(253 days)
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.
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.
Acceptance Criteria and Study for KEY Laser III 1243 US without Feedback, with Detect
Based on the provided 510(k) Summary (K073074), the KEY Laser III 1243 US without Feedback, with Detect is a combination of two previously cleared devices: the Diagnodent Laser Fluorescence Caries Detection Device and the KEY Laser III 1243. The acceptance criteria and "study" are focused on demonstrating that the performance of the individual components has not changed as a result of their combination and that the combined device meets established safety standards for laser and medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Performance | Performance of detection function is unchanged from predicate. | "Laboratory testing has revealed that the performance of the detection function... have not changed." |
| Performance of laser surgical functions is unchanged from predicate. | "Laboratory testing has revealed that the... performance of the laser surgical functions have not changed." | |
| Safety - Electrical | Compliance with IEC 601-1/VDE 0750 Part 1 | Device has been tested in accordance with IEC 601-1/VDE 0750 Part 1 and UL Std No 60601-1 (1st Edition). |
| Compliance with UL Std No 60601-1 (1st Edition) | Device has been tested in accordance with IEC 601-1/VDE 0750 Part 1 and UL Std No 60601-1 (1st Edition). | |
| Safety - Laser | Compliance with IEC 825-1 / DIN-VDE 0837 Part 1 | Device has been tested in accordance with IEC 825-1 / DIN-VDE 0837 Part 1, Regulations 21 CFR 1040, ANSI Z 136.1, and ANSI Z 136.3. |
| Compliance with Regulations 21 CFR 1040 | Device has been tested in accordance with IEC 825-1 / DIN-VDE 0837 Part 1, Regulations 21 CFR 1040, ANSI Z 136.1, and ANSI Z 136.3. | |
| Compliance with ANSI Z 136.1 | Device has been tested in accordance with IEC 825-1 / DIN-VDE 0837 Part 1, Regulations 21 CFR 1040, ANSI Z 136.1, and ANSI Z 136.3. | |
| Compliance with ANSI Z 136.3 | Device has been tested in accordance with IEC 825-1 / DIN-VDE 0837 Part 1, Regulations 21 CFR 1040, ANSI Z 136.1, and ANSI Z 136.3. | |
| Safety - EMC | Demonstrated Electromagnetic Compatibility | Device has been tested in accordance with relevant EMC standards (implied by "EMC and electrical safety testing"). |
| Biocompatibility | Compliance with ISO 7494 | Device has been tested in accordance with ISO 7494. |
| Overall Equivalence | Individual device performance and indications for use have not changed; device is substantially equivalent to predicates. | "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." "In all important respects, the KEY Laser III 1243 US without Feedback, with Detect is substantially equivalent to the individual predicates." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on the sample size used for any in-vitro or bench testing. It only states "Laboratory testing has revealed..." and "bench, and in-vitro studies." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified, as this was a premarket notification for a combination device, and detailed clinical study results are typically not required in the same way as for novel devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The "ground truth" for this submission appears to be derived from the established performance and safety profiles of the individual predicate devices and the relevant industry standards. There is no mention of human expert evaluation in establishing ground truth for the "laboratory testing" or "bench/in-vitro studies."
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of human expert review. The "studies" were technical laboratory and bench tests against pre-defined performance and safety standards.
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 applicable. This device is not an AI-assisted diagnostic tool for "human readers" in the typical sense that an MRMC study would be performed. It's a medical device with a laser for surgical procedures and a fluorescence detection function. The comparison is to predicate devices, not to human performance with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This statement is partially applicable in that the device's functional integrity (laser operation, detection sensitivity) was assessed in isolation. The "laboratory testing" and "bench, and in-vitro studies" essentially evaluated the technical performance of the device components without necessarily considering a "human-in-the-loop" performance study for this type of submission. However, it's not an "algorithm only" device; it's a physical medical instrument. The "detection function" performance was evaluated in what could be considered a standalone manner from the surgical function, but both are physical components of the device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this submission appears to be:
- Validated performance parameters of the predicate devices: The functionality of the detection and laser surgical components are compared to their previously cleared, individual versions.
- Established industry and regulatory standards: Compliance with various IEC, ISO, UL, VDE, ANSI, and 21 CFR standards for electrical safety, laser safety, and biocompatibility serves as the ground truth for safety and technical performance.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI algorithm in the context of requiring a training set for model development. The device combines existing, cleared technologies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not utilize a training set in the AI machine learning sense.
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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: info@kavousa.com Contact: Mari Lambert, Director of RA/QA July 9, 2008
-
- 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
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.
-
- 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.
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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.
-
- 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.
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- 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)
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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systeros at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
§ 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.