(159 days)
The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision. ablation, vaporization, coagulation, with hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.
The provided documents are a 510(k) summary and FDA clearance letter for the Sciton Profile 1320 Laser System. These documents primarily focus on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted directly from these documents. These types of studies are typically found in more detailed technical reports or clinical trial summaries, which are not included here.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided documents, specific quantitative acceptance criteria or reported device performance metrics (e.g., precision, accuracy, sensitivity, specificity for a specific clinical task) are not available. The 510(k) summary focuses on the device's technical specifications and intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in these documents | Not specified in these documents |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided documents. The clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical performance study detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not available in the provided documents.
4. Adjudication Method for the Test Set:
This information is not available in the provided documents.
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:
This information is not applicable/not available. The Sciton Profile 1320 Laser System is a medical laser for surgical and dermatological procedures, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable/not available. As noted above, this device is a laser system, not an algorithm.
7. The Type of Ground Truth Used:
This information is not available in the provided documents. When assessing laser systems, "ground truth" typically refers to the confirmed clinical outcome or tissue effect, which would be assessed in clinical trials. However, the details of such assessments are not present here.
8. The Sample Size for the Training Set:
This information is not applicable/not available. This device is a laser system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not available. This device is a laser system, not a machine learning algorithm.
Summary of Device and Regulatory Context (from provided documents):
- Device Trade Name: Profile 1320 Laser System
- Common Name: Nd:YAG Laser System
- Intended Use: For use in general surgery and dermatology for incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
- Predicate Device: CoolTouch Nd:YAG Laser System (K003715 and K014035)
- Regulatory Pathway: 510(k) clearance, based on substantial equivalence to the predicate device. This pathway does not typically require the detailed clinical performance studies that would include the specific acceptance criteria and study details requested, unless there are new technological characteristics or different intended uses that raise different safety and effectiveness questions.
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022 466
SCITON
DEC 3 1 2002
Attachment IV
:
510(k) Summary
| Submitter: | Sciton, Inc. |
|---|---|
| Address: | 845 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, Director of Regulatory Affairs |
| Date Prepared: | July 23, 2002 |
| Device Trade Name: | Profile 1320 Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally MarketedPredicate Device: | CoolTouch Nd:YAG Laser System (K003715 andK014035) |
| Description ofProfile 1320 Laser System: | Profile 1320 Laser System is an Nd:YAG laser producingemission at a wavelength of 1320 nm. It consists of a laserconsole, internal computer, control panel and display, anoptical delivery system comprised of an articulated armand a handpiece or scanner with cooling capability, and afootswitch. |
| Intended Use: | The Sciton, Inc. Profile 1320 Laser is intended for use ingeneral surgery and dermatology for the incision, excision.ablation, vaporization, coagulation, with hemostasis of softtissue. It is also indicated for the treatment of periorbitaland perioral wrinkles. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 31 2002
Sciton, Inc. Jay M. Patel Director of Regulatory Affairs 845 Commercial Street Palo Alto. California 94303
Rc: K022466
Trade/Device Name: Profile 1320 Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: October 30, 2002 Received: November 1, 2002
Dear Mr. Patel:
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. 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 docs 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
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Page 2 - Mr. Jay M. Patel .
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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), 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Purret
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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Attachment III
Statement of Indications for Us
K022466 510(k) Number (if known):
Profile 1320 Laser System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Profile 1320 Laser System is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21CFR801) | |
|---|---|
| OR | Over-The-Counter Use |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
§ 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.