(66 days)
The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue.
The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
The Universal WaveGuide Handpiece comes in two designs, one that accepts 1.5 mm O.D. size fiber tips and one that accepts 2.5 mm O.D. size fiber tips. The 1.5 mm handpiece is used with the Free Beam and Flexible fiber tips. The 2.5 mm handpiece is used with the rigid fiber tips.
The collet component determines the O.D. size fibers that can be inserted into the handpiece. The nozzle and tip lock collet secures the fiber and prevents twisting of the fiber tip. The hand piece is attached to the Clinicon WaveGuide Platform by the FSMA connector at the distal end of the waveguide.
The Fiber Tips are made of the same proprietary waveguide fiber as the Clinicon WaveGuide Platform, described in the premarket notification, K992472, SUREGUIDE CO2 Laser Beam Delivery System.
The waveguide fiber is inserted into a straight or curved stainless steel sheath for the 2.5 mm O.D. rigid fiber tips or into a Teflon tube for the 1.5 mm O.D. flexible fiber tips.
The fiber tips, both rigid and flexible are of various lengths for use in various surgical procedures. The rigid fiber tips are also of various degrees of curvature and certain tips may have a contact probe tip cover made of Teflon.
The fiber tips are disposable, single-use devices, and both the rigid and flexible fiber tips have a section of colored polyethylene at the distal end of the fiber cable that acts as a depth gauge to assure the fiber is completely seated in the handpiece. The colored polyethylene also acts as a sterilizer indicator that will render the tips unusable if they are re-sterilized by distorting the polyethylene and preventing the fiber from being inserted into the handpiece.
The provided text describes a 510(k) premarket notification for the Clinicon Universal WaveGuide Handpiece and Fiber Tips. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance metrics, is not available in the provided text.
Here's an analysis of why the requested information cannot be found and what is present in the document:
1. A table of acceptance criteria and the reported device performance:
- Not Available: The submission is for a medical device (CO2 Laser Powered Surgical Instrument), not an AI/ML diagnostic or predictive device. The FDA 510(k) process for such devices typically focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to a legally marketed predicate device. This usually doesn't involve defining specific performance metrics (like sensitivity, specificity, AUC) and comparing them against pre-defined acceptance criteria in a quantitative table.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Available: Since no formal performance study with a test set (in the context of AI/ML) is described, these details are not present. The submission focuses on substantial equivalence through design and material comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable/Not Available: This refers to the establishment of ground truth for a diagnostic or predictive algorithm. As this is a surgical instrument, such expert-driven ground truth establishment for a test set is irrelevant and not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Available: Similar to the above, adjudication methods are used to resolve discrepancies in expert-labeled ground truth for diagnostic studies. This is not relevant to a surgical instrument.
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/Not Available: MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a surgical tool, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Available: This refers to standalone AI algorithm performance. This device is a physical surgical instrument.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable/Not Available: The concept of "ground truth" as used in AI/ML performance validation does not apply to this surgical device. The "truth" in this context would be aspects like material properties, laser energy delivery capabilities, and sterility, which are assessed through engineering tests and regulatory compliance rather than "ground truth" derived from expert consensus or pathology data.
8. The sample size for the training set:
- Not Applicable/Not Available: No training set, in the AI/ML sense, is involved.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available: No training set or ground truth establishment for it is relevant here.
What the document does describe (relevant to substantial equivalence):
The document provides information comparing the new device to existing predicate devices, focusing on:
- Intended Use: The device is intended to deliver carbon dioxide laser energy for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissue, similar to the predicate devices.
- Technological Characteristics:
- Design Features: Descriptions of two handpiece designs (1.5mm and 2.5mm O.D. fiber tips), collet component, nozzle and tip lock collet, FSMA connector. Description of fiber tips (rigid/flexible, various lengths, curvature, Teflon contact probe tip cover), disposable nature, colored polyethylene depth gauge and sterilizer indicator.
Conclusion:
This 510(k) submission is for a conventional surgical instrument and relies on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/performance profiles, rather than presenting a statistical performance study against explicit acceptance criteria in the manner requested for an AI/ML device.
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K014048 1/2
Image /page/0/Picture/1 description: The image shows the logo for Clinicon Corporation. The logo consists of a stylized letter C followed by the word "Clinicon" in a bold, sans-serif font. To the right of "Clinicon" is the word "CORPORATION" in a smaller, less bold font. Below the logo is the address "5825 AVENIDA ENCINAS" followed by "CARLSBAD, CA 92008".
FEB 1 1 2002
510(k) Summary
| Submitter: | Clinicon Corporation5825 Avenida EncinasCarlsbad, CA 92008 |
|---|---|
| Contact person: | Sean M. Curry16787 Bernardo Center Drive, Suite ASan Diego, CA 92128 |
| Phone: | (858) 675-8200 |
| FAX: | (858) 675-8201 |
| Proprietary name: | Clinicon Universal WaveGuide Handpiece and Fiber Tips |
| Common name: | CO2 Laser Powered Surgical Instrument |
| Classification: | 878.4810 |
| Product Code: | GEX |
Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology.
Substantial equivalence claimed to:
K903079, Luxar's Endoguide ®, Microguide TM, Flexiguide™ K992472, Clinicon's SureGuide CO2 Laser Beam Delivery System
Description:
The Universal WaveGuide Handpiece comes in two designs, one that accepts 1.5 mm O.D. size fiber tips and one that accepts 2.5 mm O.D. size fiber tips. The 1.5 mm handpiece is used with the Free Beam and Flexible fiber tips. The 2.5 mm handpiece is used with the rigid fiber tips.
The collet component determines the O.D. size fibers that can be inserted into the handpiece. The nozzle and tip lock collet secures the fiber and prevents twisting of the fiber tip. The hand piece is attached to the Clinicon WaveGuide Platform by the FSMA connector at the distal end of the waveguide.
The Fiber Tips are made of the same proprietary waveguide fiber as the Clinicon WaveGuide Platform, described in the premarket notification, K992472, SUREGUIDE CO2 Laser Beam Delivery System.
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014048 2/2
The waveguide fiber is inserted into a straight or curved stainless steel sheath for the 2.5 mm O.D. rigid fiber tips or into a Teflon tube for the 1.5 mm O.D. flexible fiber tips.
The fiber tips, both rigid and flexible are of various lengths for use in various surgical procedures. The rigid fiber tips are also of various degrees of curvature and certain tips may have a contact probe tip cover made of Teflon.
The fiber tips are disposable, single-use devices, and both the rigid and flexible fiber tips have a section of colored polyethylene at the distal end of the fiber cable that acts as a depth gauge to assure the fiber is completely seated in the handpiece. The colored polyethylene also acts as a sterilizer indicator that will render the tips unusable if they are re-sterilized by distorting the polyethylene and preventing the fiber from being inserted into the handpiece.
Intended use:
The Clinicon Universal WaveGuide Handpiece and Fiber Tips are intended to be used to deliver carbon dioxide laser energy for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissue.
Summary of technological characteristics:
The Clinicon Universal WaveGuide Handpieces have the same technological characteristics as the Luxar handpieces used with Luxar medical fiber tips. The Clinicon Fiber Tips have the same technological characteristics as the Clinicon Sureguide CO2 Laser Beam Delivery System, now marketed as the Clinicon Waveguide Platform.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle, which is the symbol of the HHS.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Clinicon Corporation c/o Mr. Sean M. Curry Certified Software Solutions, Inc. 16787 Bernardo Center Drive, Suite A San Diego, California 92128
Re: K014048
Trade Name: Clinicon Universal Waveguide Handpiece and Fiber Tips Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: December 4, 2001 Received: December 7, 2001
Dear Mr. Curry:
We have reviewed your Section 510(k) premarket 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) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
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Page 2 - Mr. Sean Curry
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K 01 4048
Device Name:
Indications for Use:
The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue.
The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
Miriam C. Provost
(Division Sign-Off) (Division of General, Restorative Divisionrological Devices
510(k) Number K014048
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.