(44 days)
The SureGuide CO2 Laser Beam Delivery System is intended for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.
Refer to the laser system Directions for Use manual for specific indications for Use.
The SureGuide CO2 Laser Beam Delivery System is indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, otorhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.
The specific SureGuide CO2 Laser Beam Delivery System indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
The SureGuide CO2 Laser Beam Delivery System is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.
The SureGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.
The laser adapter design is derived from the Medical Optics laser system flexible cable assembly interface adapter and has a section designed to fit the Luxar LX-20 mast interface. Beam alignment and focus optics are built into the interface adapter to allow correction of inherent beam alignment variations between laser systems and provides optimization of laser beam coupling into the SureGuide.
The provided text describes the acceptance criteria and the study conducted for the SureGuide CO2 Laser Beam Delivery System.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Laser power loss comparable to similar cleared devices. | "The SureGuide performance characteristics have been evaluated through testing and analysis of laser power loss... compared to similar devices cleared for marketing in the past. The performance of the SureGuide is comparable." |
| Beam quality from the guide comparable to similar cleared devices. | "...and beam quality from the guide when the laser is energized, compared to similar devices cleared for marketing in the past. The performance of the SureGuide is comparable." |
| Predicted energy transmission levels meet established criteria. | "The predicted energy transmission levels... meet criteria established through evaluation of the SureGuide on various commercially available medical CO2 laser systems." |
| Beam quality meets established criteria when evaluated on various commercially available laser systems. | "...and beam quality meet criteria established through evaluation of the SureGuide on various commercially available medical CO2 laser systems." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the "test set." It mentions "testing and analysis of laser power loss and beam quality" and "evaluation of the SureGuide on various commercially available medical CO2 laser systems." This suggests a laboratory or engineering testing environment rather than a clinical study with patient data.
The data provenance is industrial/engineering testing of the device itself with various commercially available medical CO2 laser systems. It is not a retrospective or prospective clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set in the context of clinical interpretation or diagnosis. The "ground truth" here seems to be defined by established engineering parameters for laser power loss, beam quality, and energy transmission, likely set by internal company standards or industry benchmarks for CO2 laser systems.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-reviewed test set or any adjudication method. The evaluation appears to be based on objective physical measurements and comparisons to predicate devices' performance characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a component of a laser delivery system, not an AI or diagnostic tool that assists human readers.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance
Yes, the testing described appears to be a standalone performance evaluation of the device itself (the SureGuide CO2 Laser Beam Delivery System) without human intervention in its operation or interpretation of its output. The device's performance characteristics (power loss, beam quality, energy transmission) were measured directly.
7. Type of Ground Truth Used
The ground truth used is based on engineering and performance specifications for laser power loss, beam quality, and energy transmission, which are then compared to "criteria established" (presumably from industry standards or performance of predicate devices).
8. Sample Size for the Training Set
Not applicable. The document describes non-clinical performance testing of a physical device, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Premarket Notification [510(k)] SureGuide CO2 Laser Beam Delivery System
SEP 8 1999
FDA Premarket Notification [510(k)] Summary
Preparation Date: 21 July 1999
Contact: Gerald S. Palecki, Director, Quality and Regulatory
Device Name: Proprietary: SureGuide CO2 Laser Beam Delivery System
Common: CO2 Laser Waveguide
Predicate Devices: CO2 Laser Waveguide, reference K943543 & K960475.
Device Description:
The SureGuide CO2 Laser Beam Delivery System is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.
The SureGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.
Intended Use:
The SureGuide is intended for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.
Refer to the laser system Directions for Use manual for specific indications for Use.
Technological Characteristics Compared to Predicate Devices:
The SureGuide CO2 Laser Beam Delivery System has the same technological characteristics and materials as the Medical Optics, Inc. flexible fiber cable assembly and it is functionally equivalent to the Luxar fiber assembly. Clinicon Corportation purchased the products of Medical Optics, Inc. and holds a license from Rutgers University to manufacture the SureGuide flexible cable assembly.
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The laser adapter design is derived from the Medical Optics laser system flexible cable assembly interface adapter and has a section designed to fit the Luxar LX-20 mast interface. Beam alignment and focus optics are built into the interface adapter to allow correction of inherent beam alignment variations between laser systems and provides optimization of laser beam coupling into the SureGuide.
Non-Clinical Tests:
The SureGuide performance characteristics have been evaluated through testing and analysis of laser power loss and beam quality from the guide when the laser is energized, compared to similar devices cleared for marketing in the past. The performance of the SureGuide is comparable.
Conclusions Drawn from Tests and Analysis:
The predicted energy transmission levels and beam quality meet criteria established through evaluation of the SureGuide on various commercially available medical CO2 laser systems.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Mr. Gerald S. Palecki Director, Quality and Regulatory Clinicon Inc. 5825 Avenida Encinas Carlsbad, California 92008
Re: K992472
Trade Name: SUREGUIDE CO2 Laser Beam Delivery System Regulatory Class: II Product Code: GEX Dated: July 21, 1999 Received: July 26, 1999
Dear Mr. Palecki:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Mr. Gerald S. Palecki
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin McWhirter, Ph.D., M.D.
~ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K 992472
Device Name: _SureGuide CO2 Laser Beam Delivery System
Indications for Use:
The SureGuide CO2 Laser Beam Delivery System is indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, otorhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.
The specific SureGuide CO2 Laser Beam Delivery System indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992472 |
(Optional Format 3-10-98)
Prescription Use (Per 21 CFR 801.109)
2-2
SG510_Body1
§ 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.