KEY LASER III 1243 US WITH DETECT

• K Number: K073074
• Device Name: KEY LASER III 1243 US WITH DETECT
• Manufacturer: KAVO AMERICA
• Date Cleared: 2008-07-10 ( 253 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended Use

For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage. Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243.

Device Description

This device represents the combination into one device of two previously cleared devices, the Diagnodent Laser Fluorescence Caries Detection Device with the KEY Laser III 1243.

Predicate Devices

K030146, K983658/ K042394/ K051909/ K060080

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a combination of two previously cleared devices without mentioning any new AI/ML capabilities.

Therapeutic

Yes

The device is intended for "removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage," which describes a therapeutic intervention to treat a disease (periodontitis).

Diagnostic

Yes
This device explicitly states that it is a "combination into one device of two previously cleared devices, the Diagnodent Laser Fluorescence Caries Detection Device with the KEY Laser III 1243," and the "Diagnodent" part of its name and description clearly indicates a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "combination into one device of two previously cleared devices," which are hardware devices (lasers). The summary also mentions "laser surgical functions," further indicating a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the removal of subgingival calculi and using a detection function for this purpose. This is a therapeutic and diagnostic procedure performed in vivo (on the patient's body), not in vitro (on samples outside the body).
• Device Description: The device combines a laser for surgical functions and a laser for detection. Both functions are applied directly to the patient's periodontal pockets.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.

The detection function uses laser fluorescence to help identify the calculi, but this detection is part of the overall in vivo procedure for removal, not a separate diagnostic test performed on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.
Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243.

Product codes

GEX, NTK

Device Description

This device represents the combination into one device of two previously cleared devices, the Diagnodent Laser Fluorescence Caries Detection Device with the KEY Laser III 1243.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

periodontal pockets

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)

Laboratory testing has revealed that the performance of the detection function and the performance of the laser surgical functions have not changed.
Bench and in-vitro studies were conducted.
EMC and electrical safety testing was conducted.
KEY Laser III 1243 US without Feedback, with Detect meets the US Performance Standard for Lasers. The device has been tested in accordance with:

• IEC 601-1/VDE 0750 Part 1
• ISO 7494
• IEC 825-1 / DIN-VDE 0837 Part 1
• VDE 0750 Part 2-2
• Regulations 21 CFR 1040
• ANSI Z 136.1
• ANSI Z 136.3
• UL Std No 60601-1 (1st Edition)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030146, K983658/ K042394/ K051909/ K060080

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

EXHIBIT 2 510(k) Summary

JUL 10 2008

K073074 KaVo Dental Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: [e-mail] Contact: Mari Lambert, Director of RA/QA July 9, 2008

• 1. Identification of the Device: Proprietary-Trade Name: KEY Laser III 1243 US without Feedback, with Detect Classification Name: Laser Surgical Instrument: Product Code GEX with Laser Fluorescence Caries Detection Device, Product Code NTK Common/Usual Name: Surgical laser with laser fluorescence caries detection device
• 2. Equivalent legally marketed device: K030146 Kavo Key Laser combined with K983658/ K042394/ K051909/ K060080 (Diagnodent®)

Indications for Use (intended use): For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage. Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243.

• 3. Description of the Device: This device represents the combination into one device of two previously cleared devices, the Diagnodent Laser Fluorescence Caries Detection Device with the KEY Laser III 1243.

1

Image /page/1/Picture/0 description: The image shows two medical devices. On the left is a "Predicate DIAGNOdent® 2095 K983658/ K042394/ K051909/ K060080" device. On the right is a "KEY Laser III 1243 US without Feedback, with Detect" device.

• 4. Safety and Effectiveness, comparison to predicate device: The indications for use and the applied standards have not changed, nor has the performance of the individual devices changed as a result of combining two devices into one package. Laboratory testing has revealed that the performance of the detection function and the performance of the laser surgical functions have not changed.
• 5. Conclusion: In all important respects, the KEY Laser III 1243 US without Feedback, with Detect is substantially equivalent to the individual predicates. This conclusion is based on indications for use, bench, and in-vitro studies, as well as EMC and electrical safety testing. KEY Laser III 1243 US without Feedback, with Detect meets the US Performance Standard for Lasers. The device has been tested in accordance with:
  • · IEC 601-1/VDE 0750 Part 1
  • = ISO 7494
  • IEC 825-1 / DIN-VDE 0837 Part 1
  • · VDE 0750 Part 2-2
  • Regulations 21 CFR 1040
  • · ANSI Z 136.1
  • · ANSI Z 136.3
  • = UL Std No 60601-1 (1st Edition)

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KaVo America Corporation % Kamm & Associates Mr. Daniel Kamm, P.E. 340 East Main Street Lake Zurich, Illinois 60047

Re: K073074

Trade/Device Name: KEY Laser III 1243 US without Feedback, with Detect 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: June 9, 2008 Received: June 11, 2008

JUL 10 2008

Dear Mr. Kamm:

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

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Page 2 - Mr. Daniel Kamm, P.E.

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.

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 I 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systeros at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances e at its toll-free number [phone] or [phone] or at its Internet adress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millican

Mark N. Melkerson 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

510(k) Number (if known): K073074

KEY Laser III 1243 US without Feedback, with Detect Device Name:

Indications For Use:

For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.

Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243 ..

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Barbara Breen

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

510(k) Number K073074