(51 days)
Not Found
No
The summary describes a laser device for soft tissue procedures and teeth whitening, focusing on its hardware components and intended uses. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation.
Yes
The device is used for a variety of medical procedures, including incision, excision, vaporization, and coagulation of oral soft tissues, as well as laser periodontal procedures and teeth whitening. These applications indicate a therapeutic purpose.
No
The device is described as being used for surgical, non-surgical, and teeth whitening procedures on oral soft tissues, focusing on treatment rather than diagnosis.
No
The device description explicitly states that the Picasso line of lasers employs semiconductor diodes as a laser energy source and delivers energy via a fiber optic cable and handpiece, indicating it is a hardware device.
Based on the provided information, the Picasso Plus / Picasso Lite Plus device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical and non-surgical procedures performed directly on oral soft tissues and teeth. This involves physical interaction with the patient's body.
- Device Description: The device description details a laser system that delivers energy to the operating area via a fiber and handpiece. This is a therapeutic and surgical device, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to perform procedures on the patient.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Picasso Plus / Picasso Lite Plus does not fit this description.
N/A
Intended Use / Indications for Use
The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional biopsies; Exposure of unerupted teeth; Fibroma removal; Frenectomy and frenotomy; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; and Vestibuloplasty.
Laser Periodontal Procedures, including: Sulcular debridement (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening.
Product codes
GEX
Device Description
The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures. Picasso Plus and Picasso Lite Plus lasers employ semiconductor diodes as a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The laser delivery used may be in the form of strippable fiber or a multi-tip handpiece that is used in conjunction with disposable tips. The device is activated by means of a wireless footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, periodontal pocket
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Picasso Plus and Picasso Lite Plus devices have the same intended use and operating principles, with similar design features, and functional and performance characteristics as the previously-cleared devices. The devices are designed to comply with relevant federal and international safety and performance standards. Conformance to these standards, coupled with no changes in the Indications for Use and no change in the fundamental scientific technology demonstrates substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Amd Group LLC Scott Edwards Director, Quality Assurance And Regulatory Affairs 7405 Westfield Blvd. Indianapolis, Indiana 46240
Re: K152939
Trade/Device Name: Picasso Plus, Picasso Lite Plus 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: October 2, 2015 Received: October 5, 2015
Dear Scott Edwards:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number ( if known ) | K152939 |
| Device Name | Picasso Plus and Picasso Lite Plus |
| Indications for Use (Describe) | The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional biopsies; Exposure of unerupted teeth; Fibroma removal; Frenectomy and frenotomy; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; and Vestibuloplasty.
Laser Periodontal Procedures, including: Sulcular debridement (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening. |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 11 | PSC Publishing Services (301) 443-6740 |
|---|---|---|
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510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, 510(k) summary is provided.
DATE: November 23, 2015
SUBMITTER -
AMD GROUP LLC dba AMD LASERS 7405 Westfield Blvd Indianapolis, IN 46240 USA
Phone: 866-999-2635 Fax: 678-868-4108
Contact Person: Scott A. Edwards Date Prepared: November 9, 2015
II. OFFICIAL CORRESPONDENCE/CONTACT PERSON
Scott A. Edwards Director of QA/RA AMD GROUP LLC Phone: 866-999-2635 x900 e-mail: scott@amdlasers.com
III. 510(K) PREPARER
Scott A. Edwards Director of QA/RA AMD GROUP LLC Phone: 866-999-2635 x900 e-mail: scott@amdlasers.com
IV. DEVICE
Brand Name of Device: Picasso Plus and Picasso Lite Plus Common or Usual Name: Laser Instrument, Surgical, Powered Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21CFR 878.4810) Regulatory Class: II Product Code: GEX 510(k) Number: K152939
Confidential and Proprietary Copyright © 2015 AMD GROUP LLC
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V. PREDICATE DEVICE
Device Trade Name: Picasso and Picasso Lite Device Company: AMD LASERS 510(k) Numbers: K083142 andK102359
VI. DEVICE DESCRIPTION
The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures. Picasso Plus and Picasso Lite Plus lasers employ semiconductor diodes as a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The laser delivery used may be in the form of strippable fiber or a multi-tip handpiece that is used in conjunction with disposable tips. The device is activated by means of a wireless footswitch.
INDICATIONS FOR USE VII.
The Picasso Plus /Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
- 0 Gingival troughing for crown impression
- Gingivectomy
- Gingivoplasty O
- Gingival incision and excision 0
- Hemostasis and coagulation 0
- Excisional and incisional biopsies 0
- 0 Exposure of unerupted teeth
- Fibroma removal 0
- 0 Frenectomy and frenotomy
- O Implant recovery
- O Incision and drainage of abscess
- Leukoplakia 0
- Operculectomy 0
- Oral papillectomies 0
- Pulpotomy O
- O Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy 0
- Soft tissue crown lengthening 0
- Treatment of canker sores, herpetic and aphthous ulcers of the oral 0 mucosa
- Vestibuloplasty
Confidential and Proprietary Copyright © 2015 AMD GROUP LLC
5
Laser Periodontal Procedures, including:
- Sulcular debridement (curettage, removal of diseased, infected, inflamed 0 and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Removal of highly inflamed edematous tissue affected by bacteria O penetration of the pocket lining and junctional epithelium
- 0 Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Teeth Whitening Indications (Picasso Plus Only):
- Laser assisted whitening of teeth 0
- Light activation for whitening materials for teeth whitening 0
VIII. SUBSTANTIAL EQUIVALENCE
K083142: Picasso
K102359: Picasso and Picasso Lite
IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE
The Picasso Plus and Picasso Lite Plus devices have the same intended use and operating principles, with similar design features, and functional and performance characteristics as the previously-cleared devices. The devices are designed to comply with relevant federal and international safety and performance standards. Conformance to these standards, coupled with no changes in the Indications for Use and no change in the fundamental scientific technology demonstrates substantial equivalence to the predicate devices.
6
X. SUMMARY OF SIMILARITIES AND DIFFERENCES
The intended use and indications for use of the proposed Picasso Plus and Picasso Lite Plus devices are unchanged from the legally marketed predicate devices Picasso and Picasso Lite. The fundamental scientific technology of the proposed devices is unchanged from the legally marketed predicate device. The design changes implemented in the Picasso Plus and Picasso Lite Plus were aimed at improving functionality and enhancing user experience. The predicate devices and submitted devices share similar design features including identical wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and operation. The devices share similar performance specifications including power output and energy type.
XI. CONCLUSIONS
The Picasso Plus and Picasso Lite Plus lasers are substantially equivalent to the listed predicate devices (Picasso and Picasso Lite lasers) without raising any new issues of safety or effectiveness. The new devices have the same intended use and operating principles, with similar design features, and functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.