(35 days)
The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology including, but not limited to use in oculoplasty.
The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialies including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology (timited to periobital dermis).
The Phantom ScanTech handpiece is intended to be used with the Phantom Family of Medical Lasers to deliver a broad spectrum of laser light energy for use in surgical applications generally requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in a variety of medical specialties.
The Phantom ScanTech handpiece is composed of the following main components: Handpiece with dual galvo X - Y scanning capabilities Control / power cable Laser control / display panel interface CPU based Laser control system CPU controlled power supply Removable spatula-bayonet tip Screw ring attachment for articulated arm
Used in conjunction with the Phantom Family of Medical Lase automated scanning device to accurately and quickly apply computer-controlled patterns of various shapes and sizes. The Physician, or his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen.
This document is a 510(k) summary statement for the Phantom ScanTech laser accessory. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain information on acceptance criteria, device performance studies, or any of the detailed aspects of a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating that the ScanTech is "substantially equivalent" to other legally marketed devices, primarily by comparing its "Indications For Use" and general characteristics to existing laser accessories. It's a regulatory submission to allow marketing, not a scientific publication detailing performance studies.
Therefore, I cannot provide the requested table and study information based solely on the provided text. The document explicitly states:
- No acceptance criteria are listed.
- No device performance metrics are reported.
- No details of a study (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set) are present.
The document only provides:
- Device Name: ScanTech
- Intended Use/Indications for Use: Surgical applications requiring excision, incision, ablation, vaporization, coagulation, and photothermolysis of soft tissue in various medical specialties.
- Predicate Devices: Coherent (K960032, K951812, K943604, K962242), Clinicon (K964520, K955734, K941841), Laserscope Sahar (K964684, K961935, K960820, K960521), Sharplan (K955621).
- Performance Standards: UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11 (These are safety and electrical standards, not typically clinical performance criteria for accuracy or efficacy in the way requested).
To answer your request, a different type of document, such as a scientific paper, clinical trial protocol, or detailed engineering report, would be necessary.
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|<974633
JAN 16 1998
510(k) SUMMARY STATEMENT
| Applicant: | Phantom Technologies, Inc.845 Commercial AvenuePalo Alto, California 94303 |
|---|---|
| ContactPhone:Fax: | James A. Nations650-493-9155650-493-9146 |
| Manufacturing Facility: | Phantom Technologies, Inc.845 Commercial AvenuePalo Alto, California 94303 |
| EstablishmentRegistration Number: | Applied for, not yet received |
| Device Name: | ScanTech |
| Common Name: | Laser accessory; scanner |
| Device Class: | IIInstrument, laser accessory |
| Panel: | 79-GEX21 CFR 878.48 |
| Performance Standards: | UL544, UL2601.1, IEC601.1, IEC82521 CFR 1040.10 & 1040.11 |
| Reason for submission: | New laser accessory with substantialequivalence. |
| Product Description: | The Phantom ScanTech handpiece is intended to be used with thePhantom Family of Medical Lasers to deliver a broad spectrum oflaser light energy for use in surgical applications generally requiringthe ablation, vaporization, excision, incision and coagulation of softtissue in a variety of medical specialties. |
| The Phantom ScanTech handpiece is composed of the followingmain components:Handpiece with dual galvo X - Y scanning capabilities Control / power cable Laser control / display panel interface CPU based Laser control system CPU controlled power supply Removable spatula-bayonet tip Screw ring attachment for articulated arm |
Used in conjunction with the Phantom Family of Medical Lase
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automated scanning device to accurately and quickly apply computer-controlled patterns of various shapes and sizes. The Physician, or his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen. Predicate Devices: Coherent K960032, K951812, K943604 K962242 Clinicon K964520, K955734, K941841 Laserscope Sahar K964684 K961935, K960820, K960521, Sharplan K955621
Indications For Use:
The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology including, but not limited to use in oculoplasty.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 16 1998
Mr. James A. Nations Director, Regulatory Affairs Phantom Technologies, Incorporated 845 Commercial Avenue Palo Alto, California 94303
Re: K974633 Trade Name: ScanTech Laser Scanner Regulatory Class: II Product Code: GEX Dated: December 9, 1997 Received: December 12, 1997
Dear Mr. Nations
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 requirements , as set forth in the Quality System -Regulation (QS) 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
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Page 2 - Mr. Nations
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
Sincerely yours,
a 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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510(k) NUMBER (IF KNOWN): K974633
DEVICE NAME:
INDICATIONS FOR USE:
The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialies including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology (timited to periobital dermis).
(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 (Optional Format 1-2-96)
Signature of
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974633
§ 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.