(247 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the laser technology and its intended surgical uses.
Yes
The device is intended for various surgical procedures, including incision, excision, coagulation, and vaporization of soft tissue, which are therapeutic actions aimed at treating conditions or restoring function.
No
The device description and intended use/indications for use specify surgical procedures like incision, excision, coagulation, and vaporization of soft tissue, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "pulsed and cw diode laser emitting a wavelength of 980 nm" and uses a "contact fiber optical delivery system," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on soft tissue within and outside the mouth. This involves physical interaction with the patient's body for treatment and modification of tissue.
- Device Description: The device is a laser system designed for ablating, excising, and coagulating tissue using a fiber optic delivery system. This is a therapeutic and surgical function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue samples) or providing information about a patient's health status based on in vitro testing. IVDs are designed to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions. Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted / Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Product codes
GEX
Device Description
The Orion laser system is a pulsed and cw diode laser emitting a wavelength of 980 nm, that is intended for ablating, excising and coagulation of intraoral soft tissue using a contact fiber optical delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
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
JUL 2 7 2012
10(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH Orion
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH Orion laser system is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
Applicant:
ASCLEPION LASER TECHNOLOGIES GmbH Bruesseler Str. 10 07747 Jena, Germany
Contact Person:
Mrs. Antje Katzer Product Management and International Regulatory Affairs
Phone: Fax: e-mail:
Preparation Date:
November 18th, 2011
Orion
Orion
+49 3641 77 00 309
+49 3641 77 00 302
Device Name:
Common Name:
Classification Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology 79-GEX 21 CFR 878.4810
Equivalent Device: GENTLEray 980 K072262
Device Description:
The Orion laser system is a pulsed and cw diode laser emitting a wavelength of 980 nm, that is intended for ablating, excising and coagulation of intraoral soft tissue using a contact fiber optical delivery system.
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K113 489
4/1
2/2
intended Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions. Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted / Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Comparison to:
The Orion is substantially equivalent to the GENTLEray 980 Laser System K072262 with the same principles of operation, with the same parameters and with the same indications for use.
Nonclinical Performance Data: None
Clinical Performance Data:
None
Conclusion:
The Orion is as safe and effective as the predicate device and is substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and appears to be part of a document or header. The words are capitalized and evenly spaced.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Asclepion Laser Technologies, GMBH % Mrs. Antie Katzer Product Management & International Regulatory Affairs Bruesseler Street 10 Jena, Germany 07747
Re: K113489
Trade/Device Name: Orion 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 06, 2012 Received: June 08, 2012
Dear Mrs. Katzer:
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
JUL 2 7 2012
3
Page 2- Mrs. Antje Katzer
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,
Erine Keith
For Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number: K113489
Device Name: Orion
Indications for Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectorny, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted / Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Neil R. Oden for mkm
(Division Sign-Off)
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K113489 510(k) Number_
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)