(84 days)
No
The summary describes a surgical lightstic for tissue coagulation using laser energy and does not mention any AI or ML components or functionalities.
Yes
The device is used for coagulation of soft tissue in surgical procedures, which is a therapeutic function.
No
The device is described as a surgical instrument for coagulation of soft tissue, indicating a therapeutic or interventional use, not a diagnostic one.
No
The intended use and indications for use clearly describe a surgical instrument for coagulation of soft tissue using laser energy, which is a hardware-based function. The predicate devices also appear to be hardware-based laser systems and fibers.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgical instrument for coagulation of soft tissue". This describes a device used during a surgical procedure on a patient's body, not a device used to test samples outside the body (in vitro).
- Anatomical Site: The anatomical site is "soft tissue", which is a part of the human body. IVDs typically analyze biological samples like blood, urine, or tissue biopsies outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Surgical Lightstic™ 180 is a surgical device used for therapeutic purposes (coagulation), not a diagnostic device used for testing samples in vitro.
N/A
Intended Use / Indications for Use
The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic " 180 is indicated for use in medicine and surgery with 980 -1064 wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
None required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Rare Earth Medical Lightstic " Model 180, Domier's Lasertrode Fiber, Xintec's Polaris™ Diode Laser System and Accessories, and CeramOptec's Ceralas Diode Laser Systems.
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
510(k) Summary FEB 4 2000
Surgical Lightstic™ 180
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR §807 for the Surgical Lightstic™ 180.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
William A. Knape 987 University Avenue, Suite #14 Los Gatos, CA 95032-7640 Telephone: (408) 399-9347 (408) 399-9367 Facsimile:
Contact Person: same
Date Prepared: November 5, 1999
Name of Device and Name/Address of Sponsor
Surgical Lightstic™ 180 CardioFocus, Inc. 126B Mid-Tech Drive West Yarmouth, MA 02673
Common or Usual Name
Laser Fiber
Classification Name
Surgical Laser Instrument Accessories
Predicate Devices
Rare Earth Medical Lightstic " Model 180, Domier's Lasertrode Fiber, Xintec's Polaris™ Diode Laser System and Accessories, and CeramOptec's Ceralas Diode Laser Systems.
1
Intended Use
The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic " 180 is indicated for use in medicine and surgery with 980 -1064 wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.
Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the CardioFocus Surgical Lightstic" 180 and the predicate device are substantially equivalent and have the same intended use.
CardioFocus, Inc. believes the minor differences of the CardioFocus Surgical Lightstic" 180 and its predicate fiber laser accessories should not raise any concerns regarding the overall safety and effectiveness.
Performance Data
None required.
2
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 a stylized symbol that resembles three wavy lines or a caduceus, which is a symbol often associated with healthcare.
Public Health Service
FEB 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CardioFocus, Inc. c/o Mr. William A. Knape Clinical Pathways 987 University Avenue, Suite 14 Los Gatos, California 95032
K993834 Re:
Trade Name: Surgical Lightstic™ Models 180L and 180C Regulatory Class: II Product Code: GEX Dated: November 11, 1999 Received: November 12, 1999
Dear Mr. Knape:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Mr. William A. Knape
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,
fa
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K993834
Surgical Lightstic™ 180 Device Name:
Indications For Use:
The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 - 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.
These are additional indications to the already cleared indications for market Note: release in K962068.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number | K993834 | ||
| Prescription Use | (Per 21 CFR §801.109) | OR | Over-The-Counter Use |
CONFIDENTIAL