(281 days)
The NeoLas Er: Y A G laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry for:
Endodontic Surgery (Root Amputation) Indications:
· Root end preparation for retrofill amalgam or composite
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex.
NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
Laser Periodontal Procedures:
- · Full thickness flap
- · Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
· Removal of granulation tissue from bony defects
· Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures:
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Flap preparation-incision of soft tissue to prepare a flap and expose the bone.
- · Flap preparation-incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- · Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
NeoLas is a portable, microprocessor controlled dual laser system with both ER: Y AG and Soft Tissue capabilities. The NeoLas provides treatment capabilities via two separate fiber jumper and handpiece assemblies; NeoLas1 (ER:YAG) and NeoLas2 (Soft Tissue).The NeoLas1 treatment delivery system emits a 2.94um infrared photon pulses that used in the treatment of various endodonic and soft tissue indications. The NeoLas2 treatment delivery system utilizes solid-state diode laser (GaAlAs) technology to emit constant wavelength and pulsed energy of 808nm to perform soft tissue treatments.
The provided document is a 510(k) summary for the NeoLas laser system. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria from scratch. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and ground truth for a new clinical study is not explicitly present in this type of submission.
However, I can extract the information that is available and explain why some of the requested details are not in this document.
Summary of Acceptance Criteria and Performance (Based on Substantial Equivalence):
The core "acceptance criteria" here are that the NeoLas device demonstrates substantial equivalence in safety and effectiveness to its predicate devices for the stated indications for use. This is proven by showing that the NeoLas has similar specifications and treatment capabilities, and that any differences do not raise new safety or efficacy concerns.
| Acceptance Criteria Category | Reported NeoLas Performance (Relative to Predicate) |
|---|---|
| ER:YAG Laser Subsystem (NeoLas1) | Similar specifications and treatment capabilities to AdvErL Evo Er:YAG Laser (MEY-1-A) (K120377). |
| Differences/Mitigation | Acknowledged difference in average output power; NeoLas has omitted indications requiring higher output power, thereby mitigating potential safety/efficacy concerns. |
| Soft Tissue Laser Subsystem (NeoLas2) | No differences in specifications or intended use compared to Picasso Lite (K102359). |
| Sterilization (Disposable Tips) | Validated for Ethylene Oxide Sterilization, confirming effectiveness of biological indicators and revalidation testing. Complies with residual EO and ECH levels. |
| Sterilization (Handpiece Ends) | Validated for sterilization by autoclaving consistent with FDA guidance. |
Detailed Breakdown of Requested Information:
-
A table of acceptance criteria and the reported device performance
See table above. The acceptance criteria are largely implied by the concept of substantial equivalence to the predicate devices. Performance is described in terms of its similarity to these legally marketed devices. -
Sample sizes 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 applicable in the context of a 510(k) summary focused on substantial equivalence. This document does not describe a clinical study with a "test set" of patients in the way a de novo or PMA submission might. The "test set" implicitly refers to the device itself and its components undergoing non-clinical bench testing.
- Data Provenance: Not specified as no clinical data from a patient cohort is presented. The data provenance mentioned is primarily from manufacturing and validation testing (e.g., sterilization validation).
-
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)
- Number of Experts/Qualifications: Not applicable. Since this is a 510(k) submission based on substantial equivalence and primarily non-clinical testing, there is no mention of external clinical experts establishing ground truth for a patient test set. The "ground truth" for the non-clinical tests would be defined by the relevant engineering and sterilization standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this 510(k) summary.
-
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
- MRMC Study: Not applicable. The NeoLas is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study is not relevant to its type of submission.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. The NeoLas is a surgical instrument operated by a human, not an algorithm. Its "performance" is assessed through its physical specifications, safety features, and the demonstrated capabilities of its predicate devices, rather than an algorithm's standalone performance. Non-clinical bench tests (e.g., sterilization) are done in a "standalone" manner for the components.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the non-clinical tests (e.g., sterilization), the ground truth is established by validated laboratory methods and recognized consensus standards (e.g., ISO standards for sterilization, FDA guidance documents). For the device's main claim, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the NeoLas is sufficiently similar. The Note section under Indications for Use emphasizes that any removed tissue must be submitted for histopathological evaluation, which would serve as a ground truth for pathology diagnosis if such tissue is removed.
-
The sample size for the training set
- Training Set Sample Size: Not applicable. This document does not describe a machine learning algorithm that requires a training set.
-
How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
In summary, this 510(k) submission for the NeoLas laser system primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices through comparison of specifications, intended use, and non-clinical bench testing (e.g., sterilization validation). It does not present a de novo clinical study with patient cohorts, expert readers, or AI algorithms, which are typically associated with many of the detailed questions posed.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2015
Sheaumann Laser, Inc Katina Sousa Ouality Systems Administrator 45 Bartlett Street Marlborough, Massachusetts 01752
Re: K150664 Trade/Device Name: Neolas 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: November 12, 2015 Received: November 13, 2015
Dear Katina Sousa:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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,
Binita S.Ashar -S
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
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Indications for Use
510(k) Number (if known)
Device Name NeoLas
Indications for Use (Describe)
The NeoLas Er: Y A G laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry for:
Endodontic Surgery (Root Amputation) Indications:
· Root end preparation for retrofill amalgam or composite
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex.
NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
Laser Periodontal Procedures:
- · Full thickness flap
- · Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
· Removal of granulation tissue from bony defects
· Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures:
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Flap preparation-incision of soft tissue to prepare a flap and expose the bone.
- · Flap preparation-incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- · Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
FORM FDA 3881 (8/14)
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- · Implant recovery
- · Incision and drainage of abscesses
- · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- · Leukoplakia
- · Operculectomy
- · Oral papillectomies
- · Pulpotomy
- · Pulp extirpation
- · Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex
- · Root canal debridement and cleaning
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcer of the oral mucosa
- · Vestibuloplasty
NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
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)
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SHEAUMANN
510(k) Summary
| 510(k) Owner: | Sheaumann Laser, Inc.45 Bartlett StreetMarlborough, MA 01752Phone: 508-970-0600Fax: 508-481-9261 |
|---|---|
| Contact: | Katina SousaQuality Systems AdministratorSheaumann Laser, Inc.45 Bartlett StreetMarlborough, MA 01752Phone: 508-970-0600Fax: 508-491-9261Email: ksousa@sheaumann.com |
| Manufacturer: | Sheaumann Laser, Inc. |
| Date Prepared: | March 12, 2015 |
| Trade Name: | NeoLas |
| Common Name: | ER-1 |
| Product Code(s): | GEX |
| Classification: | Class II |
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Predicate Devices (Claiming Substantial Equivalence):
MEY-1-A K120377
Picasso Lite K102359
Summary Description of Device:
NeoLas is a portable, microprocessor controlled dual laser system with both ER: Y AG and Soft Tissue capabilities. The NeoLas provides treatment capabilities via two separate fiber jumper and handpiece assemblies; NeoLas1 (ER:YAG) and NeoLas2 (Soft Tissue).The NeoLas1 treatment delivery system emits a 2.94um infrared photon pulses that used in the treatment of various endodonic and soft tissue indications. The NeoLas2 treatment delivery system utilizes solid-state diode laser (GaAlAs) technology to emit constant wavelength and pulsed energy of 808nm to perform soft tissue treatments.
Intended Use/Indications for Use:
The NeoLas ER:YAG laser and its accessories are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
Endodontic Surgery (Root Amputation) Indications:
- · Root end preparation for retrofill amalgam or composite
- · Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex
NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
Laser Periodontal Procedures:
- Full thickness flap
- Partial thickness flap
- Split thickness flap
- · Laser soft tissue curettage
{6}------------------------------------------------
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
- · Removal of granulation tissue from bony defects
• Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures:
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including:
- Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- · Flap preparation-incision of soft tissue to prepare a flap and expose the bone.
- · Flap preparation-incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Implant recovery
- Incision and drainage of abscesses
• Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
{7}------------------------------------------------
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex
- Root canal debridement and cleaning
- Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcer of the oral mucosa
- Vestibuloplasty
NOTE: Any tissue growth (i.e. cyst. neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
Performance Standards:
This device is manufactured to comply with the performance standards promulgated by the FDA for products of this type and to the recognized consensus and safety standards listed below.
21 CFR 820; Ouality Systems Regulations
21 CFR 1010.1-.5; Performance Standards for Electronic Products, General
21 CFR 1010.10; Performance Standards for Light-emitting Products, Laser Products
21 CFR 1040.11a; Performance Standards for Light-emitting Products, Medical Products
IEC 60601-1-2 Edition 3: 2007-03 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC))
IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. (Radiology)
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Substantial Equivalence Summary:
Few differences exist between the NeoLas and the predicate devices, AdvErL Evo Er:YAG Laser (MEY-1-A) (K120377) and Picasso Lite (K120359) as each of the NeoLas subsystems (NeoLas 1 and NeoLas 2) reflect similar specifications and treatment capabilities as their respective predicate comparisons. Additionally, the NeoLas and the predicate devices are GUI microprocessor controlled systems that deliver energy via reusable, flexible fiber-jumper assemblies and disposable tips.
The NeoLas1 ER:YAG laser subsystem and the AdvErL Evo Er:YAG Laser (MEY-1-A) are both ER:YAG 2.94um laser systems that reflect similar indications for use and specifications. Although there is a difference between the average output power of the AdvErL Evo Er:YAG Laser (MEY-1-A) and the NeoLas1 ER:YAG, Sheaumann Laser, Inc. believes that this difference in performance does not raise any safety or efficacy concerns as the NeoLas has omitted the indications listed for the AdvErL Evo Er:YAG Laser (MEY-1-A) that require a higher output power from the statement of intended use. As the NeoLas 1 ER:YAG subsystem reflects few differences in treatment capabilities, Sheaumann Laser, Inc. believes there are no issues of safety or effectiveness that were not identified in the predicate device.
Furthermore, the NeoLas2 solid-state laser diode 810nm subsystem reflects no differences from the predicate device (Picasso Lite). As there are no differences between the two units in either the specifications or intended use, Sheaumann Laser, Inc. believes there are no issues of safety or effectiveness that were not identified in the predicate device.
Nonclinical Tests:
The disposable tips are provided sterile and have undergone testing for the Ethylene Oxide Sterilization chamber validation, process validation, verification of the effectiveness of biological indicators and revalidation testing to comply with sterilization requirements. Additionally, the disposable tips have been tested to validate the residual levels of EO and ECH in compliance with the recognized standards for the sterilization of healthcare products. The detachable fiber handpiece ends have been validated for sterilization by autoclaving consistent with the defined parameters in the FDA guidance document Reprocessing Medical Devices in Health Care Settings.
§ 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.