(72 days)
Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Ruby (694nm)
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are
- Lentigines
- café-au-lait-blotches
- Ephalides
- Benign Naevi such as:
- Naevus of Ota
- Naevus of Ito
- Epidermal Naevi
- Congenital Naevi
- Beckers Naevi
- Blue Nevus
- Naevus Spillus
- Mongolian Spot
The device includes a Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
Here's an analysis of the provided text regarding the Quanta System Q-Plus T device based on your request:
Acceptance Criteria and Study for Quanta System Q-Plus T (K073549)
The provided submission for the Quanta System Q-Plus T is a 510(k) premarket notification. This type of submission establishes "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated clinical study with defined performance metrics in the same way a PMA (Premarket Approval) might require.
Therefore, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, and that any minor technological differences raise no new issues of safety or effectiveness.
The "study" that proves the device meets these criteria is the submission itself, which primarily focuses on a comparison to predicate devices and an assessment of the device's technical specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (As per 510(k) Substantial Equivalence) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Intended Uses / Indications for Use (Nd:YAG 1064nm & 532nm):- Treatment of vascular lesions- Pigmented lesions removal- Hair removal- Tattoo removal- Incision, excision, ablation, vaporization of soft tissue for general dermatology | Q-Plus T Q-Switched laser is intended for:- Treatment of vascular lesions- Pigmented lesions removal- Hair removal- Tattoo removal- Incision, excision, ablation, vaporization of soft tissue for general dermatology(Matches predicate's intended uses) |
| Intended Uses / Indications for Use (Ruby 694nm):- Cutting, vaporization, ablation of soft tissue- Removal of tattoos- Removal of benign pigment lesions (e.g., Lentigines, café-au-lait-blotches, Ephalides, various benign Naevi) | Q-Plus T Q-Switched laser is intended for:- Cutting, vaporization, ablation of soft tissue- Removal of tattoos- Removal of benign pigment lesions (e.g., Lentigines, café-au-lait-blotches, Ephalides, various benign Naevi)(Matches predicate's intended uses) |
| Technological Characteristics:- Q-Switched Nd:YAG laser source (1064nm, 532nm)- Q-Switched Ruby laser source (694nm)- Specific energy outputs (e.g., 1000mJ max at 1064nm, 500mJ max at 532nm, 1000mJ max at 694nm)- Optical delivery system (articulated arm)- Power supply, cooling system, microprocessor controller, safety features | Q-Plus T includes:- Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064nm and 500mJ max energy at 532nm.- Q-Switched Ruby laser source with 1000mJ max energy at 694nm.- Optical delivery system for the three wavelengths is the articulated arm.- Includes power supply, cooling system, optical delivery system, microprocessor based controller, and safety features.(Technological characteristics are described and presented as similar to predicate, with specific energy outputs stated.) |
| Principles of Operation:- Q-Switched laser operation for specific wavelengths | Q-Plus T:- Operates as a Q-Switched laser system with Nd:YAG and Ruby sources.(Principles of operation are implicitly similar to predicate based on technology and intended use.) |
| Safety and Effectiveness:- No new issues of safety or effectiveness raised by technological differences. | Conclusion:- "The Quanta System Q-Plus-T is as safe and effective as the predicate devices."- "The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness."(This is the ultimate conclusion based on the comparison.) |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission, and the provided text does not describe a clinical study with a "test set" in the traditional sense for the new device's performance. The substantial equivalence argument relies on comparing the device's technical specifications and intended uses to established predicate devices that have prior market clearance. Therefore, there is no specific sample size or data provenance of a test set for this type of submission as the primary evidence is a comparison to predicates and technical documentation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As there was no traditional test set with human assessments requiring ground truth establishment, this information is not provided.
4. Adjudication Method for the Test Set
Not applicable. No such clinical test set or adjudication process is described in the provided text for the new device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not mention any MRMC comparative effectiveness study or an effect size for human readers improving with or without AI assistance. This device is a laser surgical instrument, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical laser device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices as previously cleared by the FDA and the technical specifications of the new device demonstrating its similarity to these predicates. There is no external, independent ground truth (like pathology or outcomes data) that directly evaluates the Quanta System Q-Plus T's performance in a de novo manner within this submission.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm.
{0}------------------------------------------------
510(k) SUMMARY Quanta System Q-Plus T
| Submitter: | Quanta System SpAvia IV Novembre,11621058 SolbiateOlona VA / Italy |
|---|---|
| Contact: | Dr. Isabella CarrerMedical Division Manager |
| Date Prepared: | June 28, 2007 |
| Device Trade Name: | Quanta System Q-Plus T |
| Common Name: | Laser surgical instrument for use in general surgery anddermatology |
| Classification Name: | Instrument, surgical, powered, laser |
| Predicate Devices: | - Cynosure, Inc Affinity QS Q-Switched Nd:YAGLaser System (K050382);- ASCLEPION LASER TECHNOLOGIES GmbHTattooStar R (K060787 ) |
| Intended Use /Indications for Use: | Nd:YAG (1064nm) and (532nm)The Q-Plus T Q-Switched laser is intended fortreatment of vascular lesions, pigmented lesions, andfor hair, tattoo removal and the incision, excision,ablation, vaporization of soft tissue for generaldermatology. |
| Ruby (694nm) | |
| The Q-Plus T Q-Switched laser is intended for use forcutting, vaporization and ablation of soft tissue and theremoval of tattoos and benign pigment lesion. | |
| Some examples of pigment lesions are | |
| Lentiginescafé-au-lait-blotches |
Title:
{1}------------------------------------------------
- 트 Ephalides
- Benign Naevi such as: 트
- Naevus of Ota .
- Naevus of Ito 8
- l Epidermal Naevi
- 포 Congenital Naevi
- l Beckers Naevi
- I Blue Nevus
- l Naevus Spillus
- I Mongolian Spot
Technological The device includes a Q-Switched Nd:YAG laser source Characteristics: with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece. None Performance Data
The Quanta System O-Plus-T is as safe and effective as Substantial the predicate devices. The Q-Plus T has the same Equivalence: intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness. Thus, the Q-Plus T is substantially equivalent.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with a human figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The image is simple and clean, with a focus on the department's emblem and name.
Food and Drug Administration 9200 Corporate Boulevard FEB 2 8 2008 Rockville MD 20850
Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
Re: K073549 Trade/Device Name: Q-Plus T 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: February 18, 2008 Received: February 19, 2008
Dear Mr. Job:
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. Ilsting 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
{3}------------------------------------------------
Page 2 - Mr. Mark Job
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 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), 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 Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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 Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number (if known):
Q-Plus T Device Name:
Indications for Use:
Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Ruby (694nm)
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are
- 트 Lentigines
- café-au-lait-blotches 에
- Ephalides 트
- l Benign Naevi such as:
- Naevus of Ota 트
- Naevus of Ito ■
- l Epidermal Naevi
- . Congenital Naevi
- Beckers Naevi 트
- 트 Blue Nevus
- Naevus Spillus I
- I Mongolian Spot
Prescription Use __X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
Mark A. Millman
(PLEASE DO NOT WRITE BELOW THIS LINE --IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (C
510(k) Number K0739
§ 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.