The Ceralas Fiber Coupled 980nm Diode Laser family (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. Indications include: General Surgery, Urology, Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery/ Peripheral. Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis. Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.

Device Description

The Ceralas 980nm family for Biolitec Medical Devices, Inc. is identical (contains the same components, technology and principles of operation and assembled by the same manufacturer) as the cleared Ceralas 980nm family for Biolitec. Inc..

AI/ML Overview

The provided submission is for a Ceralas 980nm Diode Laser Family for general surgical applications. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness or safety. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of, for example, AI/ML device evaluations, is not directly applicable here.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence in intended uses, indications, technological characteristics, and principles of operation to predicate devices.	The device is identical (contains the same components, technology, and principles of operation, and assembled by the same manufacturer) to the cleared Ceralas 980nm family for Biolitec. Inc. It shares the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices.
Compliance with specific voluntary consensus standards.	The device complies with: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.
Substantial equivalence to predicate device.	The FDA determined the device is substantially equivalent to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. This submission is for substantial equivalence of a physical medical device (laser) to a predicate device, not for a data-driven AI/ML model that would use a test set from patient data. The "test" here refers to demonstrating compliance with standards and equivalence, not evaluating performance on a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Ground truth in the context of clinical data interpretation by experts is not relevant to this type of device submission. The "ground truth" here is the established safety and efficacy of the predicate device, and the current device's compliance with established engineering and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are used in studies involving expert interpretation of data, which is not the nature of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This type of study is for evaluating observer performance with or without AI assistance, which is not relevant to a laser device submission focused on substantial equivalence.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This refers to AI algorithm performance studies, which are not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the established regulatory compliance, safety, and efficacy of the predicate device, as well as compliance with recognized voluntary consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. There is no clinical "ground truth" derived from patient data or pathology in this type of submission.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device submission.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As there is no training set mentioned, the establishment of its ground truth is irrelevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a substantial equivalence comparison and compliance demonstration against recognized standards.

Substantial Equivalence Study: The core of the submission relies on demonstrating that the Ceralas 980nm Diode Laser Family is "as safe and effective as" its predicate device (the Ceralas 980nm family by Biolitec, Inc.). The proof is based on the assertion that the devices are "identical in all aspects except labeling relating to the manufacturer/distributor." Specifically, it's stated they contain "the same components, technology and principles of operation and assembled by the same manufacturer." This direct identity is the primary evidence for substantial equivalence in this context.
Compliance with Voluntary Consensus Standards: The device's performance is shown to meet acceptance criteria through compliance with a list of voluntary consensus standards:
- 21 C.F.R. §§ 1040.10 & 1040.11 (likely related to radiation control for laser products).
- ANSI/AAMI ES1 (likely electrical safety).
- IEC 601-2-22 (likely specific safety requirements for surgical lasers).
- EN 60825-1 (likely laser safety classification and requirements).
- ANSI/AAMI/ISO 10993-7 (likely biocompatibility evaluation relevant to medical devices).

The FDA's review and subsequent "substantial equivalence" determination (K112324) confirms that the evidence provided was sufficient to meet the regulatory requirements for this 510(k) submission. This is a regulatory review process, not a clinical trial or AI performance study.

Summary

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K 112324

SEP - 6 2011

510(k) Summary Ceralas 980nm Diode Laser Family

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Biolitec Medical Devices, Inc.

515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: August 10, 2011

Name of Device and Name/Address of Sponsor

Ceralas 980nm Diode Laser Family Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser & accessories

Predicate Devices

Ceralas 980nm Diode Laser Family (covering models: D15, D25, D50, E15, & E30; D100, D120, D150 & D180)

Intended Use/Indication for Use

Technological Characteristics

イ

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Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.

Substantial Equivalence

The Biolitec Medical Devices Inc Ceralas 980nm family is as safe and effective as the Biolitec Inc. Ceralas 980nm family as the products are identical in all aspects except labeling relating to the manufacturer/ distributor.

The Ceralas 980nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. Thus, the Ceralas 980nm family from Biolitec Medical Devices, Inc. is substantially equivalent to its predicate devices from Biolitec, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biolitec Medical Devices, Inc. % Harry Hayes. Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K112324

Frade/Device Name: Ceralas Fiber Coupled Diode Laser Family 980mm (covering 980nm Models: D15. D25. D50. E15 & E30; D100, D120, D150 & D180) 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: August 10, 2011 Received: August 12, 2011

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.

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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 (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/ReportalProblem/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 A. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K112324

Device Name:

Ceralas Fiber-Coupled Diode Laser Family 980nm (covering 980nm Models: D15, D25, D50, E15, & E30; D100, D120, D150 & D180)

Indications for Use:

Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery/ Peripheral. Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis. Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Surgical, Orthopedic,
	and Restorative Devices
Prescription Use ✓(Per 21 C.F.R. 801.109)	510(k) Number L112329Over The Counter Use ____(Optional Format 1-2-96)

GBDA/ BioMD-980-081011-03

Regulation Number and Section

§ 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.