(92 days)
The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
The Polaris Long Pulse and Q-Switched Ruby Laser and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Energy is delivered using an articulated arm with interchangeable handpieces to adjust spot size. The wavelength is 694.3nm. The user activates laser by means of a footswitch.
The provided text describes a 510(k) summary for the Polaris Long Pulse and Q-Switched Ruby Laser, which is a medical device. For this type of device, the acceptance criteria and study designs are fundamentally different from those for AI/ML-based diagnostic devices. In the context of a 510(k) submission for a physical medical device, "acceptance criteria" typically refers to demonstrating substantial equivalence to a predicate device, based on technical specifications and intended use, rather than performance metrics like sensitivity, specificity, or F1 score derived from a clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are not reported as statistical performance metrics. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device, the LaseAway Long Pulse and Q-Switched Ruby Laser (K971193). The "reported device performance" is a comparison of technical specifications.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance (Polaris) | Predicate Device Performance (LaseAway) |
|---|---|---|
| Indications for Use: | Remove blue/black tattoos, benign dermal and epidermal pigmented lesions, and hair removal for skin types 1-4. | Remove blue/black tattoos, benign dermal and epidermal pigmented lesions, and hair removal for skin types 1-4. |
| Technical Specifications: | (See detailed table below) | (See detailed table below) |
| Laser Type | Pulsed Ruby (Single lamp) | Pulsed Ruby (Single lamp) |
| Size | H840 mm x W495 mm x D680 mm | H840 mm x W495 mm x D680 mm |
| Weight | 125Kg | 125Kg |
| Power Requirement | 110V/220V 50/60 Hz (16A peak) | 110V/220V 50/60 Hz (16A peak) |
| Cooling | Self contained refrigerated chiller | Self contained refrigerated chiller |
| Cooling Medium | De-ionised water | De-ionised water |
| Wavelength | 694.3nm | 694.3nm |
| Aiming Beam, HeNe | 633nm | 633nm |
| Repetition Rate | 1Hz | 1Hz |
| Pulse Duration, Q-Switched | 25 ns | 25 ns |
| Pulse Duration, Long Pulse | 2ms | 2ms |
| Maximum Energy Q-Switched | 1.25 joules | 1.25 joules |
| Maximum Energy, Long Pulse | 5 joules | 5 joules |
| Spot Size, Q-Switched | Selectable from 4, 5 and 6mm | Selectable from 4, 5 and 6mm |
| Spot Size, Long Pulse | Selectable from 5. 6 and 7mm | Selectable from 5. 6 and 7mm |
| Beam Delivery | Articulated arm and focusing handpiece | Articulated arm and focusing handpiece |
| Ambient Conditions | 15° to 26°C, 10 to 80% humidity | 15° to 26°C, 10 to 80% humidity |
The conclusion states: "The Polaris Long Pulse and Q-Switched Ruby Laser is identical to the predicate device in terms of indications for use, technical specifications, operating performance features, general design." This statement acts as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.
2. Sample Size Used for the Test Set and Data Provenance
The provided document explicitly states:
- "Performance Data: None"
- "Results of Clinical Study: None"
Therefore, there was no test set or clinical data used in this 510(k) submission to demonstrate performance in the way one would for an AI/ML device. The basis for clearance was a comparison of technical specifications and intended use to a legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical study or performance data was used, no ground truth was established by experts for a test set. This type of device relies on established safety and efficacy of the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring ground truth adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a laser system, not an AI/ML diagnostic interpretation tool, and no MRMC study was conducted or required for this 510(k) submission.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device (laser system), not an algorithm.
7. Type of Ground Truth Used
Not applicable, as no clinical performance data requiring ground truth was submitted or used. The "ground truth" for this 510(k) is effectively the established safety and effectiveness profile of the predicate device, demonstrated through the "substantial equivalence" framework.
8. Sample Size for the Training Set
Not applicable. No training set was used as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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K 12.1162
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Attachment 5 510(K) Summary Polaris Long Pulse and Q-Switched Ruby Laser
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This 510(K) Summary of safety and effectiveness for Polaris Long Pulse and Q-Switched Ruby Laseris submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) sümmary.
| Applicant: | Sandstone Medical Technologies, LLC | JUL 18 2012 |
|---|---|---|
| Address: | 105 Citation CourtBirmingham, AL 35209 | |
| Contact Person: | Mark Rohrer | |
| Telephone: | 205-290-8251 - phone | |
| Email: | ssmed@bellsouth.net | |
| Preparation Date: | March 30, 2012 | |
| Device Trade Name: | Polaris Long Pulse and Q-Switched Ruby Laser | |
| Common Name: | Long Pulse and Q-Switch Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 | |
| Legally MarketedPredicate Device: | LaseAway Long Pulse and Q-Switched Ruby Laser (K)971193 | |
| Description of the PolarisLong Pulse and Q-Switched Ruby Laser | The Polaris Long Pulse and Q-Switched Ruby Laserand controls are contained in a single console. Electrical poweris supplied to the console by the facility's power source. Energyis delivered using an articulated arm with interchangeablehandpieces to adjust spot size. The wavelength is 694.3nm.The user activates laser by means of a footswitch. | |
| Intended use: | The Polaris Long Pulse and Q-Switch Ruby Laser is intendedto remove blue/black tattoos and benign dermal and epidermalpigmented lesions, and, to effect hair removal of patients withskin types 1-4 through selective targeting of melanin in hairfollicles in dermatology and plastic surgery | |
| Performance Data: | None | |
| Results of Clinical Study: | None | |
| Conclusion: | The Polaris Long Pulse and Q-Switched Ruby Laseris identical to the predicate device in terms of indications foruse, technical specifications, operating performance features,general design. |
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Attachment 5 510(K) Summary Polaris Long Pulse and Q-Switched Ruby Laser
Technical Specifications Comparison
| Polaris Long Pulse and Q-Switched Ruby Laser | LaseAway Q-Switch Ruby(Predicate Device) | |
|---|---|---|
| Laser | Pulsed Ruby (Single lamp) | Pulsed Ruby (Single lamp) |
| Size | H840 mm x W495 mm x D680mm | H840 mm x W495 mm x D680mm |
| Weight | 125Kg | 125Kg |
| Power requirement | 110V/220V 50/60 Hz (16A peak) | 110V/220V 50/60 Hz (16A peak) |
| Cooling | Self contained refrigeratedchiller | Self contained refrigeratedchiller |
| Cooling medium | De-ionised water | De-ionised water |
| Wavelength | 694.3nm | 694.3nm |
| Aiming beam, HeNe | 633nm | 633nm |
| Repetition rate | 1Hz | 1Hz |
| Pulse duration, Q-Switched | 25 ns | 25 ns |
| Pulse duration, LongPulse | 2ms | 2ms |
| Maximum energy Q-Switched | 1.25 joules | 1.25 joules |
| Maximum energy, LongPulse | 5 joules | 5 joules |
| Spot size, Q-Switched | Selectable from 4, 5 and 6mm | Selectable from 4, 5 and 6mm |
| Spot Size, Long Pulse | Selectable from 5. 6 and 7mm | Selectable from 5. 6 and 7mm |
| Beam delivery | Articulated arm and focusinghandpiece | Articulated arm and focusinghandpiece |
| Ambient conditions | 15° to 26°C, 10 to 80% humidity | 15° to 26°C, 10 to 80% humidity |
: ・
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Homewood, Alabama 35209
JUL 18 2012
Re: K121162
Trade/Device Name: Polaris Long Pulse and Q-Switched Ruby Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II
Product Code: GEX Dated: June 30, 2012 Received: July 06, 2012
Dear Mr. Rohrer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. Mark Rohrer
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunice Keith
S Mark N. Melkerson Director. Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K121162 510(k) Number (if known): ____
Device Name: Polaris Long Pulse and Q-Switched Ruby Laser
The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
Prescription Use XX (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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Order for mxm
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121162
§ 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.