UltraLase Flexible CO2 Laser Waveguide

K211761 · W & R Investments, LLC Dba Laser Engineering · GEX · Jul 30, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211761
• Device Name: UltraLase Flexible CO2 Laser Waveguide
• Applicant: W & R Investments, LLC Dba Laser Engineering
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 30, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues. The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

Device Story

Flexible silica capillary waveguide; internal wall coated with reflective silver/silver iodide; delivers 10.6µm CO2 laser energy. Input: laser energy from compatible CO2 laser system (via 905 SMA or 953 ST connector). Operation: energy travels via multiple internal reflections; output at distal end for tissue interaction. Used in OR/clinic for open or endoscopic surgery; operated by physicians. Purge gas recommended to maintain internal channel clarity. Output allows precise tissue incision/ablation; benefits include flexible access to surgical sites. Single-use, sterile device.

Clinical Evidence

No clinical data. Bench testing only, including epoxy strength, intracutaneous irritation, muscle implant reaction, systemic toxicity, sterilization validation, ETO residuals, bioburden, package integrity, and laser transmission performance.

Technological Characteristics

Flexible silica capillary; internal reflective coating (silver/silver iodide); Tefzel 207 (ETFE) protective sleeve; 2-meter length; 905 SMA or 953 ST connectors. Operates at 10.6µm wavelength. ETO sterilized. Biocompatible per ISO 10993-7. Passive delivery system; no software or electronics.

Indications for Use

Indicated for patients undergoing general, plastic, neuro, ophthalmic, oral, ENT, podiatric, gynecological, or urological surgery requiring soft tissue incision, excision, ablation, vaporization, or coagulation via CO2 laser.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• UltraLase Flexible CO2 Laser Waveguide (K112166)

Reference Devices

• FiberLase CO2 Laser Waveguide (K100384)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 30, 2021

W & R Investments, LLC dba Laser Engineering Robert Rudko Chief Scientist 113 Cedar Street, SuiteS5 Milford, Massachusetts 10757

Re: K211761

Trade/Device Name: UltraLase Flexible CO2 Laser Waveguide Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 6, 2021 Received: July 7, 2021

Dear Robert Rudko:

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.

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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 mediation-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.

Purva Pandya 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

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# Indications for Use

#### 510(k) Number (if known)

#### K211761

Device Name UltraLase Flexible CO2 Laser Waveguide

#### Indications for Use (Describe)

The UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surveology, podiaty, gyneology, and urology procedures. It is used to deliver laser energy for incision, ablation, vaportzation, and coagulation of soft tissues.

The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached

| 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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# SPECIAL 510(K) SUMMARY (K211761)

# Applicant:

W and R Investments, LLC d/b/a Laser Engineering 113 Cedar Street Suite S5 Milford, MA 01757 Tel: [phone]

Contact Person: Robert I. Rudko, Ph.D. Chief Scientist [e-mail]

Date Prepared: May 19, 2021

#### Device Name: UltraLase CO2 Laser Wavequide

| Proprietary Name: | UltraLase Flexible CO2 Laser Waveguide |
|----------------------|----------------------------------------|
| | Model # HWG505 and HWG305 |
| Classification Name: | Laser Surgical Instrument |
| Classification: | 878.4810 |
| Product Code: | GEX |

### Predicate Devices:

The UltraLase Flexible CO2 Laser Wavequides (K211761) Model HWG505 and HWG305 are modifications of the currently marketed devices (K112166) Model HWG500-2.0-3.0 and the HWG300-2.0-3.0 respectively.

### Reference device:

In addition, the UltraLase Flexible CO2 Laser Wavequide is substantially equivalent to the FiberLase CO2 Laser Wavequide (K100384) manufactured by Lumenis, Ltd.

## Device Description:

The UltraLase Flexible CO2 Laser Waveguides are laser delivery systems for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue.

The wavequide consists of a flexible silica capillary who's inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the

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waveguide and the waveguide is covered with a protective sleeve.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6um and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the correct focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The laser waveguides have either a 905 SMA connector or a 953 ST connector attached and can therefore be used with any CO2 Laser that is compatible with one of these connectors. The wavequides are 2 meters long.

It is recommended that a purge gas be used to flow a gas through the wavequide to keep the inner channel of the wavequide free of debris.

The waveguides delivery systems are supplied sterile for single use.

## Indications for Use:

The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.

The UltraLase Flexible CO2Laser Wavequide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

# Technological Characteristics Compared to Cleared Device:

The new device has the same performance characteristics, the same labeling and the same indications for use as the currently cleared device. The only difference between the devices is that the protective sleeve on the cleared device is a fluoropolymer heat-shrinkable tubing and the protective sleeve on the new product is Tefzel 207, a modified ETFE (ethylene-tetrafluoroethylene) fluoroplastic that is applied when the waveguide is being drawn.

Both materials are ETO sterilizable and are biocompatible.

The reason this change is being made is that it is easier and less expensive to apply the protective sleeve during the drawing process than to

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manually put on heat shrink tubing later in the waveguide assembly process.

# Substantial Equivalence:

| Comparison chart between the cleared Laser Engineering UltraLase CO2 Laser Fiber | | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (K112166) and the submission UltraLase CO₂ Laser Fiber (K211761): | | |
| Product Name | UltraLase CO2 Laser<br>Waveguide | Ultralase CO2 Laser<br>Waveguide |
| 510(k) Number | K112166 | K211761 |
| Manufacturer | Laser Engineering | Laser Engineering |
| Part Numbers | HWG300-2.0-3.0<br>HWG500-2.0-3.0 | HWG305<br>HWG505 |
| Indications for use | The UltraLase Flexible CO2 Laser Waveguide is indicated<br>for use with CO2 laser systems<br>for general and plastic surgery<br>procedures, neurosurgery, and<br>ophthalmology, oral surgery,<br>oto-rhino-laryngology,<br>podiatry, gynecology and<br>urology procedures. It is used<br>to deliver laser energy for<br>incision, excision, ablation,<br>vaporization, and coagulation<br>of soft tissues.<br>The UltraLase Flexible<br>CO2 Laser Waveguide can be<br>used in open surgical<br>procedures and endoscopic<br>procedures.<br>The indications for use<br>for which the delivery system<br>is used are dependent upon<br>the cleared indications for use<br>of the laser system and laser<br>system accessories to which it<br>is attached. | The UltraLase Flexible CO2 Laser Waveguide is indicated<br>for use with CO2 laser systems<br>for general and plastic surgery<br>procedures, neurosurgery, and<br>ophthalmology, oral surgery,<br>oto-rhino-laryngology,<br>podiatry, gynecology and<br>urology procedures. It is used<br>to deliver laser energy for<br>incision, excision, ablation,<br>vaporization, and coagulation<br>of soft tissues.<br>The UltraLase Flexible<br>CO2 Laser Waveguide can be<br>used in open surgical<br>procedures and endoscopic<br>procedures.<br>The indications for use<br>for which the delivery system<br>is used are dependent upon<br>the cleared indications for use<br>of the laser system and laser<br>system accessories to which it<br>is attached. |
| Principle of<br>Operation | Hollow Light-Conducting<br>Waveguide | Hollow Light-Conducting<br>Waveguide |
| Operating<br>Wavelength | 10.6microns | 10.6microns |
| Maximum input<br>power | 30 Watts | 30 Watts |

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| Power<br>Transmission | Greater than 70% for 500μ waveguide, Greater than 40%<br>for 300μ fiber | Greater than 70% for 500μ waveguide, Greater than 40%<br>for 300μ fiber |
|--------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Inner Diameter | 500μ for HWG500-2.0-3.0,<br>350μ for HWG300-2.0-3.0 | 500μ for HWG505<br>350μ for HWG305 |
| Fiber Length | 200 cm | 200 cm |
| Fiber Outer<br>Diameter | 1.2 – 1.3 mm | 0.750 - 1.08 mm |
| Materials Used | Fused Silica Capillary<br>Acrylate Clad<br>fluoropolymer heat-shrinkable<br>tubing | Fused Silica Capillary<br>Acrylate Clad<br>Tefzel 207 Buffer |
| Material<br>Manufacturer | Leoni Fiber Optics | Leoni Fiber Optics |
| Internal Reflective<br>Coating | Silver/Silver Iodide | Silver/Silver Iodide |
| Connector | 905 SMA or 953 ST | 905 SMA or 953 ST |
| Packaging | Sealed Tyvek Bag | Sealed Tyvek Bag |
| Sterilization Method | ETO | ETO |
| Shelf Life | 3 Years | 1 Year |

# Summary of Nonclinical Tests:

A number of non-clinical tests were performed on the new device as shown in the chart below. The acceptance criteria were the same as the acceptance criteria for the predicate device.

| Test Performed | Acceptance Criteria<br>(K211761) | Acceptance Criteria<br>(K112166) |
|-----------------------------|-----------------------------------------|-----------------------------------------|
| Epoxy strength Test | 15 Newtons for 15 seconds | 15 Newtons for 15 seconds |
| Intracutaneous Study | No evidence of irritation | No evidence of irritation |
| Muscle Implant<br>Study | Microscopic reaction not<br>significant | Microscopic reaction not<br>significant |
| Systemic<br>Toxicity Study | No mortality or systemic<br>toxicity | No mortality or systemic<br>toxicity |
| Sterilization<br>Validation | Sterility assurance level of<br>10-6 | Sterility assurance level of<br>10-6 |
| ETO Residual | Meets requirements of ISO<br>10993-7 | Meets requirements of ISO<br>10993-7 |
| Bioburden | Less than 100 | Less than 100 |
| Shelf-Life | 1 Year | 3 Years |

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| Package Integrity | Visual Inspection, Bubble<br>Leak Test, Seal Strength<br>Test | Visual Inspection, Bubble<br>Leak Test, Seal Strength<br>Test |
|---------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Performance Testing | Meets 70% transmission<br>criteria after sterilization. | Meets 70% transmission<br>criteria after sterilization |

The only difference between the new device and the predicate is the shelf life which is 3 years for the predicate and 1 year for the new device. This was done for business reasons since these devices have always been used within 1 year of manufacture. Aside from that, the submission device (K211761) and the predicate device (K112166) perform the same.

# Summary of Clinical Tests:

No clinical tests were performed.

# Conclusion:

The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. 807.92(b)(3)