(88 days)
Not Found
No
The device description and performance studies focus on the optical and physical properties of the handpiece and fiber, with no mention of AI or ML.
No
The document describes the device as a "fiber optic delivery accessory to a laser device" and refers to the laser user manual for indications. The device itself is a handpiece for delivering the laser energy, not the laser device itself which would have therapeutic indications.
No
Explanation: The device is described as a fiber optic delivery accessory to a laser device, specifically a collimating handpiece. Its purpose is to deliver and shape the laser beam for treatment. There is no mention of it being used to gather information about a patient's health or condition, which is characteristic of a diagnostic device. The performance studies focus on beam efficiency and safety, not on diagnostic accuracy.
No
The device description explicitly states it consists of a physical handpiece made of anodized aluminum with lenses and a quartz optical fiber, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "fiber optic delivery accessory to a laser device." This describes a device used to deliver energy to the body, not to perform tests on samples taken from the body.
- Device Description: The description details a physical handpiece with lenses and a fiber optic cable. This aligns with a device used for delivering light energy, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to deliver laser energy, which is a therapeutic or surgical application, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The company's MegaBeam/Ceralas Non Sterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for complete list of indications.
Product codes
GEX
Device Description
The Mega Beam/Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in an anodized aluminum handpiece. The aluminum handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size. The MegaBeam/Ceralas Collimating Handpiece maximum power output was less than the predicate devices and its divergence angle is less than the predicate.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biolitec conducted testing comparing the MegaBeam/Ceralas Collimating Handpiece's and the MegaBeam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These performance tests demonstrate that the MegaBeam /Ceralas Collimating Handpiece is as safe and effective as the Fiber Optic Delivery System's Bare Fiber.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Biolitec Inc MegaBeam Sterile Fiber optic Delivery System's Bare Fibers, Coherent VersaSpot & Collimated Handpiece, Coherent Ultrafine TrueSpot Collimating Handpiece
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.
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K 013193
DEC 21 2001
510(k) Summary Ceralas Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611 Contact Person: Carol Morello, V.M.D. Date prepared: September 24, 2001
Name of Device and Name/Address of Sponsor
MegaBeam/Ceralas Non Sterile Collimating Handpiece Biolitec. Inc. 515 Shaker Road East Longmeadow, MA 01028
Classification Name
Accessory to Surgical Laser Instrument
Predicate Device
Biolitec Inc MegaBeam Sterile Fiber optic Delivery System's Bare Fibers Coherent VersaSpot & Collimated Handpiece Coherent Ultrafine TrueSpot Collimating Handpiece
Intended Use
The company's MegaBeam/Ceralas Non Sterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for complete list of indications.
Technological Characteristics and Substantial Equivalence
The Mega Beam/Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in an anodized aluminum handpiece. The aluminum handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size. The MegaBeam/Ceralas Collimating Handpiece maximum power output was less than the predicate devices and its divergence angle is less than the predicate. However, these technological differences do not raise any new questions of safety and effectiveness, as demonstrated by the performance data.
Performance Data
Biolitec conducted testing comparing the MegaBeam/Ceralas Collimating Handpiece's and the MegaBeam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These
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performance tests demonstrate that the MegaBeam /Ceralas Collimating Handpiece is as safe and effective as the Fiber Optic Delivery System's Bare Fiber.
Substantial Equivalencies
The MegaBeam/Ceralas Collimating Handpiece has the same intended use as all three of its predicate devices, the same indications as one of the predicate devices, except that it cannot be used in endoscopic applications, and very similar principles of operation as the predicate collimating handpieces and similar technical characteristics as a combination of the predicate devices. The minor technical differences between the MegaBeam/Ceralas Collimating Handpiece and its predicate devices do not raise new questions of safety or effectiveness. Performance data Demonstrates that the MegaBeam/Ceralas Collimating Handpiece is as safe and effective as its predicate device. Thus, the MegaBeam/Ceralas Collimating Handpiece is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a caduceus, which is a traditional symbol of medicine, but in this case, it is a modern interpretation with three abstract figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2001
Carol J. Morello, V.M.D. Manager of Regulatory Affairs Biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Re: K013193
Trade/Device Name: MegaBeam/Ceralas Non-Sterile Collimating Handpiece Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 24, 2001 Received: September 24, 2001
Dear Dr. Morello:
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.
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 (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.
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Page 2 - Carol J. Morello, V.M.D.
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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Ata Hytk Rhode
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
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Indications for Use Form K 013193 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Mega Beam/Ceralas Nonsterile Collimating Handpiece
Indications for Use:
The company's MegaBeam/Ceralas NonSterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for a complete list of indications.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph Rworde
vision of General, Restorative and Neurological Devices
510(k) Number K013193
న Prescription Use _ (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)