The CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue.

Device Description

The CardioFocus Diode Laser Ablation System is a generator designed for the delivery of 980nm laser light and may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coagulation and vaporization of tissue as required by the clinician. The instrument includes a diode laser module as the therapeutic energy source, as well as an internal thermal safety system for monitoring and disabling laser power output.

AI/ML Overview

The provided text is a 510(k) summary for the CardioFocus Diode Laser System. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating similar intended use, technology, and safety characteristics. It does NOT typically contain detailed clinical study data with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as you might find for a novel device or a Premarket Approval (PMA) application.

Therefore, many of the requested details about acceptance criteria and a "study that proves the device meets the acceptance criteria" are not present in this document. The document's primary "proof" is the demonstration of equivalence to legally marketed predicate devices, and adherence to recognized safety standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria for the CardioFocus Diode Laser System are that it is substantially equivalent to the predicate device (Ceralas Diode Laser System) and that its safety characteristics are assured through conformance with applicable U.S. and International standards. These are not quantitative performance metrics in the typical sense of accuracy, sensitivity, or specificity for a diagnostic device.

Reported Device Performance: Instead of specific performance metrics, the document states: "Both devices output optical energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards." And, "When used in accordance with the directions for use, by qualified personnel, the CardioFocus Diode Laser System is safe and effective, as indicated, for its intended use."

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device	"More similarities than differences" to predicate. Output optical energy at similar power levels and wavelengths. Similar intended uses.
Conformance to applicable U.S. and International safety standards	Conforms to UL 2601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 1000, and 21 CFR 1040.10/.11.
Safe and effective for intended use	"Safe and effective, as indicated, for its intended use."

Missing Information (Not provided in the 510(k) Summary):

The sections below require information typically found in clinical studies or performance validation reports, which are not detailed in a 510(k) summary for a device like this.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. This type of information would be relevant for a clinical trial demonstrating efficacy, which is generally not required for a 510(k) for a surgical laser system if substantial equivalence can be shown through technological comparison and adherence to standards.
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)
- Not provided. This implies a diagnostic or interpretive task that is not the primary focus of this laser system's 510(k) review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided.
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
- Not provided. This is not an AI-assisted diagnostic device, so an MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not provided. This is not an algorithmic device in the diagnostic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided.
8. The sample size for the training set
- Not provided. No "training set" in the machine learning sense is described.
9. How the ground truth for the training set was established
- Not provided.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented in this 510(k) summary is a comparative analysis of the CardioFocus Diode Laser System against legally marketed predicate devices, primarily the CeramOptec Ceralas D25 Fiber-Coupled Diode Laser System.

Key elements of this "study" (as presented):

Objective: To demonstrate substantial equivalence of the CardioFocus Diode Laser System to predicate devices.
Methodology:
- Comparison of Technical Characteristics: The document outlines the general description, device characteristics (e.g., power levels, wavelength), and technical characteristics (e.g., system controller, thermal safety system, optics module, user interface, foot switch, diode driver, diode module, power supply) of the CardioFocus system.
- Predicate Device Identification: The Ceralas Diode Laser System (K001975) is identified as the primary predicate.
- Comparison Points for Substantial Equivalence:
  - Intended Use: Both devices are for "delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue." (Identical wording).
  - Technology & Theory of Operation: Both devices use diode laser technology. "Both the predicate devices use the same technology and theory of operation."
  - Power Levels & Wavelengths: "Both devices output optical energy at similar power levels and similar wavelengths." Specifics provided are 30W and 60W models for CardioFocus, and "three configurations for different power levels" for Ceralas. Both use 980nm wavelength.
  - Safety Standards Conformance: The CardioFocus device's safety is assured through conformance with several recognized U.S. and International standards (UL 2601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 1000, 21 CFR 1040.10/.11). The predicate device is also stated to conform to recognized standards.
Results/Conclusion:
- "There are more similarities than differences between the predicate device and the CardioFocus Diode laser System."
- "Both devices output optical energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards."
- The FDA's decision letter (K013201) confirms the finding of "substantial equivalence (for the indications for use stated in the enclosure) to legally marketed predicate devices."

The 510(k) submission itself serves as the "study" demonstrating that the device meets the implicit acceptance criteria of substantial equivalence and safety through standard adherence. No separate clinical trial with specific performance metrics, ground truth, or expert review is detailed for this type of submission.

Summary

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MAR 1 8 2002

K013201 1/4

510(k) SUMMARY FOR CARDIOFOCUS DIODE LASER SYSTEM

Submitter's Name, Address, Telephone Number, and Contact Person:

CardioFocus Norton Commerce Center 10 Commerce Way Norton, MA 02766

Contact: Joe Curtis Phone: (508) 285-1700 Fax: (508) 285-7579 Email: joec@cardiofocus.com

Name of Device:

CardioFocus Laser System.

Common or Usual Name:

Surgical Laser Instrument

Classification Name:

Laser, Powered, Surgical Instrument. CFR ref: 878.4810, product Code GEX

Predicate Devices:

Ceralas Diode Laser System CeramOptec, Inc., East Longmeadow, MA K001975; S.E. 8-4-2000

Intended Use:

The CardioFocus Laser Diode System is intended for the delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue,

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General Description:

Device Characteristics:

The CardioFocus Laser Diode System is provided in two Models. The Model 30NR provides up to 30 watts, laser light and the Model 60NR provides up to 60 watts, laser light., The CardioFocus Diode Laser System may be used with the CardioFocus Lightstic 180L or Lightstic 180C delivery catheter (REF: 510K# K993834 and K011988), and successor delivery catheters from CardioFocus, Inc.

System safety characteristic are assured through conformance with applicable U.S. and International standards, including :

UL 2601-1 Medical Electrical Equipment PART 1: General t Requirements For Safety, Medical Electrical Equipment
IEC 60601-2-22 Medical Electrical Equipment PART2: Particular . requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60825-1 Safety of laser products Part 1: Equipment . classification, requirements and user's guide
IEC 60601-1-2 (EN 60601-1-2) General Requirements for Safety, 2. . Collateral Standard: Electromagnetic Compatibility
IEC 1000 Electromagnetic Compatibility .
21 CFR 1040.10/.11 Performance Standard for Light Emitting ● Products

K013201 2/

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K013201 3/4

Technical Characteristics

System Controller: the system controller represents the hardware . and software that monitors and controls the functioning of the laser instrument.
Thermal Safety System (TSS): the thermal safety system is a safety 0 circuit, intended to monitor the black body radiation associated with excessive heating in the disposable device and associated optics and to disable the laser in the event that excessive black body radiation is detected.
Optics Module: the optics module is an optical sub-system which . provides means for delivering laser energy and collecting white light energy from the delivery device and also provides means for directing black body radiation from the disposable device to the safety system IR detector.
User Interface: the user interface provides means for information . display to the user as well as a mechanism for user input. The user interface for the laser instrument will likely include an LCD display and a keypad.
Foot Switch: the laser instrument will interface to a foot switch for . on/off control of the laser emission.
Diode Driver: the diode driver block represents the electronics ● required to control power supplied to the laser module
. Diode Module: the diode module is a purchased component, comprised of a series of laser diodes, which produces the output laser energy.
. Power Supply: an AC/DC power supply provides DC power necessary to run the system electronic components. The supply is internal to the laser instrument.

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K0132014/4

Predicate information is support of Substantial equivalence

The CardioFocus Diode Laser System is substantially equivalent to the CeramOptec Celaras D25 Fiber-Coupled Diode Laser System. Both devices ocruth optor energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards.

Conclusion

There are more similarities than differences between the predicate device and the CardioFocus Diode laser System. Both the predicate devices use the same technology and theory of operation. Both the CardioFocus Laser System and the Ceralas Diode laser System use three configurations for different power levels and both devices have similar Indications for Use When used in accordance with the directions for use, by qualified personnel, the CardioFocus Diode Laser System is safe and effective, as indicated, for its intended use,

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Image /page/4/Picture/1 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 flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

CardioFocus, Inc. c/o Mr. John Greenbaum Generic Devices Consulting 20310 SW 48th Street Ft. Lauderdale, FL 33332

Re: K013201

Trade/Device Name: CardioFocus Diode Laser System 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: December 20, 2001 Received: December 21, 2001

Dear Mr. Greenbaum:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterimes and marketed predicate devices marketed in interstate 10 tuse stated in the encrosale) to tegains and the Medical Device Amendments, or to Connected pror to May 20, 1978, as eacordance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). and Cosmetic Hot (110) that as nov request to the general controls provisions of the Act. The I ou may, mereleve, manis of the Act include requirements for annual registration, listing of Economic controls profictive, 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to basil as a suese as 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 that I Drinas intatutes and regulations administered by other Federal agencies. You must or any I 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 Orth 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.

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Page 2 - Mr. John Greenbaum

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,

Muriam C. Provost

for 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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Page 1 of 1

510(k)Number(if known): KOJ320

Device Name: CardioFocus Diode Laser System

Indications For Use:

The CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or non-contact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013201

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CRF 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.