(88 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The description focuses on the laser technology and its components.
Yes
The device is described as a laser system used for incision, excision, ablation, vaporization, and coagulation of soft tissue in general surgery and dermatology, which are therapeutic medical procedures.
No.
The device's intended use is for surgical procedures (incision, excision, ablation, vaporization, coagulation) rather than for identifying or characterizing a disease or condition.
No
The device description clearly states it is a "Laser System" consisting of hardware components like a laser console, articulated arm, handpiece, and footswitch. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures on soft tissue (incision, excision, ablation, vaporization, coagulation). This is a therapeutic or surgical use, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a laser system used for direct interaction with tissue. This aligns with a surgical device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue during surgery.
N/A
Intended Use / Indications for Use
The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
S C I T O N
K 022381
OCT 1 8 2002
Attachment IV
www.varant.com/station/comments/
and the management of the comments of the comments of the comments of the many of
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 15, 2002 |
| Device Trade Name: | Profile 1320 Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed | |
| Predicate Device: | CoolTouch Nd:YAG Laser System (K002347) |
| Description of | |
| Profile 1320 Laser System: | 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. | |
| Intended Use: | The Profile 1320 Laser System is indicated for use in |
| general surgery and dermatology for the incision, excision, | |
| ablation, vaporization, coagulation, with hemostasis of soft | |
| tissue. | |
| Rationale for Substantial | |
| Equivalence: | The Profile 1320 Laser System shares the same |
| indications for use, similar design features (including | |
| wavelength, laser medium, power supply, cooling and | |
| control system), functional features (including power | |
| output, repetition rate, energy, spot size and fluence), and | |
| is therefore substantially equivalent to the above legally | |
| marketed predicate device. |
1
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 circular seal with the words "HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sciton, Inc. Jay M. Patel Director, Regulatory Affairs 845 Commercial Street Palo Alto, California 94303
Re: K022381
Trade/Device Name: Profile 1320 Laser System Regulation Number: 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 15, 2002
Received: July 22, 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. Iisting 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.
2
Page 2 – Mr. Jay M. Patel
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 vour 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 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,
Murian C. Parret
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
3
Attachment III
Statement of Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue.
(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)
Over-The-Counter Use _
uriam C. Provost
OR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number: K022381