braided | Braided | Braided |
| Suture Color | Undyed (Natural)

Dyed (green) | Undyed (Natural)

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Manufacture	Cynosure, LLC.	ImplicitCare, LLC.	Teleflex
How Supplied	Sterile; single- use	Sterile; single- use	Sterile; single- use
Sterilization
Method	Ethylene oxide	Ethylene oxide	Ethylene oxide
Biocompatibility	Meets ISO 10993-1	Meets ISO 10993-1	Meets ISO 10993-1
Additional
instruments	Manual surgical instruments per
§878.4800 supplied	Manual surgical instruments per
§878.4800 supplied	Manual surgical instruments per
§878.4800 supplied