(15 days)
The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in any surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE XL is indicated for use in skin resurfacing. The BURANE XL is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic and Aesthetic Surgery, Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin and subcutaneous tissue is encountered. Indications include excision of external tumors and lesions, complete or partial tissue dissection, excision of external tumors and lesions, tissue ablation and/or vessel coagulation.
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
BURANE XL is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The triple mode technology makes BURANE for aesthetic ideal applications. The Coagulation Mode for different AL an export dother the Ablation Mode for classical ablation procedures, and the combination of both techniques. Furthermore, the laser system enables a quick, precise ablation with minimal thermal tissue damage. Thus an optimal wound health process is achieved. -- the risk of scar formation is minimized. This is due to the BURANE XL's wavelength of 2.94 pm, which has an absorption in water and is thermal damage zone is thus minimized. While the parameters wavelength and pulse form are specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.
The provided text is a 510(k) summary for the WaveLight Burane XL device, primarily focusing on its substantial equivalence to predicate devices and its intended uses. It does not contain information about specific acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided document.
Here's what can be stated based on the text:
1. A table of acceptance criteria and the reported device performance
- Information not provided. The document states "Performance Data None presented."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. The document states "Performance Data None presented."
3. 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)
- Information not provided. The document states "Performance Data None presented."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided. The document states "Performance Data None presented."
5. 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
- Information not provided. The document states "Performance Data None presented." This device is a laser system, not an AI-assisted diagnostic tool, so an MRMC study is highly unlikely to be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not provided. The document states "Performance Data None presented." This device is a laser system, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided. The document states "Performance Data None presented."
8. The sample size for the training set
- Information not provided. The document states "Performance Data None presented."
9. How the ground truth for the training set was established
- Information not provided. The document states "Performance Data None presented."
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Wavelight Burane XL: 510(k) Review January 20, 2005
K 050317
510K Summary
FEB 2 4 2005
WaveLight®
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance rills 810(t) Samments of the SMDA 1990 and 21 CFR 807.92.
1. General Information
WaveLight Laser Technologie, AG Submitter: Am Wolfsmantel 5 91058 Erlangen Germany Alexander Popp Contact Person: Am Wolfsmantel 5 91058 Erlangen Germany Telephone: +49 (0)9131-6186-121 Fax: +49 (0)9131-6186-202 July 30, 2004 Summary Preparation Date:
-
- Names
Device Name:
- Names
BURANE XL
Classification Name:
Laser Instrument, Surgical Powered Product Code: GEX Panel: Dermatology and Plastic Surgery
3. Predicate Devices
The BURANE XL laser system is substantially equivalent to the Aesculap-Medited MCL 29 Dermablate Laser System (K992707 and K964128), the Dornier Medilas E Laser (K981438), the Cynosure CO3 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843) and the Sciton Er:YAG Laser PROFILE 3000 (K040005).
4. Device Description
BURANE XL is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The triple mode technology makes BURANE for aestheric ideor upphodibensial controllable Coagualtion Mode for different AL an export dother the Ablation Mode for classical ablation procedures, and the combination of both techniques.
0029
{1}------------------------------------------------
K050J17
2/3
Wavelight Burane XL: 510(k) Review January 20, 2005
510K Summary (con't)
S WaveLight®
510(k) Summary of Safety and Effectiveness
Furthermore, the laser system enables a quick, precise ablation with minimal Furthermore, the laser System enables a quion process is achieved.
thermal tissue damage. Thus an optimal wound health PULPANE YL's thermal tissue damage. Thus an optimal wear in the BURANE XL's
-- the risk of scar formation is minimized. This is due to the BURANE XL's -- the risk of scar lomation is minimized. This is and is water and is wavelength of 2.94 pm, which has an absorplane in thermal damage zone is thus minimized.
While the parameters wavelength and pulse form are specified by the device, While the parameters wavelengin and patool coagulation function can be
spot size, laser energy, pulse sequence, and coaggitation function can be spot size, laser encry), pullos soquenest ...
selected by the treating physician for optimal adjustment to individual requirements.
5. Indications for Use
The BURANE XL is indicated:
The BURANE XL is intended to be used in small and large joint arthroscopy, The BURANE XL is intendou to be ad all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and including the may be many ablem, and surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, in this indication such as, Skiff, Gutanoous neartilage, meniscus, mucous membrane, stratted and smooth tissue, music, organs and glands. The BURANE XL is indicated lymph vessels and nodes, organs and grands. Indicated for use in medicine
for use in skin resurfacing. The BURANE XL is indicated for use in medicine for use in skirl resultacing. The Born specialities: Dermatology, Plastic and surgery, in the following medical Spotlallabor Spotland of July 2017 - 11:40
Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinio Indications Include, epidennal nevi, colangiocacial, spiratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization The E.TAG laser is intended for the ourgery application where skin and coaguiation of Solt lissue duning general tumors and lesions, complete Incision, itssue dissection, oxolori of oxecions, tissue ablation and/or vessel coagulation.
0030
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K050317
3/3
Wavelight Burane XL: 510(k) Review January 20, 2005
510K Summary (con't)
Image /page/2/Picture/3 description: The image shows the word "WaveLight" with a symbol to the left of the word. The symbol is three horizontal lines stacked on top of each other, with each line slightly curved. The word "WaveLight" is written in a simple, sans-serif font. There is a registered trademark symbol to the upper right of the word.
510(k) Summary of Safety and Effectiveness
Genitourinary
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, Indications Include lesions of the external geniture, giant perineal scrotum and urethra (includes condyloma deaminene) ,
condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology
്യന്മാവിമയ്ക്കും.
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, molometrial adhesions, cysts and condyloma.
ENT
Indications include ear, nose and throat lesions, polyps, cysts, indications include car, nooo and the tic tissue, oral leukoplakia.
Oral/Maxillofacial Oral/Maxilloracial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Ophtalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
-
- Performance Data None presented.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
FEB 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wavelight Laser Technologie AG c/o Mr. William J. Sammons Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709
Re: K050317 Trade/Device Name: Burane XL 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: January 20, 2005 Received: February 9, 2005
Dear Mr. Sammons:
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.
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 docs 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Mr. William J. Sammons
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Stipt Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Wavelight Burane XL: 510(k) Review January 20, 2005 Indication for use
Image /page/5/Picture/1 description: The image contains the word "WaveLight" with a registered trademark symbol. To the left of the word is a symbol of three horizontal lines that are stacked on top of each other. The lines are curved to resemble a wave.
11 >
510 (k) Indications for Use
Indications for Use 510(k) Number (if known): N# K 05D 317 BURANE XL Device Name:
Indications for Use:
The BURANE XL is intended to be used in small and large joint arthroscopy, The BURANE XE is intendou to be ad all surgical procedures for laparoscopic procedures, gonoral ation, and coagulation of soft tissue and incision/excision, vaporization, abliation, and surgical procedures are included in cartilage. All soll lissues encountered in an subcutaneous tissue, straited and this indication such as, skin, outainous, meniscus, membrane, lymph vessels
smooth tissue, muscle, cartilage, meniscus, meniscus, men in clin smooth tissue, muscle, cartilage, membodo, macered for use in skin and nodes, organis and grands. The Beard for use in medicine and surgery, in the resultacing. The DONANE AE is included in Plastic Gastroenterology, ENT, following medical specialities: Domiatology, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Dermatology/Flastic ാവ്യല്
Indications include, epidermal nevi, telangiectasia, spider veins, adabulking Indications include, epidential nove, totanges, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and The E.Y.AG laser is intended for the ourgery application where skin indision, coagulation of solt trisde duning general cargony desions, complete or partial tissue dissection, excision of extornal tamble and lesions, tissue ablation and/or vessel coaqulation.
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, Indications Include lesions of the oxtomal genminate, giant perineal condyloma
scrotum and urethra (includes condyloma acuminate, giant perineal condyloma scrolum and their a (inoludos contactions, polyps and familial polyps of the colon.
Gynecology
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, muloations include ons, cysts and condyloma.
0027
{6}------------------------------------------------
510 (k) Indications for Use
ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and qinqivectomy.
Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use(21 CFR 801 Subpart C) | N/A |
|---|---|
| ------------------------------------------------ | ----- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)## Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1 ol (indication for use only
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number: K050317
§ 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.