(189 days)
Not Found
Not Found
No
The summary describes a laser system for soft tissue surgery and does not mention any AI or ML capabilities.
Yes.
The device is intended for surgical procedures such as incision, excision, vaporization, and hemostasis of soft tissue, which are therapeutic interventions.
No
The device is intended for surgical procedures such as incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, not for diagnosis.
No
The device description is not provided, but the intended use clearly describes a laser system for surgical procedures, which is a hardware device. The performance studies also mention compliance with standards related to electrical and laser safety, further indicating a hardware component.
Based on the provided information, the Ceralas D 980 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as a surgical laser system used for procedures on soft tissue within the body (incision, excision, vaporization, ablation, hemostasis, coagulation). IVD devices are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use clearly points to a surgical tool, not a diagnostic test.
- Mentions image processing, AI, DNN, or ML (Not Found): These are often associated with IVD devices that analyze images or data from specimens.
- Input Imaging Modality (Not Applicable): This further indicates it's not an imaging-based diagnostic device.
- Anatomical Site: The anatomical sites listed are all locations within the human body where surgical procedures are performed.
- Summary of Performance Studies: The listed standards (IEC 601-1, IEC 601-2-22, EN 60825-1) are related to the safety and performance of medical electrical equipment and laser products, not IVD performance metrics.
- Key Metrics (Not Found): IVD devices typically report metrics like sensitivity, specificity, PPV, and NPV to describe their diagnostic accuracy. These are not mentioned.
- Predicate Device(s): The predicate devices are also described as laser systems used for surgical procedures.
In summary, the Ceralas D 980 is a surgical laser system used for treating soft tissue during medical procedures, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
Product codes (comma separated list FDA assigned to the subject device)
OCL, 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 in ear, nose and throat and oral surgery (otolaryngology), 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device complies with the following voluntary consensus standards: 21 C.F.R. The device complies will and themes in IEC 601-1; IEC 601-2-22; and EN 60825-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ceralas D 980 Diode Laser System, CardioFocus, Inc.'s Diode Laser System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 1 9 2004
510(k) Summary Ceralas D 980 Diode Laser System
ko32863
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: (413) 525-0611 Facsimile:
Carol J. Morello, V.M.D. Contact Person: March 18, 2004 Date prepared:
Name of Device and Name/Address of Sponsor
Ceralas D 980 Diode Laser System biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser
Predicate Devices
Ceralas D 980 Diode Laser System CardioFocus, Inc.'s Diode Laser System used with CardioFocus, Inc.'s Surgical Lightstic
Intended Use/Indication for Use
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
1
Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. The device complies will and themes in IEC 601-1; IEC 601-2-22; and EN 60825-1.
Substantial Equivalence
The Ceralas D 980 has the same intended use and the exact same technological characteristics as the previously cleared Ceralas D 980, with the exception of a enturation to the handpiece for hemostasis and coagulation of cardiac tissue. In addition, all of the Ceralas D 980's general and specific indications for use are cleared indications of at least one of its predicate devices. The Ceralas D asc are around and armanderical characteristics as the CardioFocus, Inc.'s Diode Laser System, which is also a 980 nm diode laser. Thus, the Ceralas D 980 is substantially equivalent.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004
Re: K032863
Trade/Device Name: Ceralas D 980 Diode Laser System 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, GEX Dated: December 22, 2003 Received: December 22, 2003
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of March 19, 2004.
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. Jonathan Kahan
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 (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 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
ellmall
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Ceralas D 980 Diode Laser System
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
H. Office_of Device Evaluation (ODE) Concurrence of
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K032863
OR
Prescription Use X (Per 21 C.F.R. 801.109) Over-The-Counter Use_ (Optional Format 1-2-96)