AEON Laparoscopic Instruments

K192235 · Lexington Medical, Inc. · GEI · Oct 11, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192235
• Device Name: AEON Laparoscopic Instruments
• Applicant: Lexington Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AEONTM Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.

Device Story

AEON Laparoscopic Instruments are sterile, single-use, disposable surgical tools including forceps, scissors, and probes; used in general laparoscopic procedures. Instruments feature insulated shafts with rotating tips and male cautery connectors for attachment to external monopolar electrosurgical generators. Operation involves manual manipulation by a surgeon to grasp, dissect, cut, or coagulate tissue via electrical energy delivered from the generator. Devices are provided ETO-sterilized. Output is mechanical tissue interaction combined with electrosurgical effect. Benefits include precise tissue management during minimally invasive surgery.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, -5, -10, -7), and validation of sterilization/shelf life (ISO 11607-1, ISO 11135, ASTM F1980-16, ASTM F1929-15). Results demonstrated compliance with standards and confirmed the device is non-irritating, non-cytotoxic, and maintains sterility for a 3-year shelf life.

Technological Characteristics

Sterile, single-use, disposable laparoscopic instruments. Components include injection-molded medical-grade plastic handles, insulated shafts, and metal tip electrodes. Monopolar electrosurgical energy source (external generator). Shaft lengths: 22cm, 33cm, 45cm. Sterilization: Ethylene Oxide (ETO) to SAL 10^-6. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2, ISO 10993, ISO 11607, ISO 11135, ASTM F1980, ASTM F1929.

Indications for Use

Indicated for use in general laparoscopic surgical procedures requiring monopolar electrosurgical cutting and/or coagulation. Intended for use by clinicians in a surgical setting.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Unimax Laparoscopic Instrument (K103508)

Submission Summary (Full Text)

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October 11, 2019

Lexington Medical, Inc. Douglas MacBride Director of Systems Engineering 11 Executive Park Drive Billerica, Massachusetts 01862

Re: K192235

Trade/Device Name: AEON Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 15, 2019 Received: August 19, 2019

Dear Douglas MacBride:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, PhD Assistant Director DHT4A: Division of General 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) K192235

Device Name AEONTM Laparoscopic Instruments

Indications for Use (Describe)

AEONTM Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.

| Type of Use (Select one or both, as applicable) |
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| <span style="text-decoration: underline;"><b> </b></span> Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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# Section 3 - 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

## 1. Submitter Information

Lexington Medical, Inc. 11 Executive Park Drive Billerica, Massachusetts 01862 USA

### 2. Contact Person

Douglas MacBride Director of Systems Engineering Tel: [phone] Email: [e-mail]

### 3. Date Prepared

8/14/2019

### 4. Device Identification

Device Name: AEON™ Laparoscopic Instruments Device Common Name: Electrosurgical cutting and coagulation devices Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Classification Regulation: 21 CFR 878.4440 Device Class: II Classification Panel: General & Plastic Surgery Product Code: GEI

#### 5. Predicate Device Identification

510(k) Number: K103508 Product Name: Unimax Laparoscopic Instrument Manufacturer: Unimax Medical Systems Inc.

# 6. Device Description

The AEON Laparoscopic Instruments are sterile, disposable, single-use, individuallypackaged surgical instruments that are designed to cut, grasp, dissect, and coagulate selected tissue in laparoscopic surgery. The instruments are designed to be used with an electrosurgical generator (to be purchased separately).

There are 10 different instrument tip configuration variants. The only difference between the 10 variants is the geometry of the tip scissors/graspers in three shaft working lengths 22cm, 33cm, and 45cm.

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Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.

The proposed device is provided Ethylene Oxide (ETO) sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

### 7. Indications for Use Statement

AEON™ Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.

### 8. Substantial Equivalence

The AEON™ Laparoscopic Instruments are intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue. Unimax Laparoscopic Instrument (K103508) is a substantially equivalent device that has been cleared by the Food and Drug Administration. The predicate device is substantially equivalent in intended use, design, and technology characteristics and components to the AEON Laparoscopic Instruments manufactured by Lexington Medical Inc.

The proposed and predicate devices have the same intended use and mechanism of action. Both devices have the same technological characteristics and comprise substantially equivalent scissor/grasper/dissector probe tip configurations.

The AEON Laparoscopic Instruments have tip configurations that are equivalent to the predicate device product line variants. Instrument and tip dimensions are within the range established by the predicate device or similar to the predicate device range. The general shape and functional intent/mechanism of each AEON Laparoscopic Instrument is equivalent to the comparable predicate device variant.

Based on the similar intended use and technological characteristics, the AEON Laparoscopic Instruments are determined to be Substantially Equivalent (SE) to the predicate device.

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## 9. Performance Data

Nonclinical tests were conducted with the AEON Laparoscopic Instruments to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications.

Specifically, electrical safety and electromagnetic compatibility (EMC) testing was performed to:

- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for . basic safety and essential performance
- . IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- . IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-2:2014: Medical electrical equipment-Part 1-2: General requirements . for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests

Testing showed that the device complies with electrical safety and EMC standards as did the predicate device.

Biocompatibility testing was performed to:

- ISO-10993-1:2009 Biological evaluation of Medical Devices -- Part 1: Evaluation ● and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical device-Part 5: Tests for in vitro . cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical device-Part 10: Tests for irritation and skin sensitization
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.

Testing showed that the devices are non-irritating, not cytotoxic, and did not cause sensitization, supporting a finding of substantial equivalence.

Validation of sterilization and shelf life was performed to:

- . ISO11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ASTM F1980-16 Standard quide for accelerated aging of sterile barrier systems for . medical devices
- . ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration

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- ISO-11135:2014 Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices.
Testing showed that the product is sterile and supports a shelf life of 3 years.

## 10.Conclusion

The proposed device, the AEON™ Laparoscopic Instruments is demonstrated to be safe and effective based on performance testing, and is determined to be substantially equivalent to the predicate device based on intended use and technological characteristics.