(86 days)
Not Found
No
The summary describes a surgical laser device and its intended uses, with no mention of AI, ML, image processing, or any features that would typically involve such technologies.
Yes
The device is described as a surgical instrument for coagulation of soft tissue, indicating it is used to treat or manage a medical condition.
No
The device is described as a "surgical instrument for coagulation of soft tissue" and is indicated for use in "laser medicine and surgery." Its function is therapeutic (coagulation), not diagnostic.
No
The device is described as a "Surgical Lightstic™ 180" and is intended for use as a "surgical instrument" for coagulation of soft tissue using laser energy. This description strongly implies a physical hardware device that delivers laser energy, not a software-only application. The lack of a "Device Description" section prevents a definitive confirmation, but the intended use and name point away from a software-only device.
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 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 of the body (which is the definition of an IVD).
- Device Description: While the description is "Not Found", the intended use is the primary indicator.
- No mention of testing samples: There is no mention of analyzing blood, urine, tissue samples, or any other biological material in vitro.
- Surgical Specialties: The listed surgical specialties (general surgery, cardiothoracic surgery, plastic surgery, dermatology) are all areas where procedures are performed directly on the patient.
Therefore, the Surgical Lightstic™ 180 is a surgical device, not an In Vitro Diagnostic device.
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 (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), plastic surgery and dermatology.
Expanded for: Coagulation of Cardiac Tissue
These are additional indications to the already cleared indications for market release in K993834.
Product codes
OCL
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 (including cardiac 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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
SEP 2 0 2001
K011988 i/2
510(k) Summary
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
| Joseph Curtis
10 Commerce Way
| Norton, MA 02766 | |
|---|---|
| Telephone: | (508) 285-1700 |
| Facsimile: | (508) 285-7579 |
| Contact Person: | same |
| Date Prepared: | June 22, 2001 |
Name of Device and Name/Address of Sponsor
Surgical Lightstic™ 180 CardioFocus, Inc. 10 Commerce Way Norton, MA 02766
Common or Usual Name
Laser Tissue Coagulator
Classification Name
Surgical Laser Instrument Accessories
Predicate Devices
The Surgical Lightstic 180 for use in cardiac tissue is identical to the current Surgical Lightstic 180 (K993834), and substantially equivalent for indications for use in cardiac tissue to Cryomedical Sciences, Inc. CMS Blizzard K980668 .
1
K011988 4/2
Intended Use
The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), 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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
CardioFocus, Inc. c/o Mr. Joseph Curtis Vice President Clinical and Regulatory Aff airs 10 Commerce Way Norton, MA 02766
Re: K011988 Trade/Device Name: Surgical Lightstic TM 180 Regulation Number: 21 CFR 878.4810 Regulation name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL Dated: June 25, 2001 Received: June 26, 2001
Dear Mr. Curtis:
This letter corrects our substantially equivalent letter of September 20, 2001.
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 (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 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.
3
Page 2 - Mr. Joseph Curtis
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.
This letter will allow you to continue 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
el.moll.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Kolla88 510(k) Number (if known):
Device Name:
Surgical Lightstic™ 180
Indications For Use:
Expanded for: Coagulation of Cardiac Tissue
These are additional indications to the already cleared indications for market Note: release in K993834.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR §801.109)
OR
Over-The-Counter Use
SN
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011988
38