The Ceralas 1470nm Fiber-Coupled Diode Laser family (and its delivery accessories used to deliver optical energy) is 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. Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

Device Description

The Ceralas 1470nm 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 1470nm family for Biolitec, Inc..

AI/ML Overview

Here's an analysis of the provided text regarding the Ceralas 1470nm Diode Laser Family, focusing on acceptance criteria and study information:

Acceptance Criteria and Device Performance

This submission is a 510(k) for substantial equivalence, not a premarket approval (PMA) application. Therefore, it focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific clinical efficacy endpoints. The "acceptance criteria" here are compliance with recognized standards and demonstrating identical characteristics to the predicate.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Compliance with Standards/Equivalence to Predicate)	Reported Device Performance
Compliance with Voluntary Consensus Standards:	The device complies with:
- 21 C.F.R. §§ 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products)	Not explicitly detailed, but stated as "complies." These regulations cover laser product safety.
- ANSI/AAMI ES1 (Medical Electrical Equipment - Part 1: General Requirements for Safety)	Not explicitly detailed, but stated as "complies." This standard addresses electrical safety.
- IEC 601-1 (Medical electrical equipment - Part 1: General requirements for safety)	Not explicitly detailed, but stated as "complies." This standard addresses electrical safety.
- IEC 601-2-22 (Medical electrical equipment - Part 2-22: Particular requirements for safety of surgical, aesthetic and therapeutic laser equipment)	Not explicitly detailed, but stated as "complies." This standard is specific to laser safety.
- EN 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements)	Not explicitly detailed, but stated as "complies." This is an international standard for laser product safety.
- ANSI/AAMI/ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals)	Not explicitly detailed, but stated as "complies." This standard addresses biocompatibility related to sterilization.
Substantial Equivalence to Predicate Device:
- Identical components, technology, and principles of operation	The Ceralas 1470nm 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 1470nm family for Biolitec, Inc. (K073063, K082225 and K102755).
- Same intended uses and indications for use	The Ceralas 1470nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. The Indications for Use Statement lists General surgical applications (incision, excision, ablation, cutting, vaporization, hemostasis, coagulation), Endovenous Occlusion of Saphenous Veins, and Laser Assisted Lipolysis.

Study Details

This submission does not present a clinical study in the traditional sense of evaluating device performance on patients or human readers. Instead, it relies on demonstrating substantial equivalence to already cleared predicate devices. The "study" here is a comparison exercise rather than a performance trial.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This is a substantial equivalence submission based on device characteristics, not a clinical performance study with a test set of data.
- Data Provenance: Not applicable. The "data" consists of device specifications and confirmed manufacturing processes, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a clinical test set is not established in this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set or adjudication process for clinical outcomes.
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:
- No. This device is a surgical laser, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical laser, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," implicitly, is the regulatory approval and a history of safe and effective use of the predicate devices (K073063, K082225, and K102755). The substantial equivalence argument states that because the new device is identical in all relevant aspects to these predicates, it shares their established safety and effectiveness.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design, manufacturing, and testing (to meet standards like IEC 601-2-22) are the relevant "data" for its own performance, and these are compared to the predicate.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The ground truth for this submission hinges on the regulatory history and proven performance of the predicate devices.

Summary

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SEP 2 0 2011

510(k) Summary Ceralas 1470nm Diode Laser Family

KI12253

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 3, 2011

Name of Device and Name/Address of Sponsor

Ceralas 1470nm Diode Laser System Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser

Predicate Devices

Ceralas 1470nm Diode Laser System, (K073063, K082225 and K102755).

Intended Use/Indication for Use

Technological Characteristics

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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 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.

Substantial Equivalence

The Biolitec Medical Devices Inc Ceralas 1470nm family is as safe and effective as the Biolitec Inc. Ceralas 1470nm family as the products are identical in all aspects except labeling realating to the manufacturer/ distributor.

The Ceralas 1470nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. Thus, the Ceralas 1470nm family is substantially equivalent to its predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20995-0002

Biolitec Medical Devices, Inc. % Genmarhav BDA Mr. Harry Haves 1349 Main Road Granville. Massachusetts 01034

SEP 20 2011

Re: K112253

Trade/Device Name: Ceralas 1470mm Diode Laser Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 3. 2011 Received: August 5, 2011

Dear Mr. Haves:

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hiability 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.

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

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Page 2 - Mr. Harry Hayes

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/CDRHQffices/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 vours.

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

112253 510(k) Number (if known): ----------------------

Device Name: Ceralas 1470nm Diode Laser Family

Indications for Use:

The Ceralas Fiber-Coupled 1470nm 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. Endovenous Occlusion of the Saphenous Veins in

Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

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

of CDRH, Office of Device Evaluation (ODE) Concurrenc MX m (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112253

Prescription Use __ V (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)

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.