(146 days)
The KaVo KEY Laser 1242 is intended for the incision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following:
Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectorny, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement)
The KaVo KEY Laser 1242 is an Er: Y AG laser operating at 2.94 microns with energy output up to 500 mJ.
The provided document is a 510(k) summary for the KaVo KEY Laser 1242, which is a medical device for surgical applications. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically found for AI/ML-based devices or devices requiring detailed clinical validation against a ground truth.
Instead, the document states: "Performance Data: The specifications and intended uses of the KaVo KEY Laser 1242 are the same or very similar to those of the claimed predicate devices. There are no significant differences between the KaVo KEY Laser 1242 and the claimed predicates in design or under conditions of intended use. The notification included an extensive bibliography and discussions of specific articles in support of the claim for equivalence. Because of this, performance data were not required."
This indicates that the device's acceptance was based on substantial equivalence to legally marketed predicate devices, rather than a specific study demonstrating novel performance criteria. Therefore, most of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.
Here's a breakdown of the applicable information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: The KaVo KEY Laser 1242 must be substantially equivalent in specifications and intended uses to legally marketed predicate devices. | The KaVo KEY Laser 1242's specifications and intended uses are the same or very similar to those of the claimed predicate devices (SEO TriLase, Laserscope Er:YAG, Premier Centaur). No significant differences in design or intended use conditions were identified. |
2. Sample size used for the test set and the data provenance: Not applicable. Performance data was not required as equivalence was established through comparison to predicate devices, not through a test set.
3. 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 test set was not established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is not an AI/ML-based diagnostic system that would typically undergo an MRMC study. It is a surgical laser.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The device's approval was based on substantial equivalence, not a direct validation against a clinical ground truth in a performance study.
8. The sample size for the training set: Not applicable. The device is a physical surgical laser, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
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K983100
TAB E
510(k) SUMMARY
KaVo KEY Laser 1242
This 510(k) summary of safety and effectiveness for the KaVo KEY Laser 1242 is submitted in accordance with the requirements of SMDA 1990 and follows guidance from the Office of Device Evaluation concerning the organization and content of a 510(k) summary.
| Applicant: | KaVo America Corporation |
|---|---|
| 340 East Main Street | |
| Lake Zurich, IL 60047 | |
| Address (Manufacturer): | KaVo Dental GmbH |
| Bahnhofstr. 20 | |
| D-8847 Warthausen | |
| Biberach | |
| GERMANY | |
| Contact Person: | Mr. Douglas Cochrane |
| Product Manager, KaVo K•E•Y Laser 1242 | |
| KaVo America Corporation | |
| 340 East Main Street | |
| Lake Zurich, IL 60047 | |
| Telephone: | 800-323-8029 |
| 847-550-6800 | |
| 847-550-6825 (Fax) | |
| Preparation Date: | July 1998 |
| Device Trade Name: | KaVo K•E•Y Laser 1242 |
| Common Name: | Erbium:YAG surgical laser |
| Classification Name: | Surgical Laser |
| Class: | Class II |
| Legally marketedpredicate devices: | SEO TriLase; Laserscope Er:YAG, Premier Centaur |
:
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Description of Device: The KaVo KEY Laser 1242 is an Er: Y AG laser operating at 2.94 microns with energy output up to 500 mJ. Intended Use: The KaVo KiE Y Laser 1242 is intended for the incision, excision, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry . . -- • Performance Data: The specifications and intended uses of the KaVo KEY Laser 1242 are the same or very similar to those of the claimed predicate devices. There are no significant differences between the KaVo KEY Laser 1242 and the claimed predicates in design or under conditions of intended use. The notification included an extensive bibliography and discussions of specific articles in support of the claim for equivalence. Because of this, performance data were not required. CONCLUSION: Based on the foregoing, KaVo America Corporation believes that the KaVo
K E Y Laser 1242 is substantially equivalent to cited legally marketed predicate devices.
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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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent coiled around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1999
Mr. Doug Cochrane Product Manager KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047
Re: K983100 Trade Name: KaVo KEY Laser 1242 Regulatory Class: II Product Code: GEX Dated: December 3, 1998 Received: December 7, 1998
Dear Mr. Cochrane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Doug Cochrane
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TAB DI
510(k) Number (if known): K983100
Device Name KaVo K·E·Y Laser 1242
Indications For Use:
The KaVo KEY Laser 1242 is intended for the incision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following:
Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectorny, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement)
KaVo proposes that the KaVo KE Y Laser 1242 be labeled as a prescription device. This labeling will be included in manuals and other information distributed in the United States.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter-Use (Per 21 CFR 801.109)
Division of General Re
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§ 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.