(52 days)
No
The device description focuses on the physical components and function of a laser delivery system, with no mention of AI or ML technologies. The performance studies are non-clinical and relate to material properties and sterilization, not algorithmic performance.
Yes
Explanation: The device is a laser delivery system used in surgical procedures for incision, ablation, vaporization, and coagulation of soft tissues, which are therapeutic actions.
No
The device is described as a laser delivery system used for incision, ablation, vaporization, and coagulation of soft tissues, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical, flexible waveguide made of silica capillary with a reflective coating, connectors, and a protective sleeve. It is a hardware component designed to deliver laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The UltraLase Flexible CO2 Laser Waveguide is a surgical tool used to deliver laser energy directly to soft tissues for procedures like incision, ablation, vaporization, and coagulation. It is used during surgical procedures on the patient's body, not on samples taken from the body.
- Intended Use: The intended use clearly describes surgical procedures on various anatomical sites.
- Device Description: The description details a physical delivery system for laser energy, not a system for analyzing biological samples.
Therefore, the UltraLase Flexible CO2 Laser Waveguide falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UltraLase Flexible CO2 Laser 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
A number of non-clinical tests were performed on the new device:
- Epoxy strength Test: 15 Newtons for 15 seconds
- Intracutaneous Study: No evidence of irritation
- Muscle Implant Study: Microscopic reaction not significant
- Systemic Toxicity Study: No mortality or systemic toxicity
- Sterilization Validation: Sterility assurance level of 10-6
- ETO Residual: Meets requirements of ISO 10993-7
- Bioburden: Less than 100
- Shelf-Life: 1 Year
- Package Integrity: Visual Inspection, Bubble Leak Test, Seal Strength Test
- Performance Testing: Meets 70% transmission criteria after sterilization.
The acceptance criteria for the new device were the same as the predicate device, except for the shelf-life which is 1 year for the new device compared to 3 years for the predicate.
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.
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.
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
§ 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.
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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
5
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 | |
| Waveguide | Ultralase CO2 Laser | |
| Waveguide | ||
| 510(k) Number | K112166 | K211761 |
| Manufacturer | Laser Engineering | Laser Engineering |
| Part Numbers | HWG300-2.0-3.0 | |
| HWG500-2.0-3.0 | HWG305 | |
| HWG505 | ||
| Indications for 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. | 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. | ||
| Principle of | ||
| Operation | Hollow Light-Conducting | |
| Waveguide | Hollow Light-Conducting | |
| Waveguide | ||
| Operating | ||
| Wavelength | 10.6microns | 10.6microns |
| Maximum input | ||
| power | 30 Watts | 30 Watts |
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| Power
Transmission | 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 HWG505
350μ for HWG305 |
| Fiber Length | 200 cm | 200 cm |
| Fiber Outer
Diameter | 1.2 – 1.3 mm | 0.750 - 1.08 mm |
| Materials Used | Fused Silica Capillary
Acrylate Clad
fluoropolymer heat-shrinkable
tubing | Fused Silica Capillary
Acrylate Clad
Tefzel 207 Buffer |
| Material
Manufacturer | Leoni Fiber Optics | Leoni Fiber Optics |
| Internal Reflective
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
(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 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 | Meets requirements of ISO
10993-7 |
| Bioburden | Less than 100 | Less than 100 |
| Shelf-Life | 1 Year | 3 Years |
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| Package Integrity | Visual Inspection, Bubble
Leak Test, Seal Strength
Test | Visual Inspection, Bubble
Leak Test, Seal Strength
Test |
|---------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Performance Testing | Meets 70% transmission
criteria after sterilization. | Meets 70% transmission
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)