(88 days)
No
The summary does not mention any AI or ML terms, image processing, or describe any training or test sets typically associated with AI/ML development. The device description focuses on the laser technology and cooling system.
Yes
The device is cleared for various surgical applications, including the excision of tumors, tissue ablation, and treatment of leg veins, all of which are considered therapeutic interventions.
No
Explanation: The device description and intended use indicate that the Athos laser is used for various surgical procedures and treatments (e.g., tissue dissection, excision of tumors, tissue ablation, vessel coagulation) rather than for diagnosing conditions.
No
The device description clearly states it is a laser that emits a beam of coherent light and is delivered through fiber optics to handpieces and cooling systems. This indicates a hardware-based device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser used for treating soft tissue, skin, internal organs, and leg veins. These are all procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers light for surgical applications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is used in vivo (within the living body) for surgical procedures.
N/A
Intended Use / Indications for Use
The General Surgery Indications for Use for the Athos laser are modified as follow:
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, and treatment of leg veins.
The Athoscan and Constans Cooling System are indicated for use with the Athos laser for indications for which the laser has been cleared.
The Athoscan and Constans Cooling System are also labeled: "CAUTION: Federal law restricts the sale to or use by licensed professionals."
Product codes
GEX
Device Description
The Athos laser emits a beam of coherent light at 1064 microns which is delivered to the Athos handpieces, the Athoscan, or the Constans Cooling System through fiber optics. The Athoscan increases the efficiency of treating large areas of skin (during hair removal) and the Constans Cooling System reduces reduce pain and the risk of thermal damage by cooling the skin during laser treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, internal organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals
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)
None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981952, K003202, K003765, K010834, K990903, K020463
Reference Device(s)
K890865, K941841, K971024, K980001, K970757, K020071, K951033, K972002, K984110, K990417, K963947, K984601
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
SECTION 10
510(k) SUMMARY
K021650 1
This 510(k) summary of safety and effectiveness for a modification in the Indications for Use for the Athos Long Pulsed Nd: YAG laser and for two accessories for the Athos laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- Applicant: Quantel Medical
- Address: QUANTEL MEDICAL 21 rue Newton ZI du BREZET 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax)
- Contact Person: Mr. Jean Abascal
- (+33) 169 29 17 25 : (+33) 169 29 17 29
Preparation Date: April 2002 (of the Summary)
-
Device Name: Athos laser; Athoscan; Constans Cooling System
Common Name: Nd: YAG Surgical Laser (Long Pulse Nd: YAG laser) and accessories -
Laser surgical instrument for use in general and plastic surgery and in Classification Name: dermatology (see: 21 CFR 878.4810). Product Code: GEX Panel: 79
-
Predicate devices: Leg Veins: The HGM VeinLase (K981952); the Altus Family of CoolGlide Lasers (K003202); and Lyra Nd: Y AG (K003765; K010834; K990903; and K020463) are cited.
Athoscan: The Hexascan (K890865); SmartScan (K941841); the SoftScan (K971024) the Jenascan (K980001); the Skinscan (K970757); and the Viridis Derma Scanner (K020071) are cited.
1
K021650
20F2
Constans Cooling System: The Candela DCD (K951033); the Cynosure Dermatology Laser Cooling Tip ( K972002); the Laserscope CoolSpot™ (K984110); the OptoMed, Inc. DermaCool™ (K990417); the EpiLaser Normal Mode Ruby Laser [with cooling] ( K963947); and the GentleLase II Dermatology Laser - with DCD and hair removal claims (K984601) are cited.
- Device description: The Athos laser emits a beam of coherent light at 1064 microns which is delivered to the Athos handpieces, the Athoscan, or the Constans Cooling System through fiber optics. The Athoscan increases the efficiency of treating large areas of skin (during hair removal) and the Constans Cooling System reduces reduce pain and the risk of thermal damage by cooling the skin during laser treatment.
- Indications: The indications for use cleared in K020072 for General Surgery for the Athos laser are modified as follow:
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, and treatment of leg veins.
The Athoscan and Constans Cooling System are indicated for use with the Athos laser for indications for which the laser has been cleared.
The Athoscan and Constans Cooling System are also labeled: "CAUTION: Federal law restricts the sale to or use by licensed professionals."
Performance Data: None required.
- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Athos laser, with modified indications for use and the Athoscan and Constans Cooling System are substantially equivalent to predicates cited in the notification.
08
2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850
AUG 1 6 2002
Quantel Medical Roger W. Barnes, LTD. c/o Roger W. Barnes Regulatory Consultant 342 Sunset Bay Road Hot Springs, Arkansas 71913
Re: K021650
Trade/Device Name: Athos Laser (Nd:YAG Long-pulsed laser) Regulation Number: 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: May 16, 2002 Received: May 20, 2002
Dear Mr. Barnes:
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 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 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.
3
Page 2 - Mr. Roger W. Barnes
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
K. Colin McWhorter, Ph.D., M.D.
Witten, Ph.D., M.D. Celia M. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K O 2(65 D
Device Name: Athos laser (Nd: YAG Long-pulsed laser) - modification of indications for use and to provide for accessories
Indications for Use Statement:
The General Surgery Indications for Use for the Athos laser are modified as follow:
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, and treatment of leg veins.
The Athoscan and Constans Cooling System are indicated for use with the Athos laser for indications for which the laser has been cleared.
The Athoscan and Constans Cooling System are also labeled: "CAUTION: Federal law restricts the sale to or use by licensed professionals."
Mark n-Millar
(Division Sign-Off) Division of General, Restorative and Neurological Devices
021650 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use ( (Per 21 CFR 801.109)
OR
Over-The Counter Use