(184 days)
Not Found
No
The summary describes a laser device for surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is used for surgical applications like incision, excision, ablation, and vaporization of tissue, as well as percutaneous lumbar disc decompression, which are all therapeutic interventions.
No
The device description and intended use clearly state that it is a surgical laser for incision, excision, ablation, and other therapeutic applications of soft tissue. It is not described as being used to diagnose conditions.
No
The device description clearly identifies the device as a "Fiber-Coupled Diode Laser," which is a hardware device used for surgical procedures. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a laser used for surgical applications like incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue. It also mentions percutaneous lumbar disc decompression/diskectomy. These are all in vivo procedures, meaning they are performed directly on the living body.
- Lack of IVD-related terms: The document does not mention any terms related to sample analysis, laboratory testing, or diagnostic information derived from bodily fluids or tissues.
Therefore, the Ceralas Fiber-Coupled Diode Laser family 980nm is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ceralas Fiber-Coupled Diode Laser family 980nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
Added Indication for Use:
Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.
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, cartilaginous tissue, internal organs, external tumors and lesions, Lumbar Disc
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)
Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers.
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 D1950 (K072682), Ceralas G15 532 Frequency Doubled Nd:Yag (K002296), Quanta System Polysurge Diode Laser Family (K083613), Quanta System Diode Medical Laser Family (K072034), INTERmedic Diode Laser family 810nm & 980nm (K053540)
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
510(k) SUMMARY: K100726 Biolitec Inc.'s Ceralas Fiber-Coupled Diode Laser 980nm Family for an Additional Indication of Use
Submitter's Name, Facility/ Manufacturing Address, Telephone/ Fax Number, Contact Person:
Biolitec Inc. 515 Shaker Road East Longmeadow, MA 01028 Phone: (413) 525-0600 Facsimile: (413) 526-0611
SEP 1, 5 2010
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant, Biolitec Inc. - cell: (413) 250-0779 Email: harry.hayes@biolitec.com Or Nancy Foley - Manager of Regulatory Affairs, Biolitec Inc. Email: nancy.foley@biolitec.com
Date Prepared: March 8, 2010
i. Name of Device and Name/ Address of Sponsor/ Establishment Reg. Number:
Ceralas Fiber-Coupled Diode Laser 980 nm Family
Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Establishment Registration Number: 1222625
ii. Common or Usual Name: Diode Laser
iii. Classification Name:
Laser, Surgical Diode Laser System
Classification Panel: iv.
The General Surgery Devices Branch has classified Diode Lasers as Class II devices pursuant to 21 C.F.R. § 878.4810
v. Predicate Devices:
Ceralas 50W Ceralas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K083613) Quanta System Diode Medical Laser Family (K072034) INTERmedic Diode Laser family 810nm & 980nm (K053540)
1
Intended Use/ Indications for Use vi.
The Ceralas Fiber-Coupled Diode Laser family 980nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
Added Indication for Use:
Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.
vii. Technological Characteristics
The Ceralas 980nm family have substantially similar technological characteristics as compared to the Ceralas G15 532nm Frequency-Doubled Nd:YAG laser and the Ceralas D1950 laser, as well as the Quanta System Polysurge 808nm, 980nm & 1950nm laser family, Quanta System Model 30 (808nm & 940nm) laser family and the INTERmedic 810nm & 980nm family.
viii. Performance Data
Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers.
ix. Substantial Equivalence
The Ceralas 980nm family is as safe and effective for this additional Indication for Use as the Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers, the Quanta System Polysurge 808nm, 980nm & 1950nm laser family, the Quanta System Model 30 (808nm & 940nm) laser family and the INTERmedic 810nm & 980nm laser family.
The Ceralas 980nm family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas 980nm family and its predicate device raises no new issues of safety or effectiveness. Thus, the Ceralas 980nm family is substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 5 2010
Biolitec, Inc. % Genmarhay BDA Harry Hayes, Ph.D. 1349 Main Road Granville, Massachusetts 01034
Re: K100726
Trade/Device Name: Ceralas Fiber-Coupled Diode Laser 980nm Family Regulation Number: 21 CFR 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: September 07, 2010 Received: September 09, 2010
Dear Dr. Hayes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 - Harry Hayes, Ph.D.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
The Company's Indications for Use Statement for the Device is provided below.
· Indications for Use Statement:
510(k) Number (if known): K100726. Device Name:
Indications for Use:
Ceralas Fiber-Coupled Diode Laser Family 980nm (Covering 980nm Models: D15, D25, D50, E15, & E30; HPD100, HPD120, HPD150 & HPD180)
The Ceralas Fiber-Coupled Diode Laser family 980nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
Added Indication for Use:
Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.
Prescription Use ----X ---(Part 21 C.F.R. 801 Subpart D)
And/ Or
Over-The-Counter Use ---------(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R. Reuber
(Division Plan Offi. for mxm
Division of Surgical, Cithopedic, and Restorative Devices
510(k) Number K100726