(85 days)
The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, 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 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 a laser delivery system 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 waveguide consists of a flexible silica capillary whose 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 plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces.
The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm 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 supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.
The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart.
| Core Dia. (µm) | Outer Dia. (µm) | Lengths (cm) |
|---|---|---|
| 300 | 750 | 100, 150 |
| 500 | 850 | 100, 150, 200 |
| 750 | 1200 | 100, 150, 200 |
It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris.
The waveguides delivery systems are supplied sterile for single use.
Here's an analysis of the provided text regarding the UltraLase Flexible CO2 Laser Waveguide's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Transmission Bandwidth | "bench tested to establish transmission bandwidth" |
| Percent Transmission | "bench tested to establish ... percent transmission" |
| Compatibility with CO2 Lasers | "designed to operate at 10.6µm and has a broad enough transmission band to accommodate any laser operating in this region." "can be used with any CO2 Laser that is compatible with one of [905 SMA or 953 ST] connectors." |
| Single-Use | "The waveguides delivery systems are supplied sterile for single use." |
| Indicated uses (General/Plastic Surgery, Neurosurgery, Ophthalmology, Oral Surgery, Oto-rhino-laryngology, Podiatry, Gynecology, Urology, Incision, Excision, Ablation, Vaporization, Coagulation of soft tissues; Open/Endoscopic Procedures) | The device's "Indications for Use" statement directly lists these, implying the device is intended and performs for these applications as substantiated by substantial equivalence to predicate devices. |
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It largely describes the device's technical specifications and intended uses, and then states that it was "bench tested" for transmission bandwidth and percent transmission. It does not present specific numerical acceptance criteria or detailed results from these bench tests beyond confirming they were performed. The "reported device performance" in the table above is thus an inference that the device met internal criteria for its design specifications, rather than a direct report of specific performance values against pre-defined numerical objective criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a dedicated "test set" in the context of clinical trials or specific performance verification. The performance testing mentioned ("bench tested to establish transmission bandwidth, and percent transmission") refers to laboratory/engineering testing rather than a clinical study with a distinct patient test set.
- Test Set Sample Size: Not specified for clinical or comparative studies. For bench testing, the sample size of waveguides tested is not mentioned.
- Data Provenance: The bench testing is implied to be internal to Laser Engineering (the applicant). There is no mention of country of origin for any data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for this type of device, extensive clinical data from human subjects is often not required if substantial equivalence can be demonstrated through technological characteristics and engineering testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or not provided in the document. The submission is a 510(k) for a CO2 laser waveguide, which is a device for energy delivery. The performance testing described is engineering-focused (transmission bandwidth, percent transmission). There is no mention of a "test set" that would require expert-established ground truth in a diagnostic or interpretive context.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. As there's no mention of a clinical "test set" requiring expert interpretation or diagnosis, no adjudication method would be in play.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. The submission focuses on demonstrating substantial equivalence through technological characteristics and bench testing, not on comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable. The UltraLase Flexible CO2 Laser Waveguide is a physical medical device (a fiber optic waveguide) used to deliver laser energy, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the described "bench testing to establish transmission bandwidth, and percent transmission," the "ground truth" would be established by physical measurements and engineering standards/specifications for laser light transmission through a fiber optic waveguide. It is not expert consensus, pathology, or outcomes data, as those are relevant for diagnostic or treatment efficacy studies.
8. The Sample Size for the Training Set
This information is not applicable or not provided. As the device is not an AI/ML algorithm or a diagnostic tool that learns from data, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable or not provided. As there is no "training set," there is no ground truth establishment for one.
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OCT 2 1 2011
:
SECTION 5 - 510(K) SUMMARY
Applicant:
રુદ્યા બ ૩
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 rrudko@laserengineering.com
Date Prepared: July 19, 2011
Device Name:
CO2 Laser Waveguide
Proprietary Name: Classification Name: Classification: Product Code:
UltraLase Flexible CO2 Laser Waveguide Laser Surgical Instrument 878.4810 GEX
Predicate Devices:
The UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to the following devices:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| FiberLase CO2 Laser Waveguide | Lumenis Ltd | K100384 |
| SureGuide CO2 LaserBeam Delivery System | Clinicon Corp. | K992472 |
| Beam Path CO2 Mark IIIWaveGuide Fiber | OmniGuide, Inc. | K070157 |
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K112166 Pg 2 of 3
Device Description:
The UltraLase Flexible CO2 Laser Waveguide is a laser delivery system 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 waveguide consists of a flexible silica capillary whose 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 plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces.
The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm 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 supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.
The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart.
| Core Dia. (µm) | Outer Dia. (µm) | Lengths (cm) |
|---|---|---|
| 300 | 750 | 100, 150 |
| 500 | 850 | 100, 150, 200 |
| 750 | 1200 | 100, 150, 200 |
It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris.
The waveguides delivery systems are supplied sterile for single use.
{2}------------------------------------------------
K112166 pg 3 of 3
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 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.
Technological Characteristics Compared to Predicate Device:
After reviewing the technological characteristics (overall design, mechanism of action, mode of operation and performance characteristics) and the indications for use, it has been determined by Laser Engineering that the UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to existing legally marketed devices.
Performance testing:
The UltraLase Flexible CO2 Laser Waveguides are bench tested to establish transmission bandwidth, and percent transmission.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 1 2011
W and R Investments, LLC d/b/a Laser Engineering % Robert I. Rudko, Ph.D. 113 Cedar Street, Suite S5 Milford, Massachusetts 01757
Re: K112166
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 19, 2011 Received: July 28, 2011
Dear Dr. 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 Foond, Or ug, 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. 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 contractly and warranties. We remind you; however, that device labeling must be truth to bond not misleding.
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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Page 2 - Robert I. Rudko, Ph.D.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Erin Keith
forMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 - INDICATIONS FOR USE STATEMENT
K112166 510(k) Number: UltraLase Flexible CO2 Laser Waveguide Device Name: Indications for Use:
The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, 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 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.
Over-The-Counter Use Prescription Use x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) a management and consistence and the manufactures and the commended the seasonal commended the sense comments of
Concurrence of CDRH, Office of Device Evaluation (ODE)
E.M. Kuth
(Division Sign-Off) Division of Surgical " it bedie, and Restorative Device
510(k) Number K112166
§ 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.