(63 days)
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.
The provided document is a 510(k) Premarket Notification for the PhotoDerm® Nd:YAG Accessory. It primarily focuses on demonstrating substantial equivalence to existing devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against such criteria. The "Performance Standards" section only states conformity with federal regulations for medical laser systems (21 CFR 1040.10 and 1040.11), which are general safety and performance standards for laser products, not specific clinical acceptance criteria for the intended use.
Therefore, most of the requested information cannot be extracted from this document, as it is not a clinical study report.
Here's an attempt to answer based on the available information, with many points being "Not Applicable" or "Not Provided":
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance metrics for clinical efficacy/safety. The document states compliance with general federal regulations for medical laser systems (21 CFR 1040.10 and 1040.11). | Not explicitly stated in terms of specific performance metrics for clinical efficacy/safety. The device is described as emitting high energy pulses of 1-10 ms duration and up to 150 J/cm². Comparison is made to predicate devices in terms of technical specifications, operating performance features, general physical configuration, and intended uses. The energy delivered is stated to be "in the range of energy values delivered by the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided.
- Data provenance: Not provided. This document does not describe a clinical study.
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 applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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
- No. This is a laser device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth for device performance in a clinical context is described in this document. The "ground truth" for substantial equivalence is based on comparison to predicate devices' technical specifications and intended use.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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K 980537
510(K) PREMARKET NOTIFICATION
PhotoDerm® Nd:YAG Accessory ESC Medical Systems Ltd.
510(K) Summary
| Submitter: | ESC Medical Systems Ltd.Yokneam Industrial ParkYokneam,20692, IsraelPhone: 972-4-959-9000Fax: 972-4-959-9050 |
|---|---|
| Contact: | Dr. Zvi Ladin, VP, Clinical Applications and Regulatory Affairs |
| Date summary | February 5, 1998 |
| prepared: | |
| Device Trade Name: | PhotoDerm® Nd: YAG Accessory |
| Common name: | Nd: YAG Laser |
| Classification name: | Laser instrument, powered, surgical (class II medical device) |
| Equivalent Devices: | Sharplan 3100 Nd:YAG Laser SystemLaserscope Orion Laser System |
| Device Description: | The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelengthof 1064 nanometers. The device is operated by the PhotoDerm® system andemits high energy pulses of 1- 10 ms duration and up to 150 j/cm2.The Nd: YAG laser accessory is a hand held device that replaces the standardoptical treatment head used in the PhotoDerm® machines. |
| Intended Use: | Coagulation and hemostasis of pigmented vascular lesion and soft tissue |
| Comparison: | PhotoDerm® Nd:YAG Accessory is comparable to its predicate devices in termsof the technical specifications, operating performance features, general physicalconfiguration and intended uses. The energy delivered to the tissue is in therange of energy values delivered by the predicate devices. |
| PerformanceStandards: | The PhotoDerm® Nd: YAG Accessory conforms with federal regulations and theperformance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Conclusion: | The PhotoDerm® Nd: YAG Accessory is substantially equivalent to otherNd: YAG laser systems in commercial distribution for similar applications |
| AdditionalInformation: | None requested at this time |
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Image /page/1/Picture/10 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1998
Dr. Zvi Ladin ·Vice President Clinical Applications and Requlatory Affairs ESC Medical Systems Limited Yokneam Industrial Park P.O. Box 240 Yokneam, Israel 20692
Re: K980537 Trade Name: PhotoDerm® Nd:YAG Accessory Regulatory Class: II Product Code: GEX Dated: February 5, 1998 Received: February 11, 1998
Dear Dr. Ladin:
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 requlation may result in requlatory 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 requlations.
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Page 2 - Dr. Ladin
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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Nd:YAG accessory for PhotoDerm® Device Name:
Indications For Use:
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stuptin Alwdia
tive Devices K980537
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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.