(26 days)
The QuadroStar 980 Laser System is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
The QuadroStar 980 is a diode laser system emitting a laser beam at a wavelength of 980 nm with a maximum power of 25 W.
The provided text describes a 510(k) summary for the Asclepion Laser Technologies GmbH QuadroStar 980 Laser System. This submission focuses on establishing substantial equivalence to a predicate device rather than detailing a study with acceptance criteria for device performance. Therefore, many of the requested fields cannot be filled.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance Study
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predicate Device Comparison: Substantially equivalent to the predicate device (Ceralas D 980) based on: | The QuadroStar 980 has the same principles of operation, the same wavelength (980nm), and essentially the same power range (max 25W) as the predicate device. |
| - Principles of operation | Matches predicate device. |
| - Wavelength | Matches predicate device (980 nm). |
| - Power range | Essentially the same as predicate device (max 25 W). |
| - Indications for Use | Matches predicate device. |
| Safety and Effectiveness: Safe and effective for intended uses. | "The QuadroStar 980 Laser System is another safe and effective device..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported for this device in the provided summary. The submission is based on substantial equivalence to a predicate device.
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)
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This is a laser system, not an AI-assisted diagnostic device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a medical device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for acceptance is substantial equivalence to a legally marketed predicate device, not a comparison to a defined ground truth derived from a specific study.
8. The sample size for the training set
Not applicable. This is a medical device, and the submission does not mention machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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MAR 2 () 2006
510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar miXT Laser System
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStar 980 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 GmbHGoeschwitzer Str. 51-5207745 Jena, Germany |
|---|---|
| Contact Person: | Mr Reinhard ThiemeQuality Assurance andInternational Regulatory Affairs |
| Phone: | +49 3641 220 211 |
| Fax: | +49 3641 220 322 |
| e-mail: | reinhard.thieme@asclepion.com |
| Preparation Date: | January 31st, 2006 |
| Device Name: | QuadroStar 980 |
| Common Name: | QuadroStar 980 |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Device: | Ceralas D 980 |
| Device Description: | The QuadroStar 980 is a diode laser system emitting a laserbeam at a wavelength of 980 nm with a maximum powerof 25 W. |
| Intended Use: | Delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including viaendoscopes, introducers or catheters. The QuadroStar 980 isgenerally indicated for incision, excision, vaporization,ablation, hemostasis or coagulation of soft tissue in ear,nose and throat and oral surgery (otolaryngology), dentalprocedures, arthroscopy, gastroenterology, general surgery,dermatology, plastic surgery, podiatry, urology, gynecology,neurosurgery (peripheral nervous system), pulmonarysurgery cardiothoracic surgery. This QuadroStar 980 is |
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specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue). The QuadroStar 980 Laser System is substantially equivalent Comparison to: to the Ceralas D 980 Laser System, with the same principles of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses. None Nonclinical Performance Data: Clinical Performance Data: None The QuadroStar 980 Laser System is another safe and Conclusion: effective device for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
Additional Information :
None
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion Laser Technologies GmbH c/o Mr. Reinhard Thieme Goeschwitzerstrasse Str. 51-52 07745 Jena, Germany
Re: K060459
Trade/Device Name: QuadroStar 980 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: February 14, 2006 Received: February 22, 2006
Dear Mr. Thieme:
This letter corrects our substantially equivalent letter of March 20, 2006.
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 (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 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.
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Page 2 - Mr. Reinhard Thieme
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 reguirements as set forth in 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.
This letter will allow you to continue 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _KO6 DYS 9
Device Name: QuadroStar 980 Laser System
Indications for Use:
The QuadroStar 980 Laser System is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
of Device Evaluation (ODE) Conci Division of General, Restorative, and Neurological Devices
510(k) Number_ko60459
14.FEB.2006 00 00112
§ 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.