(52 days)
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, podiatry, 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
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 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.
The provided text describes a 510(k) premarket notification for a medical device called the "UltraLase Flexible CO2 Laser Waveguide." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new studies. Therefore, many of the requested categories for a typical medical device study that proves predefined acceptance criteria are not applicable in this context.
However, I can extract the information that is present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical tests performed are listed, along with their acceptance criteria. The document states that the new device met these criteria, implying its performance aligns with them.
| Test Performed | Acceptance Criteria (K211761 - New Device) | Reported Device Performance (Implied by document's conclusion of meeting criteria) |
|---|---|---|
| Epoxy strength Test | 15 Newtons for 15 seconds | Met 15 Newtons for 15 seconds |
| Intracutaneous Study | No evidence of irritation | No evidence of irritation |
| Muscle Implant Study | Microscopic reaction not significant | Microscopic reaction not significant |
| Systemic Toxicity Study | No mortality or systemic toxicity | No mortality or systemic toxicity |
| Sterilization Validation | Sterility assurance level of 10^-6 | Sterility assurance level of 10^-6 |
| ETO Residual | Meets requirements of ISO 10993-7 | Met requirements of ISO 10993-7 |
| Bioburden | Less than 100 | Less than 100 |
| Shelf-Life | 1 Year | 1 Year |
| Package Integrity | Visual Inspection, Bubble Leak Test, Seal Strength Test | Met Visual Inspection, Bubble Leak Test, Seal Strength Test |
| Performance Testing | Meets 70% transmission criteria after sterilization | Met 70% transmission criteria after sterilization |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the non-clinical tests. It refers to these as generic "tests." The data provenance is not explicitly stated, but these are non-clinical tests, meaning they were likely conducted in a laboratory setting by the manufacturer, Laser Engineering, in the US (Milford, MA). The tests are retrospective, as they were conducted to support a premarket notification for a device modified from a previously cleared one.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For non-clinical tests like material biocompatibility or mechanical strength, "ground truth" would typically be defined by established international standards (e.g., ISO for ETO residual) or internal product specifications rather than expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving diagnostic interpretations by multiple human readers, not for non-clinical engineering or biological safety tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive surgical tool (a laser waveguide), not an AI-powered diagnostic or assistive tool. No MRMC study was performed, and no AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm-only performance testing was done.
7. The type of ground truth used
For the non-clinical tests:
- Performance Testing (Power Transmission): The ground truth is the engineering specification of greater than 70% transmission after sterilization.
- Biocompatibility (Intracutaneous, Muscle Implant, Systemic Toxicity): The ground truth is established by specific biological endpoints (e.g., "no evidence of irritation," "microscopic reaction not significant," "no mortality or systemic toxicity") as defined by relevant biocompatibility standards (e.g., ISO 10993 series).
- Sterilization & Residuals (Sterilization Validation, ETO Residual, Bioburden): The ground truth is defined by specific quantitative targets or compliance with standards (e.g., "sterility assurance level of 10^-6", "Meets requirements of ISO 10993-7", "Less than 100").
- Mechanical (Epoxy Strength, Package Integrity): The ground truth is based on engineering specifications (e.g., "15 Newtons for 15 seconds") or visual/physical inspection criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (508) 520-2552
Contact Person: Robert I. Rudko, Ph.D. Chief Scientist r.rudko@laserengineering.com
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
{4}------------------------------------------------
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 LaserWaveguide | Ultralase CO2 LaserWaveguide |
| 510(k) Number | K112166 | K211761 |
| Manufacturer | Laser Engineering | Laser Engineering |
| Part Numbers | HWG300-2.0-3.0HWG500-2.0-3.0 | HWG305HWG505 |
| Indications for use | The UltraLase Flexible CO2 Laser Waveguide is indicatedfor use with CO2 laser systemsfor general and plastic surgeryprocedures, neurosurgery, andophthalmology, oral surgery,oto-rhino-laryngology,podiatry, gynecology andurology procedures. It is usedto deliver laser energy forincision, excision, ablation,vaporization, and coagulationof soft tissues.The UltraLase FlexibleCO2 Laser Waveguide can beused in open surgicalprocedures and endoscopicprocedures.The indications for usefor which the delivery systemis used are dependent uponthe cleared indications for useof the laser system and lasersystem accessories to which itis attached. | The UltraLase Flexible CO2 Laser Waveguide is indicatedfor use with CO2 laser systemsfor general and plastic surgeryprocedures, neurosurgery, andophthalmology, oral surgery,oto-rhino-laryngology,podiatry, gynecology andurology procedures. It is usedto deliver laser energy forincision, excision, ablation,vaporization, and coagulationof soft tissues.The UltraLase FlexibleCO2 Laser Waveguide can beused in open surgicalprocedures and endoscopicprocedures.The indications for usefor which the delivery systemis used are dependent uponthe cleared indications for useof the laser system and lasersystem accessories to which itis attached. |
| Principle ofOperation | Hollow Light-ConductingWaveguide | Hollow Light-ConductingWaveguide |
| OperatingWavelength | 10.6microns | 10.6microns |
| Maximum inputpower | 30 Watts | 30 Watts |
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| PowerTransmission | Greater than 70% for 500μ waveguide, Greater than 40%for 300μ fiber | Greater than 70% for 500μ waveguide, Greater than 40%for 300μ fiber |
|---|---|---|
| Inner Diameter | 500μ for HWG500-2.0-3.0,350μ for HWG300-2.0-3.0 | 500μ for HWG505350μ for HWG305 |
| Fiber Length | 200 cm | 200 cm |
| Fiber OuterDiameter | 1.2 – 1.3 mm | 0.750 - 1.08 mm |
| Materials Used | Fused Silica CapillaryAcrylate Cladfluoropolymer heat-shrinkabletubing | Fused Silica CapillaryAcrylate CladTefzel 207 Buffer |
| MaterialManufacturer | Leoni Fiber Optics | Leoni Fiber Optics |
| Internal ReflectiveCoating | 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(K211761) | Acceptance Criteria(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 ImplantStudy | Microscopic reaction notsignificant | Microscopic reaction notsignificant |
| SystemicToxicity Study | No mortality or systemictoxicity | No mortality or systemictoxicity |
| SterilizationValidation | Sterility assurance level of10-6 | Sterility assurance level of10-6 |
| ETO Residual | Meets requirements of ISO10993-7 | Meets requirements of ISO10993-7 |
| Bioburden | Less than 100 | Less than 100 |
| Shelf-Life | 1 Year | 3 Years |
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| Package Integrity | Visual Inspection, BubbleLeak Test, Seal StrengthTest | Visual Inspection, BubbleLeak Test, Seal StrengthTest |
|---|---|---|
| Performance Testing | Meets 70% transmissioncriteria after sterilization. | Meets 70% transmissioncriteria 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)
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.