(106 days)
The Umeco OPTIMA 694 system is intended for the use in the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery.
The Umeco OPTIMA 694 system is based on an optical cavity containing a Ruby laser rod. which is activated by means of the use of flashlamps. After the cavity, a red helium neon aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode. The System is capable of emitting up to 2.2 Joules of light at 694 nm, with a nomimal pulsewidth of 20 nanoseconds. The laser is intended to be used for intended for the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery. The Ruby laser system is designed with 3 major sub-systems: a) An articulated arm delivery system terminated in a focusing handpiece. b) An electronic power supply and interface circuitry. c} An optical chamber containing laser rod and laser cavity optics.
This 510(k) summary for the Umeco OPTIMA 694 Ruby Laser System does not contain specific acceptance criteria or an analytical study proving the device meets said criteria in the way typically found for diagnostic algorithms or AI-driven systems.
The document is a submission for a medical device (a laser system), not a diagnostic software or an AI algorithm. Therefore, the information provided focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than meeting specific performance metrics against a defined ground truth through an algorithmic study.
As such, many of the requested fields cannot be directly answered from the provided text. However, I can extract information relevant to the device's characteristics and the regulatory process.
Here's an attempt to address your request based on the provided text, with clear indications where information is not available or not applicable to this type of device submission:
Acceptance Criteria and Study for Umeco OPTIMA 694 Ruby Laser System
The provided 510(k) summary for the Umeco OPTIMA 694 Ruby Laser System focuses on demonstrating substantial equivalence to predicate devices already on the market (Derma-Lase DLR-1 and Spectrum RD 1200 Ruby laser systems). This type of submission does not typically involve the setting of specific, quantitative "acceptance criteria" for diagnostic performance or a "study that proves the device meets the acceptance criteria" in the way one would for an AI algorithm or a diagnostic test. Instead, the "acceptance" is based on demonstrating the new device is as safe and effective as existing legally marketed devices.
The "performance" of the device, in this context, refers to its technical specifications and intended use, aligning with the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion (Based on Predicate Equivalence) | Umeco OPTIMA 694 Reported Performance |
|---|---|
| Intended Use | Removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery. |
| Wavelength | 694 nm |
| Pulsed Operation | Yes |
| Nominal Pulsewidth | 20 nanoseconds (nominal) |
| Maximum Energy Output | Up to 2.2 Joules |
| Spotsize Range (Diameter) | 4 - 8 mm |
| Delivery System | Articulated arm delivery system |
| Aiming Beam | Class I (red helium neon) |
| Thermal Control | Internal closed loop water-air heat exchanger circuit |
Note on "Acceptance Criteria": The acceptance criteria for a 510(k) submission are generally met if the device demonstrates it is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness data. The table above reflects the shared technical characteristics that support this equivalence, rather than specific performance metrics (e.g., sensitivity/specificity) against a diagnostic ground truth.
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical trial or test set for evaluating diagnostic performance. The substantial equivalence argument relies on comparing technical specifications and intended uses with existing devices.
- Data Provenance: Not applicable. No specific data (e.g., images, patient records) are described as being used in a test set.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not applicable. No ground truth establishment by experts for a test set is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. This type of study is typically performed for diagnostic devices or AI algorithms that assist human readers. The Umeco OPTIMA 694 is a therapeutic laser system.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done?: No. The Umeco OPTIMA 694 is a physical laser system, not an algorithm. Its performance is evaluated through its physical characteristics and safety, not through standalone algorithmic testing.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of diagnostic "ground truth." For a therapeutic device like this laser, "ground truth" might loosely refer to the expected physiological response or the efficacy of tattoo/lesion removal, but this document does not detail studies establishing such "ground truth" for comparative effectiveness in a quantitative manner. The premise is that Ruby lasers at 694nm with similar pulse parameters are effective for the stated indications.
8. Sample Size for Training Set
- Sample Size: Not applicable. This is not an AI algorithm requiring a training set.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment: Not applicable. No training set is involved.
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982113
ದ್ದಾರೆ ರಾಜ
510k summary: Umeco OPTIMA 694 Ruby Laser System
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510k summary
Submitter's name: lain D. Miller, Ph.D. Medical Laser Solutions LLC 65 School Street Charlestown, MA 02129 on behalf of : Umeco Corporation 501/5F Chungang Apt. Plant # 278-51 Sungsoo 2-ga-1-dong Sungdong-ku Scoul, Korea 133-120 Dovice Trade Name: Umeco OPTIMA 694 Ruby Laser System Common Name: Dermatology Laser Classification Name: Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology
Device Class:
· ··· class II
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Summary of Safety and Effectiveness Data Appendix E .
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General Information and Description
The Umeco OPTIMA 694 system is based on an optical cavity containing a Ruby laser rod. which is activated by means of the use of flashlamps. After the cavity, a red helium neon aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode.
The System is capable of emitting up to 2.2 Joules of light at 694 nm, with a nomimal pulsewidth of 20 nanoseconds. The laser is intended to be used for intended for the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery.
The Ruby laser system is designed with 3 major sub-systems:
- a) An articulated arm delivery system terminated in a focusing handpiece.
- b) An electronic power supply and interface circuitry.
- c} An optical chamber containing laser rod and laser cavity optics.
No accessories are available for use with the OPTIMA 694 ruby laser system.
Summary of Substantial Equivalence
Umeco believes that its OPTIMA 694 Ruby laser is substantially equivalent to the Derma-Lase DLR-1 and Spectrum RD 1200 Ruby laser systems.
The Derma-Lase DLR-1 and Spectrum RD 1200 Ruby laser systems are both intended for the removal of blue/black tattoos and benign pigmented lesions. They therefore have the same Intended Use as the its OPTIMA 694 Ruby laser system.
All three lasers emit at a wavelength of 694nm, a wavelength which is highly absorbed in the ink comprising blue/black tattoos and in the naturally occurring melaning comprising benign pigmented. All three lasers are therefore absorbed in an equally small volume of tissue, allowing for very precise action on the target tissue components.
All three lasers have a nominal pulsewidth in the range 20-30 nanoseconds and therefore realize similar peak power with minimal thermal conduction during the pulse.
All three lasers offer a range of available spotsizes with diameter in the range 4 - 8 mm.
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All three lasers utilize an articulated arm delivery system for maximum flexibility and reliability. Both lasers utilize class I aiming beams which pose no hazard to the user.
.
All three systems utilize an internal closed loop water-air hear exchanger circuit for optimal thermal control of the laser cavity.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing hair or water. The overall design is simple and symbolic, representing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Umeco Incorporated c/o Iain D. Miller, Ph.D. President Medical Laser Solutions LLC 65 School Street Charlestown, MA 02129
Re: K982113 Trade Name: Umeco OPTIMA 694 Ruby Laser System Regulatory Class: II Product Code: GEX August 25, 1998 Dated: Received: August 31, 1998
Dear Dr. Miller:
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 The general controls provisions of the Act 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. ದ 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 - Iain D. Miller, Ph.D.
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,
C. Celia M. Whitten, Ph.D., M.D.
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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Appendix l
510(k) Number (if known): K98 2113
Device Name: Umeco OPTIMA 694
Indications for Use:
.
The Umeco OPTIMA 694 system is intended for the use in the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K982113 |
| 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.